Cidara Therapeutics' Drug in the FDA Approval Process
This section highlights FDA-related milestones and regulatory updates for drugs developed by Cidara Therapeutics (CDTX).
Over the past two years, Cidara Therapeutics has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
CD388. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
CD388 FDA Regulatory Timeline and Events
CD388 is a drug developed by Cidara Therapeutics for the following indication: Universal Prevention and Treatment of Influenza.
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:
- CD388
- Announced Date:
- October 23, 2025
- Indication:
- Universal Prevention and Treatment of Influenza
Announcement
Cidara Therapeutics, Inc. announced it gave a late-breaking presentation on its non-vaccine influenza preventative candidate, CD388, at the European Scientific Working Group on Influenza (ESWI)'s 10th Influenza Conference taking place October 20-23, 2025 in Valencia, Spain.
AI Summary
Cidara Therapeutics announced it gave a late-breaking presentation on its non-vaccine influenza preventative candidate, CD388, at the European Scientific Working Group on Influenza’s 10th Influenza Conference in Valencia, Spain, October 20–23, 2025. Using its Cloudbreak® platform, Cidara highlighted translational efficacy data linking preclinical mouse models to outcomes from its Phase 2b NAVIGATE study.
The presentation showed that a single dose of CD388 provided potent protection against 12 seasonal and multiple pandemic influenza subtypes in mice, with plasma concentrations at infection time conferring complete protection. In the Phase 2b trial, CD388 achieved statistically significant prevention efficacy across all dose groups, and a clear concentration–response relationship emerged: lower drug levels correlated with higher infection rates. These results reinforce Cidara’s confidence in CD388 as a single-dose flu preventative and support the company’s ongoing Phase 3 ANCHOR trial aimed at protecting vulnerable populations.
Read Announcement- Drug:
- CD388
- Announced Date:
- October 21, 2025
- Indication:
- Universal Prevention and Treatment of Influenza
Announcement
Cidara Therapeutics, Inc. announced it presented late-breaking Phase 2b clinical data on its non-vaccine influenza preventative candidate, CD388, during ID Week 2025, taking place October 19-22, 2025, in Atlanta, GA.
AI Summary
Cidara Therapeutics announced that it presented late-breaking Phase 2b clinical data on CD388, its non-vaccine influenza preventative, at ID Week 2025 in Atlanta, Georgia. The company shared results on October 20, 2025, demonstrating how a single dose of CD388 can prevent illness caused by influenza A and B in healthy unvaccinated adults.
The randomized, placebo-controlled trial was led by James Alexander, MD, MPH, FIDSAS, and evaluated both safety and efficacy. The presentation took place during the “Extra, Extra! New Info on Treating and Preventing RSV and Influenza” session in room B401-B402 from 3:15 PM to 4:30 PM ET.
Built on Cidara’s Cloudbreak® platform, CD388 is a long-acting drug-Fc conjugate designed to directly inhibit viral replication. Positive Phase 2b findings support its potential for universal seasonal and pandemic flu prevention with a single administration.
Read Announcement- Drug:
- CD388
- Announced Date:
- October 13, 2025
- Indication:
- Universal Prevention and Treatment of Influenza
Announcement
Cidara Therapeutics, Inc. announced it will be presenting late-breaking Phase 2 clinical data on its antiviral influenza candidate, CD388, during ID Week 2025, taking place October 19-22, 2025, in Atlanta, GA.
Read Announcement- Drug:
- CD388
- Announced Date:
- October 10, 2025
- Indication:
- Universal Prevention and Treatment of Influenza
Announcement
Cidara Therapeutics, Inc announced it will have a late-breaking presentation at the European Scientific Working Group on Influenza (ESWI)'s 10th Influenza Conference taking place October 20-23, 2025 in Valencia, Spain.
AI Summary
Cidara Therapeutics announced it will present at the European Scientific Working Group on Influenza (ESWI)’s 10th Influenza Conference in Valencia, Spain, from October 20 to 23, 2025. The company will share its latest research on a new antiviral approach that could help prevent influenza with a single dose.
The late-breaking session, “Novel and Outstanding Discoveries,” will feature Voon Ong, Ph.D., presenting on Thursday, October 23, from 2:00 to 3:30 pm CET. Her talk is titled “Translational efficacy of CD388, a novel Drug Fc-Conjugate in mouse influenza models: application to prevention efficacy in the Ph2b NAVIGATE study.”
Cidara uses its proprietary Cloudbreak® platform to develop drug-Fc conjugates (DFCs). Its lead candidate, CD388, is designed for long-acting antiviral protection against seasonal and pandemic flu. Results from the Phase 2b NAVIGATE trial showed positive top-line data in June 2025, and the company has since launched its Phase 3 ANCHOR trial. Cidara is headquartered in San Diego, California.
Read Announcement- Drug:
- CD388
- Announced Date:
- October 9, 2025
- Indication:
- Universal Prevention and Treatment of Influenza
Announcement
Cidara Therapeutics, Inc. announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation for CD388 for prevention of influenza A and B in adults and adolescents who are at higher risk of influenza complications due to underlying immunodeficiency, are at higher risk of severe influenza despite influenza vaccination, or those for whom vaccines are contraindicated.
Read Announcement- Drug:
- CD388
- Announced Date:
- October 2, 2025
- Indication:
- Universal Prevention and Treatment of Influenza
Announcement
Cidara Therapeutics, Inc. announced it has received an award valued up to $339M from the Biomedical Advanced Research and Development Authority (BARDA), part of the Administration for Strategic Preparedness and Response (ASPR) within the U.S. Department of Health and Human Services (HHS).
AI Summary
Cidara Therapeutics announced it has secured an award worth up to $339 million from the Biomedical Advanced Research and Development Authority (BARDA), part of the Administration for Strategic Preparedness and Response within HHS. This multi-year agreement includes a 24-month Base contract of $58 million and optional funding of up to $281 million if the U.S. government exercises its options.
The Base funding will support onshoring of CD388 manufacturing in the United States, a clinical trial to compare higher-concentration formulations, studies of activity against pandemic influenza strains in non-clinical models, and the development of protocols for broader patient populations. If the option periods are exercised, additional clinical and non-clinical studies of CD388 will be funded to complement plans for a potential Biologics License Application.
Jeffrey Stein, Ph.D., Cidara’s CEO, said CD388 could become a long-acting, non-vaccine preventative against all influenza strains. He added that BARDA’s partnership will speed up domestic supply, expand commercial capacity, and ensure U.S. readiness in the event of an influenza pandemic.
Read Announcement- Drug:
- CD388
- Announced Date:
- September 25, 2025
- Indication:
- Universal Prevention and Treatment of Influenza
Announcement
Cidara Therapeutics, Inc announced that the first participants have been dosed in its Phase 3 trial to evaluate the safety and efficacy of CD388, a non-vaccine preventative of seasonal influenza, in populations at high-risk for complications of influenza.
AI Summary
Cidara Therapeutics announced the first participants have been dosed in its Phase 3 trial, called ANCHOR, for CD388. This new preventative treatment for seasonal flu is not a vaccine and works by directly blocking the virus.
The global, randomized, double-blind, placebo-controlled study will enroll about 6,000 people during the Northern Hemisphere flu season. It will include adults over 65, individuals with certain health conditions, and people who have weakened immune systems. Each participant will get a single 450-mg shot under the skin.
The trial will track safety and how well CD388 prevents flu. After reviewing early data, researchers will adjust enrollment for the Southern Hemisphere season. If this trial succeeds, it could support a product license for high-risk groups based on one study.
Read Announcement- Drug:
- CD388
- Announced Date:
- September 24, 2025
- Indication:
- Universal Prevention and Treatment of Influenza
Announcement
Cidara Therapeutics, Inc. announced updates to its planned Phase 3 registrational trial of CD388 following its End-of-Phase 2 (EOP2) meeting with the U.S. Food and Drug Administration (FDA). Cidara is proceeding with an expanded and accelerated development plan seeking biologics license application (BLA) approval based on a single Phase 3 study.
AI Summary
Cidara Therapeutics Inc. announced updates to its planned Phase 3 registrational trial of CD388 following its End-of-Phase 2 meeting with the FDA. The company will seek biologics license application approval based on a single pivotal study.
The trial will start six months early in fall 2025 in the Northern Hemisphere, aiming to enroll about 6,000 participants. It will be randomized, double-blind, and placebo-controlled. Participants will receive a single 450-milligram subcutaneous injection of CD388 or placebo. An interim analysis after that flu season will guide further enrollment.
Following FDA feedback, the study population is expanded to include adults over 65 with no specific health conditions, along with individuals aged 12 and up who have high-risk comorbidities or are immunocompromised. This broader design could more than double the eligible U.S. population, potentially accelerating enrollment and addressing the needs of those most vulnerable to influenza.
Read Announcement- Drug:
- CD388
- Announced Date:
- September 17, 2025
- Indication:
- Universal Prevention and Treatment of Influenza
Announcement
Cidara Therapeutics, Inc. announced two presentations during the International Society for Respiratory Viruses (ISRV) 8th AntiViral Group (AVG) Meeting and 3rd International Meeting on Respiratory Pathogens (IMRP).
AI Summary
Cidara Therapeutics announced two oral presentations during the International Society for Respiratory Viruses (ISRV) 8th AntiViral Group (AVG) Meeting and 3rd International Meeting on Respiratory Pathogens (IMRP) in Singapore, September 17–20, 2025. In a late-breaking session, Rick Bright, Ph.D., presented results from the Phase 2b NAVIGATE trial of CD388, a single-dose, non-vaccine influenza preventative. Over 5,000 healthy adults received 150 mg, 300 mg, or 450 mg of CD388 or placebo. CD388 was well tolerated and provided significant protection against laboratory-confirmed influenza over 24 weeks after one subcutaneous dose.
Andreev Konstantin, Ph.D., shared preclinical data on CD388’s ability to prevent H5N1 infection in ferrets. A single 3 mg/kg dose given 24 hours before exposure protected 75% of animals, while 10 mg/kg achieved 100% survival. Treated ferrets showed less weight loss, milder symptoms, lower viral titers, and no neuroinvasion. These findings support CD388’s potential for broad, long-lasting influenza protection.
Read Announcement- Drug:
- CD388
- Announced Date:
- September 3, 2025
- Indication:
- Universal Prevention and Treatment of Influenza
Announcement
Cidara Therapeutics, Inc. announced it will have two oral presentations, one of which is late-breaking, during the International Society for Respiratory Viruses (ISRV) 8th AntiViral Group (AVG) Meeting and 3rd International Meeting on Respiratory Pathogens (IMRP).
AI Summary
Cidara Therapeutics will present two oral talks, including a late-breaking session, at the ISRV 8th AntiViral Group Meeting and 3rd International Meeting on Respiratory Pathogens from September 17 to 20, 2025, in Singapore.
The late-breaking abstract will report results from NAVIGATE, a Phase 2b trial testing CD388 for flu prevention in healthy adults. Rick Bright, Ph.D., presents it on Wednesday, September 17, from 3:50 to 4:05 p.m. SGT in AVG Session 3.
Another presentation will describe a single prophylactic dose of CD388 protecting ferrets against a deadly H5N1 influenza strain. Andreev Konstantin, Ph.D., will speak on Friday, September 19, from 10:30 a.m. to 12:30 p.m. SGT in Parallel Session 2 (Track 1).
Cidara’s Cloudbreak platform uses drug-Fc conjugates like CD388, a long-acting antiviral aiming to prevent seasonal and pandemic influenza with one dose.
Read Announcement- Drug:
- CD388
- Announced Date:
- June 23, 2025
- Indication:
- Universal Prevention and Treatment of Influenza
Announcement
Cidara Therapeutics, Inc. announced positive topline results from its randomized, double-blind, placebo-controlled Phase 2b NAVIGATE trial evaluating CD388 for the prevention of seasonal influenza in healthy unvaccinated adults aged 18 to 64.
AI Summary
Cidara Therapeutics, Inc. recently announced positive topline results from its Phase 2b NAVIGATE trial evaluating CD388 as a once-per-season approach to prevent seasonal influenza. In this randomized, double-blind, placebo-controlled study, healthy unvaccinated adults aged 18 to 64 received a single dose of CD388 at 150 mg, 300 mg, or 450 mg at the start of the flu season. Over 24 weeks, the trial showed that CD388 provided 58%, 61%, and 76% protection against symptomatic influenza for the 150 mg, 300 mg, and 450 mg doses, respectively, compared to placebo. All primary and secondary endpoints were met, with efficacy maintained up to 28 weeks at key temperature thresholds. Additionally, CD388 was well-tolerated, with no safety signals or serious adverse events reported across any dose groups.
Read Announcement- Drug:
- CD388
- Announced Date:
- March 18, 2025
- Indication:
- Universal Prevention and Treatment of Influenza
Announcement
Cidara Therapeutics, Inc. announced two upcoming presentations at the 38th International Conference on Antiviral Research (ICAR).
AI Summary
Cidara Therapeutics, Inc. announced two upcoming presentations at the 38th International Conference on Antiviral Research (ICAR), held in Las Vegas, Nevada from March 17-21, 2025.
The first presentation, titled "NAVIGATE: A Phase 2b, Randomized, Double-blind, Placebo-controlled, Multicenter Dose-ranging Study to Evaluate the Efficacy and Safety of CD388," will share the trial’s study design, participant demographics, and preliminary safety information from the ongoing trial involving more than 5,000 participants. The second presentation, "Real World Data-Based Modeling of Seasonal Influenza Variations to Support Clinical Dose Selection of CD388," will discuss how advanced modeling helps improve clinical dose selection. Both presentations, scheduled during specific poster sessions on March 18 and 20, aim to provide key insights into the trial results and dose optimization for future Phase 3 studies.
Read Announcement- Drug:
- CD388
- Announced Date:
- March 17, 2025
- Indication:
- Universal Prevention and Treatment of Influenza
Announcement
Cidara Therapeutics, Inc. announced the publication of preclinical data assessing CD388, the company's influenza DFC, in the peer-reviewed scientific journal Nature Microbiology.
AI Summary
Cidara Therapeutics recently published preclinical data in Nature Microbiology assessing its investigational drug-Fc conjugate, CD388. The study shows that CD388 has the potential to work as a potent, universal antiviral against influenza A and B viruses in both healthy and high-risk populations. Researchers demonstrated that CD388’s intrinsic antiviral activity can protect against various influenza strains, including severe and resistant types, regardless of the immune status of the subjects. The findings in mice indicate that the drug is effective even in immune-compromised models, suggesting broad protection without relying on a strong immune response.
The publication supports the promise of CD388 as a single-dose preventive treatment for influenza. This breakthrough could offer an alternative to vaccines, providing season-long protection that may be particularly beneficial during both seasonal and pandemic flu outbreaks.
Read Announcement- Drug:
- CD388
- Announced Date:
- December 4, 2024
- Indication:
- Universal Prevention and Treatment of Influenza
Announcement
Cidara Therapeutics, Inc. announced it has reached full planned enrollment of 5,000 subjects in the Phase 2b NAVIGATE trial across clinical sites in the US and UK.
AI Summary
Cidara Therapeutics has reached a major milestone by enrolling 5,000 subjects in its Phase 2b NAVIGATE trial at clinical sites in the United States and United Kingdom. This trial is designed to evaluate the safety, proper dosing, and effectiveness of CD388, a novel drug-Fc conjugate intended to prevent seasonal influenza. The investigational treatment aims to serve as a long-acting, universal influenza preventive through a single dose given at the start of the flu season.
The study targets healthy, unvaccinated adults, who will be monitored throughout the flu season for any breakthrough cases of influenza. Achieving this enrollment at the beginning of the northern hemisphere’s flu season positions Cidara Therapeutics to thoroughly assess CD388’s potential as a one-dose treatment, marking a significant development in the fight against seasonal influenza.
Read Announcement- Drug:
- CD388
- Announced Date:
- September 25, 2024
- Indication:
- Universal Prevention and Treatment of Influenza
Announcement
Cidara Therapeutics, Inc. announced two presentations at OPTIONS XII for the Control of Influenza conference, to be held September 29 through October 2, 2024 in Brisbane, Australia.
AI Summary
Cidara Therapeutics, Inc. announced that it will present two key sessions on its influenza drug candidate, CD388, at the upcoming OPTIONS XII for the Control of Influenza conference in Brisbane, Australia from September 29 to October 2, 2024. One session is an oral presentation scheduled for October 1, where Dr. Taylor Sandison will share safety data from Phase 1 and Phase 2a studies involving 108 subjects. The study reported that CD388, given by subcutaneous or intramuscular injection, was safe and well-tolerated across various doses. The second session, which is a poster presentation on September 29, will cover pharmacokinetic (PK) and safety results from a study involving 27 healthy Japanese participants. These findings reinforce the potential of CD388 to offer season-long protection against influenza A and B in both immune-compromised and immune-competent individuals.
Read Announcement- Drug:
- CD388
- Announced Date:
- September 23, 2024
- Indication:
- Universal Prevention and Treatment of Influenza
Announcement
Cidara Therapeutics, Inc. announced the first subjects dosed in the Phase 2b NAVIGATE trial to evaluate the efficacy and safety of CD388 for the pre-exposure prophylaxis of influenza during the current flu season.
AI Summary
Cidara Therapeutics, Inc. has begun dosing the first subjects in its Phase 2b NAVIGATE trial to test CD388 for preventing influenza before exposure. The trial is designed to study how effective and safe CD388 is during the current flu season. It will involve about 5,000 healthy adults who have not been vaccinated and are not at high risk from the flu. Participants will receive either one of three single doses of CD388 or a placebo at the start of the season. Researchers will follow the subjects throughout the flu season to compare rates of laboratory and clinically confirmed influenza cases. According to the company’s CEO, CD388 may offer a new way to prevent both seasonal and pandemic flu strains, especially for those who do not benefit as much from traditional vaccines.
Read Announcement- Drug:
- CD388
- Announced Date:
- September 12, 2024
- Indication:
- Universal Prevention and Treatment of Influenza
Announcement
Cidara Therapeutics, Inc. announced a reduction in its workforce to focus on the clinical development of CD388, the Company's novel DFC candidate for influenza A and B.
AI Summary
Cidara Therapeutics, Inc. has announced a strategic decision to reduce its workforce by around 30% to focus on the clinical development of CD388, its innovative drug-Fc conjugate (DFC) candidate for influenza A and B. This move is aimed at reducing capital needs and streamlining operations, allowing the company to concentrate resources on the upcoming Phase 2b trial of CD388. The candidate is designed to provide universal prevention against seasonal and pandemic influenza with just a single dose, potentially setting a new standard for flu prevention.
By making these changes, Cidara aims to speed up the advancement of CD388 while improving overall efficiency. The workforce reduction was a difficult but necessary choice to help ensure long-term success and the proper allocation of resources to this promising immunotherapy candidate.
Read Announcement
Cidara Therapeutics FDA Events - Frequently Asked Questions
As of now, Cidara Therapeutics (CDTX) has not received any FDA approvals for its therapy in the last two years.
In the past two years, Cidara Therapeutics (CDTX) has reported FDA regulatory activity for CD388.
The most recent FDA-related event for Cidara Therapeutics occurred on October 23, 2025, involving CD388. The update was categorized as "Late Breaking Presentation," with the company reporting: "Cidara Therapeutics, Inc. announced it gave a late-breaking presentation on its non-vaccine influenza preventative candidate, CD388, at the European Scientific Working Group on Influenza (ESWI)'s 10th Influenza Conference taking place October 20-23, 2025 in Valencia, Spain."
Currently, Cidara Therapeutics has one therapy (CD388) targeting the following condition: Universal Prevention and Treatment of Influenza.
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FDA Event Stage Terminology & Abbreviation Guide
- NDA: New Drug Application
- ANDA: Abbreviated New Drug Application
- sNDA: Supplemental New Drug Application
- BLA: Biologics License Application
- sBLA: Supplemental Biologics License Application
- FDA Approved: Approved by the FDA
- EMA: European Medicines Agency
- CE Mark: European Union Certification
- NMPA: China National Medical Products Administration
- MHLW: Japanese Ministry of Health
- FDA Meeting: Consultation with FDA
- Pre-IND: Pre-Investigational New Drug Meeting
- Breakthrough Therapy: Special FDA designation for promising therapies
- Fast Track: Accelerated FDA approval pathway
- Orphan Drug: Designation for rare disease treatments
- RPD: Rare Pediatric Disease Designation
- RMAT: Regenerative Medicine Advanced Therapy
- DSMB Review: Data Safety Monitoring Board Review
- IDMC Review: Independent Data Monitoring Committee
- MAA: MHRA Marketing Authorization Application
- RTF: Refusal to File (Rejected Application)
- 510(k): FDA Clearance for Medical Devices
- Rolling Submission: Staggered regulatory review process
FDA progress for NASDAQ:CDTX last updated on 10/23/2025 by MarketBeat.com Staff. We continuously monitor for new FDA events and market data.
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