Amylyx Pharmaceuticals Receives Negative CHMP Opinion On Its Marketing Authorisation Application For AMX0035 For The Treatment Of ALS In The European Union Following Re-Examination Process
Portfolio Pulse from Benzinga Newsdesk
Amylyx Pharmaceuticals has received a negative opinion from the Committee for Medicinal Products for Human Use (CHMP) on its marketing authorisation application for AMX0035 for the treatment of ALS in the European Union. The final decision from the European Commission is expected by the end of 2023. The PHOENIX Phase 3 trial topline results are on track for mid-2024.
October 13, 2023 | 11:46 am
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NEGATIVE IMPACT
Amylyx Pharmaceuticals' stock may be negatively impacted in the short term due to the negative CHMP opinion on its marketing authorisation application for AMX0035.
The negative opinion from CHMP on Amylyx's marketing authorisation application for AMX0035 could potentially delay or prevent the drug's approval in the EU. This could impact the company's potential revenues from the drug and thus negatively affect its stock price in the short term.
CONFIDENCE 90
IMPORTANCE 80
RELEVANCE 100