This section highlights FDA-related milestones and regulatory updates for drugs developed by Tonix Pharmaceuticals (TNXP).
Over the past two years, Tonix Pharmaceuticals has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
TNX-102, TNX-102, TNX-1300, TNX-1500, TNX-1700, TNX-801, and Tonmya. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
TNX-102 SL - FDA Regulatory Timeline and Events
TNX-102 SL is a drug developed by Tonix Pharmaceuticals for the following indication: Fibromyalgia.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- TNX-102 SL
- Announced Date:
- July 9, 2025
- Indication:
- Fibromyalgia
Announcement
Tonix Pharmaceuticals announced that full results from its confirmatory Phase 3 RESILIENT trial of TNX-102 SL (cyclobenzaprine HCl sublingual tablets) for the management of fibromyalgia have been published online in the peer reviewed Pain Medicine, the official journal of the American Academy of Pain Medicine.
AI Summary
Tonix Pharmaceuticals announced that full results from its confirmatory Phase 3 RESILIENT trial of TNX-102 SL (cyclobenzaprine HCl sublingual tablets) for managing fibromyalgia have been published online in Pain Medicine, the official journal of the American Academy of Pain Medicine. The study enrolled 457 adults and demonstrated that once-nightly TNX-102 SL produced a statistically significant reduction in fibromyalgia pain compared to placebo. Treatment showed a mean reduction of 1.8 points on the pain scale versus 1.2 points for placebo, while also meeting all key secondary endpoints. Researchers emphasized that the medication was generally well tolerated with only mild, transient side effects such as oral tingling and a noticeable aftertaste. These findings reinforce previous results from the RELIEF phase 3 study and highlight TNX-102 SL’s potential to address the unmet needs of fibromyalgia patients.
Read Announcement- Drug:
- TNX-102 SL
- Announced Date:
- June 16, 2025
- Indication:
- Fibromyalgia
Announcement
Tonix Pharmaceuticals presented data in a poster presentation at the Annual European Congress of Rheumatology (EULAR) 2025, held June 11-14, 2025, in Barcelona, Spain. A copy of the Company's poster, titled "Advancing Fibromyalgia Treatment: Transmucosal Sublingual Cyclobenzaprine (TNX-102 SL) Targets Non-restorative Sleep and Provides Sustained Pain Reduction" is available under the Scientific Presentations tab of the Tonix website at www.tonixpharma.com.
AI Summary
Tonix Pharmaceuticals presented new data on TNX-102 SL at the Annual European Congress of Rheumatology (EULAR) 2025 in Barcelona, Spain, held from June 11 to 14. The poster presentation, titled “Advancing Fibromyalgia Treatment: Transmucosal Sublingual Cyclobenzaprine (TNX-102 SL) Targets Non-restorative Sleep and Provides Sustained Pain Reduction,” detailed findings on this innovative sublingual formulation of cyclobenzaprine. TNX-102 SL is engineered for transmucosal delivery to bypass first-pass metabolism, aiming to improve non-restorative sleep and deliver lasting pain relief in fibromyalgia patients. Preliminary results from Phase 3 studies showed statistically significant improvements in fibromyalgia pain reduction. A full copy of the poster is available under the Scientific Presentations tab on the Tonix website at www.tonixpharma.com.
Read Announcement- Drug:
- TNX-102 SL
- Announced Date:
- May 22, 2025
- Indication:
- Fibromyalgia
Announcement
Tonix Pharmaceuticals announced that Seth Lederman, M.D., Chief Executive Officer of Tonix Pharmaceuticals participated in a fireside chat at A.G.P.'s Annual Healthcare Company Showcase.
AI Summary
Tonix Pharmaceuticals Holding Corp. announced that its CEO, Seth Lederman, M.D., took part in a fireside chat at A.G.P.’s Annual Healthcare Company Showcase. During the webcast, Dr. Lederman discussed the company’s focus on developing innovative therapies for pain management and central nervous system disorders, emphasizing key assets such as TNX-102 SL, which is being evaluated for the management of fibromyalgia. The conversation also touched on Tonix’s broader development portfolio and its commitment to advancing treatments that address public health challenges. Viewers can access the full webcast under the IR Events tab on Tonix’s website. This event underscores Tonix’s strategy of open communication with investors and stakeholders, while highlighting its progress in key therapeutic areas and its dedication to future innovations in biotechnology.
Read Announcement- Drug:
- TNX-102 SL
- Announced Date:
- May 21, 2025
- Indication:
- Fibromyalgia
Announcement
Tonix Pharmaceuticals announced the first patient has been dosed in the Phase 2, investigator-initiated OASIS trial to evaluate TNX-102 SL in reducing the severity of acute stress reaction (ASR) and the frequency of acute stress disorder (ASD).
AI Summary
Tonix Pharmaceuticals announced that the first patient has been dosed in their Phase 2, investigator-initiated OASIS trial. This study will evaluate the potential of TNX-102 SL to reduce the severity of acute stress reaction (ASR) and the frequency of acute stress disorder (ASD). Sponsored by the University of North Carolina Institute for Trauma Recovery and supported by a $3 million grant from the U.S. Department of Defense, the trial focuses on patients experiencing trauma, such as those from motor vehicle collisions. Participants will be randomly assigned to receive either a two-week course of TNX-102 SL or a placebo. Previous findings suggest TNX-102 SL may improve sleep quality and help manage stress-related symptoms early in treatment. Topline results are expected in the second half of 2026, potentially offering a new treatment option for acute stress responses following traumatic events.
Read Announcement- Drug:
- TNX-102 SL
- Announced Date:
- March 27, 2025
- Indication:
- Fibromyalgia
Announcement
Tonix Pharmaceuticals announced that Seth Lederman, M.D., Chief Executive Officer, will present a poster at the AAPM 2025 Annual Meeting, PainConnect, in Austin, Texas on April 5, 2025, at 11:45 a.m. CT. The meeting will take place from April 3-6, 2025.
AI Summary
Tonix Pharmaceuticals announced that Dr. Seth Lederman, the company’s Chief Executive Officer, will present a poster at the AAPM 2025 Annual Meeting, PainConnect. The presentation is scheduled for April 5, 2025, at 11:45 a.m. CT in Austin, Texas. The event itself will run from April 3-6, 2025, providing an ideal forum for professionals to discuss the latest in pain management and related research. Following the conference, a copy of Dr. Lederman’s poster will be available on the Tonix website under the Scientific Presentations tab, ensuring that interested parties can review the insights and findings shared during the poster session. This engagement underscores Tonix’s commitment to advancing research and fostering dialogue in the field of pain therapy, signaling their continuous involvement in significant scientific and medical conferences.
Read Announcement- Drug:
- TNX-102 SL
- Announced Date:
- March 24, 2025
- Indication:
- Fibromyalgia
Announcement
Tonix Pharmaceuticals announced that the U.S. Food and Drug Administration (FDA) will not require an Advisory Committee meeting to discuss the Company's New Drug Application (NDA) for TNX-102 SL for the management of fibromyalgia.
AI Summary
Tonix Pharmaceuticals announced that the FDA will not require an Advisory Committee meeting to review its New Drug Application for TNX-102 SL, a non-opioid analgesic for managing fibromyalgia. This decision is seen as a positive step that streamlines the regulatory process for the drug, which could become the first new treatment for fibromyalgia in over 15 years if approved.
Tonix is optimistic about TNX-102 SL’s potential and plans to launch the drug in the fourth quarter of 2025. The company believes the drug will address significant unmet needs for over 10 million U.S. adults suffering from fibromyalgia. The expedited review process reflects the FDA’s confidence in TNX-102 SL's potential benefits and safety profile, further supporting Tonix’s push for a timely market entry.
Read Announcement- Drug:
- TNX-102 SL
- Announced Date:
- March 18, 2025
- Indication:
- Fibromyalgia
Announcement
Tonix Pharmaceuticals provided an overview of recent operational highlights.
AI Summary
Tonix Pharmaceuticals recently presented an operational update outlining key developments across its pipeline and business strategy. The company is preparing for a potential fourth quarter launch of its TNX-102 SL sublingual tablet for fibromyalgia, which, if approved, would be the first new non‐opioid analgesic for the condition in over 15 years. CEO Seth Lederman emphasized that the company is well positioned, with sufficient cash resources to fund its operations through the upcoming FDA target date of August 15, 2025, and beyond the anticipated launch period. Additionally, Tonix shared encouraging progress on other promising projects, including positive Phase 1 results for TNX-1500, a candidate for preventing kidney transplant rejection, as well as advancements in developing TNX-801, a potential mpox vaccine. The update also highlighted several strategic leadership additions to support these growth initiatives.
Read Announcement- Drug:
- TNX-102 SL
- Announced Date:
- March 4, 2025
- Indication:
- Fibromyalgia
Announcement
Tonix Pharmaceuticals presented data in an oral presentation at the 7th International Congress on Controversies in Fibromyalgia, held March 3-4, 2025, in Vienna, Austria.
AI Summary
Tonix Pharmaceuticals presented promising data on TNX-102 SL at the 7th International Congress on Controversies in Fibromyalgia, held in Vienna, Austria, on March 3-4, 2025. The company discussed results from two double-blind, randomized Phase 3 studies where their sublingual cyclobenzaprine formulation demonstrated a statistically significant reduction in fibromyalgia pain. TNX-102 SL is designed for transmucosal delivery and aims to provide durable pain relief for up to three months by targeting non-restorative sleep with bedtime dosing. This novel approach may offer fibromyalgia patients a long-awaited alternative to current treatments. The oral presentation highlighted how bypassing first-pass hepatic metabolism improves cyclobenzaprine's bioavailability while minimizing the formation of norcyclobenzaprine, a metabolite linked to shorter duration of pain relief. Overall, these findings could signal an important advancement in the treatment of fibromyalgia.
Read Announcement- Drug:
- TNX-102 SL
- Announced Date:
- December 23, 2024
- Estimated Event Date Range:
- August 15, 2025 - August 15, 2025
- Target Action Date:
- August 15, 2025
- Indication:
- Fibromyalgia
Announcement
Tonix Pharmaceuticals announced that the U.S. Food and Drug Administration (FDA) assigned a Prescription Drug User Fee Act (PDUFA) goal date of August 15, 2025, for a decision on marketing approval for TNX-102 SL (cyclobenzaprine HCl sublingual tablets) for fibromyalgia.
AI Summary
Tonix Pharmaceuticals announced that the FDA has set a Prescription Drug User Fee Act (PDUFA) goal date of August 15, 2025, for its decision on marketing approval for TNX-102 SL. This drug, a sublingual tablet formulation of cyclobenzaprine HCl, is a non-opioid, centrally acting analgesic aimed at treating fibromyalgia—a chronic pain condition that affects over 10 million U.S. adults, mostly women. According to Tonix’s CEO, the pivotal Phase 3 studies demonstrated significant pain reduction with TNX-102 SL, and the drug was generally well tolerated. The NDA submission is backed by two double-blind, placebo-controlled clinical trials, which reinforce its safety and potential effectiveness. Tonix looks forward to collaborating with the FDA through the review process ahead of the August 15, 2025, milestone in hopes of offering the first new fibromyalgia treatment in more than 15 years.
Read Announcement- Drug:
- TNX-102 SL
- Announced Date:
- December 17, 2024
- Indication:
- Fibromyalgia
Announcement
Tonix Pharmaceuticals The FDA is expected to assign the NDA a Prescription Drug User Fee Act (PDUFA) target action date in a Day 74 Letter.
AI Summary
Tonix Pharmaceuticals Holding Corp. announced an important milestone for its TNX-102 SL, a non-opioid, centrally acting analgesic for fibromyalgia. The U.S. Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for TNX-102 SL. In its upcoming Day 74 Letter, the FDA is expected to assign a Prescription Drug User Fee Act (PDUFA) target action date and indicate if Priority Review has been granted for the application.
This decision comes as Tonix advances its efforts to provide the first drug in a new class for fibromyalgia. Successful Phase 3 studies showed that TNX-102 SL can significantly reduce daily pain while maintaining a well-tolerated safety profile. Tonix remains optimistic that this progress will lead to a potential approval and commercial launch in 2025, offering hope to the millions of fibromyalgia sufferers in the U.S.
Read Announcement- Drug:
- TNX-102 SL
- Announced Date:
- December 17, 2024
- Indication:
- Fibromyalgia
Announcement
Tonix Pharmaceuticals announced that the U.S. Food and Drug Administration (FDA) has accepted the filing of its New Drug Application (NDA) for TNX-102 SL (cyclobenzaprine HCl sublingual tablets), a 5.6 mg, non-opioid, centrally-acting analgesic, for the management of fibromyalgia.
AI Summary
Tonix Pharmaceuticals announced that the FDA has accepted its New Drug Application (NDA) for TNX-102 SL, a 5.6 mg cyclobenzaprine HCl sublingual tablet designed as a non-opioid, centrally acting analgesic for managing fibromyalgia. This condition affects over 10 million adults in the U.S., many of whom have had limited treatment options for more than 15 years.
TNX-102 SL is supported by two Phase 3 clinical trials that showed significant reductions in daily pain, and it was granted Fast Track designation in July 2024 to help speed up development. The FDA will soon provide a Prescription Drug User Fee Act (PDUFA) target action date and inform Tonix whether Priority Review has been granted, marking an important milestone towards potential market approval.
Read Announcement- Drug:
- TNX-102 SL
- Announced Date:
- November 18, 2024
- Indication:
- Fibromyalgia
Announcement
Tonix Pharmaceuticals presented data in a poster presentation at the ACR Convergence 2024 Annual Meeting, held November 14-19, 2024, in Washington, D.C. A copy of the Company's presentation, titled "Randomized, Double-Blind, Placebo-Controlled Confirmatory Phase 3 Trial of Bedtime Sublingual Cyclobenzaprine (TNX-102 SL) in Fibromyalgia"
AI Summary
Tonix Pharmaceuticals presented important results at the ACR Convergence 2024 Annual Meeting in Washington, D.C. from November 14-19, 2024. The company’s poster, titled “Randomized, Double-Blind, Placebo-Controlled Confirmatory Phase 3 Trial of Bedtime Sublingual Cyclobenzaprine (TNX-102 SL) in Fibromyalgia,” detailed findings from the RESILIENT study. In this Phase 3 trial, TNX-102 SL showed statistically significant reductions in daily fibromyalgia pain along with marked improvements across six key secondary endpoints, including enhanced sleep quality.
The investigational drug is designed as a non-opioid option targeted for bedtime use to address the non-restorative sleep common among fibromyalgia patients. The compelling data presented at the meeting supports Tonix’s ongoing efforts, as the company awaits further feedback following their FDA New Drug Application submission. This development could lead to the first new treatment option for fibromyalgia in over 15 years.
Read Announcement- Drug:
- TNX-102 SL
- Announced Date:
- September 23, 2024
- Indication:
- Fibromyalgia
Announcement
Tonix Pharmaceuticals announced data in two oral presentations and a poster presentation at the 11th Global Conference on Pharmaceutics and Novel Drug Delivery Systems (PDDS 2024), held September 19-21, 2024, in Rome, Italy.
AI Summary
Tonix Pharmaceuticals presented new data on TNX-102 SL during the 11th Global Conference on Pharmaceutics and Novel Drug Delivery Systems (PDDS 2024) in Rome, Italy, held from September 19-21, 2024. The company shared findings in two oral presentations and one poster presentation, highlighting the proprietary formulation technology of TNX-102 SL, a sublingual cyclobenzaprine HCl product. One presentation, led by Prof. Marino Nebuloni, explained how the eutectic formation of cyclobenzaprine and mannitol creates a stable product with rapid dissolution and efficient absorption through the sublingual route. Another presentation addressed the pharmacokinetic profile of TNX-102 SL and how its formulation design helps manage sleep-related issues by optimizing drug levels. The poster presentation detailed in vitro tests used to evaluate tablet characteristics, supporting both clinical development and future manufacturing plans.
Read Announcement- Drug:
- TNX-102 SL
- Announced Date:
- September 4, 2024
- Estimated Event Date Range:
- July 1, 2024 - December 31, 2024
- Target Action Date:
- H2 2024
- Indication:
- Fibromyalgia
Announcement
Tonix announced that it is finalizing the filing of the New Drug Application (NDA) for TNX-102 SL, which it plans to submit to the FDA in the second half of 2024.
AI Summary
Tonix Pharmaceuticals is finalizing the filing of a New Drug Application (NDA) for TNX-102 SL, a pioneering non-opioid treatment for fibromyalgia, which is expected to be submitted to the FDA in the second half of 2024. TNX-102 SL, a sublingual formulation of cyclobenzaprine hydrochloride, is designed to enhance sleep quality in patients suffering from fibromyalgia—a condition linked with nociplastic pain, a form of chronic pain driven by altered nervous system processing. The therapy aims to offer a well-tolerated, non-addictive alternative to current treatments, addressing a significant unmet need among millions of fibromyalgia sufferers dissatisfied with existing options. Tonix’s NDA submission aligns with recent clinical successes and discussions with the FDA, and the company plans to request Priority Review, which could speed up the regulatory process.
Read Announcement- Drug:
- TNX-102 SL
- Announced Date:
- August 29, 2024
- Indication:
- Fibromyalgia
Announcement
Tonix Pharmaceuticals presented clinical data on? acute stress reaction and prevention of PTSD data of TNX-102 SL in two poster presentations and presented preclinical data demonstrating automated high-throughput assay enabling screening for therapeutics to accelerate wound healing in a third poster presentation at the 2024 Military Health System Research Symposium (MHSRS), held August 26-29, 2024, in Kissimmee, Fla. Copies of the Company's posters
AI Summary
At the 2024 Military Health System Research Symposium in Kissimmee, Fla., Tonix Pharmaceuticals presented important clinical and preclinical data. Two poster presentations detailed findings on TNX-102 SL, a sublingual treatment being evaluated for reducing acute stress reaction symptoms and for preventing PTSD when given within 24 hours of a traumatic event. The clinical data showed that TNX-102 SL may improve sleep quality and lessen PTSD-related symptoms, suggesting that early intervention could help reduce progression from acute stress disorder to PTSD.
In a third poster, the company introduced preclinical results on an automated high-throughput assay that combines a scratch-wound method with cell painting. This innovative approach enables rapid screening of new therapies aimed at accelerating wound healing, offering a promising tool to discover effective treatments for wound repair.
Read Announcement- Drug:
- TNX-102 SL
- Announced Date:
- August 29, 2024
- Estimated Event Date Range:
- July 1, 2024 - September 30, 2024
- Target Action Date:
- Q3 2024
- Indication:
- Fibromyalgia
Announcement
Tonix Pharmaceuticals announced that Investigator-initiated Phase 2 trial to evaluate TNX-102 SL's potential to reduce severity of acute stress reaction (ASR) and frequency of acute stress disorder (ASD) and posttraumatic stress disorder (PTSD) expected to begin third quarter 2024
AI Summary
Tonix Pharmaceuticals announced an investigator-initiated Phase 2 trial to study TNX-102 SL’s ability to reduce the severity of acute stress reaction (ASR) and lower the frequency of acute stress disorder (ASD) and posttraumatic stress disorder (PTSD). The trial, which is expected to begin in the third quarter of 2024, will test the drug’s potential when given within 24 hours after a traumatic event, such as a motor vehicle collision.
The study will enroll around 180 trauma patients in U.S. emergency departments, who will be randomized to receive a two-week course of either TNX-102 SL or a placebo. Early data suggest that TNX-102 SL may improve sleep quality and reduce stress symptoms, potentially setting the stage for improved recovery and overall quality of life for patients exposed to trauma.
Read Announcement- Drug:
- TNX-102 SL
- Announced Date:
- August 28, 2024
- Indication:
- Fibromyalgia
Announcement
Tonix Pharmaceuticals Holding Corp presented data in an oral presentation at the 2024 Military Health System Research Symposium (MHSRS), held August 26-29, 2024, in Kissimmee, Fla..
AI Summary
Tonix Pharmaceuticals presented key data from its Phase 3 RESILIENT study at the 2024 Military Health System Research Symposium in Kissimmee, Fla. The study examined TNX-102 SL, a sublingual formulation of cyclobenzaprine HCl, as a potential non-opioid treatment for fibromyalgia. Results showed a statistically significant reduction in daily nociplastic pain compared to placebo. In addition, all six major secondary endpoints, including improvements in sleep quality, fatigue, and overall fibromyalgia symptoms, were met. A post hoc analysis indicated a strong link between better sleep quality and pain relief, suggesting that targeting sleep might lead to broad improvements for patients. Tonix is preparing to submit a new drug application (NDA) for TNX-102 SL in the second half of 2024, with an FDA decision expected in 2025, advancing their efforts to offer a new treatment option for fibromyalgia.
Read Announcement - Drug:
- TNX-102 SL
- Announced Date:
- August 21, 2024
- Indication:
- Fibromyalgia
Announcement
Tonix Pharmaceuticals announced that representatives of the Company will deliver an oral presentation and present three posters at the 2024 Military Health System Research Symposium (MHSRS), being held August 26-29, 2024, in Kissimmee, Fla.
AI Summary
Tonix Pharmaceuticals announced that its representatives will participate in the 2024 Military Health System Research Symposium (MHSRS) held from August 26-29 in Kissimmee, Florida. At this event, CEO Dr. Seth Lederman will deliver an oral presentation titled “Assuaging Agony: Novel Pain Therapeutics.” His presentation will discuss the efficacy and safety of TNX-102 SL (sublingual cyclobenzaprine HCl) for managing fibromyalgia, highlighting statistically significant results from the Phase 3 RESILIENT study. In addition to the oral talk, the Company will present three posters. These posters cover topics such as using TNX-102 SL for treating acute stress disorder, the integration of an automated high-throughput assay to screen therapeutics for wound healing, and research on interventions to reduce acute stress reactions. Copies of the presentation and posters will be available on Tonix’s website after the conference.
Read Announcement- Drug:
- TNX-102 SL
- Announced Date:
- August 12, 2024
- Indication:
- Fibromyalgia
Announcement
Tonix Pharmaceuticals presented data in a poster presentation at the International Association for the Study of Pain (IASP) 2024 World Congress on Pain, held August 5-9, 2024 in Amsterdam, the Netherlands.
AI Summary
Tonix Pharmaceuticals presented key data at the IASP 2024 World Congress on Pain in Amsterdam. The poster presentation detailed findings from the Phase 3 RESILIENT trial for their fibromyalgia treatment, Bedtime TNX-102 SL, a sublingual formulation of cyclobenzaprine HCl. Results showed that the treatment significantly reduced nociplastic pain—a type of pain linked to fibromyalgia—compared to placebo. In addition, all six key secondary endpoints, including improvements in sleep quality, fatigue reduction, and overall fibromyalgia symptom relief, reached statistical significance. A post hoc analysis also revealed strong correlations between improvements in pain and sleep quality, supporting the idea that better quality sleep may help improve overall fibromyalgia symptoms. This data underscores the potential for TNX-102 SL to be an important new therapy for fibromyalgia patients, with further steps planned towards regulatory submission later in 2024.
Read Announcement- Drug:
- TNX-102 SL
- Announced Date:
- August 12, 2024
- Estimated Event Date Range:
- July 1, 2024 - December 31, 2024
- Target Action Date:
- H2 2024
- Indication:
- Fibromyalgia
Announcement
Tonix Pharmaceuticals announced that NDA submission on track for second half 2024
AI Summary
Tonix Pharmaceuticals announced that its New Drug Application (NDA) submission for TNX-102 SL is on track for the second half of 2024. The company is developing TNX-102 SL, a sublingual formulation of cyclobenzaprine HCl, as a bedtime treatment for managing fibromyalgia. Recent Phase 3 results from the RESILIENT study show that TNX-102 SL significantly reduced daily fibromyalgia pain and improved sleep quality in patients. These findings support the idea that better sleep plays a critical role in reducing fibromyalgia symptoms. Additionally, the U.S. Food and Drug Administration (FDA) has granted TNX-102 SL Fast Track designation for fibromyalgia, highlighting its potential as a much-needed treatment option. Tonix’s continued progress and upcoming NDA submission mark key steps in advancing a promising new therapy for fibromyalgia patients.
Read Announcement- Drug:
- TNX-102 SL
- Announced Date:
- August 1, 2024
- Indication:
- Fibromyalgia
Announcement
Tonix Pharmaceuticals announced that The FDA has granted Tonix Pharmaceuticals (NASDAQ:TNXP) a fully integrated biopharmaceutical company Fast Track designation for TNX-102 SL (cyclobenzaprine HCl sublingual tablets), its drug candidate for the management of fibromyalgia.
AI Summary
Tonix Pharmaceuticals (NASDAQ: TNXP) recently announced that the FDA has granted its drug candidate TNX-102 SL (cyclobenzaprine HCl sublingual tablets) a fully integrated biopharmaceutical Fast Track designation. This special status is given to treatments that address serious conditions and unmet medical needs, and it is expected to speed up the overall review and development process.
The Fast Track designation validates the need for better management options for fibromyalgia, a condition that causes widespread pain, fatigue, and sleep disturbances. TNX-102 SL, with its potential to improve sleep quality and reduce fibromyalgia symptoms without known addictive properties, aims to offer a valuable alternative to current treatment methods. This recognition by the FDA highlights the drug's promise and supports more direct and frequent communication during its clinical development.
Read Announcement- Drug:
- TNX-102 SL
- Announced Date:
- May 30, 2024
- Estimated Event Date Range:
- April 1, 2024 - June 30, 2024
- Target Action Date:
- Q2 2024
- Indication:
- Fibromyalgia
Announcement
Tonix Pharmaceuticals Holding Corp. announced that First patient in OASIS expected to enroll in second quarter 2024
AI Summary
Tonix Pharmaceuticals Holding Corp. announced that the first patient in its Phase 2 OASIS trial is expected to enroll in the second quarter of 2024. The study is designed to examine the safety and efficacy of TNX-102 SL, a sublingual formulation of cyclobenzaprine, for the treatment of Acute Stress Disorder following motor vehicle collisions. The OASIS trial aims to determine whether early intervention with TNX-102 SL can reduce the severity of acute stress reactions and help prevent the development of post-traumatic stress disorder. This trial comes after promising results from previous studies in related conditions, with the company looking to expand its understanding of how TNX-102 SL works across different stress-related disorders. The outcome of the OASIS trial may open a new approach in managing acute trauma symptoms in civilians.
Read Announcement- Drug:
- TNX-102 SL
- Announced Date:
- May 30, 2024
- Indication:
- Fibromyalgia
Announcement
Tonix Pharmaceuticals Holding Corp. announced two poster presentations at the American Society of Clinical Psychopharmacology (ASCP) Annual Meeting being held May 28-31, 2024 in Miami Beach, Fla. Copies of the presentations are available under the Scientific Presentations tab of the Tonix website at www.tonixpharma.com.
AI Summary
Tonix Pharmaceuticals Holding Corp. announced two poster presentations at the American Society of Clinical Psychopharmacology (ASCP) Annual Meeting from May 28 to 31, 2024 in Miami Beach, Florida. These presentations focus on the evaluation of their TNX-102 SL compound in different clinical settings.
The first poster covers a Phase 2 study in fibromyalgia-type Long COVID, where bedtime TNX-102 SL demonstrated notable improvements in fatigue, sleep, and cognitive function despite not reaching the primary endpoint on pain reduction. The second poster presents the design for the OASIS trial, which will examine TNX-102 SL’s effectiveness in treating acute stress disorder after motor vehicle collisions. The first patient for the OASIS trial is expected to enroll in the second quarter of 2024. Copies of the presentations are available under the Scientific Presentations tab of the Tonix website at www.tonixpharma.com.
Read Announcement- Drug:
- TNX-102 SL
- Announced Date:
- May 22, 2024
- Indication:
- Fibromyalgia
Announcement
Tonix Pharmaceuticals announced that the Company will deliver an oral presentation and present two posters at the American Society of Clinical Psychopharmacology (ASCP) Annual Meeting being held May 28-31, 2024 at the Loews Miami Beach Hotel in Miami Beach, Fla.
AI Summary
Tonix Pharmaceuticals Holding Corp. announced that it will deliver an oral presentation and present two posters at the American Society of Clinical Psychopharmacology (ASCP) Annual Meeting from May 28-31, 2024, at the Loews Miami Beach Hotel in Miami Beach, Florida. The oral presentation will share key study findings on Tonmya™ (TNX-102 SL), a sublingual formulation of cyclobenzaprine HCl being developed for fibromyalgia treatment.
Additionally, one poster will detail a Phase 2 proof-of-concept study of TNX-102 SL in patients with fibromyalgia-type Long COVID, while the other will outline an upcoming investigator-initiated Phase 2 trial. The trial aims to evaluate TNX-102 SL’s potential to treat acute stress disorder and prevent PTSD after motor vehicle collisions. These presentations highlight Tonix's continued work to advance new therapeutic options for central nervous system disorders.
Read Announcement- Drug:
- TNX-102 SL
- Announced Date:
- May 21, 2024
- Estimated Event Date Range:
- July 1, 2024 - December 31, 2024
- Target Action Date:
- H2 2024
- Indication:
- Fibromyalgia
Announcement
Tonix Pharmaceuticals announced that New Drug Application (NDA) submission to the FDA on track for the second half of 2024
AI Summary
Tonix Pharmaceuticals announced that it plans to submit a New Drug Application (NDA) to the FDA in the second half of 2024 for Tonmya, a potential first-line, centrally acting non-opioid treatment for fibromyalgia. This move follows two positive Phase 3 trials that demonstrated statistically significant improvements in daily pain reductions and other fibromyalgia-related symptoms. The company’s decision to advance Tonmya stems from the high unmet medical needs observed among fibromyalgia patients and the current reliance on addictive opioid treatments despite known risks. Tonix is working with EVERSANA® Life Science Services to shape its commercialization strategy and assess the U.S. market potential. If approved, Tonmya is expected to provide an important non-opioid alternative for patients while offering an innovative option in a treatment landscape where physician dissatisfaction with existing therapies remains high.
Read Announcement- Drug:
- TNX-102 SL
- Announced Date:
- May 21, 2024
- Indication:
- Fibromyalgia
Announcement
Tonix Pharmaceuticals announced that EVERSANA® Life Science Services, LLC, a leading provider of commercialization services to the global life sciences industry, completed the initial phase of an assessment of the U.S market opportunity for TonmyaTM (also known as TNX-102 SL, cyclobenzaprine HCl sublingual tablets), a potential new first line therapy for the management of fibromyalgia.
AI Summary
Tonix Pharmaceuticals announced that EVERSANA® Life Science Services, LLC has completed the initial phase of assessing the U.S. market opportunity for Tonmya™ (also known as TNX-102 SL). This potential new first-line, centrally acting non-opioid treatment for fibromyalgia was evaluated using medical claims data and direct physician feedback.
The research revealed significant interest among physicians, with a median interest rating of 4 out of 5, and suggested that nearly 40% of fibromyalgia patients could be considered for Tonmya, should it receive FDA approval. EVERSANA’s analysis highlighted the challenges in the current treatment landscape, where off-label opioids, despite their risk of dependency, dominate prescriptions. These insights will help Tonix refine its commercialization strategy ahead of the planned launch of Tonmya in 2025 and the NDA submission later this year.
Read Announcement
TNX-102 SL1 - FDA Regulatory Timeline and Events
TNX-102 SL1 is a drug developed by Tonix Pharmaceuticals for the following indication: Targets Non-restorative Sleep and Provides Sustained Pain Reduction.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- TNX-102 SL1
- Announced Date:
- June 5, 2025
- Indication:
- Targets Non-restorative Sleep and Provides Sustained Pain Reduction
Announcement
Tonix Pharmaceuticals Holding Corp announced a poster presentation at the Annual European Congress of Rheumatology (EULAR) 2025, being held June 11-14, 2025, in Barcelona, Spain. .
AI Summary
Tonix Pharmaceuticals Holding Corp has announced a poster presentation at the Annual European Congress of Rheumatology (EULAR) 2025, which will be held in Barcelona, Spain from June 11 to 14, 2025. The presentation, titled "Advancing Fibromyalgia Treatment: Transmucosal Sublingual Cyclobenzaprine (TNX-102 SL1) Targets Non-restorative Sleep and Provides Sustained Pain Reduction," will be presented by Dr. Iredell Iglehart during the Basic and Clinical Poster Tours session on pain in rheumatic musculoskeletal diseases. The session is scheduled for Friday, June 13, 2025, at 12:48 p.m. CEST. Further details about the presentation and the session, including the poster number (POS02016), will be available on the Tonix website under the Scientific Presentations tab after the conference. For additional information about the event, visit the EULAR website.
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TNX-1300 - FDA Regulatory Timeline and Events
TNX-1300 is a drug developed by Tonix Pharmaceuticals for the following indication: Cocaine Intoxication.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- TNX-1300
- Announced Date:
- April 25, 2025
- Indication:
- Cocaine Intoxication
Announcement
Tonix Pharmaceuticals Discontinued Enrollment And Terminated Phase 2 Catalyst Study Of Its TNX-1300 Product; The Company Is Evaluating New Study Designs And New Endpoints For Further Development Of TNX-1300
Read Announcement- Drug:
- TNX-1300
- Announced Date:
- August 20, 2024
- Estimated Event Date Range:
- January 1, 2025 - June 30, 2025
- Target Action Date:
- H1 2025
- Indication:
- Cocaine Intoxication
Announcement
Tonix Pharmaceuticals announced that Topline results are expected in the first half of 2025
AI Summary
Tonix Pharmaceuticals recently initiated its Phase 2, single-blind, placebo-controlled trial to evaluate TNX-1300, a recombinant enzyme designed to rapidly break down cocaine in patients with acute cocaine intoxication in emergency departments. The study is being conducted at several U.S. academic medical centers and involves comparing a single 200 mg dose of TNX-1300 plus standard care against a placebo with standard care.
Tonix announced that topline results from the study are expected in the first half of 2025. The trial aims to assess both the safety and the effectiveness of TNX-1300 in reducing the severe cardiovascular and neurological effects caused by cocaine toxicity, offering a potential new treatment option where currently no FDA-approved therapy exists.
Read Announcement- Drug:
- TNX-1300
- Announced Date:
- August 20, 2024
- Indication:
- Cocaine Intoxication
Announcement
Tonix Pharmaceuticals announced the first patient has been dosed in the Phase 2, single-blind, placebo-controlled, proof of concept trial of TNX-1300 (double-mutant cocaine esterase 200 mg, i.v. solution) for the treatment of acute cocaine intoxication in the emergency department (ED).
AI Summary
Tonix Pharmaceuticals recently announced that the first patient has been dosed in a Phase 2, single-blind, placebo-controlled, proof-of-concept trial of TNX-1300. This study evaluates a 200 mg intravenous dose of TNX-1300, a double-mutant cocaine esterase, for treating acute cocaine intoxication in the emergency department. The trial is being conducted at six academic medical centers across the United States and will enroll around 60 patients who present with cocaine intoxication.
The aim of the study is to assess whether TNX-1300 can safely and rapidly reduce the harmful symptoms associated with cocaine overdose, such as high systolic blood pressure. By breaking down cocaine quickly, TNX-1300 may offer a new treatment option for this life-threatening condition. The trial is an important step toward addressing the increasing emergency room visits and fatalities linked to cocaine use.
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TNX-1500 - FDA Regulatory Timeline and Events
TNX-1500 is a drug developed by Tonix Pharmaceuticals for the following indication: Humanized monoclonal antibody.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- TNX-1500
- Announced Date:
- April 9, 2025
- Indication:
- Humanized monoclonal antibody
Announcement
Tonix Pharmaceuticals Holding Corp. announced a collaborative research agreement under which Tonix and Makana will study Tonix's anti-CD40L (CD40 ligand, also called CD154) monoclonal antibody candidate, TNX-1500, in combination with Makana's human-compatible organs and cells for the treatment of organ failure.
AI Summary
Tonix Pharmaceuticals and Makana Therapeutics have announced a collaborative research agreement to study TNX-1500, Tonix’s anti-CD40L monoclonal antibody candidate, in combination with Makana’s human-compatible organs and cells for treating organ failure. This partnership focuses on developing an immunomodulatory regimen aimed at reducing organ rejection in xenotransplantation procedures. The preclinical studies will span several Makana programs, including kidney, heart, and islet cell transplants. By integrating TNX-1500’s promising pharmacokinetic and pharmacodynamic profile with Makana’s genetically engineered pig organs, the collaborators hope to enhance transplant outcomes. The goal is to generate robust preclinical data that could support an investigational new drug application to the FDA for compassionate use in patients who urgently require organ transplants. This strategic initiative marks a significant step toward addressing the persistent challenge of organ rejection and advancing clinical xenotransplantation.
Read Announcement- Drug:
- TNX-1500
- Announced Date:
- February 6, 2025
- Indication:
- Humanized monoclonal antibody
Announcement
Tonix Pharmaceuticals announced positive topline results from its Phase 1, single ascending dose trial of TNX-1500 (Fc-modified humanized anti-CD40L monoclonal antibody, or mAb)* in healthy participants.
AI Summary
Tonix Pharmaceuticals announced positive topline results from its Phase 1 single ascending dose study of TNX-1500, a next-generation, Fc-modified humanized anti-CD40L monoclonal antibody. The trial in healthy participants focused on safety, tolerability, pharmacokinetics, and pharmacodynamics, showing promising data for future use. At 10 mg/kg and 30 mg/kg doses, TNX-1500 successfully blocked both primary and secondary antibody responses to a test antigen. Additionally, the study found that at these doses, the mean half-life of the antibody was between 34 and 38 days, supporting the possibility of monthly dosing in upcoming trials. The treatment was generally well-tolerated, with only mild adverse events reported. These encouraging findings have paved the way for a planned Phase 2 trial, which aims to evaluate the drug’s effectiveness in preventing kidney transplant rejection while offering a potentially safer alternative to existing therapies.
Read Announcement- Drug:
- TNX-1500
- Announced Date:
- June 6, 2024
- Indication:
- Humanized monoclonal antibody
Announcement
Tonix Pharmaceuticals Holding Corp. announces two oral presentations and a poster presentation at the American Transplant Congress 2024, held June 1-5, 2024 at the Pennsylvania Convention Center, Philadelphia, Pa. A copy of the oral and poster presentation is available under the Scientific Presentations tab of the Tonix website at www.tonixpharma.com.
AI Summary
Tonix Pharmaceuticals Holding Corp. announced that it will present two oral presentations and one poster presentation at the American Transplant Congress 2024, which takes place from June 1 to 5 at the Pennsylvania Convention Center in Philadelphia. These presentations focus on TNX-1500, the company’s Fc-modified humanized anti-CD40L monoclonal antibody, which shows promise in preventing rejection in both allograft and xenograft transplants. CEO Seth Lederman highlighted the potential of TNX-1500 to offer improved treatment options by combining it with other therapies, such as anti-CD28 antibodies, to provide durable graft protection in organ transplantation. This research could also impact the treatment of autoimmune diseases. Interested parties can access copies of the oral and poster presentations under the Scientific Presentations tab on the Tonix website at www.tonixpharma.com.
Read Announcement- Drug:
- TNX-1500
- Announced Date:
- May 29, 2024
- Indication:
- Humanized monoclonal antibody
Announcement
Tonix Pharmaceuticals Holding Corp announced two oral presentations and a poster presentation at the American Transplant Congress 2024, being held June 1-5, 2024 at the Pennsylvania Convention Center, Philadelphia, Pa. Details on each presentation can be found below.
AI Summary
Tonix Pharmaceuticals Holding Corp announced it will showcase its research at the American Transplant Congress 2024, held from June 1-5 at the Pennsylvania Convention Center in Philadelphia, PA. The company plans two oral presentations and one poster presentation at the event.
Dr. Kohei Kinoshita from Massachusetts General Hospital will deliver an oral presentation titled “Combined Blockade of the CD154 and CD28 Co-Stimulation Pathways Attenuates Pathogenic Alloimmunity and Prolongs Survival in Cynomolgus Cardiac Allografts” on Tuesday, June 4 at 9:45 a.m. ET. Additionally, Dr. Ikechukwu Ileka of Massachusetts General Hospital and Harvard Medical School will present on “Extended Survival of 9- and 10-Gene-Edited Pig Heart Xenografts with Ischemia Minimization and CD154 Costimulation Blockade-Based Immunosuppression” on June 4 at 10:15 a.m. ET, and a poster presentation on “Experience with a Novel Delayed Immune Tolerance Protocol in Nonhuman Primates Based on Anti-CD154, Anti-CD2, and Anti-CD28” on Monday, June 3 at 9:15 a.m. ET.
Read Announcement- Drug:
- TNX-1500
- Announced Date:
- May 29, 2024
- Indication:
- Humanized monoclonal antibody
Announcement
Tonix Pharmaceuticals Holding Corp. announced two oral presentations and a poster presentation at the American Transplant Congress 2024, being held June 1-5, 2024 at the Pennsylvania Convention Center, Philadelphia, Pa. Details on each presentation can be found below.
AI Summary
Tonix Pharmaceuticals Holding Corp. has announced its participation in the American Transplant Congress 2024 at the Pennsylvania Convention Center in Philadelphia from June 1–5, 2024. The company will present two oral presentations and one poster presentation. One oral presentation, led by Dr. Kohei Kinoshita, will focus on how blocking both CD154 and CD28 co-stimulation pathways can lessen alloimmune responses and extend the survival of cardiac allografts in cynomolgus monkeys. A second oral presentation by Dr. Ikechukwu Ileka will discuss prolonging the survival of gene-edited pig heart xenografts through ischemia minimization and a specific CD154 costimulation blockade-based immunosuppression strategy. Additionally, Dr. Ileka will present a poster on using a novel delayed immune tolerance protocol based on anti-CD154, anti-CD2, and anti-CD28, with more details available on the Tonix website following the congress.
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TNX-1700 - FDA Regulatory Timeline and Events
TNX-1700 is a drug developed by Tonix Pharmaceuticals for the following indication: Recombinant human TFF2-human serum albumin or HSA) for the treatment of colon and gastric cancers.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- TNX-1700
- Announced Date:
- July 2, 2025
- Indication:
- Recombinant human TFF2-human serum albumin or HSA) for the treatment of colon and gastric cancers.
Announcement
Tonix Pharmaceuticals Holding Corp announced the publication of a paper entitled, "A CXCR4 Partial Agonist, Improves Immunotherapy by Targeting Immunosuppressive Neutrophils and Cancer-Driven Granulopoiesis,"1 in the peer-reviewed journal Cancer Cell, that represents a collaboration between scientists at Tonix and Columbia University's Medical School and presents data demonstrating that treatment with murine TNX-1700 (mTNX-1700) increased survival and decreased metastases in animal models of gastric cancer.
AI Summary
Tonix Pharmaceuticals Holding Corp. recently published a paper in the peer-reviewed journal Cancer Cell titled "A CXCR4 Partial Agonist, Improves Immunotherapy by Targeting Immunosuppressive Neutrophils and Cancer-Driven Granulopoiesis." The study, a collaboration with Columbia University Medical School, presents data showing that treatment with murine TNX-1700 (mTNX-1700) increases survival and reduces metastases in animal models of gastric cancer. Researchers found that combining mTNX-1700 with an anti-PD1 antibody not only shrank primary tumors but also activated cancer-killing CD8+ T cells while limiting immunosuppressive neutrophils. These findings suggest that mTNX-1700 may help overcome resistance to anti-PD1 immunotherapy by effectively targeting the tumor microenvironment, potentially offering a new approach for treating gastric cancer and other tumors. The positive results support further investigation into TNX-1700 in preclinical studies for better immunotherapy outcomes.
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TNX-801 - FDA Regulatory Timeline and Events
TNX-801 is a drug developed by Tonix Pharmaceuticals for the following indication: Potential Vaccine to Prevent Mpox and Smallpox.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- TNX-801
- Announced Date:
- July 10, 2025
- Indication:
- Potential Vaccine to Prevent Mpox and Smallpox
Announcement
Tonix Pharmaceuticals announced the presentation of new findings on TNX-801 (recombinant horsepox, live virus vaccine) at the Vaccine Congress 2025 in Vienna on July 10, 2025, by Sina Bavari, PhD, Executive Vice President, Infectious Disease Research and Development.
AI Summary
Tonix Pharmaceuticals recently presented new findings on TNX-801—a recombinant horsepox, live virus vaccine—at Vaccine Congress 2025 in Vienna on July 10, 2025. The data, shared by Sina Bavari, PhD, Executive Vice President of Infectious Disease Research and Development, show that TNX-801 is significantly less virulent than traditional smallpox vaccines. Preclinical studies indicate that the vaccine delivers durable immunity and robust protection against mpox and rabbitpox, with protection lasting over one year in animal models. Notably, subcutaneous administration of TNX-801 was found to offer equivalent protection to the traditional percutaneous method, which may help reduce side effects like scarring and bacterial infection at the injection site.
These promising results suggest that TNX-801 could become a critical tool in preventing mpox outbreaks and preparing for potential smallpox threats. Further clinical evaluations and collaborations with public health partners are expected as Tonix advances this innovative vaccine candidate.
Read Announcement- Drug:
- TNX-801
- Announced Date:
- July 7, 2025
- Indication:
- Potential Vaccine to Prevent Mpox and Smallpox
Announcement
Tonix Pharmaceuticals announced that Sina Bavari, PhD, Executive Vice President of Infectious Disease Research and Development at Tonix Pharmaceuticals, will present new data on TNX-801 (recombinant horsepox virus, live vaccine) at the upcoming Vaccine Congress 2025.
AI Summary
Tonix Pharmaceuticals recently announced that Dr. Sina Bavari, Executive Vice President of Infectious Disease Research and Development, will present new data on its TNX-801 candidate at Vaccine Congress 2025. TNX-801 is a recombinant horsepox virus vaccine that has shown promising preclinical results. In animal studies, a single dose offered durable protection against mpox, demonstrating both robust immunogenicity and safety. The vaccine was well tolerated even in immunocompromised animals, with no evidence of spreading to other tissues, supporting its potential for further clinical evaluation.
Dr. Bavari’s presentation, scheduled for July 10th at 11:20am GMT+2 in Vienna, will detail the safety, immunogenicity, and efficacy findings of TNX-801. This data underscores Tonix’s commitment to advancing innovative vaccine platforms to combat mpox and other emerging viral diseases.
Read Announcement- Drug:
- TNX-801
- Announced Date:
- April 24, 2025
- Indication:
- Potential Vaccine to Prevent Mpox and Smallpox
Announcement
Tonix Pharmaceuticals presented data in an oral presentation at the World Vaccine Congress Washington 2025, held April 21-24, 2025, in Washington, D.C.
AI Summary
Tonix Pharmaceuticals recently presented promising new data on its TNX-801 vaccine at the World Vaccine Congress Washington 2025, held from April 21–24 in Washington, D.C. The oral presentation, titled “A Novel Single-Dose, Attenuated Live, Minimally Replicative Mpox Vaccine,” detailed preclinical findings demonstrating that TNX-801, a single-dose live virus vaccine, effectively protected animals against both mpox and smallpox challenges.
The data highlighted the vaccine’s durability, showing six-month protection against a lethal challenge with rabbitpox, as well as its tolerability in immunocompromised animals—with no evidence of virus spreading to blood or tissues, even at high doses. These encouraging results suggest that TNX-801 could offer a safer and more effective alternative compared to earlier live-virus vaccines, paving the way for improved prevention of mpox and related diseases.
Read Announcement- Drug:
- TNX-801
- Announced Date:
- March 10, 2025
- Indication:
- Potential Vaccine to Prevent Mpox and Smallpox
Announcement
Tonix Pharmaceuticals announced it has been awarded a grant from the Medical CBRN Defense Consortium (MCDC) to support the development of TNX-801 (recombinant horsepox virus, live vaccine).
AI Summary
Tonix Pharmaceuticals has been awarded a grant from the Medical CBRN Defense Consortium (MCDC) to support the advancement of its TNX-801 vaccine candidate. TNX-801 is a recombinant horsepox virus-based live vaccine under development for mpox and smallpox, and it is designed to provide durable, single-dose immunity. The vaccine aims to offer improved tolerability as well as simpler shipping and storage, making it a promising option for broader use. With the MCDC grant, Tonix will conduct comprehensive market analyses, work on target market identification, and refine its commercialization strategy for both private and government sectors. The consortium, which includes industrial, academic, and non-profit groups, helps the U.S. government prepare for chemical, biological, radiological, and nuclear threats. This funding marks an important step for Tonix as it works to meet global public health needs and strengthen epidemic prevention efforts.
Read Announcement- Drug:
- TNX-801
- Announced Date:
- September 16, 2024
- Indication:
- Potential Vaccine to Prevent Mpox and Smallpox
Announcement
Tonix Pharmaceuticals announced that that the World Health Organization's (WHO's) preferred target product profile (TPP), released at the WHO sponsored Mpox Research and Innovation Scientific Conference held August 29-30, 2024, aligns with the characteristics of TNX-801 (horsepox, live virus) vaccine, which is being developed for preventing mpox (formerly known as monkeypox).
AI Summary
Tonix Pharmaceuticals announced that the World Health Organization’s preferred target product profile (TPP) for mpox vaccines aligns closely with the characteristics of its TNX-801 vaccine candidate. Developed using a live horsepox virus, TNX-801 is designed to provide durable, single-dose protection against mpox (formerly known as monkeypox) without requiring special injection equipment. The WHO’s TPP, shared at the recent Mpox Research and Innovation Scientific Conference, emphasizes factors such as ease of administration, stability at ambient temperatures, and the potential to limit forward transmission. In preclinical studies, TNX-801 demonstrated effective protection against lethal monkeypox challenges, which could support strategies like ring vaccination in outbreak settings. This alignment with WHO’s TPP suggests that TNX-801 has the potential to be a practical and scalable solution in controlling the spread of mpox in diverse global settings.
Read Announcement- Drug:
- TNX-801
- Announced Date:
- September 9, 2024
- Indication:
- Potential Vaccine to Prevent Mpox and Smallpox
Announcement
Tonix Pharmaceuticals announced data presented at a symposium hosted by the Department of Medical Microbiology & Immunology and the Li Ka Shing Institute of Virology to celebrate the career and honor the retirement of Tonix's collaborator, David Evans, Ph.D., FCAHS, Emeritus Professor, Department of Cell Biology, University of Alberta.
AI Summary
Tonix Pharmaceuticals recently presented promising preclinical data at a symposium hosted by the Department of Medical Microbiology & Immunology and the Li Ka Shing Institute of Virology. The event celebrated the career and retirement of their long-time collaborator, David Evans, Ph.D., FCAHS, Emeritus Professor from the University of Alberta. During the session titled “Using Synthetic Biology to Battle Mpox,” Tonix detailed the performance of TNX-801—a synthetic, live horsepox-based vaccine designed to prevent mpox. The data demonstrated that TNX-801 successfully protected animals from a lethal clade I monkeypox challenge.
Furthermore, the presentation highlighted TNX-801’s improved tolerability in immunocompromised animals, with no spread into blood or tissues even at very high doses. This work underscores the role of synthetic biology in advancing next-generation vaccines, offering a promising, single-dose solution against mpox.
Read Announcement- Drug:
- TNX-801
- Announced Date:
- August 26, 2024
- Indication:
- Potential Vaccine to Prevent Mpox and Smallpox
Announcement
Tonix Pharmaceuticals announced a collaboration to advance TNX-801, Tonix's mpox vaccine candidate.
AI Summary
Tonix Pharmaceuticals has announced a collaboration with Bilthoven Biologicals to advance its mpox vaccine candidate, TNX-801. This live, replicating vaccine is based on recombinant horsepox virus and is in preclinical development to prevent both mpox and smallpox. In animal studies, TNX-801 provided strong immune protection with a single dose, suggesting it could block the disease and limit its spread by reducing virus shedding in the mouth and lungs. Tonix believes the single dose approach will increase vaccine acceptance compared to the current two-dose options and will avoid the need for a costly ultra-cold storage supply chain. Bilthoven Biologicals, part of a major global vaccine manufacturer, brings expertise in vaccine production and pandemic preparedness to support the rapid scale-up and potential global distribution of TNX-801.
Read Announcement- Drug:
- TNX-801
- Announced Date:
- August 23, 2024
- Indication:
- Potential Vaccine to Prevent Mpox and Smallpox
Announcement
Tonix has successfully completed non-human primate studies showing protection from challenge with lethal doses of the Clade 1 monkeypox virus that is driving the new epidemic.
AI Summary
Tonix Pharmaceuticals has announced encouraging results from its non-human primate studies with the vaccine candidate TNX-801. The studies showed that a single dose of TNX-801 protected animals against lethal doses of the Clade 1 monkeypox virus, which is currently driving a new epidemic in parts of Africa and beyond. Researchers observed that the vaccine not only prevented death and severe disease but also reduced viral shedding, indicating a lower risk of spreading the virus. This outcome suggests that TNX-801 may trigger a lasting T-cell response, potentially offering long-term immunity similar to the historic smallpox vaccine developed by Edward Jenner. While further testing and human trials are needed, these findings mark a significant step forward in combating the reemerging monkeypox threat, offering hope for an easier, more durable vaccination approach compared to current mRNA vaccines.
Read Announcement- Drug:
- TNX-801
- Announced Date:
- August 16, 2024
- Indication:
- Potential Vaccine to Prevent Mpox and Smallpox
Announcement
Tonix Pharmaceuticals has reiterated its commitment to advance development of its live attenuated virus vaccine, TNX-801 (recombinant horsepox virus), for preventing mpox (formerly known as monkeypox) and other infectious diseases.
AI Summary
Tonix Pharmaceuticals has reaffirmed its commitment to advancing TNX-801, a live attenuated virus vaccine based on recombinant horsepox virus, aimed at preventing mpox (formerly monkeypox) and other infectious diseases. The company highlighted that a single dose of TNX-801 has shown promising results in preclinical trials, effectively protecting animals from lethal monkeypox virus challenges. This vaccine candidate is designed to offer long-term immunity with improved tolerability compared to older vaccinia-based vaccines. Tonix emphasizes that TNX-801 may help block virus transmission and provide an important countermeasure during global public health emergencies. Additionally, its stable formulation could eliminate the need for ultra-cold storage, making it easier to distribute in regions severely affected by mpox outbreaks. The ongoing focus on innovative vaccine strategies underscores Tonix’s role in addressing emerging infectious disease threats worldwide.
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Tonmya - FDA Regulatory Timeline and Events
Tonmya is a drug developed by Tonix Pharmaceuticals for the following indication: For the management of fibromyalgia.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- Tonmya
- Announced Date:
- July 31, 2024
- Estimated Event Date Range:
- July 1, 2024 - December 31, 2024
- Target Action Date:
- H2 2024
- Indication:
- For the management of fibromyalgia.
Announcement
Tonix Pharmaceuticals : NDA submission target is second half of 2024
AI Summary
Tonix Pharmaceuticals is advancing its development of Tonmya™, an investigational treatment for fibromyalgia, by targeting an NDA submission to the FDA in the second half of 2024. The company is working toward potential FDA approval in 2025. Tonmya, a sublingual formulation of cyclobenzaprine HCl, has already shown promising results in reducing daily pain and improving related symptoms in patients with fibromyalgia. This innovative, non-opioid therapy is being developed as a daily bedtime medication.
Additionally, recent updates suggest that diagnosing fibromyalgia in Long COVID patients may boost the market potential for Tonmya. With the new definition from the U.S. National Academies, Tonix is optimistic that the therapy will benefit a larger group of patients experiencing chronic pain. The FDA Fast Track designation further supports the accelerated development and review process for Tonmya.
Read Announcement- Drug:
- Tonmya
- Announced Date:
- July 31, 2024
- Indication:
- For the management of fibromyalgia.
Announcement
Tonix Pharmaceuticals today provided an update on the potential impact on the size of the fibromyalgia market for its development candidate Tonmya (TNX-102 SL or cyclobenzaprine HCl sublingual tablets), based on the new definition of Long COVID by the U.S. National Academies of Sciences, Engineering and Medicine (NASEM) announced on June 11, 20241.
AI Summary
Tonix Pharmaceuticals announced an update on the fibromyalgia market potential for its candidate Tonmya (TNX-102 SL) following the new Long COVID definition from the U.S. National Academies of Sciences, Engineering and Medicine released on June 11, 2024. The updated definition recognizes fibromyalgia as a diagnosable condition in Long COVID patients, which Tonix believes expands the potential pool of individuals who could benefit from the drug. Prior to the COVID-19 pandemic, fibromyalgia affected over 10 million U.S. adults. With estimates indicating that about 14 million adults now suffer from Long COVID, many of whom have overlapping fibromyalgia symptoms, the expanded market may lead to increased demand for Tonmya if approved. The company views this as a significant opportunity to reach patients with unmet clinical needs in managing chronic pain associated with fibromyalgia.
Read Announcement- Drug:
- Tonmya
- Announced Date:
- July 31, 2024
- Indication:
- For the management of fibromyalgia.
Announcement
Tonix Pharmaceuticals announced that NDA submission target is second half of 2024, with potential for FDA approval in 2025
AI Summary
Tonix Pharmaceuticals announced plans to move forward with a New Drug Application (NDA) for its investigational drug Tonmya. The company is targeting the second half of 2024 for the submission to the U.S. Food and Drug Administration (FDA) with a potential approval in 2025. Tonmya is being developed as a daily, sublingual, non-opioid medication for the management of fibromyalgia. Recent insights have suggested that fibromyalgia can be diagnosed in patients suffering from Long COVID, which could expand the addressable market for the drug. The firm believes that recognizing fibromyalgia in Long COVID patients may lead to a broader patient base compared to pre-pandemic estimates. With FDA Fast Track designation already granted for the treatment of fibromyalgia, Tonix is hopeful that this development will help more patients access effective care.
Read Announcement- Drug:
- Tonmya
- Announced Date:
- July 25, 2024
- Indication:
- For the management of fibromyalgia.
Announcement
Tonix Pharmaceuticals announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to Tonmya™ (cyclobenzaprine HCl sublingual tablets) for the management of fibromyalgia. Tonmya is a non-opioid, centrally-acting analgesic drug under development for treating fibromyalgia, which is a common chronic pain condition affecting mostly women.
AI Summary
Tonix Pharmaceuticals announced that the FDA has granted Fast Track designation to its investigational drug Tonmya™ (cyclobenzaprine HCl sublingual tablets) for treating fibromyalgia, a chronic pain condition that mainly affects women. This designation is a significant step because it helps speed up the review process for drugs that address serious conditions and meet unmet medical needs. Tonmya is a non-opioid, centrally acting analgesic that, if approved, could become the first new treatment for fibromyalgia in over 15 years. The company is preparing to submit its NDA to the FDA in the second half of 2024, aiming for market availability by 2025. This progress has raised hope among patients who have long been dissatisfied with currently available treatments for fibromyalgia, and it underscores Tonix’s commitment to introducing a more effective and well-tolerated therapy for managing this challenging disorder.
Read Announcement- Drug:
- Tonmya
- Announced Date:
- July 17, 2024
- Estimated Event Date Range:
- July 1, 2024 - December 31, 2024
- Target Action Date:
- H2 2024
- Indication:
- For the management of fibromyalgia.
Announcement
Tonix Pharmaceuticals Holding Corp announced it is filing an NDA submission in 2H 2024 and laying plans for the commercial launch of Tonmya™* for the management of fibromyalgia, assuming approval by the FDA in 2H 2025..
AI Summary
Tonix Pharmaceuticals Holding Corp has announced plans to file a New Drug Application (NDA) submission in the second half of 2024 for its drug Tonmya™, a sublingual tablet designed to improve sleep quality in fibromyalgia patients. The company is preparing for a commercial launch of Tonmya™ in the second half of 2025, pending FDA approval. Fibromyalgia, which affects millions of Americans, has not seen a new FDA-approved treatment in over 15 years, making this development particularly significant. Tonmya™ is a non-opioid, non-addictive option that aims to address key symptoms of the condition, such as poor sleep quality and pain, as shown in its Phase 3 trial. With encouraging clinical results and positive pre-NDA discussions with the FDA, Tonix is positioning Tonmya™ to compete in a market that has long awaited an innovative treatment solution.
Read Announcement- Drug:
- Tonmya
- Announced Date:
- July 8, 2024
- Estimated Event Date Range:
- July 1, 2024 - December 31, 2024
- Target Action Date:
- H2 2024
- Indication:
- For the management of fibromyalgia.
Announcement
Tonix Pharmaceuticals announced that NDA submission target confirmed for second half 2024
AI Summary
Tonix Pharmaceuticals has confirmed its plan to submit a New Drug Application (NDA) for Tonmya™, a centrally acting, non-opioid analgesic, in the second half of 2024. The FDA meeting recently reaffirmed that the company's data package is sufficient to support the submission for managing fibromyalgia. Tonmya is designed to address the needs of fibromyalgia patients, many of whom are dissatisfied with current treatment options and may be forced to use addictive opioids off-label.
The company highlighted that this milestone could lead to a potential FDA approval by the second half of 2025. Tonmya’s development responds to the significant number of U.S. adults suffering from fibromyalgia, predominantly women, and offers a promising new approach to managing the chronic pain and numerous symptoms associated with the disorder.
Read Announcement- Drug:
- Tonmya
- Announced Date:
- July 8, 2024
- Estimated Event Date Range:
- July 1, 2025 - December 31, 2025
- Target Action Date:
- H2 2025
- Indication:
- For the management of fibromyalgia.
Announcement
Tonix Pharmaceuticals announced that potential for FDA approval in second half 2025
AI Summary
Tonix Pharmaceuticals announced a significant milestone for its investigational drug, Tonmya™, which is being developed for the management of fibromyalgia. The company confirmed that it will submit a New Drug Application (NDA) in the second half of 2024. Based on recent discussions, there is potential for Tonmya to receive FDA approval in the second half of 2025. Tonmya is a non-opioid, centrally acting analgesic that may offer a new treatment option for fibromyalgia patients, many of whom are unsatisfied with current therapies. This development underlines the company’s commitment to addressing the needs of patients struggling with chronic pain and other fibromyalgia symptoms. Tonix believes that with this new treatment, patients might avoid the risks associated with opioid therapies while obtaining significant symptom relief.
Read Announcement- Drug:
- Tonmya
- Announced Date:
- July 8, 2024
- Indication:
- For the management of fibromyalgia.
Announcement
Tonix Pharmaceuticals announced receipt of the formal minutes from a recent pre-New Drug Application (NDA) meeting with the U.S. Food and Drug Administration (FDA) for Tonmya™ (cyclobenzaprine HCl sublingual tablets) for the management of fibromyalgia.
AI Summary
Tonix Pharmaceuticals announced that it received the formal minutes from their recent pre-New Drug Application meeting with the FDA regarding Tonmya™ (cyclobenzaprine HCl sublingual tablets) for managing fibromyalgia. During the meeting, both the company and the FDA agreed that the data package Tonix plans to submit is strong enough to support the upcoming NDA. This milestone confirms that the nonclinical, clinical pharmacology, and clinical features data are sufficient and well-aligned with FDA expectations. The company remains on track to file the NDA in the second half of 2024, setting the stage for a potential FDA approval in the latter half of 2025. Tonix’s CEO expressed optimism about the benefits Tonmya could offer fibromyalgia patients, who often have limited treatment choices, and noted that the guidance received reinforces confidence in Tonmya’s registration path.
Read Announcement- Drug:
- Tonmya
- Announced Date:
- June 20, 2024
- Indication:
- For the management of fibromyalgia.
Announcement
Tonix Pharmaceuticals announced that On track to submit NDA to the FDA in the second half of 2024
AI Summary
Tonix Pharmaceuticals announced that it is on track to submit its New Drug Application (NDA) for Tonmya, aimed at managing fibromyalgia, to the FDA in the second half of 2024. This submission milestone follows the company’s completion of the second and final pre-NDA meeting, where they discussed nonclinical, clinical pharmacology, and other clinical matters with the FDA. Tonix is currently awaiting the formal release of the meeting minutes.
During a previous CMC meeting, the FDA and Tonix aligned on key topics such as commercial specifications for the drug substance and product, shelf-life assignment, and strategies for manufacturing and packaging. This progress is an important step as Tonix finalizes its NDA package, moving closer to offering a new treatment option for patients suffering from fibromyalgia.
Read Announcement- Drug:
- Tonmya
- Announced Date:
- June 20, 2024
- Indication:
- For the management of fibromyalgia.
Announcement
Tonix Pharmaceuticals announced receipt of the formal minutes from a recent pre-New Drug Application (NDA) Type-B Chemistry, Manufacturing, and Controls (CMC) meeting with the U.S. Food and Drug Administration (FDA) for Tonmya™ for the management of fibromyalgia.
AI Summary
Tonix Pharmaceuticals recently received the formal minutes from its pre-New Drug Application (NDA) Type-B Chemistry, Manufacturing, and Controls (CMC) meeting with the U.S. Food and Drug Administration (FDA) regarding Tonmya™ for managing fibromyalgia. This meeting was held to ensure alignment on critical CMC topics essential for an upcoming NDA submission. The FDA’s written feedback confirmed that both parties are in agreement on key areas, which include the proposed specifications for the drug substance and drug product, shelf life assignments, along with plans for manufacturing and commercial packaging. This positive outcome indicates that Tonix is well-positioned with the FDA for the imminent submission of the NDA in the second half of 2024. Such alignment is a crucial step as the company pushes ahead in finalizing the regulatory package for what could be the first new treatment for fibromyalgia in over a decade.
Read Announcement- Drug:
- Tonmya
- Announced Date:
- June 17, 2024
- Estimated Event Date Range:
- July 1, 2024 - December 31, 2024
- Target Action Date:
- H2 2024
- Indication:
- For the management of fibromyalgia.
Announcement
Tonix Pharmaceuticals Holding Corp. announced that New Drug Application (NDA) submission to the FDA on track for the second half of 2024
AI Summary
Tonix Pharmaceuticals announced that it is on track to submit a New Drug Application (NDA) to the U.S. Food and Drug Administration in the second half of 2024. The submission is for Tonmya™, a treatment candidate using sublingual cyclobenzaprine HCl, aimed at managing fibromyalgia symptoms. This step follows successful Phase 3 trials where Tonmya significantly reduced daily pain and improved a range of fibromyalgia-related symptoms. The company’s data showed benefits in areas like sleep quality, fatigue reduction, and overall patient well-being. The positive trial results support Tonix’s effort to offer a new therapy option for fibromyalgia, a condition that has limited treatment choices. Tonix’s upcoming NDA submission marks an important milestone in their development program, with hopes to provide relief and improved quality of life for individuals affected by fibromyalgia.
Read Announcement- Drug:
- Tonmya
- Announced Date:
- June 17, 2024
- Indication:
- For the management of fibromyalgia.
Announcement
Tonix Pharmaceuticals announced that RESILIENT was the second Phase 3 study to reach statistical significance on the primary endpoint
AI Summary
Tonix Pharmaceuticals announced encouraging results from its Phase 3 RESILIENT trial for Tonmya™ (TNX-102 SL). The study met its primary pain endpoint with statistical significance, marking the second Phase 3 study to achieve this milestone. In the trial, Tonmya significantly reduced daily pain and improved a range of fibromyalgia symptoms, including better sleep quality and reduced fatigue, while maintaining a favorable safety profile. These promising outcomes support Tonix’s plan to move forward with filing a New Drug Application (NDA) with the FDA in the second half of 2024. This development adds new hope for patients with fibromyalgia who have struggled with daily pain and reduced quality of life. The recent results were part of a poster presentation at the Annual European Congress of Rheumatology, underscoring the potential of Tonmya as a broad-spectrum treatment option.
Read Announcement- Drug:
- Tonmya
- Announced Date:
- June 17, 2024
- Indication:
- For the management of fibromyalgia.
Announcement
Tonix Pharmaceuticals Holding Corp. presented data from a poster presentation at the Annual European Congress of Rheumatology (EULAR) 2024, held June 12-15, 2024 at the Messe Wien Congress Center in Vienna, Austria. A copy of the Company's poster presentation is available under the Scientific Presentations tab of the Tonix
AI Summary
Tonix Pharmaceuticals Holding Corp. presented key data at the Annual European Congress of Rheumatology (EULAR) 2024 in Vienna, Austria. The company’s poster, titled "Targeting Non-Restorative Sleep in Fibromyalgia with Bedtime TNX-102 SL," detailed results from the Phase 3 RESILIENT trial. In this study, treatment with Tonmya™ (TNX-102 SL, sublingual cyclobenzaprine HCl) significantly reduced daily pain compared to placebo. Participants with fibromyalgia experienced notable improvements in sleep quality, fatigue, overall fibromyalgia symptoms, and function, with statistically significant results recorded across all six key secondary endpoints. The data also highlighted improvements in depressive symptoms and female sexual function in exploratory analyses.
Interested parties can view the complete poster presentation on the Tonix website under the Scientific Presentations tab.
Read Announcement- Drug:
- Tonmya
- Announced Date:
- June 3, 2024
- Estimated Event Date Range:
- July 1, 2024 - December 31, 2024
- Target Action Date:
- H2 2024
- Indication:
- For the management of fibromyalgia.
Announcement
Tonix Pharmaceuticals announced that New Drug Application (NDA) submission to the FDA on track for the second half of 2024
AI Summary
Tonix Pharmaceuticals announced that its New Drug Application (NDA) for Tonmya is on track to be submitted to the U.S. Food and Drug Administration (FDA) in the second half of 2024. This important step is part of the company’s effort to secure approval for Tonmya, a treatment candidate for managing fibromyalgia. The announcement comes as the company reports promising results from the Phase 3 RESILIENT trial. During the trial, patients treated with Tonmya experienced improvements in depressive symptoms, as measured by the Beck Depression Inventory-II, along with better scores in anxiety, memory, and energy on the Fibromyalgia Impact Questionnaire-Revised.
The positive trial outcomes suggest that Tonmya could offer broader relief for fibromyalgia symptoms. Tonix’s focus on advancing its application reflects its commitment to bringing new treatment options to patients suffering from this challenging condition.
Read Announcement- Drug:
- Tonmya
- Announced Date:
- June 3, 2024
- Indication:
- For the management of fibromyalgia.
Announcement
Tonix Pharmaceuticals presented new data from the Phase 3 RESILIENT trial of Tonmya (TNX-102 SL, cyclobenzaprine HCl sublingual tablets) for the management of fibromyalgia in an oral presentation at the American Society of Clinical Psychopharmacology (ASCP) Annual Meeting on May 29, 2024 in Miami Beach, Fla.
AI Summary
Tonix Pharmaceuticals presented promising Phase 3 RESILIENT trial data for its fibromyalgia treatment Tonmya (TNX-102 SL) at the ASCP Annual Meeting in Miami Beach, Florida. The study focused on evaluating the impact of Tonmya on depressive symptoms, which are common among fibromyalgia patients. Using the Beck Depression Inventory-II, researchers observed that by Week 2, and more significantly by Week 14, patients treated with Tonmya showed improved depressive scores compared to placebo. Post hoc analyses also indicated benefits in reducing anxiety, memory issues, and increasing energy, as measured by the Fibromyalgia Impact Questionnaire-Revised, suggesting that Tonmya may help alleviate a range of fibromyalgia-related symptoms.
These encouraging results support the ongoing development of Tonmya, with a New Drug Application to the FDA planned for submission in the second half of 2024.
Read Announcement
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