Sagimet’s License Partner Ascletis Announced Acceptance of New Drug Application for Denifanstat for the Treatment of Moderate to Severe Acne by China’s National Medical Products Administration
Rhea-AI Summary
Sagimet (Nasdaq: SGMT) announced that Ascletis’ parent company said China’s National Medical Products Administration accepted a New Drug Application (NDA) for denifanstat (ASC40) for the treatment of moderate to severe acne on Dec 10, 2025. Sagimet granted Ascletis an exclusive license for denifanstat in China while Sagimet retains development rights for MASH in the rest of world. The NDA filing reflects Ascletis’ Phase 3 trial in acne, in which denifanstat met all primary and secondary endpoints and was generally well tolerated.
Positive
- NDA accepted by NMPA on Dec 10, 2025
- Phase 3 trial met all primary and secondary endpoints
- Exclusive China license granted to Ascletis
Negative
- NMPA acceptance is not regulatory approval
- China commercialization rights held by Ascletis, not Sagimet
Market Reality Check
Peers on Argus
Peers show mixed moves: SLN -9.88%, ACIU -9.61%, NMRA -6.11%, PRQR +8.92%, THRD -0.55%. This pattern does not indicate a unified sector trend around SGMT’s China NDA news.
Historical Context
| Date | Event | Sentiment | Move | Catalyst |
|---|---|---|---|---|
| Dec 09 | Inducement grants | Neutral | +1.4% | Stock options granted to new hires under Nasdaq inducement rules. |
| Nov 20 | Conference participation | Neutral | -7.4% | Announcement of participation in Evercore ISI healthcare conference. |
| Nov 13 | Quarterly earnings | Neutral | -12.2% | Q3 2025 results with net loss and clinical program updates. |
| Nov 10 | Clinical poster data | Positive | +10.8% | FASCINATE-2 Phase 2b denifanstat data showing fibrosis and biomarker benefits. |
| Oct 24 | Phase 3 acne data | Positive | +24.7% | China Phase 3 acne trial met all endpoints with strong efficacy and tolerability. |
Positive denifanstat clinical updates (especially acne and MASH data) have historically coincided with strong upside moves, while financial/meeting updates have seen more mixed or negative reactions.
Over the past few months, Sagimet highlighted multiple denifanstat milestones. On Oct 24, Phase 3 acne data in China showed all endpoints met with a 24.69% gain. Earlier, FASCINATE-2 fibrosis and biomarker improvements drove a 10.77% move on Nov 10. In contrast, Q3 2025 results on Nov 13 and conference participation on Nov 20 coincided with declines. The current NMPA NDA acceptance builds directly on the prior successful Phase 3 acne results and earlier pre‑NDA updates.
Market Pulse Summary
This announcement confirms that China’s NMPA has accepted the NDA for denifanstat in moderate to severe acne, advancing the program beyond the previously reported successful Phase 3 trial that met all endpoints. It reinforces Sagimet’s strategy of partnering in China while developing denifanstat for MASH elsewhere. Investors may track future NMPA decisions, additional MASH data, and any updates on combination studies as key markers for the overall denifanstat franchise.
Key Terms
new drug application regulatory
nda regulatory
nmpa regulatory
AI-generated analysis. Not financial advice.
SAN MATEO, Calif., Dec. 10, 2025 (GLOBE NEWSWIRE) -- Sagimet Biosciences Inc. (Nasdaq: SGMT), a clinical-stage biopharmaceutical company developing novel therapeutics targeting dysfunctional metabolic and fibrotic pathways, today announced that Ascletis Pharma Inc. issued a December 10 statement that China’s National Medical Products Administration (NMPA) has accepted its New Drug Application (NDA) for denifanstat for the treatment of moderate to severe acne. Sagimet has granted an exclusive license to denifanstat for China to Ascletis Bioscience Co. Ltd. (Ascletis), of which Ascletis Pharma Inc. is the parent company.
Denifanstat is a once-daily oral small molecule fatty acid synthase (FASN) inhibitor being developed by Ascletis for acne in China as ASC40, and by Sagimet for metabolic dysfunction associated steatohepatitis (MASH) in the rest of world. The NDA is based on data from Ascletis’ successful Phase 3 clinical trial of denifanstat for the treatment of moderate to severe acne vulgaris, in which denifanstat met all primary and secondary endpoints and was generally well tolerated.
About Sagimet Biosciences
Sagimet is a clinical-stage biopharmaceutical company developing novel FASN inhibitors designed to target dysfunctional metabolic and fibrotic pathways in conditions resulting from the overproduction of the fatty acid, palmitate. Denifanstat, an oral, once-daily pill, met all primary endpoints in its Phase 2b FASCINATE-2 clinical trial in MASH as well as all primary and secondary endpoints in Sagimet’s license partner for China’s Phase 3 clinical trial in moderate-to-severe acne. A combination of denifanstat and resmetirom is currently being tested in a Phase 1 PK clinical trial and is planned to be developed for cirrhotic patients living with F4-stage MASH. TVB-3567, a second oral FASN inhibitor which is planned to be developed for acne, is currently being tested in a Phase 1 first-in-human clinical trial. For additional information about Sagimet, please visit www.sagimet.com.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of, and made pursuant to the safe harbor provisions of, The Private Securities Litigation Reform Act of 1995. All statements contained in this press release, other than statements of historical facts or statements that relate to present facts or current conditions, including but not limited to, statements regarding: the expected timing of the presentation of data from ongoing clinical trials, Sagimet’s clinical development plans and related anticipated development milestones, Sagimet’s cash and financial resources and expected cash runway are forward-looking statements. These statements involve known and unknown risks, uncertainties and other important factors that may cause Sagimet’s actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. In some cases, these statements can be identified by terms such as “may,” “might,” “will,” “should,” “expect,” “plan,” “aim,” “seek,” “anticipate,” “could,” “intend,” “target,” “project,” “contemplate,” “believe,” “estimate,” “predict,” “forecast,” “potential” or “continue” or the negative of these terms or other similar expressions. The forward-looking statements in this press release are only predictions. Sagimet has based these forward-looking statements largely on its current expectations and projections about future events and financial trends that Sagimet believes may affect its business, financial condition and results of operations. These forward-looking statements speak only as of the date of this press release and are subject to a number of risks, uncertainties and assumptions, some of which cannot be predicted or quantified and some of which are beyond Sagimet’s control, including, among others: the clinical development and therapeutic potential of denifanstat, TVB-3567 or any other drug candidates or combination therapies developed by Sagimet; Sagimet’s ability to advance drug candidates into and successfully complete clinical trials within anticipated timelines; Sagimet’s relationship with Ascletis, and the success of its development efforts for denifanstat; the accuracy of Sagimet’s estimates regarding its capital requirements; and Sagimet’s ability to maintain and successfully enforce adequate intellectual property protection. These and other risks and uncertainties are described more fully in the “Risk Factors” section of Sagimet’s most recent filings with the Securities and Exchange Commission and available at www.sec.gov. You should not rely on these forward-looking statements as predictions of future events. The events and circumstances reflected in these forward-looking statements may not be achieved or occur, and actual results could differ materially from those projected in the forward-looking statements. Moreover, Sagimet operates in a dynamic industry and economy. New risk factors and uncertainties may emerge from time to time, and it is not possible for management to predict all risk factors and uncertainties that Sagimet may face. Except as required by applicable law, Sagimet does not plan to publicly update or revise any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise.
Investor Contact:
Joyce Allaire
LifeSci Advisors
JAllaire@LifeSciAdvisors.com
Media Contact:
Michael Fitzhugh
LifeSci Advisors
mfitzhugh@lifescicomms.com
FAQ
What did Sagimet announce about denifanstat (SGMT) on Dec 10, 2025?
What does NMPA acceptance of the denifanstat NDA mean for SGMT shareholders?
What clinical data supported the denifanstat NDA for ASC40 in China?
Who holds rights to denifanstat in China versus the rest of world for SGMT?
Does the announcement state a regulatory approval date or commercialization timeline for ASC40 in China?
