Zevra Therapeutics
Tracked across 3 events · 41 articles · First seen Jun 08, 2026 · Last active Aug 11, 2026
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Regulatory
Impact: Zevra Therapeutics has strengthened its intellectual property protection for MIPLYFFA by submitting a new patent for Orange Book listing, extending its exclusivity until 2041. This action aims to maximize the long-term value of the drug and support patients with Niemann-Pick disease type C.
Jun 08, 2026 · 6 articles
Regulatory
On July 24, 2026, the European Union — European Medicines Agency's European Union — Committee for Medicinal Products for Human Use (CHMP) adopted a negative opinion on the Marketing Authorization Application for arimoclomol, branded Meplyffa,…
Impact: Zevra Therapeutics is the central entity, facing a 24% stock drop and a securities investigation following the CHMP's negative opinion on its lead drug arimoclomol. The company plans to request a re-examination and continues its Expanded Access Program.
Jul 24, 2026 · 29 articles
Business
Impact: Commercial product MIPLYFFA included in acquired portfolio.
Jul 14, 2026 · 6 articles
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European Union — Committee for Medicinal Products for Human Use adopted negative opinion Zevra TherapeuticsZevra CHMP Negative...
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European Union — European Medicines Agency adopted negative opinion Zevra TherapeuticsZevra CHMP Negative...
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Zevra Therapeutics plans to request re-examination European Union — Committee for Medicinal Products for Human UseZevra CHMP Negative...
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Zevra Therapeutics requested re-examination European Union — European Medicines AgencyZevra CHMP Negative...
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Zevra Therapeutics issued press releaseZevra CHMP Negative...
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Pomerantz LLP investigating claims Zevra TherapeuticsZevra CHMP Negative...
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Levi & Korsinsky commenced investigation Zevra TherapeuticsZevra CHMP Negative...
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