Soligenix Successfully Completes U.S. Manufacturing Transfer of Synthetic Hypericin with Sterling Pharma Solutions

July 1, 2025

DENVER, Colo., Jul 01, 2025 (247marketnews.com)- Soligenix (NASDAQ:SNGX) successfully completed the U.S.-based manufacturing process transfer for synthetic hypericin, the active pharmaceutical ingredient in its topical drug candidates HyBryte and SGX302. The process transfer, conducted in partnership with Sterling Pharma Solutions, included optimization and implementation of a commercially viable and scalable cGMP manufacturing process. Synthetic hypericin is a potent photosensitizer developed for the treatment of cutaneous T-cell lymphoma (CTCL) and psoriasis.

Soligenix and Sterling have now enabled U.S.-based cGMP production for ongoing clinical development and potential future commercialization.

Christopher J. Schaber, PhD, President and CEO of Soligenix, said, “We are pleased to have successfully produced larger quantities of cGMP synthetic hypericin, and look forward to continuing to work with Sterling to refine the process for process validation while further reducing our cost of goods. We look forward to building on our already strong relationship to advance our topical hypericin clinical programs, most notably, HyBryte for the treatment of early-stage CTCL, toward potential commercialization worldwide.”

“Sterling is pleased to be collaborating with Soligenix on this important program. We believe that Sterling’s expertise in active pharmaceutical ingredient manufacturing, including developing innovative solutions such as continuous flow chemistry for this product, will continue to provide great value to the Soligenix program while we work towards a commercial supply agreement,” added Adam Kujath, Site Head at Sterling Pharma Solutions’ Germantown, WI facility.

About HyBryte

HyBryte (research name SGX301) is a first-in-class photodynamic therapy that uses synthetic hypericin activated by visible red-yellow spectrum light to treat CTCL. The treatment is topically applied and selectively targets malignant T-cells in skin lesions. This mechanism allows for deeper penetration than UV light, with minimal risk of secondary malignancies, offering a safer alternative to DNA-damaging therapies.

HyBryte has demonstrated statistically significant results in a Phase 2 trial and in the pivotal Phase 3 FLASH study, with additional favorable data from extended treatment cycles. The product has received orphan drug and fast track designations from the FDA, as well as orphan designation from the EMA.

Following discussions with both the FDA and EMA, a second Phase 3 confirmatory study, FLASH 2, is expected to launch before the end of 2024. The study will enroll approximately 80 early-stage CTCL patients, with primary endpoints assessed after 18 weeks of continuous, double-blind treatment.

The FDA has also awarded a $2.6 million Orphan Products Development grant to the University of Pennsylvania to further evaluate HyBryte in expanded settings, including at-home treatment.

Soligenix continues to engage with regulators while advancing HyBryte toward global commercialization, supported by its newly established U.S. supply chain.

About 24/7 Market News
As a pioneer in digital financial market media, 24/7 Market News (24/7MN) is dedicated to the swift distribution of financial market news and information. 24/7 MN incorporates comprehensive corporate communications resources and tools to engage the investment community. Visit 24/7 Market News website here.

24/7 MARKET NEWS, INC Disclaimer
Please go to https://247marketnews.com/disclaimer/ for disclaimer information.

CONTACT:
24/7 Market News
Editor@247marketnews.com

Related news for (SNGX)

NASDAQ and NYSE quotes and data are delayed 15 minutes unless indicated otherwise. Market data and exchange information are provided for informational purposes only and is not intended for trading purposes. Neither 24/7 Market News Editors, 247 Market News, or data and content providers shall be liable for any errors or omissions, delays, misquotes or other market information relayed in any press materials. You should Use Realtime data to conduct due diligence before investing or trading, and trading in any stock is risky you could lose all your money.