Sagimet Biosciences Inc. Stock Price, News & Analysis

Sagimet Biosciences presented Phase 2b data for denifanstat, its fatty acid synthase (FASN) inhibitor, at AASLD 2024. The FASCINATE-2 trial showed significant improvement in liver fibrosis in high-risk MASH patients, particularly in the F3 population where 49% of denifanstat-treated patients showed improvement versus 13% for placebo. AI-based digital pathology confirmed denifanstat's strong anti-fibrotic activity, especially in portal and peri-portal regions. Preclinical data also demonstrated FASN inhibitor's potential in reducing atherosclerosis, cholesterol, and inflammatory markers, suggesting broader cardiometabolic benefits.

Sagimet Biosciences (SGMT) reported Q3 2024 financial results and corporate updates. Key highlights include FDA's Breakthrough Therapy designation for denifanstat in MASH treatment, publication of Phase 2b FASCINATE-2 study results in The Lancet, and successful completion of end-of-Phase 2 FDA interactions. The company plans to initiate Phase 3 program by end of 2024. Financial position shows $170.0 million in cash and equivalents as of September 30, 2024, with runway through 2025. Q3 net loss was $14.6 million, with R&D expenses at $12.7 million and G&A expenses at $4.2 million.

Ascletis Pharma has completed enrollment of 480 patients in its Phase III clinical trial of ASC40 (denifanstat), a once-daily oral tablet for treating moderate to severe acne. The randomized, double-blind, placebo-controlled trial began on January 24, 2024, with patients divided equally between treatment and placebo groups. The study will evaluate 50 mg ASC40 over 12 weeks, with topline results expected in Q2 2025.

ASC40 is a first-in-class FASN inhibitor that works by inhibiting facial sebum production and reducing inflammation. The Phase II trial previously met primary and secondary endpoints with 19.4% of patients achieving treatment success versus 5.1% for placebo.

Sagimet Biosciences (Nasdaq: SGMT) has announced its participation in the UBS Global Healthcare Conference. The clinical-stage biopharmaceutical company, which focuses on developing therapeutics for metabolic and fibrotic pathways, will engage in a fireside chat on Wednesday, November 13, 2024, at 5 p.m. PST in Rancho Palos Verdes, California.

The event will be accessible via webcast through Sagimet's website in the Investors & Media section, with replay availability for 90 days after the live presentation.

Sagimet Biosciences (SGMT) has successfully completed end-of-Phase 2 interactions with the FDA for denifanstat in metabolic-dysfunction associated steatohepatitis (MASH). The company plans to initiate two Phase 3 trials by end of 2024: FASCINATE-3 for F2/F3 non-cirrhotic MASH patients, focusing on liver biopsy and 4.5-year clinical outcomes, and FASCINIT for MASLD/MASH patients, evaluating safety and tolerability. The Phase 3 program will include a minimum of 1,800 patients exposed to denifanstat.

Sagimet Biosciences (Nasdaq: SGMT) announced three presentations at the AASLD - The Liver Meeting® 2024 in San Diego, showcasing data on their fatty acid synthase (FASN) inhibitor, denifanstat. The presentations include:

1. An oral presentation on AI-based digital pathology results from the FASCINATE-2 study, demonstrating denifanstat's improvement of fibrosis parameters and reduction of progression to cirrhosis in MASH patients.

2. A poster on denifanstat's reduction of atherosclerosis development in a mouse model of dyslipidaemia and MASH, suggesting potential cardiovascular and liver health benefits.

3. A poster highlighting denifanstat's significant improvement of liver fibrosis in difficult-to-treat MASH patients, based on conventional and AI-based pathology from the Phase 2b FASCINATE-2 trial.

These presentations underscore denifanstat's potential as a novel therapeutic for metabolic and fibrotic pathways in liver disease.

Sagimet Biosciences Inc. (Nasdaq: SGMT) announced the publication of results from their Phase 2b FASCINATE-2 clinical trial of denifanstat in The Lancet Gastroenterology & Hepatology. The trial, conducted on patients with biopsy-confirmed metabolic-dysfunction associated steatohepatitis (MASH) and stage 2 or 3 fibrosis, showed statistically significant and clinically meaningful improvements in disease activity, MASH resolution, and fibrosis.

Key findings include:

• 36% of denifanstat-treated patients achieved MASH resolution without worsening of fibrosis (vs 13% with placebo)
• 52% of denifanstat-treated patients showed ≥2-point reduction in NAS without worsening of fibrosis (vs 20% with placebo)
• 41% of denifanstat-treated patients demonstrated fibrosis improvement by ≥ 1 stage without worsening of steatohepatitis (vs 18% with placebo)

The results support the advancement of denifanstat into Phase 3 development, with Sagimet planning to start their Phase 3 program in 2024.

Sagimet Biosciences Inc. (Nasdaq: SGMT) announced that the FDA has granted Breakthrough Therapy designation to denifanstat for treating noncirrhotic metabolic dysfunction-associated steatohepatitis (MASH) with moderate to advanced liver fibrosis. This designation was supported by positive data from the Phase 2b FASCINATE-2 trial, where denifanstat showed statistically significant improvements in MASH resolution and fibrosis reduction. The company plans to initiate a Phase 3 clinical program for denifanstat in MASH by the end of 2024.

Denifanstat, as the only fat synthesis inhibitor targeting the three main drivers of MASH (fat accumulation, inflammation, and fibrosis), demonstrated efficacy in meeting primary and secondary endpoints in the trial. The treatment was generally well-tolerated, positioning it as a potential leading treatment option for MASH patients.

Sagimet Biosciences Inc. (Nasdaq: SGMT), a clinical-stage biopharmaceutical company developing fatty acid synthase (FASN) inhibitors, announced two key updates:

1. Management will participate in a virtual fireside chat at the H.C. Wainwright 8th Annual MASH Virtual Conference on October 7, 2024, at 2:30 PM ET. A live webcast will be available on Sagimet's website.

2. The company approved inducement grants for four newly-hired employees, consisting of stock options to purchase shares of Sagimet's Series A common stock with a total aggregate value of $611,000. These options, granted under Nasdaq Rule 5635(c)(4), have a ten-year term and vest over four years, with specific vesting conditions based on continued service.