About two months after reporting that enrollment of its phase II/III study with buntanetap in Alzheimer’s disease had completed enrollment, Annovis Bio Inc. disappointed Wall Street by saying that findings from the phase III in Parkinson’s disease – hoped for by the end of this month – would be delayed for data-cleaning reasons.
Sciwind Biosciences Co. Ltd.’s oral ecnoglutide (XW-004) produced strong weight loss results after short-term treatments, up to a 6.8% body weight decrease in obese and overweight participants after once-daily dosing for six weeks, according to data from the first four cohorts of the phase I trial.
Biontech SE and Duality Biologics Co. Ltd. have progressed BNT-323/DB-1303 to pivotal phase III trials, beginning in China in patients with hormone receptor-positive and HER2-low metastatic breast cancer.
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).
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.
With one approved myosin inhibitor on the market and another coming up fast, researchers such as those at Tenaya Therapeutics Inc. are casting for new strategies to treat hypertrophic cardiomyopathy (HCM).
After the U.S. FDA granted clearance in March 2023, sales began promptly of Acadia Pharmaceuticals Inc.’s new Rett syndrome therapy, Daybue (trofinetide), and questions during the recent J.P. Morgan Healthcare Conference in San Francisco had to do with – among other matters – sales guidance from the firm, which is hardly alone in seeking treatments for the disease. Other players include Anavex Life Sciences Corp., Neurogene Inc. and Taysha Gene Therapies Inc.
Dxcover Ltd. initiated three pivotal trials to measure the efficacy of its liquid biopsy platform for early detection of brain, colorectal and lung cancers. The company hopes the trials will provide the evidence needed to gain regulatory approval and begin commercial operations of its diagnostic technology in Europe and the U.S.
Acurx Pharmaceuticals Inc. continues to post positive data for its lead candidate ibezapolstat but that didn’t stop the stock from tumbling. The antibiotic outperformed vancomycin in a phase IIb study treating Clostridioides difficile infection (CDI). Vancomycin is a standard of care in the indication. Ibezapolstat eradicated fecal CDI at day 3 in 15 of 16 patients compared to vancomycin, which eradicated fecal CDI in 10 of 14 patients.
Kriya Therapeutics Inc.’s unveiling of its new gene therapy program for thyroid eye disease (TED), KRIYA-586, added yet another player to the burgeoning space, where a handful of developers have reached the phase III stage.
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