The stock’s decline to $9.20 marks a sharp reversal for investors, despite the company’s 50% gain throughout the year leading up to Thursday’s close. The Committee for Medicinal Products for Human Use (CHMP) rejected the marketing authorization application, stalling the drug’s potential path into the European market.
In section Market Quotes
Zevra Therapeutics Shares Plunge on European Regulatory Setback
A 27% premarket slide hit Zevra Therapeutics on Friday after the European Medicines Agency’s advisory committee issued a negative opinion on arimoclomol. The treatment, intended for the rare, life-threatening Niemann-Pick disease type C, now faces a major hurdle as the company prepares to contest the decision.
Zevra intends to formally challenge the ruling. Chief Executive Neil McFarlane stated that the company plans to request a re-examination of the committee’s opinion, promising a detailed justification for the appeal. While the current decision represents a significant setback, management maintains that they are investigating alternative pathways to provide the therapy to European patients.
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