SGMT

Secured equity financing with gross proceeds of $175M in April 2026 Phase 3 clinical trial of denifanstat in moderate to severe acne patients for the U.S. planned to initiate in second half of 2026 First-in-human Phase 1 clinical trial of FASN inhibitor TVB-3567 ongoing Cumulative cash, cash equivalents and marketable securities expected to fund current operations through 2028, including through data readout of denifanstat Phase 3 trial in moderate to severe acne SAN MATEO, Calif., May 12, 2026 (GLOBE NEWSWIRE) -- Sagimet Biosciences Inc. (Nasdaq: SGMT), a clinical-stage biopharmaceutical company developing novel therapeutics targeting dysfunctional metabolic and fibrotic pathways, today reported financial results for the quarter ended March 31, 2026, and provided corporate updates. “Our recent strategic decision to focus on dermatology marks a turning point for Sagimet, and we are excited about the path ahead. In the near term, we are targeting the second half of 2026 to initiate a Phase 3 clinical trial of denifanstat in moderate to severe acne in the U.S. We believe that denifanstat, with its differentiated mode of action, could potentially offer a convenient oral once-daily treatment option for those living with moderate to severe acne. The clinical community caring for patients with acne has waited more than 40 years for an innovative oral treatment,” said David Happel, Chief Executive Officer of Sagimet. “We recently strengthened Sagimet’s ability to move forward with its innovative dermatology programs with the completion of a $175 million equity financing. Combined with our existing cash balance, we are well capitalized to fund our programs through 2028 including data readout of our planned denifanstat Phase 3 clinical trial in moderate to severe acne.” Recent Corporate Highlights The Company recently completed an underwritten offering of 29,166,700 shares of its Series A common stock at a price of $6.00 per share, resulting in $175.0 million gross proceeds, before deducting underwriting discounts and commissions and other offering expenses. The financing included participation from new and existing investors, including Balyasny Asset Management, Blue Owl Healthcare Opportunities, BVF Partners L.P., Caligan Partners, Coastlands Capital, Farallon Capital Management, Great Point Partners, LLC, Woodline Partners LP and a large mutual fund. The Company c...

Sagimet Biosciences Inc. (NASDAQ:SGMT) earns a place on our list of the top 10 stocks under $5 that could triple. As of March 19, 2026, 91% of analysts remain bullish on Sagimet Biosciences Inc. (NASDAQ:SGMT). The stock boasts a consensus price target of $27.50, indicating an upside of 437.27%. On March 11, 2026, in its fourth-quarter and full-year 2025 financial results update, Sagimet Biosciences Inc. (NASDAQ:SGMT) emphasized ongoing pipeline momentum, which strengthened investor confidence. In the second half of 2026, the company plans to commence a Phase 2 trial in F4 MASH patients. This development comes after the company successfully completed a Phase 1 pharmacokinetic trial, assessing denifanstat in combination with resmetirom, with no significant adverse effects. Its ongoing first-in-human Phase 1 trial for TVB-3567, which targets acne, is another example of Sagimet Biosciences Inc.’s (NASDAQ:SGMT) progress. Additionally, Ascletis, a partner, published positive Phase 3 acne data and obtained NDA acceptance in China. In terms of finances, Sagimet Biosciences Inc. (NASDAQ:SGMT) concluded 2025 with $113.1 million in cash, $39.1 million in R&D costs, and a $51.0 million net loss as opposed to a $45.6 million loss in 2024. Importantly, HC Wainwright reaffirmed its “Buy” rating that same day, demonstrating confidence in the stock. Sagimet Biosciences Inc. (NASDAQ:SGMT) is a clinical-stage biopharmaceutical company developing FASN inhibitors, such as denifanstat, to address metabolic and dermatological disorders, particularly for MASH and acne treatments. While we acknowledge the potential of SGMT as an investment, we believe certain AI stocks offer greater upside potential and carry less downside risk. If you're looking for an extremely undervalued AI stock that also stands to benefit significantly from Trump-era tariffs and the onshoring trend, see our free report on the best short-term AI stock. READ NEXT: 33 Stocks That Should Double in 3 Years and 15 Stocks That Will Make You Rich in 10 Years Disclosure: None. Follow Insider Monkey on Google News.

Completed Phase 1 pharmacokinetic (PK) clinical trial of denifanstat and resmetirom combination Phase 2 trial of denifanstat/resmetirom combination in F4 MASH patients planned to initiate in 2H 2026 Secured global, exclusive license to TAPI’s innovative forms of resmetirom active pharmaceutical ingredients (API) First-in-human Phase 1 clinical trial of FASN inhibitor TVB-3567 ongoing Positive topline results in open-label Phase 3 trial evaluating the long-term safety of denifanstat in patients with moderate to severe acne in China reported by Ascletis China’s National Medical Products Administration (NMPA) accepted Ascletis’ New Drug Application (NDA) for denifanstat for the treatment of moderate to severe acne SAN MATEO, Calif., March 11, 2026 (GLOBE NEWSWIRE) -- Sagimet Biosciences Inc. (Nasdaq: SGMT), a clinical-stage biopharmaceutical company developing novel therapeutics targeting dysfunctional metabolic and fibrotic pathways, today reported financial results for the fourth quarter and full year ended December 31, 2025, and provided recent corporate updates. “2025 saw important advances in both our MASH and acne programs,” said David Happel, Chief Executive Officer of Sagimet. “We completed our Phase 1 PK clinical trial of denifanstat and resmetirom combination and anticipate advancing the combination into a proof-of-concept Phase 2 clinical trial in F4 MASH, for which there are currently no approved treatments, in the second half of the year. In acne, positive 52-week data from our license partner Ascletis’ Phase 3 open-label acne trial with denifanstat will support Ascletis’ NDA that was accepted by the Chinese NMPA. We anticipate further exploring the potential role of FASN inhibition in acne in clinical development in 2026.” Recent Corporate Highlights Clinical and Regulatory Updates In December 2025, Sagimet announced the completion of its open-label Phase 1 pharmacokinetic (PK) clinical trial of its oral once-daily fatty acid synthase (FASN) inhibitor, denifanstat, and a thyroid hormone receptor beta (THR-β) agonist, resmetirom, to evaluate pharmacokinetics and potential drug-drug interactions (DDI), and to assess the safety and tolerability of the combination. The combination of denifanstat and resmetirom was generally well-tolerated over the duration of the study, with no safety signals. No serious adverse events occurred, and there were no clin...

The combination of denifanstat and resmetirom was generally well-tolerated Pharmacokinetic (PK) results support further development of the combination A Phase 2 trial of a denifanstat/resmetirom combination in F4 MASH patients is planned to initiate in 2H 2026 SAN MATEO, Calif., Dec. 18, 2025 (GLOBE NEWSWIRE) -- Sagimet Biosciences Inc. (Nasdaq: SGMT), a clinical-stage biopharmaceutical company developing novel therapeutics targeting dysfunctional metabolic and fibrotic pathways, today announced positive results in the Phase 1 pharmacokinetic (PK) trial of a combination of its oral once-daily fatty acid synthase (FASN) inhibitor, denifanstat, and a thyroid hormone receptor beta (THR-β) agonist, resmetirom. The Phase 1 PK trial (NCT07216313) of denifanstat and resmetirom was an open-label, 2-cohort study that enrolled 40 healthy adult participants. The objectives were to evaluate multiple-dose and single-dose pharmacokinetics, identify any potential drug-drug interactions (DDIs), and assess the safety and tolerability of the combination. The combination of denifanstat and resmetirom was generally well-tolerated over the duration of the study, with no safety signals. No Serious Adverse Events (SAEs) occurred, and there were no clinically significant laboratory results, and no treatment discontinuations. Sagimet plans to use these data to advance the development of the combination into a Phase 2 proof-of-concept efficacy trial for patients living with metabolic dysfunction-associated steatohepatitis (MASH) with F4 fibrosis, subject to consultation with regulatory authorities. “The successful completion of the Phase 1 PK trial is an important step in our journey to develop a new, potentially synergistic combination treatment for MASH. Patients with cirrhosis of the liver associated with MASH currently have no approved options and our goal is to combine two therapies with complementary mechanisms of action into a single tablet to address this underserved medical need,” said David Happel, Chief Executive Officer of Sagimet. “Our recent presentations at AASLD demonstrated denifanstat’s ability to address advanced fibrosis in MASH patients, including in fibrosis stage qF4 as defined by AI-based digital pathology, and we previously have presented preclinical data demonstrating the synergistic effect of a FASN inhibitor combined with resmetirom on important liver dise...

Phase 1 clinical trial to evaluate the PK of a combination of denifanstat and resmetirom ongoing with data readout expected 1H 2026 First-in-human Phase 1 clinical trial of FASN inhibitor TVB-3567 ongoing Ascletis announced completion of its pre-NDA consultation with China’s NMPA and plans to submit an NDA for denifanstat in China for treatment of moderate-to-severe acne vulgaris SAN MATEO, Calif., Nov. 13, 2025 (GLOBE NEWSWIRE) -- Sagimet Biosciences Inc. (Sagimet, Nasdaq: SGMT), a clinical-stage biopharmaceutical company developing novel therapeutics targeting dysfunctional metabolic and fibrotic pathways, today reported financial results for the quarter ended September 30, 2025, and provided recent corporate updates. “This is a dynamic period for Sagimet as we explore the therapeutic potential of FASN inhibition across different indications,” said David Happel, Chief Executive Officer of Sagimet. “As part of our MASH development program targeting cirrhosis of the liver, we have initiated a Phase 1 PK trial evaluating the compatibility of a once-daily combination of denifanstat and resmetirom. We plan to use this data, if positive, to advance the combination to proof-of-concept studies in MASH patients with F4 fibrosis. Additionally, we initiated a Phase 1 clinical trial of our second FASN inhibitor, TVB-3567, for development of an acne indication. We continue to explore how FASN inhibition could benefit patients living with conditions that are currently underserved by approved therapies,” he concluded. Recent Corporate Highlights In September 2025, Sagimet dosed the first participants in a Phase 1 pharmacokinetic (PK) trial of a combination of its oral once-daily fatty acid synthase (FASN) inhibitor, denifanstat, and a thyroid hormone receptor beta (THR-β) agonist, resmetirom. The Phase 1 PK trial of denifanstat and resmetirom is an open-label, 2-cohort study and has enrolled approximately 40 healthy adult participants. The objectives are to evaluate multiple-dose and single-dose pharmacokinetics, identify any potential drug-drug interactions (DDI), and assess the safety and tolerability of the combination. Topline data from this trial are anticipated in the first half of 2026 and, if positive, may be used to advance the development of the combination for patients living with metabolic dysfunction associated steatohepatitis (MASH) into a Phase 2 clinical...

About Sagimet Biosciences Sagimet is a clinical-stage biopharmaceutical company developing novel 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. Sagimet’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). FASCINATE-2, a Phase 2b clinical trial of denifanstat in MASH with liver biopsy-based primary endpoints, was successfully completed with positive results. Denifanstat has been granted Breakthrough Therapy designation by the FDA for the treatment of non-cirrhotic MASH with moderate to advanced liver fibrosis (consistent with stages F2 to F3 fibrosis), and end-of-Phase 2 interactions with the FDA have been successfully completed, supporting the advancement of denifanstat into further development. Sagimet has recently initiated a Phase 1 first-in-human clinical trial with a second oral FASN inhibitor drug candidate, TVB-3567, that is planned to be developed for acne in the U.S. For additional information about Sagimet, please visit www.sagimet.com. About Acne There are 5.1 million acne patients treated by dermatologists annually in the U.S., and a total U.S. acne market of over 50 million people.1,2 There is no cure for acne; and due to its pathology, most patients require chronic management and multiple courses of treatment for flare control annually. Additionally, adherence to topical therapies is lower than with oral agents, with an estimated 30% to 40% of patients not adhering to their topical treatments.3 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...

Denifanstat met all primary and secondary endpoints in Phase 3 clinical trial in moderate to severe acne conducted by license partner Ascletis in China Initiated first-in-human Phase 1 clinical trial of FASN inhibitor TVB-3567 being developed for acne in the U.S. Phase 1 clinical trial to evaluate the pharmacokinetics (PK) of a combination of denifanstat and resmetirom expected to initiate in 2H 2025; data readout expected 1H 2026 SAN MATEO, Calif., Aug. 13, 2025 (GLOBE NEWSWIRE) -- Sagimet Biosciences Inc. (Nasdaq: SGMT), a clinical-stage biopharmaceutical company developing novel therapeutics targeting dysfunctional metabolic and fibrotic pathways, today reported financial results for the quarter ended June 30, 2025, and provided recent corporate updates. “We are making strong progress advancing our differentiated therapeutics, which are in development for the treatment of MASH and acne,” said David Happel, Chief Executive Officer of Sagimet. “Following our license partner Ascletis’ announcement that denifanstat met all primary and secondary endpoints in its Phase 3 clinical trial in moderate to severe acne in China, in June, we initiated a Phase 1 clinical trial of our second FASN inhibitor, TVB-3567, for development of an acne indication. Additionally, pending consultation with regulatory authorities, we plan to initiate a Phase 1 clinical trial to evaluate the PK and tolerability of a combination of our FASN inhibitor denifanstat and resmetirom in the second half of 2025 as the first step towards development of a combination product for patients living with MASH. We continue to believe in the significant therapeutic potential of FASN inhibition across multiple disease states and are pioneering the development of our FASN inhibitors to benefit underserved patients,” he concluded. Recent Corporate Highlights In June, the Company’s license partner Ascletis Bioscience Co. Ltd. (Ascletis) reported that denifanstat met all primary and secondary endpoints and was generally well-tolerated in a Phase 3 clinical trial for the treatment of moderate to severe acne vulgaris in China. The randomized, double-blind, placebo-controlled, multicenter clinical trial evaluated the safety and efficacy of denifanstat for the treatment of patients with moderate to severe acne in China with 480 enrolled patients randomized 1:1 to receive denifanstat 50mg or placebo, once daily...

Sagimet Biosciences Inc. (NASDAQ:SGMT) said on Wednesday that denifanstat met all primary and secondary endpoints in a Phase 3 trial for moderate to severe acne vulgaris. The trial was conducted by Sagimet’s license partner, Ascletis Bioscience Co. Ltd., in China. Denifanstat is a once-daily oral small-molecule fatty acid synthase (FASN) inhibitor being developed by Ascletis as ASC40 for acne in China and by Sagimet for metabolic dysfunction-associated steatohepatitis (MASH) in the rest of the world. Also Read: Nano-Cap Dermata Therapeutics Unveils Positive Data From Once Weekly Drug Study For Acne Additionally, Sagimet recently initiated a Phase 1 first-in-human trial with a second FASN inhibitor, TVB-3567, that is planned to be developed for acne in the U.S. The trial randomized 480 patients in China to receive either denifanstat once daily or a placebo for 12 weeks. For the primary endpoint of treatment success, defined as an Investigator’s Global Assessment score of 0 (clear) or 1 (almost clear) with at least a 2-point decrease from baseline at week 12, the denifanstat group demonstrated a statistically significant 33.2% rate over the placebo group’s 14.6%. Additional goals further corroborated denifanstat’s efficacy versus placebo, including: Reduction in total lesion count (57.4% vs 35.4%). Reduction in inflammatory lesion count (63.5% vs 43.2%). Reduction in non-inflammatory lesion count (51.9% vs. 28.9%). Ascletis reported that denifanstat was generally well-tolerated. Following 12 weeks of once-daily oral administration at 50 mg, treatment-emergent adverse events (TEAE) incidence rates were comparable between denifanstat and placebo. All denifanstat-related adverse events (AEs) were mild or moderate. There were no denifanstat-related grade 3 or 4 AEs and no denifanstat-related serious AEs. No deaths were reported. These Phase 3 results confirm that FASN inhibition represents a potential therapeutic approach within acne. Ascletis has indicated that it plans to submit denifanstat for approval to the China National Medical Products Administration. Building on Ascletis’ Phase 3 results, Sagimet has recently initiated a Phase 1 first-in-human clinical trial with a second oral FASN inhibitor drug candidate, TVB-3567, that is planned to be developed for acne in the U.S. In other notable pharmaceutical industry news, GSK plc (NYSE:GSK) agreed to acquire Bos...

Denifanstat met all primary and secondary endpoints versus placebo Denifanstat was well tolerated Oral FASN inhibitors offer a novel mechanism of action for the potential treatment of moderate to severe acne Sagimet initiated first-in-human Phase 1 clinical trial of a second FASN inhibitor, TVB-3567, that is planned to be developed for acne in the U.S. SAN MATEO, Calif., June 04, 2025 (GLOBE NEWSWIRE) -- Sagimet Biosciences Inc. (Nasdaq: SGMT), a clinical-stage biopharmaceutical company developing novel therapeutics targeting dysfunctional metabolic and fibrotic pathways, today reported denifanstat met all primary and secondary endpoints in a Phase 3 clinical trial for the treatment of moderate to severe acne vulgaris conducted by Sagimet’s license partner Ascletis Bioscience Co. Ltd. (Ascletis) in China. Denifanstat is a once-daily oral small molecule fatty acid synthase (FASN) inhibitor being developed by Ascletis as ASC40 for acne in China and by Sagimet for MASH in the rest of world. Additionally, Sagimet recently initiated a Phase 1 first-in-human clinical trial with a second FASN inhibitor, TVB-3567, that is planned to be developed for acne in the US. “We are highly encouraged by the positive results from Ascletis’ Phase 3 acne trial in China,” said David Happel, Chief Executive Officer of Sagimet. “FASN inhibition represents a novel potential approach to treat moderate to severe acne vulgaris, a widespread condition impacting more than 640 million people worldwide. These positive data support the rationale for our development of our FASN inhibitor TVB-3567 for moderate-to-severe acne and add to the body of evidence of the broad consequences of unchecked overactivity of FASN.” “It is very exciting to see this novel oral acne product candidate progressing through development in light of the limited innovation within the acne space over the past 40 years,” said Dr. Neal Bhatia, Director of Clinical Dermatology at Therapeutics Clinical Research in San Diego and a past Vice President of the American Academy of Dermatology. “These data demonstrate the significant clinical response that a FASN inhibitor can achieve for moderate to severe acne patients by addressing the overproduction of sebum and the inflammatory cascade, two of the primary pathways of acne, and most importantly through a novel mechanism of action. With currently available treatments either...

Phase 1 clinical trial to evaluate the pharmacokinetics (PK) of a combination of denifanstat and resmetirom expected to initiate in 2H 2025; data readout expected 1H 2026 SAN MATEO, Calif., May 08, 2025 (GLOBE NEWSWIRE) -- Sagimet Biosciences Inc. (Nasdaq: SGMT), a clinical-stage biopharmaceutical company developing novel therapeutics targeting dysfunctional metabolic and fibrotic pathways, today reported financial results for the quarter ended March 31, 2025, and provided recent corporate updates. “Sagimet is committed to bringing innovative therapies to MASH patients, following the successful results of our Phase 2b FASCINATE-2 clinical trial of denifanstat in MASH F2-F3 patients, particularly in more advanced F3 stage patients. In a Phase 1 clinical trial in patients with and without hepatic impairment, denifanstat exhibited similar pharmacokinetic characteristics and was well tolerated among all groups. Considering these strong Phase 1 and Phase 2 data, further development of denifanstat in MASH, including as part of a combination program, could potentially offer an opportunity to serve patient groups with the strongest need of treatment including those with stage 4 fibrosis,” said David Happel, Chief Executive Officer of Sagimet. “Building on our presentation of compelling preclinical data at 2024 EASL demonstrating the synergistic effect of a FASN inhibitor combined with resmetirom on important liver disease markers, we anticipate initiating a Phase 1 clinical trial to evaluate the PK and tolerability of a combination of denifanstat and resmetirom in the second half of 2025. If the outcome of this Phase 1 trial is positive, we will explore moving into the development of a combination product -- which we envision as a single tablet -- for patients living with MASH. We remain strongly convinced of the significant therapeutic potential associated with FASN inhibition across multiple disease states.” Recent Corporate Highlights Pre-clinical data presented at EASL in 2024 for two mouse models of MASH showed that the combination of a FASN inhibitor (TVB-3664, a surrogate for denifanstat) and resmetirom had a synergistic effect on important liver disease markers, including improvement of NAS (NAFLD Activity Score) by histologic analysis and more robust improvement in hepatic collagen content compared to the single agents. Synergistic activity of the combinati...