Day One Biopharmaceuticals

Day One Biopharmaceuticals, Inc. operates as a holding company. The firm through its subsidiary develops and commercializes targeted therapies for patients of all ages with genetically defined cancers. Its products include DAY101 and pimsertib. The company was founded by Julie Grant and Samuel Blackman in November 2018 and is headquartered in Brisbane, CA.

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Day One Biopharmaceuticals reports robust Q3 earnings and eyes growth opportunities

Day One Biopharmaceuticals delivered strong Q3 earnings, showcasing commercial success and financial stability, with OJEMDA leading revenue generation.
Challenges lie in maintaining patient starts and addressing physician feedback, while opportunities in trials and partnerships offer avenues for growth and innovation.
Overall, Day One Biopharmaceuticals' performance reflects a promising trajectory with a solid foundation for future expansion and market leadership.

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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 relapsed or progressive pediatric low-grade glioma (pLGG).

Day One Announces FDA Acceptance of NDA and Priority Review for Tovorafenib in Relapsed or Progressive Pediatric Low-Grade Glioma (pLGG)

Day One Biopharmaceuticals, Inc. is awaiting an FDA filing decision on its lead drug tovorafenib for the treatment of pediatric low grade glioma in mid-November of 2023. The company is also running a phase 3 study to evaluate tovorafenib as a first-line treatment for pLGG. Tovorafenib is being explored alone and in combination with another drug in ongoing phase 1b/2 studies for MAPK pathway mutated solid tumors.

Day One Biopharmaceuticals: NDA Filing Decision Is An Inflection Point To Watch

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 developing and commercializing targeted therapies for people of all ages with life-threatening diseases, today announced the recently completed submission of the rolling New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for tovorafenib as a monotherapy in relapsed or progressive pediatric low-grade glioma (pLGG).

Day One Announces Updated FIREFLY-1 Data for Tovorafenib and Completion of Rolling NDA Submission to FDA for Relapsed or Progressive Pediatric Low-Grade Glioma (pLGG)

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

Day One Reports Second Quarter 2023 Financial Results and Corporate Progress

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.

Diving Into Day One Biopharmaceuticals

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.

Day One Announces Closing of Public Offering and Full Exercise of the Underwriters' Option to Purchase Additional Shares

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.

Day One Announces Pricing of Public Offering of Common Stock

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.

Day One Announces Proposed Public Offering of Common Stock

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.

Why Shares of Day One Pharmaceuticals Are Up Monday

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Shares of several cancer drug firms surged on Monday after the companies reported positive clinical trial data from their therapies at an ongoing industry conference in Chicago.

Cancer drugmakers rise as industry meet fuels investor interest

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 shares jump 23% on positive results for glioma treatment

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

Day One Announces New FIREFLY-1 Data for Tovorafenib (DAY101) and Initiation of Rolling NDA Submission to FDA for Relapsed or Progressive Pediatric Low-Grade Glioma

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.

Day One to Participate in the Goldman Sachs 44th Annual Healthcare Conference

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:

CORRECTION -- Day One Announces Tovorafenib (DAY101) Data and Additional Abstracts to be Presented 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 Conference call and webcast scheduled on Sunday, June 4, 2023 at 6:00 p.m. CT BRISBANE, Calif.

Day One Announces Tovorafenib (DAY101) Data and Additional Abstracts to be Presented at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting

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 stock rallies as 1Q results show the brain tumor treatment candidate producer is funded into 2025

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

Day One Reports First Quarter 2023 Financial Results and Corporate Progress

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 biopharmaceutical company dedicated to developing and commercializing targeted therapies for people of all ages with life-threatening diseases, today announced the acceptance of three abstracts at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting to take place in Chicago, IL from June 2 – 6, 2023.

Day One Announces Abstracts Accepted for Presentation at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting

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.

Day One Announces Upcoming Presentation at 19th European Association of Dermato-Oncology (EADO) Congress

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.

Day One Biopharmaceuticals: Strong Potential, Price Drop Opportunity, Some Concerns

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)

Day One Reports Fourth Quarter and Full Year 2022 Financial Results and Corporate Progress

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.

Day One to Participate in the Cowen 43rd Annual Health Care Conference

Shares of Day One Pharmaceuticals Inc. DAWN, +0.95% jumped 21% in premarket trading on Monday after the company shared positive data from an ongoing Phase 2 clinical trial for its glioma treatment. Glioma is the most common type of brain tumor in children.

Day One to submit its glioma drug to the FDA this year

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.

Day One Announces Topline Data from Pivotal Phase 2 FIREFLY-1 Trial Demonstrating Meaningful Responses with Tovorafenib (DAY101) in Recurrent or Progressive Pediatric Low-Grade Glioma

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.

News for Day One Biopharmaceuticals Stock (DAWN)