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PARIS - Sagimet Biosciences Inc. (NASDAQ:SGMT), a clinical-stage biopharmaceutical company with a market capitalization of $201.63 million, announced Wednesday that its fatty acid synthase (FASN) inhibitor denifanstat met all primary and secondary endpoints in a Phase 3 clinical trial for moderate to severe acne vulgaris conducted by its license partner Ascletis Bioscience in China. According to InvestingPro data, the company maintains a strong liquidity position with more cash than debt on its balance sheet.
The 12-week randomized, double-blind, placebo-controlled trial enrolled 480 patients who received either 50mg denifanstat or placebo once daily. The drug demonstrated an 18.6% placebo-adjusted increase in treatment success rate, 22.0% reduction in total lesions, and 20.2% reduction in inflammatory lesions compared to placebo. The company reported that the treatment was generally well-tolerated. While the stock has experienced recent volatility, dropping 13% in the past week, it has shown remarkable strength with a 64% gain over the past six months. Discover more market insights and 10+ additional ProTips for SGMT with InvestingPro.
The results are being presented at the European Academy of Dermatology and Venerology Congress in Paris by Professor Leihong Flora Xiang of Fudan University.
Denifanstat represents a novel mechanism of action for acne treatment through FASN inhibition. While Ascletis advances the drug for approval in China, Sagimet has initiated a Phase 1 first-in-human clinical trial with a second FASN inhibitor, TVB-3567, also intended for acne treatment.
"FASN inhibition represents a novel mechanism of action for the treatment of acne, a condition that impacts more than 50 million people in the U.S. annually, with limited innovation over the last 40 years," said David Happel, Chief Executive Officer of Sagimet, according to the press release. Analyst sentiment remains bullish, with price targets ranging from $11 to $33, suggesting significant upside potential. For comprehensive analysis and detailed financial metrics, access the full Pro Research Report available exclusively on InvestingPro.
Sagimet is also developing denifanstat for metabolic dysfunction associated steatohepatitis (MASH) outside of China. The FDA has granted the drug Breakthrough Therapy designation for non-cirrhotic MASH with moderate to advanced liver fibrosis.
In other recent news, Sagimet Biosciences announced a significant change in its auditing firm, appointing KPMG LLP as its independent registered public accounting firm for the fiscal year ending December 31, 2025. This decision also included the dismissal of Deloitte & Touche LLP, although Deloitte’s previous audit reports did not contain any adverse opinions or disclaimers. Sagimet Biosciences has also entered into a sales agreement with Leerink Partners, allowing the company to offer and sell up to $75 million of its Series A common stock through at-the-market offerings. Under this agreement, Leerink Partners will act as the sales agent, receiving a commission of up to 3.0% of the gross proceeds from each sale.
Additionally, Wedbush has initiated coverage on Sagimet Biosciences with an Outperform rating and a price target of $28.00, highlighting the company’s development of treatments for conditions such as metabolic dysfunction-associated steatohepatitis and acne. JMP Securities also reiterated its Market Outperform rating and a $31.00 price target following positive results from a Phase 3 acne trial conducted by Sagimet’s Chinese partner, Ascletis. The trial results showed significant improvements in all primary and secondary endpoints without serious adverse events. These developments indicate ongoing interest and confidence from analysts in Sagimet Biosciences’ potential.
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