Soligenix Inc Stock Price, News & Analysis

Soligenix (Nasdaq: SNGX) reported completion of enrollment of 50 of 80 patients required for a planned interim analysis in its confirmatory Phase 3 FLASH2 study of HyBryte for cutaneous T‑cell lymphoma (CTCL).

The company said the blinded study response rate to date is 48%, above the study's anticipated blinded estimate of 25%. The Data Monitoring Committee will perform the interim analysis in Q2 2026 and topline results are expected in the second half of 2026. The announcement references prior Phase 3 FLASH results (49% response at 18 weeks) and an investigator study reporting 75% response at 18 weeks. The company also noted a benign safety profile observed to date.

Soligenix (Nasdaq: SNGX) reported third quarter 2025 results and recent program updates on Nov 7, 2025. The company reported no revenue for Q3 2025 and a net loss of $2.5 million (($0.58) per share). Research and development expense was $1.6 million for the quarter, driven by costs for a second confirmatory Phase 3 CTCL trial and contract manufacturing.

Clinical progress: the first DMC review of the Phase 3 HyBryte™ CTCL study found no safety concerns, enrollment remains on track, and top-line Phase 3 results are anticipated in H2 2026. Cash was approximately $10.5 million at Sept 30, 2025; management said this provides runway through 2026 while evaluating strategic options.

Soligenix (Nasdaq: SNGX) announced an update to its U.S. Medical Advisory Board (MAB) for cutaneous T‑cell lymphoma (CTCL) to support the Phase 3 FLASH2 pivotal study of HyBryte (synthetic hypericin) on October 14, 2025. The refreshed MAB includes dermatology and oncology leaders who have served as HyBryte principal investigators and will advise on clinical strategy, patient needs, potential home‑use applications, health economics, reimbursement and worldwide regulatory interactions. The release lists MAB members and credentials, noting clinical experience such as treating >1,000 lymphoma patients and principal‑investigator roles across HyBryte trials.

Soligenix (Nasdaq: SNGX) reported that the first Data Monitoring Committee meeting for its confirmatory Phase 3 FLASH2 study of HyBryte found no safety concerns and an acceptable safety profile consistent with prior trials.

Enrollment is proceeding on track with an ~80-subject randomized, double-blind, placebo-controlled design; an enrollment update is expected in 4Q2025. The DMC will support a pre-specified blinded interim efficacy analysis targeted for 1H2026, and topline results remain planned for the second half of 2026. The summary notes the earlier FLASH Phase 3 observed a 49% treatment response (p<0.0001) in patients completing 18 weeks of therapy.

Soligenix (NASDAQ:SNGX) has announced the expansion of its European Medical Advisory Board (MAB) to support its confirmatory Phase 3 study of HyBryte™ for treating cutaneous T-cell lymphoma (CTCL). The expanded board includes two new esteemed dermatologists, bringing the total to five internationally renowned physicians.

The Phase 3 study will be an 18-week, multicenter, double-blind, placebo-controlled trial evaluating HyBryte™ in early-stage CTCL patients. The study aims to enroll approximately 80 patients with top-line results expected in the second half of 2026.

The expanded MAB will provide strategic guidance for the clinical study, regulatory interactions, and aspects such as health economics and reimbursement. The board includes distinguished members from France, Italy, Spain, the UK, and the Netherlands, each bringing extensive experience in CTCL research and treatment.

Soligenix (NASDAQ:SNGX) has successfully closed its previously announced public offering, raising $7.5 million in gross proceeds. The offering consisted of 5,555,560 shares of common stock (or equivalents) and warrants at a combined price of $1.35 per share and accompanying warrant.

The warrants are immediately exercisable at $1.35 per share and will expire in five years. Additionally, certain existing warrants from May 2023, April 2024, and July 2024 will be amended to match the new $1.35 exercise price. The funding extends Soligenix's cash runway through 2026, supporting research, development, and commercialization activities.

Soligenix (NASDAQ:SNGX), a late-stage biopharmaceutical company, has announced the pricing of a $7.5 million public offering. The offering includes 5,555,560 shares of common stock (or equivalents) and warrants at a combined price of $1.35 per share and warrant.

The warrants will have an exercise price of $1.35, immediate exercisability, and a five-year expiration. Additionally, certain existing warrants from May 2023, April 2024, and July 2024 will be amended to match the new $1.35 exercise price. The offering is expected to close around September 29, 2025, with A.G.P./Alliance Global Partners serving as the sole placement agent.

Soligenix (NASDAQ:SNGX), a late-stage biopharmaceutical company, has appointed former White House Economic Adviser Dr. Tomas J. Philipson as Strategic Advisor. Dr. Philipson brings extensive experience in U.S. economic and healthcare policy, having served as vice chairman and acting chairman of the White House Council of Economic Advisers from 2017 to 2020.

Dr. Philipson's notable experience includes advisory roles at the FDA and CMS, and he currently serves as Managing Partner at MEDA Ventures. His appointment comes as Soligenix advances HyBryte™, its lead product candidate, through a confirmatory Phase 3 clinical trial, along with other fast-tracked rare disease pipeline programs.

Soligenix (Nasdaq: SNGX) announced the successful long-term stability testing of its ebolavirus vaccines using the ThermoVax® platform. The company demonstrated that both bivalent and trivalent vaccine formulations maintained their potency after two years of storage at temperatures up to 40°C (104°F).

In collaboration with the University of Hawaiʻi, the vaccines, which target Zaire ebolavirus, Sudan ebolavirus, and Marburg marburgvirus, showed significant stability advantages. The vaccines only require reconstitution with sterile water before use, eliminating complex cold-storage requirements typical of other vaccine technologies.

The research highlights the potential of Soligenix's ThermoVax® platform in developing thermostable vaccines that could improve global vaccination efforts, particularly in virus-endemic African regions and strategic national stockpiles.