Ascletis Submits NDA for Denifanstat, a Novel Acne Treatment
Written by Emily J. Thompson, Senior Investment Analyst
Updated: Dec 10 2025
0mins
Should l Buy SGMT?
Source: Newsfilter
- 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
10 Analyst Rating
9 Buy
1 Hold
0 Sell
Strong Buy
Current: 5.150
Low
8.00
Averages
27.00
High
37.00
Current: 5.150
Low
8.00
Averages
27.00
High
37.00
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
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.
Sagimet Stock Increases Following Acne Treatment Success
- Stock Performance: Shares of Sagimet Biosciences increased by up to 12% on Tuesday morning.
- Clinical Trial Results: The rise in stock price was driven by positive results from clinical trials for its acne treatment.
- Analyst Recommendation: Guggenheim Securities issued a new Buy recommendation for Sagimet Biosciences.
- Market Reaction: The combination of clinical success and analyst support contributed to the stock's upward movement.
See More
Guggenheim Initiates Buy on Sagimet Biosciences with Blockbuster Potential
- Buy Rating Initiation: Guggenheim has initiated a buy rating on Sagimet Biosciences (SGMT), suggesting that its assets targeting metabolic dysfunction-associated steatohepatitis (MASH) and acne could become a blockbuster drug, with shares rising approximately 10% in Tuesday morning trading.
- Price Target Set: The firm has set a price target of $27, indicating about a 333% upside based on the February 2 close, reflecting optimistic market expectations for the company's future growth.
- Clinical Progress: Sagimet's lead candidate, denifanstat, is currently in phase 2 for MASH and phase 3 for acne, while also being studied in phase 1 for solid tumors, showcasing its potential for multiple indications.
- Market Opportunity: Analysts noted that phase 2b data for denifanstat in MASH could position it well for a fixed-dose combination with Madrigal Pharmaceuticals' Rezdiffra, targeting a market potential exceeding $5 billion for F4 cirrhotic MASH, indicating a broad market outlook for the drug.
See More
Sagimet Biosciences Shares Drop 9% Following Partner's Trial Data Release
- Trial Data Release: Ascletis Pharma's initial data for ASC40 indicates a favorable safety and tolerability profile after 40 weeks in a study of 240 moderate-to-severe acne patients in China, potentially boosting market confidence.
- Market Reaction: Sagimet Biosciences saw a premarket drop of approximately 9% on Thursday, reflecting investor concerns over the clinical data from its partner Ascletis, which may impact the company's future market performance.
- Regulatory Review Progress: Ascletis is undergoing regulatory review for denifanstat in China, following a successful 100% efficacy rate in a double-blind Phase 3 trial involving 480 patients, laying a foundation for future market launch.
- Strategic Partnership Impact: The collaboration between Sagimet and Ascletis is crucial for new drug development; although current data did not significantly boost stock prices, successful clinical outcomes could present long-term market opportunities for both companies.
See More
Ascletis' Denifanstat Receives Approval for Acne Treatment
- Clinical Trial Success: Denifanstat (ASC40) demonstrated favorable safety and tolerability in a Phase III open-label study involving 240 patients with moderate-to-severe acne, with no serious adverse events reported, indicating its potential in acne treatment.
- Significant Efficacy: The previously reported Phase III randomized double-blind trial showed that Denifanstat (ASC40) met all primary and secondary endpoints, highlighting its exceptional efficacy in treating moderate to severe acne, which could represent a major breakthrough in the market.
- NDA Approval: The New Drug Application for Denifanstat (ASC40) for acne has been accepted by the China National Medical Products Administration, marking a significant step in its commercialization process and expected to create substantial market opportunities for the company.
- Unique Mechanism: Denifanstat (ASC40) addresses the underlying causes of acne by directly inhibiting sebum production and inflammation, setting it apart from most existing treatments and potentially offering patients a more effective therapeutic option.
See More
Ascletis' Denifanstat Receives Approval for Acne Treatment
- Clinical Trial Results: Denifanstat (ASC40) demonstrated favorable safety and tolerability in a Phase III open-label study involving 240 patients over 40 weeks, with all adverse events being mild or moderate, indicating strong potential for acne treatment applications.
- Efficacy Validation: The previously conducted randomized double-blind trial confirmed that Denifanstat (ASC40) met all primary and secondary endpoints, showcasing its exceptional efficacy in treating moderate to severe acne, potentially positioning it as the first drug targeting the root cause of acne.
- Mechanism Innovation: Denifanstat (ASC40) uniquely addresses the primary causes of acne by directly inhibiting sebum production and inflammatory responses, setting it apart from other treatments and likely attracting a broader patient base.
- Market Prospects: The acceptance of Denifanstat (ASC40) for New Drug Application by the China National Medical Products Administration marks a significant breakthrough for Ascletis in the acne treatment sector, expected to generate substantial market share and revenue growth for the company.
See More
CancerVAX Appoints Dr. George Kemble as Senior Scientific Advisor
- New Advisor Appointment: CancerVax has appointed Dr. George Kemble, a former AstraZeneca executive, as Senior Scientific Advisor, leveraging his extensive experience in virology and vaccines to advance the company's cancer treatment platform.
- Industry Background: Dr. Kemble previously served as CEO at Sagimet Biosciences, where he led multiple cancer treatment initiatives, particularly in developing fatty acid synthase inhibitors, showcasing his deep expertise in the biopharmaceutical sector.
- Innovative Treatment Concept: CancerVax's platform disguises cancer cells as foreign viruses to harness the immune system for attack, and Dr. Kemble's involvement is expected to enhance this innovative strategy and improve treatment efficacy.
- Scientific Leadership: George Katibah, Chief Scientific Officer of CancerVax, noted that Dr. Kemble's expertise will provide critical insights for the company's progress in cancer immunotherapy, aiding in translating fundamental immunology into practical therapies.
See More
Sagimet Stock Increases Following Acne Treatment Success
- Stock Performance: Shares of Sagimet Biosciences increased by up to 12% on Tuesday morning.
- Clinical Trial Results: The rise in stock price was driven by positive results from clinical trials for its acne treatment.
- Analyst Recommendation: Guggenheim Securities issued a new Buy recommendation for Sagimet Biosciences.
- Market Reaction: The combination of clinical success and analyst support contributed to the stock's upward movement.
See More
Guggenheim Initiates Buy on Sagimet Biosciences with Blockbuster Potential
- Buy Rating Initiation: Guggenheim has initiated a buy rating on Sagimet Biosciences (SGMT), suggesting that its assets targeting metabolic dysfunction-associated steatohepatitis (MASH) and acne could become a blockbuster drug, with shares rising approximately 10% in Tuesday morning trading.
- Price Target Set: The firm has set a price target of $27, indicating about a 333% upside based on the February 2 close, reflecting optimistic market expectations for the company's future growth.
- Clinical Progress: Sagimet's lead candidate, denifanstat, is currently in phase 2 for MASH and phase 3 for acne, while also being studied in phase 1 for solid tumors, showcasing its potential for multiple indications.
- Market Opportunity: Analysts noted that phase 2b data for denifanstat in MASH could position it well for a fixed-dose combination with Madrigal Pharmaceuticals' Rezdiffra, targeting a market potential exceeding $5 billion for F4 cirrhotic MASH, indicating a broad market outlook for the drug.
See More
Sagimet Biosciences Shares Drop 9% Following Partner's Trial Data Release
- Trial Data Release: Ascletis Pharma's initial data for ASC40 indicates a favorable safety and tolerability profile after 40 weeks in a study of 240 moderate-to-severe acne patients in China, potentially boosting market confidence.
- Market Reaction: Sagimet Biosciences saw a premarket drop of approximately 9% on Thursday, reflecting investor concerns over the clinical data from its partner Ascletis, which may impact the company's future market performance.
- Regulatory Review Progress: Ascletis is undergoing regulatory review for denifanstat in China, following a successful 100% efficacy rate in a double-blind Phase 3 trial involving 480 patients, laying a foundation for future market launch.
- Strategic Partnership Impact: The collaboration between Sagimet and Ascletis is crucial for new drug development; although current data did not significantly boost stock prices, successful clinical outcomes could present long-term market opportunities for both companies.
See More
Ascletis' Denifanstat Receives Approval for Acne Treatment
- Clinical Trial Success: Denifanstat (ASC40) demonstrated favorable safety and tolerability in a Phase III open-label study involving 240 patients with moderate-to-severe acne, with no serious adverse events reported, indicating its potential in acne treatment.
- Significant Efficacy: The previously reported Phase III randomized double-blind trial showed that Denifanstat (ASC40) met all primary and secondary endpoints, highlighting its exceptional efficacy in treating moderate to severe acne, which could represent a major breakthrough in the market.
- NDA Approval: The New Drug Application for Denifanstat (ASC40) for acne has been accepted by the China National Medical Products Administration, marking a significant step in its commercialization process and expected to create substantial market opportunities for the company.
- Unique Mechanism: Denifanstat (ASC40) addresses the underlying causes of acne by directly inhibiting sebum production and inflammation, setting it apart from most existing treatments and potentially offering patients a more effective therapeutic option.
See More
Ascletis' Denifanstat Receives Approval for Acne Treatment
- Clinical Trial Results: Denifanstat (ASC40) demonstrated favorable safety and tolerability in a Phase III open-label study involving 240 patients over 40 weeks, with all adverse events being mild or moderate, indicating strong potential for acne treatment applications.
- Efficacy Validation: The previously conducted randomized double-blind trial confirmed that Denifanstat (ASC40) met all primary and secondary endpoints, showcasing its exceptional efficacy in treating moderate to severe acne, potentially positioning it as the first drug targeting the root cause of acne.
- Mechanism Innovation: Denifanstat (ASC40) uniquely addresses the primary causes of acne by directly inhibiting sebum production and inflammatory responses, setting it apart from other treatments and likely attracting a broader patient base.
- Market Prospects: The acceptance of Denifanstat (ASC40) for New Drug Application by the China National Medical Products Administration marks a significant breakthrough for Ascletis in the acne treatment sector, expected to generate substantial market share and revenue growth for the company.
See More
CancerVAX Appoints Dr. George Kemble as Senior Scientific Advisor
- New Advisor Appointment: CancerVax has appointed Dr. George Kemble, a former AstraZeneca executive, as Senior Scientific Advisor, leveraging his extensive experience in virology and vaccines to advance the company's cancer treatment platform.
- Industry Background: Dr. Kemble previously served as CEO at Sagimet Biosciences, where he led multiple cancer treatment initiatives, particularly in developing fatty acid synthase inhibitors, showcasing his deep expertise in the biopharmaceutical sector.
- Innovative Treatment Concept: CancerVax's platform disguises cancer cells as foreign viruses to harness the immune system for attack, and Dr. Kemble's involvement is expected to enhance this innovative strategy and improve treatment efficacy.
- Scientific Leadership: George Katibah, Chief Scientific Officer of CancerVax, noted that Dr. Kemble's expertise will provide critical insights for the company's progress in cancer immunotherapy, aiding in translating fundamental immunology into practical therapies.
See More
