DAWN Stock Recent News

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.

Day One receives exclusive license for development and commercialization of MTX-13 (DAY301), which received IND clearance by the FDA in April 2024

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).

BRISBANE, Calif., Dec. 19, 2023 (GLOBE NEWSWIRE) -- Day One Biopharmaceuticals (Nasdaq: DAWN) (“Day One” or the “Company”), a clinical-stage biopharmaceutical company dedicated to developing and commercializing targeted therapies for people of all ages with life-threatening diseases, today announced that Dr. Jeremy Bender, chief executive officer, will present during the 42nd Annual J.P. Morgan Healthcare Conference on Monday, January 8 at 10:30 a.m. Pacific Time / 1:30 p.m. Eastern Time.

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 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 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 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.

Day One Biopharmaceuticals is looking to file an NDA after successful glioma data. DAWN is well-financed, having been VC supported in the initial years.

SOUTH SAN FRANCISCO, Calif., Dec. 20, 2022 (GLOBE NEWSWIRE) -- Day One Biopharmaceuticals (Nasdaq: DAWN), a clinical-stage biopharmaceutical company dedicated to developing and commercializing targeted therapies for people of all ages with life-threatening diseases, today announced that Dr. Jeremy Bender, chief executive officer, will present during the 41st Annual J.P. Morgan Healthcare Conference on Monday, January 9 at 4:30 p.m. Pacific Time / 7:30 p.m. Eastern Time.