On May 30, 2024 Day One Biopharmaceuticals (Nasdaq: DAWN) ("Day One" or the "Company"), a commercial-stage biopharmaceutical company dedicated to developing and commercializing targeted therapies for people of all ages with life-threatening diseases, reported it sold its Priority Review Voucher ("PRV") for $108 million to an undisclosed buyer (Press release, Day One, MAY 30, 2024, View Source [SID1234643852]). The Company was awarded the PRV following the U.S. Food and Drug Administration ("FDA") accelerated approval of OJEMDA (tovorafenib).
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"The sale of the PRV delivers true non-dilutive capital to Day One and further strengthens our balance sheet as we continue executing on the launch of OJEMDA and investing in clinical development opportunities for children and adults living with cancer," said Charles York II, chief operating and financial officer of Day One.
Under the Rare Pediatric Disease Priority Review Voucher Program, FDA awards PRVs to sponsors of rare pediatric disease product applications that meet certain criteria. The program is intended to encourage development of new drugs and biologics for the prevention and treatment of rare diseases. A PRV can be redeemed to receive priority review of a subsequent marketing application for a different product, sold or transferred.
As part of the transaction, $8.1 million of the total consideration received from the sale of the PRV will be paid to Viracta Therapeutics, Inc. ("Viracta") to fully satisfy PRV related obligations of the Company’s license agreement with Viracta, dated December 16, 2019, as amended.