Shares of Cincor Pharma Inc. (NASDAQ:CINC) took a serious hit on top-line findings from the completed phase II Halo study with once-daily oral baxdrostat, but the clinical program with the aldosterone synthase inhibitor remains on track, and an NDA submission is targeted for 2025. The stock closed at $14.11, down $12.42, or 46.8% after Waltham, Mass.-based Cincor informed Wall Street that results from Halo, which enrolled patients taking as many as two blood pressure medications at the maximally tolerated doses without satisfactory results, missed statistical significance on its primary endpoint evaluating change from baseline in mean seated systolic blood pressure in the intent-to-treat population, which included 249 patients. Read More
Axsome Therapeutics Inc.’s AXS-05 (dextromethorphan + bupropion) has notched another success by hitting its phase III primary endpoint in treating a notoriously difficult Alzheimer’s disease (AD) indication when compared to placebo. Newly released data from the Accord study showed AXS-05, an oral, NMDA receptor antagonist with multimodal activity, statistically significantly delayed time to relapse of AD agitation vs. placebo (p=0.014), which was the primary endpoint. Read More
With only a year to go before 100% compliance with the U.S. Drug Supply Chain Security Act’s serialization provisions will be required from the beginning to the end of the drug supply chain, most biopharma manufacturers are pretty confident they’re ready for the Nov. 27, 2023, deadline. But distributors? Not so much. And they lay the blame at the manufacturers’ feet. Read More
C4X Discovery Holdings plc has outlicensed its once daily oral NRF2 (Nuclear factor-erythroid factor 2-related factor 2) activator to Astrazeneca plc in a deal with a potential value of $402 million. Of that, $2 million is being paid up front, with a further $14 million in preclinical milestones, which C4X CEO Clive Dix expects to trigger within the next two years. Read More
Spectrum Pharmaceuticals Inc. president and CEO Tom Riga said the company would "immediately deprioritize" its poziotinib program after the U.S. FDA issued a complete response letter (CRL) suggesting the company would have to generate new clinical data prior to potential approval. Read More
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Allegro, Akos, Alytas, BMS, Curediab, DRI, Enveric, Grünenthal, Kyowa Kirin, Ikena, Lyvgen, WHO and Xlife. Read More
