Ascletis Submits NDA for Denifanstat, a Novel Acne Treatment
Written by Emily J. Thompson, Senior Investment Analyst
Source: Newsfilter
Updated: 24 minutes ago0mins
- Clinical Trial Success: In a randomized, double-blind, placebo-controlled Phase III trial, denifanstat (ASC40) significantly improved moderate-to-severe acne vulgaris, achieving all primary and key secondary efficacy endpoints, showcasing its potential as a groundbreaking therapy.
- Good Safety Profile: Denifanstat (ASC40) demonstrated a favorable safety and tolerability profile, with all treatment-emergent adverse events being mild or moderate, and no serious adverse events reported, indicating its viability for clinical use.
- Regulatory Progress: Ascletis' New Drug Application (NDA) for denifanstat (ASC40) has been accepted by the China National Medical Products Administration, marking a significant step towards commercialization and potentially opening up substantial market opportunities for the company.
- Technological Innovation: Leveraging its Artificial Intelligence-Assisted Drug Discovery technology, Ascletis has developed multiple potential first-in-class therapeutics, and the success of denifanstat (ASC40) will further solidify its leading position in the biopharmaceutical sector.
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Analyst Views on SGMT
Wall Street analysts forecast SGMT stock price to rise over the next 12 months. According to Wall Street analysts, the average 1-year price target for SGMT is 29.00 USD with a low forecast of 25.00 USD and a high forecast of 35.00 USD. However, analyst price targets are subjective and often lag stock prices, so investors should focus on the objective reasons behind analyst rating changes, which better reflect the company's fundamentals.
7 Analyst Rating
7 Buy
0 Hold
0 Sell
Strong Buy
Current: 6.190
Low
25.00
Averages
29.00
High
35.00
Current: 6.190
Low
25.00
Averages
29.00
High
35.00
Citizens JMP
Jonathan Wolleben
Outperform
maintain
$33 -> $35
2025-11-14
Reason
Citizens JMP
Jonathan Wolleben
Price Target
$33 -> $35
2025-11-14
maintain
Outperform
Reason
Citizens JMP analyst Jonathan Wolleben raised the firm's price target on Sagimet Biosciences to $35 from $33 and keeps an Outperform rating on the shares. Sagimet will have first-in-human data next year for the denifanstat and resmetirom combination which could be a promising option for F4 MASH patients and its next-gen FASN inhibitor TVB-3567 which could be an effective acne treatment, the analyst tells investors in a research note. Given denifanstat's potent anti-fibrotic effects in F2/F3 patients and resmetirom's non-invasive data in cirrhotics, the combination could be compelling, the firm says.
Wedbush
NULL -> Outperform
initiated
$28
2025-08-11
Reason
Wedbush
Price Target
$28
2025-08-11
initiated
NULL -> Outperform
Reason
Wedbush initiated coverage of Sagimet Biosciences with an Outperform rating and $28 price target.
H.C. Wainwright
Brandon Folkes
initiated
$29
2025-08-07
Reason
H.C. Wainwright
Brandon Folkes
Price Target
$29
2025-08-07
initiated
Reason
H.C. Wainwright analyst Brandon Folkes assumed coverage of Sagimet Biosciences with a Buy rating and $29 price target. The company is has a potential best-in-class fatty acid synthase inhibitor platform with "multiple shots on goal" across a number of diseases, including near-term clinical catalysts in metabolic dysfunction-associated steatohepatitis and dermatology, the analyst tells investors in a research note.
Canaccord
Edward Nash
Buy
initiated
$28
2025-07-24
Reason
Canaccord
Edward Nash
Price Target
$28
2025-07-24
initiated
Buy
Reason
Canaccord analyst Edward Nash initiated coverage of Sagimet Biosciences with a Buy rating and $28 price target.
See All Ratings
About SGMT
Sagimet Biosciences Inc. is a clinical-stage biopharmaceutical company developing fatty acid synthase (FASN) inhibitors that are designed to target dysfunctional metabolic and fibrotic pathways in diseases resulting from the overproduction of the fatty acid, palmitate. The Company's lead drug candidate, denifanstat, is an oral, once-daily pill and selective FASN inhibitor in development for the treatment of metabolic dysfunction associated steatohepatitis (MASH). Denifanstat has been granted Breakthrough Therapy designation by the FDA for the treatment of non-cirrhotic MASH with moderate to advanced liver fibrosis. The Company is also exploring the use of its FASN inhibitors, which include denifanstat and its pipeline product candidate, TVB-3567, in acne and in select forms of cancer. Denifanstat is being tested in China by its license partner, Ascletis BioScience Co. Ltd., for moderate to severe acne vulgaris and recurrent glioblastoma multiforme in combination with bevacizumab.
About the author
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Emily J. Thompson
Emily J. Thompson, a Chartered Financial Analyst (CFA) with 12 years in investment research, graduated with honors from the Wharton School. Specializing in industrial and technology stocks, she provides in-depth analysis for Intellectia’s earnings and market brief reports.
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