OJEMDA™ (tovorafenib) launch underway following U.S. FDA accelerated approval for relapsed or refractory BRAF-altered Pediatric Low-Grade Glioma (pLGG) First prescriptions received in the U.S. BRISBANE, Calif., May 06, 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... Read More

First and only FDA-approved type II RAF inhibitor for patients with relapsed or refractory pLGG harboring a BRAF fusion or rearrangement, or BRAF V600 mutation RAPNO LGG overall response rate (ORR) of 51% Day One receives rare pediatric disease priority review voucher Conference call and webcast to be April 24, 8:30 a.m. Eastern Time BRISBANE, Calif., April 23, 2024 (GLOBE NEWSWIRE) -- Day One Biopharmaceuticals, Inc.... Read More

PDUFA target action date for tovorafenib NDA in relapsed or progressive pLGG remains set for April 30, 2024 Phase 2 FIREFLY-1 tovorafenib registrational data published in Nature Medicine Ended 2023 with $366.3 million in cash, cash equivalents and short-term investments providing runway into 2026 BRISBANE, Calif., Feb. 26, 2024 (GLOBE NEWSWIRE) -- Day One Biopharmaceuticals (Nasdaq: DAWN) (“Day One” or the “Company”), a... Read More

BRISBANE, Calif., Jan. 17, 2024 (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 the appointments of Habib Dable and Dr. William Grossman to its Board of Directors. “We are excited to welcome Habib and Bill... Read More

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 42 nd Annual J.P. Morgan Healthcare Conference on... Read More

BRISBANE, Calif., Nov. 17, 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 the publication of the registrational Phase 2 FIREFLY-1 trial results evaluating the investigational agent tovorafenib in... Read More

BRISBANE, Calif., Nov. 14, 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 management will participate in a fireside chat at the Piper Sandler 35 th Annual Healthcare Conference on Tuesday,... Read More

NDA for tovorafenib in relapsed or progressive pLGG accepted for FDA priority review PDUFA target action date of April 30, 2024 BRISBANE, Calif., Nov. 06, 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... Read More

BRISBANE, Calif., Oct. 30, 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 the U.S. Food and Drug Administration (FDA) accepted its New Drug Application (NDA) for tovorafenib as a monotherapy in... Read More

Overall response rate (ORR) greater than 50% across three assessment criteria Median duration of tovorafenib treatment of 15.8 months as of June 5, 2023, with 66% of patients remaining on treatment FDA filing decision expected by mid-November BRISBANE, Calif., Sept. 11, 2023 (GLOBE NEWSWIRE) -- Day One Biopharmaceuticals (Nasdaq: DAWN) (“Day One” or the “Company”), a clinical-stage biopharmaceutical company dedicated to... Read More

Day One receives an exclusive license to develop and commercialize small molecule drug candidates for pediatric and adult cancers with high unmet need Collaboration augments Day One’s portfolio of targeted therapies in oncology BRISBANE, Calif., Aug. 16, 2023 (GLOBE NEWSWIRE) -- Day One Biopharmaceuticals (Nasdaq: DAWN), a clinical-stage biopharmaceutical company dedicated to developing and commercializing targeted therapies... Read More

Results from FIREFLY-1 demonstrate overall response rate (ORR) of 67% and clinical benefit rate (CBR) of 93% in 69 heavily pretreated Response Assessment Neuro-Oncology High-Grade Glioma (RANO-HGG) evaluable patients presented at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting Initiated rolling submission of the tovorafenib New Drug Application (NDA) in relapsed or progressive pediatric low-grade glioma... Read More

BRISBANE, Calif., June 12, 2023 (GLOBE NEWSWIRE) -- Day One Biopharmaceuticals, Inc. (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 the closing on June 12, 2023 of its previously announced underwritten public offering of 13,269,231 shares of its common stock, including the full... Read More

BRISBANE, Calif., June 06, 2023 (GLOBE NEWSWIRE) -- Day One Biopharmaceuticals, Inc. (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 the pricing of its underwritten public offering of 11,538,462 shares of its common stock at a public offering price of $13.00 per share. All shares of... Read More

SOUTH SAN FRANCISCO, Calif., June 06, 2023 (GLOBE NEWSWIRE) -- Day One Biopharmaceuticals, Inc. (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 it has commenced an underwritten public offering of $150.0 million of shares of its common stock. All of the shares of common stock... Read More

Overall response rate (ORR) of 67% and clinical benefit rate (CBR) of 93% in 69 heavily pretreated RANO-HGG evaluable patients The Company expects to complete rolling NDA submission in October 2023 Conference call and webcast today at 6:00 p.m. CT BRISBANE, Calif., June 04, 2023 (GLOBE NEWSWIRE) -- Day One Biopharmaceuticals (Nasdaq: DAWN) (“Day One” or the “Company”), a clinical-stage biopharmaceutical Company dedicated to... Read More

BRISBANE, Calif., May 30, 2023 (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 management will participate in a fireside chat at the Goldman Sachs 44 th Annual Global Healthcare Conference on Wednesday, June 14 at 11:20 a.m. PT. A live... Read More

BRISBANE, Calif., May 25, 2023 (GLOBE NEWSWIRE) -- In a release issued under the same headline earlier today by Day One Biopharmaceuticals, Inc. (Nasdaq: DAWN), please note that in the second paragraph of the release and just below it, the oral session timing has changed. The corrected release follows: New clinical data from registrational FIREFLY-1 study to be featured as an oral presentation Conference call and webcast... Read More

New clinical data from registrational FIREFLY-1 study to be featured as an oral presentation Conference call and webcast scheduled on Sunday, June 4, 2023 at 6:00 p.m. CT BRISBANE, Calif., May 25, 2023 (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,... Read More

FIREFLY-1 clinical abstract selected for oral presentation at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting Leadership team strengthened with executive appointments in clinical development and commercialization Pre-New Drug Application (NDA) meeting held April 19, 2023 with U.S. Food and Drug Administration (FDA) for tovorafenib (DAY101) for relapsed or progressive pediatric low-grade glioma (pLGG)... Read More

New clinical data from registrational FIREFLY-1 study to be featured as an oral presentation Trial-in-progress poster from FIREFLY-2 and healthcare resource use for pediatric low-grade glioma care poster to be presented Company to host conference call and webcast on Sunday, June 4, 2023 at 6:00 PM CT BRISBANE, Calif., April 26, 2023 (GLOBE NEWSWIRE) -- Day One Biopharmaceuticals (Nasdaq: DAWN), a clinical-stage... Read More

BRISBANE, Calif., April 12, 2023 (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 an upcoming poster presentation at the 19 th European Association of Dermato-Oncology (EADO) Congress being held from April 20-22, 2023 in Rome, Italy.... Read More

First patient dosed in pivotal Phase 3 FIREFLY-2/LOGGIC trial evaluating tovorafenib (DAY101) as a frontline therapy for patients newly diagnosed with pediatric low-grade glioma (pLGG) Reported topline data in January 2023 from ongoing, pivotal Phase 2 FIREFLY-1 trial demonstrating meaningful responses with tovorafenib (DAY101) in relapsed or progressive pLGG Additional data from FIREFLY-1 planned for presentation at a... Read More

SOUTH SAN FRANCISCO, Calif., Feb. 27, 2023 (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 management will participate in a fireside chat at the Cowen 43 rd Annual Health Care Conference on Tuesday, March 7 at 9:10 a.m. ET. A live audio... Read More

Overall response rate (ORR) of 64% and clinical benefit rate (CBR) of 91% in 69 heavily-pretreated, RANO-evaluable patients Median duration of 8.4 months on therapy as of September 28, 2022, with 77% of patients remaining on treatment Additional data to be presented at a medical meeting in the second quarter of 2023 New Drug Application submission planned for first half of 2023 SOUTH SAN FRANCISCO, Calif., Jan. 08, 2023... Read More

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 41 st Annual J.P. Morgan Healthcare Conference on Monday, January 9 at... Read More