Sagimet Biosciences Inc. stock (NASDAQ:SGMT) had more than doubled at midday, with shares trading 112% higher at $14.57 each, as a phase IIb study of lead candidate denifanstat performed well against nonalcoholic steatohepatitis (NASH) compared to placebo. Top-line data from the Fascinate-2 trial showed the oral fatty acid synthase (FASN) inhibitor resulted in statistically significant improvements in biopsy-confirmed NASH patients with stage 2 or stage 3 fibrosis at week 52. The Fascinate-1 phase II study met its primary endpoint of relative change from baseline in liver fat at 12 weeks and a key secondary endpoint of the percentage of those with at least a 30% reduction in liver fat at 12 weeks. NASH has no approved treatments in the U.S. and Europe. Sagimet also is investigating FASN inhibition for acne and certain forms of cancer.

2023 gainers and losers: Positive trial outcomes and M&As propel biopharma stocks to strong finish

Biopharma stocks saw a resurgence in 2023, with the BioWorld Stock Index finishing the year with a gain of 33.59%, in contrast to the 32.75% decline in 2022. An analysis of 516 stocks from the index showed that 193 companies (37%) concluded the year on a positive note, while shares of 322 companies (62%) experienced a downturn.

US FDA’s trade secret disclosure still a live legal question

What’s the recourse when U.S. FDA reviewers disclose a brand company’s claimed trade secrets or confidential commercial information to competitors? That’s a question the U.S. Court of Federal Claims declined to fully answer last week. While the court dismissed some of Vanda Pharmaceuticals Inc.’s claims against the FDA, it left open the debate of whether such disclosures, intentional or inadvertent, are an unconstitutional taking. Saying it would be premature to resolve that part of the question at this point, the court noted that ”the more vexing issue in this case is whether Vanda can assert a cognizable property interest in the alternative dissolution specification the FDA proposed to Vanda during the approval process” of the company’s schizophrenia drug, Fanapt (iloperidone), and sleep disorder drug, Hetlioz (tasimelteon).

Gilead disappoints with top-line phase III data in metastatic NSCLC

Gilead Sciences Inc.’s eagerly awaited data from the phase III Evoke-01 study fell short of expectations, with its TROP2-targeted antibody-drug conjugate, Trodelvy (sacituzumab govitecan), failing to meet the overall survival primary endpoint in patients with previously treated metastatic non-small-cell lung cancer (NSCLC). The readout, which had been hailed by analysts as a major catalyst for the Foster City, Calif.-based firm, sent shares (NASDAQ:GILD) falling nearly 11% at midday, though the company noted numerical improvements in patients with both squamous and nonsquamous disease, along with solid safety data, could provide Trodelvy a path forward in metastatic NSCLC.

FDA offers life support to Mesoblast’s Revascor via rare pediatric disease designation

The U.S. FDA has granted Mesoblast Ltd.’s allogeneic cell therapy Revascor (rexlemestrocel-L) rare pediatric disease designation following submission of results from a clinical trial in children with hypoplastic left heart syndrome (HLHS), a potentially life-threatening congenital heart condition. In an HLHS trial, a single intramyocardial administration of Revascor at the time of staged surgery resulted in significantly larger increases in left ventricular end-systolic and end-diastolic volumes over 12 months compared with controls as measured by 3D echocardiography.

Latest US continuing budget resolution leaves docs dyspeptic 

The U.S. Congress has passed a continuing resolution (CR) for the fiscal 2024 budget, an exercise that has become all too common as a substitute for a full suite of spending bills in an era of growing deficits. Professional medical societies are none too happy with the CR, however, as it fails to override cuts in the Medicare rates paid to physicians who prescribe and administer pharmaceuticals and implant medical devices, making the latest CR a controversy that bears watching by all companies in the life sciences.

Biden administration concedes to court on copay accumulators

With little fanfare, the Biden administration last week dropped its appeal of a recent court decision that vacated a final U.S. Health and Human Services (HHS) rule permitting the use of copay accumulators that prevent copay assistance for prescription drugs from counting toward a patient’s deductible or out-of-pocket maximum. In issuing that rule in 2021, HHS reversed a rule, issued the previous year, that restricted the use of copay accumulators. The administration’s decision to withdraw its appeal followed bipartisan congressional pressure on HHS to revert to the 2020 rule as quickly as possible.

Also in the news

Abpro, AC Immune, Aeon, Anges, Apnimed, Arrivent, Astrazeneca, Basilea, Bayer, Calcimedica, Cara, Coherus, Deciphera, Eiger, Elevation Oncology, Fauna, Hyloris, Ikena, Mesoblast, Mitosense, Neumora, NMD, Optinose, Oric, PMV, Prilenia, Processa, Promis, Propagenix, Reithera, Respirerx, Sandoz, Sensorion, Siga, Stemcell, Transgene, Tris, Vaxart, Verastem