This section highlights FDA-related milestones and regulatory updates for drugs developed by Soligenix (SNGX).
Over the past two years, Soligenix has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
HyBryte, MarVax, and SuVax. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
HyBryte - FDA Regulatory Timeline and Events
HyBryte is a drug developed by Soligenix for the following indication: In the treatment of cutaneous T-cell lymphoma (CTCL).
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:
- HyBryte
- Announced Date:
- July 8, 2025
- Indication:
- In the treatment of cutaneous T-cell lymphoma (CTCL)
Announcement
Soligenix Corporate Update Letter - Key Highlights and Upcoming Milestones
AI Summary
Soligenix’s update letter highlights several key milestones for its rare disease pipeline. The company is focused on advancing its confirmatory Phase 3 FLASH2 trial for HyBryte™ in early-stage cutaneous T-cell lymphoma. Top-line results from this study are expected in the second half of 2026, with updated enrollment news coming later this year. The update also notes upcoming clinical milestones, including top-line results from a Phase 2a trial for mild-to-moderate psoriasis with SGX302 in Q4 2025, and from a Phase 2a proof-of-concept trial for Behçet’s Disease with SGX945 in Q3 2025.
The CEO emphasized the company’s efforts in exploring strategic options, such as partnerships or mergers and acquisitions. These milestones, if achieved, may drive significant commercial returns and position Soligenix for stronger market success in its focused rare disease portfolio.
Read Announcement- Drug:
- HyBryte
- Announced Date:
- April 14, 2025
- Indication:
- In the treatment of cutaneous T-cell lymphoma (CTCL)
Announcement
Soligenix, Inc announced interim results from the ongoing open-label, investigator-initiated study (IIS) evaluating extended HyBryte™ (synthetic hypericin) treatment for up to 54 weeks in patients with early-stage cutaneous T-cell lymphoma (CTCL).
AI Summary
Soligenix, Inc. announced interim results from an open-label, investigator-initiated study evaluating extended treatment with HyBryte™ (synthetic hypericin) in patients with early-stage cutaneous T-cell lymphoma (CTCL). The study allows treatment for up to 54 weeks, and data from the Week 18 timepoint showed that 75% of evaluated patients achieved “Treatment Success,” which is defined as a 50% or greater improvement in lesion severity scores.
Lead investigator Dr. Ellen Kim of the University of Pennsylvania noted that this rapid response is a clear advantage over other CTCL treatments, which typically take six to 12 months to show meaningful improvements. The encouraging interim results suggest that HyBryte™ is well tolerated and may offer a faster, effective treatment option for patients with this challenging and underserved condition.
Read Announcement- Drug:
- HyBryte
- Announced Date:
- January 14, 2025
- Indication:
- In the treatment of cutaneous T-cell lymphoma (CTCL)
Announcement
Soligenix, Inc announced an interim update on the open-label, investigator-initiated study (IIS) evaluating extended HyBryte™ (synthetic hypericin) treatment for up to 12 months in patients with early-stage cutaneous T-cell lymphoma (CTCL).
AI Summary
Soligenix, Inc. announced an interim update on an open-label, investigator-initiated study evaluating extended HyBryte™ (synthetic hypericin) treatment for up to 12 months in patients with early-stage cutaneous T-cell lymphoma (CTCL). In this trial, nine patients have been treated for up to 54 weeks. Among the six subjects who have completed at least 18 weeks of therapy, over 70% achieved "Treatment Success," defined as a 50% or greater improvement in the cumulative mCAILS score compared to baseline.
Notably, three patients reached their treatment goals within the first 12 weeks, and two achieved a complete response by 18 weeks. While two patients recently started treatment and two have dropped out due to logistical reasons, early results indicate that HyBryte™ is safe and well tolerated. The positive interim results support further evaluation of extended therapy in a real-world setting.
Read Announcement- Drug:
- HyBryte
- Announced Date:
- December 16, 2024
- Indication:
- In the treatment of cutaneous T-cell lymphoma (CTCL)
Announcement
Soligenix, Inc said it has opened patient enrollment for its confirmatory Phase 3 study evaluating HyBryte (synthetic hypericin) for cutaneous T-cell lymphoma (CTCL).
AI Summary
Soligenix, Inc. has begun enrolling patients for FLASH2, its confirmatory Phase 3 study evaluating HyBryte™ (synthetic hypericin) for the treatment of cutaneous T-cell lymphoma (CTCL). This study will enroll around 80 patients in the United States and Europe. FLASH2 is a randomized, double-blind, placebo-controlled, multicenter trial that extends the treatment duration to a continuous 18-week course, compared to the previous study design. The trial’s primary efficacy endpoint will be measured after the 18-week treatment period, aiming to confirm and expand upon earlier positive results seen in patients with early-stage CTCL. With strong engagement from the CTCL community, medical advisory boards, and patient advocacy groups, accelerated enrollment is anticipated. A formal interim analysis is expected early in 2026, paving the way for potential regulatory advancement of HyBryte™ as a new treatment option.
Read Announcement- Drug:
- HyBryte
- Announced Date:
- November 19, 2024
- Indication:
- In the treatment of cutaneous T-cell lymphoma (CTCL)
Announcement
Soligenix, Inc announced the formation of a European Medical Advisory Board (MAB) to provide additional medical/clinical strategic guidance to the Company as it advances its confirmatory Phase 3 multicenter, double-blind, placebo-controlled study evaluating the safety and efficacy of HyBryte™ (synthetic hypericin) in the treatment of cutaneous T-cell lymphoma (CTCL) patients with early-stage disease.
AI Summary
Soligenix, Inc. has formed a European Medical Advisory Board (MAB) made up of leading CTCL experts. This Board will provide crucial medical and clinical guidance as the company advances its confirmatory Phase 3 multicenter, double-blind, placebo-controlled study. The trial is designed to evaluate the safety and effectiveness of HyBryte™ (synthetic hypericin) in treating early-stage cutaneous T-cell lymphoma (CTCL). Approximately 80 patients in the U.S. and Europe are expected to participate during this 18-week study, with patient enrollment scheduled to begin by the end of 2024 and top-line results anticipated in the second half of 2026.
The involvement of these respected European clinicians will help shape clinical strategies, improve study design, and guide key regulatory interactions, strengthening Soligenix’s efforts to offer a new treatment option for CTCL patients worldwide.
Read Announcement- Drug:
- HyBryte
- Announced Date:
- October 7, 2024
- Indication:
- In the treatment of cutaneous T-cell lymphoma (CTCL)
Announcement
Soligenix, Inc. announced that that two of its lead investigators are presenting findings from recent additional, supportive trials with HyBryte™ (synthetic hypericin) in the treatment of cutaneous T-cell lymphoma (CTCL).
AI Summary
Soligenix, Inc. announced that two lead investigators will present new findings from additional supportive trials of HyBryte™ (synthetic hypericin) for treating cutaneous T-cell lymphoma (CTCL). Dr. Ellen Kim from the University of Pennsylvania will share expanded preliminary results from her investigator-initiated study, emphasizing the usefulness of extended treatment times. Meanwhile, Dr. Brian Poligone of the Rochester Skin Lymphoma Medical Group will present data from two extra treatment studies that evaluated the advantages of longer therapy duration and increased light doses.
The results from these trials show that prolonged treatment with HyBryte™ leads to improved response rates, while the product maintains a strong safety profile with little to no systemic exposure. These presentations will take place at the European Organisation for Research and Treatment of Cancer (EORTC) Cutaneous Lymphoma Tumour Group Annual Meeting in Lausanne, Switzerland, highlighting promising advancements in CTCL therapy.
Read Announcement- Drug:
- HyBryte
- Announced Date:
- August 1, 2024
- Indication:
- In the treatment of cutaneous T-cell lymphoma (CTCL)
Announcement
PCG Digital -- Soligenix, Inc a late-stage biopharmaceutical company, is making significant strides in the treatment of Cutaneous T-Cell Lymphoma (CTCL) with its investigational drug, HyBryte™.
AI Summary
Soligenix, Inc., a late-stage biopharmaceutical company, is making significant strides in the treatment of Cutaneous T-Cell Lymphoma (CTCL) with its investigational drug HyBryte™. The company announced interim results for extended HyBryte treatment in early-stage CTCL patients, which have sparked interest due to the positive early indications. This development highlights the potential of HyBryte to provide a new treatment option for a difficult-to-treat form of lymphoma, offering hope to patients who currently have limited choices. The promising results underline Soligenix’s commitment to innovative therapies and mark an important step forward in the advancement of targeted treatments for CTCL. Overall, this progress is drawing attention in the biotech community as the company continues to explore effective methods to manage and treat this rare disease.
Read Announcement- Drug:
- HyBryte
- Announced Date:
- July 9, 2024
- Indication:
- In the treatment of cutaneous T-cell lymphoma (CTCL)
Announcement
Soligenix, Inc announced an interim update on the open-label, investigator-initiated study (IIS) evaluating extended HyBryte™ treatment for up to 12 months in patients with early-stage cutaneous T-cell lymphoma (CTCL).
AI Summary
Soligenix, Inc. has provided an interim update on its investigator-initiated, open-label study evaluating extended use of HyBryte™ for up to 12 months in patients with early-stage cutaneous T-cell lymphoma (CTCL). In this trial, six patients have been treated, with durations reaching up to 44 weeks. Among the four patients who have completed at least 12 weeks of therapy, three (75%) have already achieved “Treatment Success”—defined as a 50% or greater improvement in their mCAILS scores from baseline. Two of these successes were noted within the first 12 weeks, and one within 18 weeks. The study indicates that extended HyBryte™ therapy may enhance treatment outcomes, and early data suggest the treatment is safe and well tolerated, with no treatment-related adverse events reported thus far.
Read Announcement- Drug:
- HyBryte
- Announced Date:
- June 25, 2024
- Indication:
- In the treatment of cutaneous T-cell lymphoma (CTCL)
Announcement
Soligenix, Inc announced positive clinical results from a comparability study evaluating HyBryte™ (synthetic hypericin) versus Valchlor® (mechlorethamine gel) in the treatment of cutaneous T-cell lymphoma (CTCL).
AI Summary
Soligenix, Inc. announced positive clinical results from a study comparing HyBryte™ (synthetic hypericin) with Valchlor® (mechlorethamine gel) in treating cutaneous T-cell lymphoma (CTCL). In this open-label study, 10 patients were divided equally between the two treatments. After 12 weeks, 60% of the patients using HyBryte™ achieved a 50% or more improvement in their mCAILS scores, compared to only 20% of the Valchlor® group. Also, HyBryte™ showed a better safety profile, as no patients experienced adverse skin reactions, while several on Valchlor® did, including one who had to stop treatment due to allergic contact dermatitis. These results suggest that HyBryte™ not only works faster but also is safer for patients with CTCL, supporting its potential as an effective alternative treatment option.
Read Announcement- Drug:
- HyBryte
- Announced Date:
- May 21, 2024
- Indication:
- In the treatment of cutaneous T-cell lymphoma (CTCL)
Announcement
PRISM MarketView Highlights Soligenix, Inc. as it Builds on Compelling Phase 3 Data with Key Catalysts on the Horizon
AI Summary
PRISM MarketView recently spotlighted Soligenix, Inc., emphasizing the company’s strong progress following promising Phase 3 data for HyBryte™, a synthetic hypericin treatment for cutaneous T-cell lymphoma (CTCL). The successful trial achieved statistical significance in its primary endpoint and paves the way for a second confirmatory Phase 3 study scheduled to begin in 2024 across the US and Europe. This milestone is seen as a major catalyst for the company, bolstering confidence in HyBryte’s potential for global regulatory approval. In addition to this success, Soligenix is advancing other critical programs, including studies for SGX302 in psoriasis and SGX945 for aphthous mouth ulcers in Behçet’s Disease. The company’s innovative approach is further highlighted by its use of the ThermoVax process to develop heat-stable vaccines, aiming to address unmet medical needs and expand its therapeutic portfolio.
Read Announcement- Drug:
- HyBryte
- Announced Date:
- May 16, 2024
- Indication:
- In the treatment of cutaneous T-cell lymphoma (CTCL)
Announcement
Soligenix, Inc announced today that the results of its compatibility study evaluating HyBryte™ (synthetic hypericin) for the treatment of cutaneous T-cell lymphoma (CTCL) have been published in the Journal of the European Academy of Dermatology & Venereology (JEADV) Clinical Practice.
AI Summary
Soligenix, Inc announced the publication of its latest study results in the Journal of the European Academy of Dermatology & Venereology (JEADV) Clinical Practice. The study focused on the compatibility of HyBryte™, a synthetic form of hypericin, for treating cutaneous T-cell lymphoma (CTCL). The research highlights how HyBryte interacts within the body and its potential use as a therapeutic option for CTCL, a rare type of skin lymphoma.
The compatibility study offers insights into HyBryte’s safety and efficacy, presenting data that could influence future treatment protocols for CTCL patients. The publication in JEADV Clinical Practice underscores the significance of the findings and the ongoing scientific efforts to explore new treatments for challenging skin cancers. This development is an important step for those impacted by CTCL and provides a promising outlook for novel treatment avenues.
Read Announcement
MarVax - FDA Regulatory Timeline and Events
MarVax is a drug developed by Soligenix for the following indication: Against Marburg Marburgvirus Infection.
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:
- MarVax
- Announced Date:
- May 21, 2024
- Indication:
- Against Marburg Marburgvirus Infection
Announcement
Soligenix, Inc announced today that Professor Axel Lehrer, University of Hawaiʽi at Mānoa (UHM), will be presenting key data from the Company's thermostable vaccine technology platform developed in collaboration with UHM, including results from the filovirus vaccine candidates for both Sudan ebolavirus (SuVax™) and Marburg marburgvirus (MarVax™). The presentation will be given at the upcoming Vaccine Technology IX, Los Cabos, Mexico, May 19-24, 2024.
AI Summary
Soligenix, Inc. announced that Professor Axel Lehrer from the University of Hawaiʽi at Mānoa will present key data at the Vaccine Technology IX Conference in Los Cabos, Mexico from May 19-24, 2024. His presentation will showcase the company’s thermostable vaccine technology platform developed in collaboration with UHM. The data will include results from the filovirus vaccine candidates SuVax™ for Sudan ebolavirus and MarVax™ for Marburg marburgvirus. These vaccines, designed using a novel lyophilization process and GRAS excipients, have shown promising results in preclinical studies, providing 100% protection in non-human primate challenge trials. The thermostable formulations could simplify distribution, as they remain effective at higher temperatures. This presentation highlights a significant step forward in developing accessible, heat-stable vaccines to combat diseases caused by filoviruses.
Read Announcement- Drug:
- MarVax
- Announced Date:
- April 15, 2024
- Indication:
- Against Marburg Marburgvirus Infection
Announcement
Soligenix, Inc announced that the Office of Orphan Products Development of the United States (U.S.) Food and Drug Administration (FDA) has granted orphan drug designation to the active ingredient in MarVax™, the subunit protein vaccine of recombinantly expressed Marburg marburgvirus (MARV) glycoprotein, for "the prevention and post-exposure prophylaxis against MARV infection."
AI Summary
Soligenix, Inc. announced that the FDA’s Office of Orphan Products Development has granted orphan drug designation for the active ingredient in MarVax™, its subunit protein vaccine. This designation supports the vaccine’s use in both preventing and providing post-exposure prophylaxis against Marburg marburgvirus (MARV) infection. Under the U.S. Orphan Drug Act, this status is intended to promote the development of medical products for rare diseases, which affect fewer than 200,000 people in the United States.
With the orphan designation, MarVax™ could gain significant benefits including a seven-year market exclusivity period upon FDA approval, government grants to accompany clinical trials, waivers for certain FDA user fees, and eligibility for tax credits. These benefits may help advance the vaccine’s path to providing a critical health solution for a highly fatal viral infection.
Read Announcement
SuVax - FDA Regulatory Timeline and Events
SuVax is a drug developed by Soligenix for the following indication: For the Prevention and Post-Exposure Prophylaxis.
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:
- SuVax
- Announced Date:
- June 14, 2024
- Indication:
- For the Prevention and Post-Exposure Prophylaxis
Announcement
Soligenix, Inc. announced today that Professor Axel Lehrer, University of Hawaiʽi at Mānoa (UHM), will be presenting key data from the Company's thermostable vaccine technology platform developed in collaboration with UHM, including results from the filovirus vaccine candidates for both Sudan ebolavirus (SuVax™) and Marburg marburgvirus (MarVax™).
AI Summary
Soligenix, Inc. announced that Professor Axel Lehrer from the University of Hawaiʽi at Mānoa will present important data on their thermostable vaccine platform. The presentation, taking place at the upcoming ASM Microbe Conference in Atlanta, will focus on the vaccine candidates developed for filoviruses. Specifically, Professor Lehrer will share key results from the filovirus vaccines SuVax™ for Sudan ebolavirus and MarVax™ for Marburg marburgvirus. These vaccine candidates use a protein subunit approach, combined with a novel adjuvant and safe excipients, to create a heat-stable, single-vial formulation. This technology simplifies storage and distribution by eliminating the need for extremely low temperatures while still inducing a strong immune response. The data presented at the conference highlights significant progress in vaccine development that could help protect against deadly outbreaks caused by these filoviruses.
Read Announcement- Drug:
- SuVax
- Announced Date:
- May 21, 2024
- Indication:
- For the Prevention and Post-Exposure Prophylaxis
Announcement
Soligenix, Inc announced today that Professor Axel Lehrer, University of Hawaiʽi at Mānoa (UHM), will be presenting key data from the Company's thermostable vaccine technology platform developed in collaboration with UHM, including results from the filovirus vaccine candidates for both Sudan ebolavirus (SuVax™) and Marburg marburgvirus (MarVax™). The presentation will be given at the upcoming Vaccine Technology IX, Los Cabos, Mexico, May 19-24, 2024.
AI Summary
Soligenix, Inc. announced that Professor Axel Lehrer from the University of Hawaiʻi at Mānoa will present key data on the company’s thermostable vaccine technology platform at the Vaccine Technology IX conference in Los Cabos, Mexico from May 19-24, 2024. This presentation will highlight important advancements in vaccine formulations for challenging filoviruses.
Professor Lehrer’s talk will focus on data from vaccine candidates targeting Sudan ebolavirus (SuVax™) and Marburg marburgvirus (MarVax™). Developed in collaboration with UHM, the technology uses a combination of Generally Recognized as Safe excipients and a freeze-drying process to produce a single-vial vaccine that remains stable at higher temperatures. Early studies in non-human primates have shown complete protection, marking a promising step forward in combatting these deadly viruses.
Read Announcement- Drug:
- SuVax
- Announced Date:
- April 25, 2024
- Indication:
- For the Prevention and Post-Exposure Prophylaxis
Announcement
Soligenix, Inc. announced that it has received notice of intent to grant additional patents based on its patent application titled "Compositions and Methods of Manufacturing Trivalent Filovirus Vaccines" in the United Kingdom and South Africa, with other international jurisdictions pending.
AI Summary
Soligenix, Inc. announced that it has received notice of intent to grant additional patents for its innovative approach to vaccine manufacturing. The patents are based on the application titled "Compositions and Methods of Manufacturing Trivalent Filovirus Vaccines" and are set to be granted in the United Kingdom and South Africa, with additional filings pending in other international jurisdictions. The patent claims focus on unique proprietary compositions and methods that combine glycoprotein antigens with nanoemulsion adjuvants, specifically sucrose fatty acid esters, before lyophilization. This technique has successfully been applied to develop vaccines for deadly filoviruses, including Ebola and Marburg. By securing these patents, Soligenix strengthens its intellectual property portfolio, potentially paving the way for broader global access to thermostable vaccine formulations that could enhance outbreak response and overall public health preparedness.
Read Announcement- Drug:
- SuVax
- Announced Date:
- April 11, 2024
- Indication:
- For the Prevention and Post-Exposure Prophylaxis
Announcement
Soligenix, Inc announced that the Office of Orphan Products Development of the United States (U.S.) Food and Drug Administration (FDA) has granted orphan drug designation to the active ingredient in SuVax™, the subunit protein vaccine of recombinantly expressed Sudan ebolavirus (SUDV) glycoprotein, for "the prevention and post-exposure prophylaxis against SUDV infection."
AI Summary
Soligenix, Inc. announced that the FDA’s Office of Orphan Products Development has granted orphan drug designation for the active ingredient in SuVax™. This designation applies to the subunit protein vaccine, which is made from recombinantly expressed Sudan ebolavirus glycoprotein. SuVax™ is designed for the prevention and post-exposure prophylaxis against Sudan ebolavirus (SUDV) infection. The orphan drug designation is a significant milestone because it positions the vaccine for a seven‐year period of market exclusivity, pending final FDA approval. Additionally, this status brings various benefits, such as access to government grants for clinical trials, the waiver of costly FDA user fees associated with licensing applications, and eligibility for certain tax credits. This strategic move aims to support the development of a crucial vaccine for a rare and potentially lethal disease, fulfilling an unmet medical need in combating Sudan ebolavirus infections.
Read Announcement
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