Oct. 1 Quick Takes: Omeros’ shares dive after FDA flags ‘deficiencies’

Omeros Corp. (NASDAQ:OMER) shed more than a third of its value Friday after it said FDA “identified deficiencies that preclude discussion of labeling and post-marketing requirements/commitments” in its BLA for MASP2 inhibitor narsoplimab to treat hematopoietic stem cell transplant-associated thrombotic microangiopathy (HSCT-TMA). Although the biotech intends to work with FDA to address the issues, Omeros does not expect to resolve them by narsoplimab’s Oct. 17 PDUFA date. The biotech lost $5.25 (38%) to $8.54, leaving the company with a market cap of about $534 million.

Bristol Myers Squibb Co. (NYSE:BMS) said EMA is reviewing applications for two therapies: mavacamten for obstructive hypertrophic cardiomyopathy, and relatlimab plus Opdivo nivolumab to treat unresectable or metastatic melanoma in a first-line setting. Mavacamten, a first-in-class small molecule allosteric modulator of cardiac myosin, met a composite primary endpoint measuring symptoms and function in the Phase 3 EXPLORER-HCM trial. Relatlimab, a LAG3 inhibitor in a closely-watched class, led to a significant progression-free survival benefit over PD-1 inhibitor Opdivo alone in the Phase II/III RELATIVITY-047 study. Both treatments are already under FDA review...