Sagimet Biosciences Inc. stock (NASDAQ:SGMT) more than doubled Jan. 22 as shares closed 170% higher at $18.42 each as a phase IIb study of lead candidate denifanstat performed well against nonalcoholic steatohepatitis (NASH) compared to placebo. Top-line data from the 52-week, randomized, double-blind Fascinate-2 trial showed the oral fatty acid synthase inhibitor resulted in statistically significant improvements in biopsy-confirmed NASH patients with stage 2 or stage 3 fibrosis, which is moderate to severe disease, at week 52. Read More
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. Anebulo Pharmaceuticals Inc. (NASDAQ:ANEB), a biopharma focused on substance use disorders, saw its stock end 2023 at the same price as its 2022 closing. Meanwhile, the BioWorld Biopharmaceutical Index ended November up 4.37%. Read More
Is it an unconstitutional taking when U.S. FDA reviewers disclose a brand company’s claimed trade secrets or confidential commercial information to would-be competitors? That’s a question the U.S. Court of Federal Claims has yet to answer. While the court dismissed some of Vanda Pharmaceuticals Inc.’s claims against the FDA, its Jan. 18 opinion left open the debate of whether such disclosures, intentional or inadvertent, are a per se or regulatory taking. Read More
What had been viewed as a major catalyst for Gilead Sciences Inc. going into 2024 turned into a disappointment on the stock market, as antibody-drug conjugate Trodelvy (sacituzumab govitecan) failed to meet the overall survival primary endpoint in the phase III Evoke-01 study in previously treated metastatic non-small-cell lung cancer (NSCLC). Read More
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, a potentially life-threatening congenital heart condition. Read More
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. Read More
With little fanfare, the Biden administration dropped its appeal Jan. 16 of a recent court decision that vacated a 2021 U.S. Health and Human Services rule permitting health insurance issuers and group health plans to use so-called copay accumulator adjustment programs that prevent drug manufacturers’ copay assistance from counting toward a patient’s deductible or out-of-pocket maximum. Read More
New hires and promotions in the biopharma industry, including: Apnimed, Bayer, Elevation Oncology, Neumora, NMD, Respirerx, Siga, Transgene, Tris. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Aeon, Coherus, Deciphera, Optinose, Prilenia. Read More
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Abpro, AC Immune, AFT, Atlantic Coastal, Basilea, Cara, Coherus, Fauna, Genentech, Hyloris, Ikena, Knight, PMV, Promis, Propagenix, Reithera, Roche, Sandoz, Stemcell, Vaxart. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Anges, Astrazeneca, Eiger, Mesoblast, Processa, Sensorion, Verastem. Read More
