Day One BiopharmaceuticalsNASDAQ: DAWN

Day One (DAWN) gains 11% on in-licensing exclusive worldwide rights to MabCare???s MTX-13, which is set to begin clinical studies for adult and pediatric solid tumor indications.

BRISBANE, Calif., May 30, 2024 (GLOBE NEWSWIRE) -- 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, today announced it sold its Priority Review Voucher (PRV) for $108 million to an undisclosed buyer. The Company was awarded the PRV following the U.S. Food and Drug Administration (FDA) accelerated approval of OJEMDA™ (tovorafenib).

Shares of precision oncology concern Day One Biopharmaceuticals, Inc. are down over 50% from their 2023 high as Novartis' combination therapy received first approval for pLGG. However, its lead candidate (tovorafenib) has the potential to treat all BRAF-mutated pLGG patients, whereas Novartis' combo only addresses about 10% to 20% of that population. With tovorafenib's somewhat risky rolling NDA submission slated for October 2023 and ample cash for commercialization, the recent beneficial owner buying merited a look into this busted IPO.

Day One Biopharmaceuticals DAWN, -0.37% shares climbed 23% in premarket trading Monday after the company shared new data on tovorafenib, an investigational treatment for relapsed or progressive pediatric low-grade glioma. Trial data showed high rates of durable tumor reduction and a safety profile that allows for potential long-term dosing, the company said in a release.

Day One has begun a rolling NDA for its candidate DAY101 as a monotherapy for relapsed or progressive pediatric low-grade glioma (pLGG). The company said the drug showed a high overall response rate on heavily pretreated patients with a type of brain tumor.

Day One Biopharmaceuticals stock added more than 16% Monday afternoon after the company posted its first-quarter financial results.  The Brisbane, California company reported a cash position of $318.2 million as of March 31, which management believes is sufficient to fund operations into 2025.