Zevra Shares Rally Premarket After FDA Panel Backs Arimoclomol

By Colin Kellaher

Shares of Zevra Therapeutics jumped more than 20% in premarket trading Monday after a Food and Drug Administration advisory committee recommended approval of the company's arimoclomol drug candidate for Niemann-Pick disease type C.

The Celebration, Fla., company late Friday said the FDA panel voted 11-5 that data support arimoclomol as effective in treating patients with the rare neurodegenerative disorder.

The FDA had previously set a June target action date for the application but extended the date to Sept. 21 so it could hold the meeting.

The agency often turns to advisory committees to obtain input from experts who work outside of the government when a scientific, technical or policy question arises, such as whether an unapproved product is safe and effective.

The FDA usually follows the advice of its advisory committees, but it isn't bound by the recommendations.

Zevra shares, which closed Thursday at $6.30, were recently up nearly 22% at $7.66 in premarket trading. Trading in the stock was halted during Friday's session.

Write to Colin Kellaher at colin.kellaher@wsj.com

(END) Dow Jones Newswires

August 05, 2024 07:25 ET (11:25 GMT)

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