Amylyx Pharmaceuticals shares fell Friday after its ALS (amyotrophic lateral sclerosis) drug was denied marketing authorization by European Union regulators for the second time.
The repeat rebuff comes after Amylyx asked in June for a formal re-examination of the original denial adopted by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA).
Shares of the company eased 1.8% to $17.31.
Going forward, Amylyx said it intends to prioritize completing the late-stage study of the drug, at which point it will seek approval once again from the EU. Data from that study is expected in mid-2024.
Notably, Amylyx’s drug has already been approved by the US Food and Drug Administration and has received conditional approval in Canada.
The drug is a combination of sodium phenylbutyrate and taurursodiol compounds that work to prevent nerve cells in the brain and spinal cord from dying prematurely.
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