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FAQ: Soligenix's Phase 3 FLASH2 Trial Milestone and HyBryte™ Development
TL;DR
Soligenix's Phase 3 FLASH2 trial shows a 48% blinded response rate, offering investors a potential advantage with Zacks' $25 per share valuation and an attractive risk-reward profile.
Soligenix reached milestone enrollment in its Phase 3 FLASH2 trial for HyBryte, with a 48% blinded response rate in CTCL patients, leading to a $25 per share valuation based on probability-adjusted discounted cash flow.
Soligenix's HyBryte therapy for cutaneous T-cell lymphoma addresses an unmet medical need, potentially improving treatment for rare diseases and enhancing patient quality of life worldwide.
Soligenix's novel photodynamic therapy uses safe visible light to treat CTCL, with a 48% response rate and a $25 per share valuation from Zacks Research.
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Soligenix has reached a milestone enrollment of 50 patients in its ongoing confirmatory Phase 3 FLASH2 trial for HyBryte™ (SGX301), a treatment for cutaneous T-cell lymphoma, with a 48% blinded response rate for patients who have completed treatment.
This milestone is significant because it advances the Phase 3 trial toward potential regulatory approval and commercialization of HyBryte™ for treating cutaneous T-cell lymphoma, a rare disease with unmet medical needs, and Zacks Research maintains a $25 per share valuation based on this progress.
HyBryte™ (also called SGX301 or synthetic hypericin) is Soligenix's novel photodynamic therapy that uses safe visible light to treat cutaneous T-cell lymphoma (CTCL), a type of cancer affecting the skin.
The 48% blinded response rate for patients who have completed treatment indicates encouraging clinical results, giving Zacks Research confidence that the trial is trending in the right direction toward potential success.
The next major catalyst mentioned is the second quarter 2026 interim analysis of the Phase 3 FLASH2 trial, which will provide further data on the treatment's effectiveness.
Zacks maintains a $25 per share valuation for Soligenix based on a probability-adjusted discounted cash flow model that considers potential future revenues from the company's product pipeline, including HyBryte™, SGX302, and SGX945.
Beyond HyBryte™, Soligenix has development programs including SGX302 for psoriasis, SGX942 for oral mucositis, SGX945 for Behçet's disease, and vaccine programs for ricin toxin, filoviruses (Marburg and Ebola), and COVID-19 (CiVax™).
You can visit Soligenix's website at www.Soligenix.com or view the full article at https://ibn.fm/e9XQ5 for more detailed information.
Curated from InvestorBrandNetwork (IBN)
