Trading in shares of Amylyx Pharmaceuticals Inc. is halted Wednesday ahead of a key U.S. Food and Drug Administration advisory committee meeting on the company's AMX0035 drug candidate.
The FDA in July said it would reconvene the meeting to focus on additional analyses of study data that Amylyx had submitted on the proposed treatment for amyotrophic lateral sclerosis, a progressive neurodegenerative disease also known as Lou Gehrig's disease that robs patients of their ability to move and speak.
The FDA's advisory panel of neuroscience experts voted 6-to-4 in March that a study hadn't provided sufficient evidence that AMX0035 works, raising fears that the agency would reject the drug.
However, the FDA extended its target action date on AMX0035 to Sept. 29 from June 29 to allow more time to review the additional analyses, raising renewed hopes for the drug, which in June won approval from Canadian health authorities.
Those hopes took a hit last week after the FDA posted briefing documents for Wednesday's meeting that showed continued concerns about the reliability of the drug's study data.
FDA reviewers called some of Amylyx's new analyses "questionable" and noted that the Cambridge, Mass., company is conducting a new Phase 3 study with results expected in late 2023 or early 2024, which they said puts the agency "in a challenging situation of potentially making a regulatory decision that may not be subsequently aligned with the results of the ongoing study."
The advisory committee meeting is slated for noon ET.
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