Articles from Day One Biopharmaceuticals, Inc.

BRISBANE, Calif., Feb. 11, 2025 (GLOBE NEWSWIRE) -- Day One Biopharmaceuticals (Nasdaq: DAWN) (“Day One” or the “Company”), a biopharmaceutical company dedicated to developing and commercializing targeted therapies for people of all ages with life-threatening diseases, today announced it will host a live conference call and webcast on Tuesday, February 25, 2025 at 4:30 p.m. ET to report financial results and discuss corporate progress for the fourth quarter and full-year 2024.

Preliminary 2024 OJEMDA™ (tovorafenib) net product revenue of approximately $57.2 million (unaudited)

BRISBANE, Calif., Dec. 17, 2024 (GLOBE NEWSWIRE) -- Day One Biopharmaceuticals (Nasdaq: DAWN) (“Day One” or the “Company”), a 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 43rd Annual J.P. Morgan Healthcare Conference on Monday, January 13 at 3:45 p.m. Pacific Time / 6:45 p.m. Eastern Time.

Dr. Blackman’s departure planned for end of 2024

BRISBANE, Calif., Nov. 18, 2024 (GLOBE NEWSWIRE) -- Day One Biopharmaceuticals, Inc. (Nasdaq: DAWN) (“Day One” or the “Company”), a 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 36th Annual Healthcare Conference on Tuesday, December 3 at 3:00 p.m. EST.

Achieved $20.1 million in OJEMDATM (tovorafenib) net product revenue

BRISBANE, Calif., Oct. 16, 2024 (GLOBE NEWSWIRE) -- Day One Biopharmaceuticals (Nasdaq: DAWN) (“Day One” or the “Company”), a biopharmaceutical company dedicated to developing and commercializing targeted therapies for people of all ages with life-threatening diseases, today announced it will host a live conference call and webcast on Wednesday, October 30, 2024 at 4:30 p.m. ET to report financial results and discuss corporate progress for the third quarter 2024.

Achieved $8.2 million in OJEMDATM (tovorafenib) net product revenues in initial 2 months of launch

BRISBANE, Calif., July 30, 2024 (GLOBE NEWSWIRE) -- Day One Biopharmaceuticals, Inc. (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 has entered into a securities purchase agreement for an oversubscribed private placement of its securities for gross proceeds of approximately $175.0 million, before deducting placement agent fees and other expenses.

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).

OJEMDA™ (tovorafenib) launch underway following U.S. FDA accelerated approval for relapsed or refractory BRAF-altered Pediatric Low-Grade Glioma (pLGG)

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

PDUFA target action date for tovorafenib NDA in relapsed or progressive pLGG remains set for April 30, 2024

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.

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.

Data subsets to be shared today in plenary oral presentations at the 2023 Society for Neuro-Oncology Annual Meeting

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 35th Annual Healthcare Conference on Tuesday, November 28 at 11:30 a.m. EST.

NDA for tovorafenib in relapsed or progressive pLGG accepted for FDA priority review

Priority review granted with PDUFA target action date of April 30, 2024

Overall response rate (ORR) greater than 50% across three assessment criteria

Day One receives an exclusive license to develop and commercialize small molecule drug candidates for pediatric and adult cancers with high unmet need

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

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 exercise of the underwriters’ option to purchase 1,730,769 additional shares, at a public offering price of $13.00 per share. All shares of common stock were offered by Day One. The gross proceeds to Day One from the offering, before deducting underwriting discounts and commissions and other offering expenses, were approximately $172.5 million.

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 common stock are being offered by Day One. The gross proceeds to Day One from the offering, before deducting underwriting discounts and commissions and other offering expenses, are expected to be approximately $150.0 million. In addition, Day One has granted the underwriters a 30-day option to purchase up to an additional 1,730,769 shares of its common stock at the public offering price, less underwriting discounts and commissions. The offering is expected to close on or about June 9, 2023, subject to the satisfaction of customary closing conditions.

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 are being offered by Day One. In addition, Day One intends to grant the underwriters a 30-day option to purchase up to an additional $22.5 million of shares of its common stock at the public offering price, less underwriting discounts and commissions. The proposed offering is subject to market and other conditions, and there can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the proposed offering.

Overall response rate (ORR) of 67% and clinical benefit rate (CBR) of 93% in 69 heavily pretreated RANO-HGG evaluable patients

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 44th Annual Global Healthcare Conference on Wednesday, June 14 at 11:20 a.m. PT.

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

FIREFLY-1 clinical abstract selected for oral presentation at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting

New clinical data from registrational FIREFLY-1 study to be featured as an oral presentation

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 19th European Association of Dermato-Oncology (EADO) Congress being held from April 20-22, 2023 in Rome, Italy.

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)

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 43rd Annual Health Care Conference on Tuesday, March 7 at 9:10 a.m. ET.

SOUTH SAN FRANCISCO, Calif., Jan. 08, 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 positive topline results from the ongoing, open-label, pivotal Phase 2 FIREFLY-1 trial evaluating the investigational agent, tovorafenib (DAY101), as a monotherapy in recurrent or progressive pediatric low-grade glioma (pLGG). Pediatric low-grade glioma is the most common brain tumor diagnosed in children and for which there is no standard of care, and for which there are no approved therapies for the majority of patients. Additional data will be submitted for presentation at an upcoming medical meeting in the second quarter of 2023.

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.

SOUTH SAN FRANCISCO, Calif., Nov. 17, 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 management will participate in a fireside chat at the Piper Sandler 34th Annual Healthcare Conference on Tuesday, November 29, 2022 at 11:00 a.m. EST.

SOUTH SAN FRANCISCO, Calif., Nov. 11, 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 two upcoming presentations at the Society for Neuro-Oncology (SNO) annual meeting, being held from November 16-20, 2022 in Tampa, FL.

Topline results for full pivotal FIREFLY-1 study population with tovorafenib (DAY101) in relapsed or progressive pediatric low-grade glioma (pLGG) are expected in the first quarter of 2023

SOUTH SAN FRANCISCO, Calif., Oct. 17, 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 it has entered into a Cooperative Research and Development Agreement (CRADA) with the National Cancer Institute's (NCI) Division of Cancer Treatment and Diagnosis, Cancer Therapy Evaluation Program (CTEP) to expand therapeutic research opportunities using tovorafenib (DAY101). Under the terms of the CRADA, NCI investigators will have the opportunity to study tovorafenib in CTEP-sponsored trials to be conducted by NCI funded extramural clinical networks in several solid tumor and hematologic cancers based upon encouraging anti-tumor activity observed in previous studies.