BIIB - Amylyx has a very realistic shot Evercore says after FDA briefing docs on ALS drug

Following a sharp decline, the clinical-stage pharma company, Amylyx (NASDAQ:AMLX -41.3%) pared losses after Evercore ISI issued favorable views on the briefing documents released by the U.S. regulators on the company’s candidate for amyotrophic lateral sclerosis, AMX0035. Ahead of an AdCom meeting scheduled for this week, the U.S. Food and Drug Administration (FDA) flagged statistical issues in the data supporting the therapy. While there is an unmet medical need for the therapy, the statistical significance of the CENTAUR Phase 3 trial for the treatment was “not highly persuasive,” the FDA wrote. “Does the briefing document read materially worse than expectation? Absolutely,” Evercore ISI analysts led by Umer Raffat argued. “Does it mean FDA won’t approve it? That’s a loaded question … and we will go on a limb to say it still has a very realistic shot,” they added. In addition to the positives in the documents, the analysts listed why

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Amylyx has a “very realistic shot”, Evercore says after FDA briefing docs on ALS drug