Company: ZVRA
Filing Date: 2025-02-27
Form Type: 8-K
Source: 0001193125-25-037619
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Company: ZEVRA THERAPEUTICS, INC.
Filing Date: 2025-02-27
Form: 8-K
Item: Item 1.01
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Item 1.01.      Entry into a Material Definitive Agreement  

On February 26, 2025, Zevra Therapeutics, Inc. (the “ Company”) and Zevra Denmark A/S entered into an asset purchase agreement (the “ PRV Transfer Agreement”), pursuant to which the Company agreed to sell a Rare Pediatric Disease Priority Review Voucher (“ PRV”) to the buyer. The Company was awarded the voucher under a U. S. Food and Drug Administration (“ FDA”) program intended to encourage the development of certain rare pediatric disease product applications. The Company received the PRV when MIPLYFFA (arimoclomol) was approved by the FDA to be used in combination with miglustat for the treatment of neurological manifestations of Niemann-Pick disease type C (NPC) in adult and pediatric patients 2 years of age and older. Pursuant to the PRV Transfer Agreement, the buyer agreed to pay the Company $150 million, payable in cash, upon the closing of the sale.

The PRV Transfer Agreement contains customary representations, warranties, covenants, and indemnification provisions subject to certain limitations. The transaction remains subject to customary closing conditions, including the expiration or termination of the applicable waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976.

The foregoing description of the PRV Transfer Agreement does not purport to be complete and is qualified in its entirety by the full text of the PRV Transfer Agreement.