Ascletis Completes Denifanstat (ASC40) Pre-NDA Consultation with China National Medical Products Administration
Sagimet Biosciences Inc. - Series A (SGMT)
Company Research
Source: PR Newswire
- Denifanstat (ASC40) met all primary, key secondary and secondary efficacy endpoints (ITT analysis) and significantly improved moderate-to-severe acne vulgaris compared with placebo in a Phase III randomized, double-blind, placebo-controlled, multicenter clinical trial. HONG KONG, Oct. 14, 2025 /PRNewswire/ -- Ascletis Pharma Inc. (HKEX: 1672, "Ascletis") announces today that it recently completed the pre-New Drug Application (NDA) consultation with China National Medical Products Administration (NMPA) for denifanstat (ASC40) for the treatment of moderate-to-severe acne vulgaris and plans to submit an NDA soon. The pre-NDA consultation was initiated from June 2025 and completed in October 2025. Ascletis has completed the Phase II (NCT05104125) and Phase III (NCT06192264) studies of denifanstat (ASC40) for the treatment of moderate-to-severe acne vulgaris. In the Phase III
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- Sagimet Biosciences (NASDAQ:SGMT) was downgraded by analysts at <a style="font-weight:bold" href="https://www.wallstreetzen.com/newsletters/zen-ratings?ticker=SGMT&utm_campaign=getratings&utm_medium=online&utm_source=MarketBeat">Wall StrMarketBeat
- Sagimet Biosciences (NASDAQ:SGMT) was downgraded by analysts at <a style="font-weight:bold" href="https://www.wallstreetzen.com/newsletters/zen-ratings?ticker=SGMT&utm_campaign=getratings&utm_medium=online&utm_source=MarketBeat">Wall StrMarketBeat
- Sagimet Biosciences to Participate in the 8th Annual Evercore ISI Healthcare Conference [Yahoo! Finance]Yahoo! Finance
- Sagimet Biosciences to Participate in the 8th Annual Evercore ISI Healthcare ConferenceGlobeNewswire
- Sagimet Biosciences Advances Denifanstat: Q3 Earnings And Upcoming Catalysts [Seeking Alpha]Seeking Alpha
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- 11/13/25 - Beat
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- 11/21/25 - Form 4
- 11/20/25 - Form 144
- 11/14/25 - Form SCHEDULE
- SGMT's page on the SEC website