Sagimet Biosciences: FDA Eases Path for MASH Drug Development with Fatty Acid Synthase Blocker Denifanstat

Sagimet Biosciences Inc. (NASDAQ:SGMT) has gained momentum with the FDA easing the path for MASH drug development. The company's denifanstat, a fatty acid synthase inhibitor, has a novel mechanism that could give it an edge in the MASH market. With this development, Sagimet's shares are expected to rise.

Sagimet Biosciences Inc. (NASDAQ:SGMT) has seen significant momentum following the FDA's decision to ease the path for MASH drug development. The company's lead drug, Denifanstat, a fatty acid synthase inhibitor, has shown promising results in Phase 2b trials, demonstrating both fat reduction and fibrosis regression. The FDA's approval of a non-invasive liver stiffness scan as a valid surrogate endpoint for MASH trials has made it easier and faster for developers to run studies, potentially shaving years and millions of dollars off the clinical pathway.

Denifanstat, which is designed to block fatty acid synthase, an enzyme tied to fat buildup and fibrosis in the liver, has shown encouraging biopsy-based results in its Phase 2b trial. The drug has demonstrated meaningful improvements in both steatosis and fibrosis, with a clean daily pill profile. This dual effect could make Denifanstat a compelling competitor in the MASH market, where regulators and payers are looking for drugs that not only clear fat but also alter the disease course.

The FDA's decision has been well-received by investors, with Sagimet's stock rising by over 10% on August 27th. The stock has since seen a 24% decrease over the past month, but investors still see potential in the company's pipeline. Sagimet's balance sheet remains strong, with approximately $135.5 million in cash, cash equivalents, and marketable securities at the end of the second quarter of 2025. The company has a runway of 8 to 10 quarters, depending on the burn rate and the need for additional capital.

The total addressable market for MASH is substantial, with estimates pegging the global market at north of $2 to $8 billion a year. Sagimet is looking to capture just a small, single-digit share of this market, which could translate into potential revenues in the hundreds of millions annually. The company's focus on Denifanstat's Phase 3 trials and eventual commercialization will be key to driving the stock's momentum going into the second half of 2025.

References:
[1] https://seekingalpha.com/article/4817896-sagimet-gains-momentum-as-fda-eases-path-for-mash-drug-development