Anavex Life Sciences Corp.’s stock (NASDAQ:AVXL) sunk 35% on Jan. 2 after a phase II/III study failure in Rett syndrome but posted a next-day rebound of 8% on Jan. 3 with shares closing at $6.53 each. Top-line data from the randomized, double-blind, placebo-controlled study of the company’s lead asset, Anavex 2-73 (blarcamesine), showed improvement but did not reach statistical significance on the co-primary endpoint, the Rett Syndrome Behaviour Questionnaire.
Sciwind Biosciences Co. Ltd.’s injectable glucagon-like peptide-1 (GLP-1) analog, ecnoglutide (XW-003), achieved positive top-line results in a phase III trial in Chinese adults with type 2 diabetes. A long-acting, cAMP signaling biased GLP-1 analog, ecnoglutide is being developed for treating type 2 diabetes and obesity. GLP-1 receptor agonists are increasingly gaining attention in the obesity therapy area.
Starpharma Holdings Ltd.’s DEP docetaxel phase II trial met its primary endpoints, demonstrating antitumor activity in multiple advanced, metastatic cancers, including pancreatic, gastro-esophageal, non-small-cell lung cancer and cholangiocarcinoma.
Longboard Pharmaceuticals Inc.’s positive – and then some – phase Ib/IIa top-line data with 5-HT2C receptor superagonist bexicaserin (LP-352) in developmental and epileptic encephalopathies (DEEs) sparked Wall Street speculation about competitive odds as well as the shape of the firm’s upcoming phase III effort.
Clinical trial updates saw a 5.82% increase for the period of January to November 2023 compared to the same period last year. In November, BioWorld reported on 354 phase I-III trial updates. Although marking a decline from the 416 reported in October, the number of updates still surpasses the previous three months.
Cytokinetics Inc. received a slightly last minute Christmas gift in the form of positive top-line data from the pivotal phase III study of aficamten in treating symptomatic obstructive hypertrophic cardiomyopathy.
As its pharma peers continue to place big bets on antibody-drug conjugates (ADCs), Sanofi SA is ditching the only advertised ADC program in its pipeline, after it failed an independent interim analysis.
Starpharma Holdings Ltd.’s DEP docetaxel phase II trial met its primary endpoints, demonstrating antitumor activity in multiple advanced, metastatic cancers, including pancreatic, gastro-esophageal, non-small-cell lung cancer and cholangiocarcinoma.
Argenx SE CEO Tim Van Hauwermeiren said that, with subcutaneous efgartigimod (efgartigimod alfa and hyaluronidase-qvfc) in pemphigus, the company is “facing a situation where, even with a strong scientific hypothesis and well-executed trial, we encountered the unknown-unknown,” and the phase III experiment failed. “We are committed to doubling down” on the execution of the firm’s business plan, he added.
On-again, off-again investor enthusiasm for Uniqure NV’s Huntington’s disease (HD) gene therapy AMT-130 got another boost as the company followed this summer’s news from phase I/II trials with additional interim data. Shares of Uniqure (NASDAQ:QURE) closed Dec. 19 at $6.64, down $1.34, or 17%, as the company offered results on up to 30 months of follow-up from 39 patients enrolled in the ongoing U.S. and European experiment.
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