- Amylyx Pharmaceuticals ( NASDAQ: AMLX ), a company focused on neurodegenerative diseases, lost ~28% in value on Friday after the FDA posted briefing documents ahead of an advisory committee meeting scheduled for next week on its candidate for amyotrophic lateral sclerosis AMX0035.
- The shares of Reata Pharmaceuticals ( RETA ), a developer focused on another neurological disease called Friedreich’s ataxia, have also come under pressure in reaction.
- Sep. 07 meeting will be the second the FDA’s independent experts will review the drug after voting against its approval in March.
- However, the FDA extended the review period of AMLX’s new drug application (NDA) for AMX0035 by three months to review additional data extending the PDUFA date to Seep. 29 from the original date of Jun. 29.
- This is a developing story. Check back for more updates.
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Amylyx plunges 28% after FDA briefing documents on ALS drug