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Zevra Q3 revenue climbs 45% to $37.8M as MIPLYFFA sales drive growth

🇺🇸 Zevra Therapeutics, Inc. (ZVRA) · Tue 03 Nov 2026

The US company also seeks EU re-examination of arimoclomol and plans a paediatric sNDA for infants under 24 months in the first quarter of 2027.

Zevra Therapeutics reported net revenue of $37.8M for the third quarter of 2026, a 45% rise. MIPLYFFA (arimoclomol), its treatment for Niemann-Pick disease type C, contributed $34.0M of the total. The company announced the results on 3 November 2026.

Net income for the quarter was $19.2M, and cash stood at $270.9M. The summary provided does not give comparative prior-year figures beyond the 45% revenue increase.

On regulatory plans, Zevra has requested re-examination of its EU marketing authorisation application for arimoclomol. In the EU, re-examination is the procedure by which an applicant can ask for an unfavourable opinion from the EMA's scientific committee to be reviewed. The summary does not state the grounds for the request or the expected timetable.

In the US, Zevra expects to file a supplemental new drug application (sNDA) in the first quarter of 2027 for infants under 24 months, after meeting the FDA.

Zevra also enrolled six more patients in the Phase 3 DiSCOVER trial of celiprolol for vascular Ehlers-Danlos syndrome. It held a Type C meeting with the FDA on a submission strategy for the product. No details of the meeting outcome were given in the material available.

What it means for your team

  • EU regulatory teams should watch the outcome of the arimoclomol re-examination, as it will determine whether the product can reach the EU market.
  • A planned US sNDA for infants under 24 months points to a possible label expansion in a younger NPC population, with timing dependent on FDA discussions.
  • Market-access teams can note that MIPLYFFA now provides most of Zevra's revenue, with $34.0M of $37.8M in the quarter.
  • Celiprolol's Type C meeting and continued DiSCOVER enrolment suggest a regulatory pathway for vascular EDS is still being defined.

Company's press release (SEC filing): Zevra Therapeutics, Inc. ↗

Article written by VigiEye from the official source (Zevra Therapeutics, Inc.). Claims are the company's own. AI-assisted; check the source before acting.

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