Biotech and Medical Tech Stocks to Watch - Big Moves Following Clinical Trial News October 8, 2025 - (Investorideas.com Newswire), a go-to investing platform covering biotech and medtech stocks releases an industry snapshot looking at recent clinical trial updates, featuring Aethlon Medical, Inc. (Nasdaq: AEMD), a medical therapeutic company focused on developing products to treat cancer and life-threatening infectious diseases. Recent clinical trial update news from Aethlon Medical, Inc. (Nasdaq: AE ...

FLASH 2 Study Interim Efficacy Analysis Targeted for 1H2026 HyBryteTM (0.25%) hypericin (PRNewsfoto/SOLIGENIX, INC.) "We are pleased to have reached this important milestone, confirming the expected safety to date in the confirmatory FLASH2 study," stated Christopher J. Schaber, PhD, President and Chief Executive Officer of Soligenix. "As patient enrollment continues to track with our initial estimates, we anticipate providing an update, including enrollment progress and the blinded aggregate response rate, ...

Core Viewpoint - Soligenix, Inc. is expanding its European Medical Advisory Board to enhance strategic guidance for the Phase 3 study of HyBryte™ in treating cutaneous T-cell lymphoma (CTCL), with top-line results expected in the second half of 2026 [1][2]. Company Overview - Soligenix is a late-stage biopharmaceutical company focused on developing treatments for rare diseases with unmet medical needs, particularly through its Specialized BioTherapeutics segment [20]. - The company is advancing HyBryte™ (SGX301), a novel photodynamic therapy utilizing synthetic hypericin, aimed at treating CTCL [20]. Clinical Study Details - The confirmatory Phase 3 study, named FLASH2, will enroll approximately 80 patients and is designed to replicate the successful elements of the previous Phase 3 FLASH trial, which showed a 49% treatment response rate [15]. - The FLASH2 study will extend the double-blind, placebo-controlled assessment to 18 weeks, with the primary endpoint assessed at the end of this period [15]. Advisory Board Expansion - The European Medical Advisory Board now includes five esteemed dermatologists, enhancing the company's expertise in clinical strategies and regulatory interactions [2][3][4][7][8]. - The board members are recognized leaders in the field of dermatology and CTCL, contributing valuable insights for the upcoming clinical study [2][3][4][7][8]. Treatment Mechanism and Efficacy - HyBryte™ employs synthetic hypericin activated by visible light, which penetrates deeper into the skin compared to ultraviolet light, potentially treating more severe skin conditions [9]. - In previous studies, HyBryte™ demonstrated a statistically significant improvement in lesion reduction compared to placebo, with a 16% response rate in the first treatment cycle [10]. Safety Profile - HyBryte™ is noted for its safety, with no systemic absorption and a mechanism of action that does not involve DNA damage, making it a safer alternative to existing therapies [14]. - The treatment has been well tolerated across multiple cycles, with a significant portion of patients opting to continue treatment in the optional safety cycle [13]. Market Context - CTCL is a rare form of non-Hodgkin's lymphoma affecting approximately 31,000 individuals in the U.S. and 38,000 in Europe, with no current cure available [19][18]. - The company aims to address the significant safety risks associated with existing treatments, positioning HyBryte™ as a potentially safer and effective option for patients [14].

Cash runway extended through 2026 to fund multiple expected key inflection points  , /PRNewswire/ -- Soligenix, Inc. (Nasdaq: SNGX) ("Soligenix" or the "Company"), a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need, today announced the closing of its previously announced "reasonable best efforts" public offering with participation from existing and certain healthcare focused institutional investors for the pu ...

Core Viewpoint - Soligenix, Inc. has announced a public offering of common stock and warrants, aiming to raise approximately $7.5 million to fund research, development, and general corporate purposes [3]. Group 1: Offering Details - The company is offering 5,555,560 shares of common stock and warrants to purchase an equal number of shares at a combined price of $1.35 per share and warrant [1]. - The existing warrants will be amended to have a reduced exercise price of $1.35 per share and will expire in line with the new warrants [2]. - The closing of the offering is expected around September 29, 2025, pending customary closing conditions [3]. Group 2: Use of Proceeds - The net proceeds from the offering will be utilized for research and development, commercialization activities, working capital, and general corporate purposes [3]. Group 3: Company Overview - Soligenix is a late-stage biopharmaceutical company focused on developing products for rare diseases with unmet medical needs [7]. - The company is advancing HyBryte™ (SGX301) for the treatment of cutaneous T-cell lymphoma and has completed a second Phase 3 study [7]. - Other development programs include treatments for psoriasis, inflammatory diseases, and a ricin toxin vaccine candidate [8].

Core Insights - Soligenix, Inc. has appointed Dr. Tomas J. Philipson as a Strategic Advisor, bringing extensive experience in U.S. economic and healthcare policy to the company [1][2][3] - The company is advancing its lead product candidate, HyBryte, which is currently in a confirmatory Phase 3 clinical trial for the treatment of cutaneous T-cell lymphoma (CTCL) [3][9] Company Overview - Soligenix is a late-stage biopharmaceutical company focused on developing and commercializing products for rare diseases with unmet medical needs [15] - The company’s Specialized BioTherapeutics segment is working on HyBryte, a novel photodynamic therapy utilizing synthetic hypericin for CTCL treatment [15] Product Details - HyBryte (SGX301) is a first-in-class photodynamic therapy that uses safe, visible light for activation, targeting malignant T-cells in skin lesions [4] - The treatment has shown significant efficacy in clinical trials, with a 16% response rate in the first treatment cycle compared to 4% in the placebo group [5] - In the second treatment cycle, a 40% response rate was observed among patients receiving 12 weeks of HyBryte treatment [6] Clinical Trials - The first Phase 3 FLASH trial enrolled 169 patients, demonstrating statistically significant improvements in lesion reduction [5] - A second confirmatory Phase 3 trial, FLASH2, is expected to begin before the end of 2024, aiming to replicate the successful design of the first trial [9][10] - The FDA has awarded a $2.6 million Orphan Products Development grant to support an investigator-initiated study of HyBryte for early-stage CTCL [12] Market Context - CTCL is a rare form of non-Hodgkin's lymphoma affecting approximately 31,000 individuals in the U.S. and 38,000 in Europe, with no current cure available [14][13] - The safety profile of HyBryte is a significant advantage, as it is not associated with DNA damage, unlike many existing therapies [8]

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Core Viewpoint - Soligenix, Inc. has demonstrated the extended stability of its ebolavirus vaccines using the ThermoVax® platform, maintaining potency after two years at high temperatures, which is crucial for deployment in virus-endemic regions and for pandemic preparedness [1][2]. Group 1: Vaccine Stability and Efficacy - The bivalent and trivalent vaccines, targeting Zaire ebolavirus, Sudan ebolavirus, and Marburg marburgvirus, showed no change in potency after two years of storage at 40°C (104°F) [1]. - The vaccines have exhibited broad immune responses in mice and up to 100% protection in non-human primates [2][3]. - The ThermoVax® platform enhances the stability of vaccines, making them competitive with other technologies that require stringent cold-storage [2][3]. Group 2: Vaccine Development and Manufacturing - The filovirus vaccines are subunit protein vaccines developed in collaboration with Dr. Axel Lehrer, utilizing a robust protein manufacturing process [3][4]. - The vaccines are designed to be heat-stable and can be lyophilized, allowing for easy reconstitution with water prior to use [3]. - The adjuvant used in the vaccines has been tested in Phase 1 and Phase 2 clinical studies, supporting its safety and efficacy [4]. Group 3: Regulatory and Market Position - Soligenix has received Orphan Drug Designation from the FDA for its filovirus vaccines, providing market exclusivity and various financial benefits [5]. - The company is positioned to leverage government grants and regulatory advantages to support clinical trials and potential market entry [5]. Group 4: Public Health Context - Filoviruses, including Ebola and Marburg, have high mortality rates and limited treatment options, highlighting the need for effective vaccines [6][7]. - Recent outbreaks of Sudan and Marburg viruses underscore the importance of developing vaccines that can be stored and distributed easily in affected regions [6][7].

Company Overview - Soligenix, Inc. is a late-stage biopharmaceutical company focused on developing and commercializing products for rare diseases with unmet medical needs [3] - The company has a Specialized BioTherapeutics segment that is advancing HyBryte™ (SGX301), a novel photodynamic therapy for cutaneous T-cell lymphoma (CTCL), towards potential commercialization following the successful completion of a second Phase 3 study [3] - Other development programs include SGX302 for psoriasis, SGX942 for inflammatory diseases, and SGX945 for Behçet's Disease [3] Public Health Solutions - The Public Health Solutions segment includes the development of RiVax®, a ricin toxin vaccine candidate, and vaccines targeting filoviruses and COVID-19 [4] - The vaccine programs utilize the proprietary ThermoVax® technology and have received support from government grants and contracts from agencies such as NIAID, DTRA, and BARDA [4] Upcoming Events - Christopher J. Schaber, Ph.D., President and CEO of Soligenix, will present at the H.C. Wainwright 27th Annual Global Investment Conference from September 8-10, 2025, with an on-demand presentation available on September 5, 2025 [1] - Key management members will hold one-on-one meetings throughout the conference, and registered attendees can schedule meetings via the conference platform [2]

Core Viewpoint - Soligenix, Inc. has seen a significant increase in stock price following the U.S. FDA granting orphan drug designation to dusquetide for Behçet's Disease, supported by recent positive clinical trial results demonstrating efficacy and safety [1][6]. Company Summary - The orphan drug designation provides Soligenix with a seven-year market exclusivity upon final FDA approval, along with various financial and regulatory benefits such as government grants for clinical trials, waiver of FDA user fees for New Drug Application submission, and certain tax credits [3]. - Dusquetide has shown safety and tolerability in a Phase 1 study involving 84 healthy volunteers, and positive efficacy results in Phase 2 and 3 studies with over 350 subjects suffering from oral mucositis due to chemoradiation therapy for head and neck cancer [6]. - The stock price of Soligenix has increased by 67.29%, reaching $4.65 at the time of publication [7]. Industry Summary - Behçet's Disease is a rare inflammatory disorder affecting up to 18,000 people in the U.S., 50,000 in Europe, 350,000 in Turkey, and potentially one million people worldwide, characterized by painful sores and eye inflammation [4]. - The U.S. Orphan Drug Act aims to encourage the development of therapies for rare diseases, providing incentives for companies like Soligenix to invest in these areas [2].