Ascletis Reports Positive Long-Term Phase III Safety Data for First-in-Class Oral Acne Drug Denifanstat

The latest announcement is out from Ascletis Pharma, Inc. ( (HK:1672) ).

Ascletis Pharma has reported positive topline data from a Phase III open-label, multicenter study in China evaluating its first-in-class, once-daily oral fatty acid synthase inhibitor denifanstat (ASC40) in 240 patients with moderate-to-severe acne vulgaris, showing a favorable long-term safety and tolerability profile over 40 weeks with mostly mild to moderate treatment-emergent adverse events and no drug-related serious or grade 3/4 adverse events or deaths. Combined with previously disclosed Phase III placebo-controlled efficacy data, these results strengthen the case for denifanstat as a potentially breakthrough acne therapy that directly targets sebum overproduction and inflammation, and follow the recent acceptance of the drug’s New Drug Application by China’s National Medical Products Administration, potentially enhancing Ascletis’s dermatology pipeline value and competitive positioning in the Chinese acne treatment market.

The most recent analyst rating on (HK:1672) stock is a Hold with a HK$14.00 price target. To see the full list of analyst forecasts on Ascletis Pharma, Inc. stock, see the HK:1672 Stock Forecast page.

More about Ascletis Pharma, Inc.

Ascletis Pharma Inc. is a Cayman Islands–incorporated biopharmaceutical company listed in Hong Kong that focuses on developing innovative small-molecule therapeutics, with a particular emphasis on dermatology and other disease areas in Greater China through both in-house R&D and in-licensed assets.

Average Trading Volume: 5,315,108

Technical Sentiment Signal: Buy

Current Market Cap: HK$13.4B

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