Day One Sells Priority Review Voucher for $108 Million

BRISBANE, Calif., May 30, 2024 — Day One Biopharmaceuticals, a company specializing in developing and commercializing targeted therapies for individuals of all ages with serious diseases, has announced the sale of its Priority Review Voucher (PRV) for $108 million to an unnamed buyer. The PRV was granted to Day One following the accelerated approval of OJEMDA™ (tovorafenib) by the U.S. Food and Drug Administration (FDA).

The sale of the PRV provides Day One with substantial non-dilutive capital, bolstering its financial standing as it continues to launch OJEMDA and explore further clinical development opportunities for pediatric and adult cancer patients. Charles York II, the company's chief operating and financial officer, emphasized the financial strength this transaction contributes as they execute their ongoing plans.

The FDA’s Rare Pediatric Disease Priority Review Voucher Program awards PRVs to sponsors of drug applications for rare pediatric diseases that meet specific criteria. These vouchers are designed to incentivize the development of new drugs and biologics aimed at treating or preventing rare diseases. PRVs can be redeemed for priority review of a subsequent marketing application for a different product, or they can be sold or transferred.

As part of this financial transaction, Day One will pay $8.1 million to Viracta Therapeutics, Inc. to fully settle obligations related to the PRV under a license agreement dated December 16, 2019, and subsequently amended.

About Day One Biopharmaceuticals

Day One Biopharmaceuticals is a commercial-stage biopharmaceutical company committed to pediatric cancer treatment advancements. The company was established to address the significant unmet need in pediatric cancer therapeutics. Inspired by "The Day One Talk" that doctors have with patients and their families about initial cancer diagnoses and treatment plans, Day One aims to transform cancer drug development and expand possibilities for all cancer patients, irrespective of age, from the very first day of diagnosis.

Day One collaborates with leading clinical oncologists, families, and scientists to identify, acquire, and develop crucial targeted cancer treatments. Their current pipeline includes tovorafenib (OJEMDA™) and pimasertib. The company is headquartered in Brisbane, California.

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