Day One Sells Priority Review Voucher for $108 Million

Rare Daily Staff

Day One Biopharmaceuticals said it sold its Priority Review Voucher for $108 million to an undisclosed buyer.

The company was awarded the PRV following the U.S. Food and Drug Administration accelerated approval of Ojemda.

“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.

Ojemda, a type II RAF kinase inhibitor of mutant BRAF V600, wild-type BRAF, and wild-type CRAF kinases, was approved to treat pediatric low-grade glioma (pLGG), the most common brain tumor diagnosed in children, with patients suffering profound tumor- and treatment-associated morbidities that can impact their life trajectory. BRAF is the most commonly altered gene in pLGG, with up to 75 percent of children having a BRAF alteration. In children with BRAF-altered pLGG, approximately 80 percent have BRAF fusions or rearrangements, while the remaining 20 percent have a V600 mutation. Until now, there had been no medicines approved for patients with pLGG driven by BRAF fusions. It is the only systemic therapy for pLGG that offers once-weekly dosing, with or without food, as a tablet or oral suspension.

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 to fully satisfy PRV related obligations of the company’s license agreement with Viracta, dated December 16, 2019, as amended.