Day One Biopharmaceuticals, Inc., a clinical-stage biopharmaceutical company, develops and commercializes targeted therapies for patients with genetically defined cancers. Its lead product candidate is DAY101, an oral brain-penetrant type II pan-rapidly accelerated fibrosarcoma kinase inhibitor that is in Phase II clinical trial for pediatric patients with relapsed/progressive low-grade glioma. The company is also developing Pimasertib, an oral small molecule inhibitor of mitogen-activated protein kinase kinases 1 and 2. Day One Biopharmaceuticals, Inc. was incorporated in 2018 and is headquartered in South San Francisco, California.
IPO Year: 2021
Exchange: NASDAQ
Website: dayonebio.com
Date | Price Target | Rating | Analyst |
---|---|---|---|
10/9/2024 | $32.00 → $33.00 | Buy | Needham |
8/1/2024 | $11.00 → $24.00 | Underperform → Buy | BofA Securities |
4/24/2024 | $30.00 → $33.00 | Buy | Needham |
4/25/2023 | $34.00 → $9.00 | Buy → Underperform | BofA Securities |
2/8/2023 | $40.00 | Overweight | CapitalOne |
2/3/2023 | Perform | Oppenheimer | |
12/15/2022 | $35.00 | Buy | H.C. Wainwright |
12/14/2022 | $40.00 | Buy | Needham |
12/5/2022 | $45.00 | Buy | Goldman |
12/1/2022 | $34.00 | Buy | BofA Securities |
8-K - Day One Biopharmaceuticals, Inc. (0001845337) (Filer)
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8-K - Day One Biopharmaceuticals, Inc. (0001845337) (Filer)
10-Q - Day One Biopharmaceuticals, Inc. (0001845337) (Filer)
8-K - Day One Biopharmaceuticals, Inc. (0001845337) (Filer)
S-3ASR - Day One Biopharmaceuticals, Inc. (0001845337) (Filer)
10-Q - Day One Biopharmaceuticals, Inc. (0001845337) (Filer)
8-K - Day One Biopharmaceuticals, Inc. (0001845337) (Filer)
8-K - Day One Biopharmaceuticals, Inc. (0001845337) (Filer)
8-K - Day One Biopharmaceuticals, Inc. (0001845337) (Filer)
Preliminary 2024 OJEMDA™ (tovorafenib) net product revenue of approximately $57.2 million (unaudited) First dose cohort cleared in Phase 1a/b clinical trial of DAY301 (PTK7-targeted ADC) Ended 2024 with approximately $531.7 million in cash, cash equivalents and short-term investments (unaudited) Company to present at 43rd Annual J.P. Morgan Healthcare Conference today at 3:45 p.m. Pacific Time (6:45 p.m. Eastern Time) BRISBANE, Calif., Jan. 13, 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, to
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. A live audio webcast of the presentation will be available by visiting the Events & Presentations section of the Company's website at www.dayonebio.com. An archived replay of the webcast will be available for 30 days fo
Dr. Blackman's departure planned for end of 2024 Company's search for a new Head of R&D is ongoing BRISBANE, Calif., Nov. 20, 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 Samuel Blackman, M.D., Ph.D, co-founder and Head of Research & Development (R&D) of the Company, will be retiring effective at the end of 2024. He will continue to serve as a strategic advisor and consultant while the Company seeks a new Head of R&D. "Sam's passion for pediatric oncology
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. A live webcast of the discussion will be available by visiting the Events & Presentations section of the Day One Investors & Media page. An archived replay of the webcast will be available for 30 days following the live event. About Day One Biopharmaceutica
Achieved $20.1 million in OJEMDATM (tovorafenib) net product revenue Ended the third quarter with $558.4 million in cash, cash equivalents and short-term investments Company to host conference call and webcast today, October 30, 4:30 p.m. Eastern Time BRISBANE, Calif., Oct. 30, 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 its third quarter 2024 financial results and highlighted recent corporate achievements. "Our third quarter results demonstrate continued patient demand
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. Live audio of the webcast will be accessible on the Day One Investors & Media page. An archived version of the webcast will be available for replay on the Events & Presentations section of the Day One Investors & Media page for 30
Achieved $8.2 million in OJEMDATM (tovorafenib) net product revenues in initial 2 months of launch Expanded pipeline with DAY301, potential first-in-class Antibody Drug Conjugate (ADC) targeting PTK7 Entered into exclusive licensing agreement with Ipsen to commercialize tovorafenib outside of the U.S. for approximately $111 million upfront in cash and equity investment at a premium Entered into a definitive agreement for an oversubscribed private placement of its securities for total gross proceeds of approximately $175 million Company to host conference call and webcast today, July 30, 8:00 a.m. Eastern Time
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. The private placement includes participation from both new and existing investors including Fairmount, Braidwell LP, Deerfield Management, Wellington Management, Frazier
Ipsen secures ex-U.S. regulatory and commercial rights to tovorafenib for most common childhood brain tumor, pediatric low-grade glioma (pLGG), and any future indicationsOJEMDA™ (tovorafenib) is the first FDA-approved treatment for relapsed or refractory pLGG harboring a BRAF fusion or rearrangement, or V600 mutation, following the pivotal Phase II trial, FIREFLY-1Day One receives approximately $111 million upfront in cash and equity investment with up to approximately $350 million in milestone payments and double-digit tiered royalties Ongoing Phase III trial, FIREFLY-2, is evaluating tovorafenib as a monotherapy for newly diagnosed children and young adults with RAF-altered low-grade g
Day One receives exclusive license for development and commercialization of MTX-13 (DAY301), which received IND clearance by the FDA in April 2024 Targets PTK7, highly expressed in broad range of adult and pediatric solid tumors BRISBANE, Calif., June 18, 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 has entered into an exclusive licensing agreement (the Agreement) with MabCare Therapeutics (MabCare) for MTX-13, a novel ADC targeting protein-tyrosine kinase 7
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For Immediate Release: April 30, 2024 Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: Today, the FDA published the FDA Voices: “A Milestone in Facilitating the Development of Safe and Effective Biosimilars,” by Sarah Yim, Director of the Office of New Drugs’ Office of Therapeutic Biologics and Biosimilars, Hilary Marston, M.D., M.P.H., and Patriz
For Immediate Release: April 26, 2024 Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: Today, the FDA published the FDA Voices: “A Milestone in Facilitating the Development of Safe and Effective Biosimilars,” by Sarah Yim, Director of the Office of New Drugs’ Office of Therapeutic Biologics and Biosimilars, Hilary Marston, M.D., M.P.H., and Patriz
Submission status for DAY ONE BIOPHARMACEUTICALS INC's drug OJEMDA (ORIG-1) with active ingredient TOVORAFENIB has changed to 'Approval' on 04/23/2024. Application Category: NDA, Application Number: 218033, Application Classification: Type 1 - New Molecular Entity
Submission status for DAY ONE BIOPHARMACEUTICALS INC's drug OJEMDA (ORIG-1) with active ingredient TOVORAFENIB has changed to 'Approval' on 04/23/2024. Application Category: NDA, Application Number: 217700, Application Classification: Type 1 - New Molecular Entity
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Dr. Blackman's departure planned for end of 2024 Company's search for a new Head of R&D is ongoing BRISBANE, Calif., Nov. 20, 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 Samuel Blackman, M.D., Ph.D, co-founder and Head of Research & Development (R&D) of the Company, will be retiring effective at the end of 2024. He will continue to serve as a strategic advisor and consultant while the Company seeks a new Head of R&D. "Sam's passion for pediatric oncology
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 to our Board during this pivotal phase of our growth," said Jeremy Bender, Ph.D., chief executive officer of Day One. "Their deep expertise and leadership in oncology will further strengthen our Board and will be a great asset as we prepare for the potential launch of ou
SOUTH SAN FRANCISCO, Calif., Sept. 12, 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 the appointment of Garry Nicholson as chairman of its board of directors. Mr. Nicholson brings more than 30 years of pharmaceutical and biotech oncology experience and previously served as president of Pfizer Oncology where he led its global oncology franchise. Day One co-founder Julie Grant, who served as board chair since 2021, will continue to serve as a member of the board of directors. "Garry is an accompl
Enrollment Progresses in the Pivotal Phase 2 FIREFLY-1 Clinical Trial of DAY101 in Patients with pLGG; Initial Data Expected in 1H 2022 Upcoming CTOS Meeting to Highlight Single Agent Activity of Lead Drug Candidate, DAY101, in Spindle Cell Carcinoma Compassionate Use Case SOUTH SAN FRANCISCO, Calif., Nov. 08, 2021 (GLOBE NEWSWIRE) -- Day One Biopharmaceuticals (NASDAQ:DAWN), a clinical-stage biopharmaceutical company dedicated to developing and commercializing targeted therapies for patients of all ages with genomically defined cancers, today announced financial results for the third quarter of 2021 and highlighted recent corporate achievements. "We continue to build momentum in our le
SOUTH SAN FRANCISCO, Calif., Sept. 13, 2021 (GLOBE NEWSWIRE) -- Day One Biopharmaceuticals (NASDAQ:DAWN), a clinical-stage biopharmaceutical company dedicated to developing and commercializing targeted therapies for patients of all ages with genomically-defined cancers, today announced the appointment of Jaa Roberson as chief people officer. In her role, Ms. Roberson will oversee all aspects of Day One's human resources and talent acquisition efforts. "Day One is built on a foundation of talented employees who share a strong commitment and passion for developing innovative targeted therapies to improve the lives of children and people of all ages living with cancer," said Jeremy Bender, P
SOUTH SAN FRANCISCO, Calif., Aug. 17, 2021 (GLOBE NEWSWIRE) -- Day One Biopharmaceuticals (NASDAQ:DAWN), a clinical-stage biopharmaceutical company dedicated to developing and commercializing targeted therapies for patients of all ages with genomically defined cancers, today announced the appointment of Scott Garland to the Company's board of directors. Mr. Garland is a 30-year veteran of the biopharmaceutical industry with deep commercial and executive leadership experience. "We are very pleased to welcome Scott to our board of directors at this important stage in Day One's evolution," said Jeremy Bender, Ph.D., chief executive officer of Day One. "Having led the launch of multiple new m
Achieved $20.1 million in OJEMDATM (tovorafenib) net product revenue Ended the third quarter with $558.4 million in cash, cash equivalents and short-term investments Company to host conference call and webcast today, October 30, 4:30 p.m. Eastern Time BRISBANE, Calif., Oct. 30, 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 its third quarter 2024 financial results and highlighted recent corporate achievements. "Our third quarter results demonstrate continued patient demand
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. Live audio of the webcast will be accessible on the Day One Investors & Media page. An archived version of the webcast will be available for replay on the Events & Presentations section of the Day One Investors & Media page for 30
Achieved $8.2 million in OJEMDATM (tovorafenib) net product revenues in initial 2 months of launch Expanded pipeline with DAY301, potential first-in-class Antibody Drug Conjugate (ADC) targeting PTK7 Entered into exclusive licensing agreement with Ipsen to commercialize tovorafenib outside of the U.S. for approximately $111 million upfront in cash and equity investment at a premium Entered into a definitive agreement for an oversubscribed private placement of its securities for total gross proceeds of approximately $175 million Company to host conference call and webcast today, July 30, 8:00 a.m. Eastern Time
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. (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 that th
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 clinical-stage biopharmaceutical company dedicated to developing and commercializing targeted therapies for people of all ages with life-threatening diseases, today announced its fourth quarter and full year 2023 financial results and highlighted recent corporate achievem
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 developing and commercializing targeted therapies for people of all ages with life-threatening diseases, today announced new data from the registrational Phase 2 FIREFLY-1 trial evaluating the investigational agent tovorafenib (DAY101). These data were shared in an or
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, today announced the publication of three abstracts on the American Society of Clinical Oncology (ASCO) website. Dr. Lindsay Kilburn of Children's National Hospital will present new and updated clinical data from the registrational FIREFLY-1 trial on June 4, 2023 during
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) Company to host conference call on June 4th at 6:00 PM CT BRISBANE, Calif., May 01, 2023 (GLOBE NEWSWIRE) -- Day One Biopharmaceuticals (NASDAQ:DAWN), a clinical-stage biopharmaceutical company dedicated to developing and commercializing targeted therapies for people o
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
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 medical meeting in second quarter of 2023 New Drug Application (NDA) submission planned for tovorafenib (DAY101) in first half of 2023 BRISBANE, Calif., March 06, 2023 (GLOBE NEWSWIRE) -- Day One Biopharmaceuticals (NASDAQ:DAWN), a clinical-stage biopharmaceutical compan
Needham reiterated coverage of Day One Biopharmaceuticals with a rating of Buy and set a new price target of $33.00 from $32.00 previously
BofA Securities upgraded Day One Biopharmaceuticals from Underperform to Buy and set a new price target of $24.00 from $11.00 previously
Needham reiterated coverage of Day One Biopharmaceuticals with a rating of Buy and set a new price target of $33.00 from $30.00 previously
BofA Securities downgraded Day One Biopharmaceuticals from Buy to Underperform and set a new price target of $9.00 from $34.00 previously
CapitalOne initiated coverage of Day One Biopharmaceuticals with a rating of Overweight and set a new price target of $40.00
Oppenheimer initiated coverage of Day One Biopharmaceuticals with a rating of Perform
H.C. Wainwright initiated coverage of Day One Biopharmaceuticals with a rating of Buy and set a new price target of $35.00
Needham initiated coverage of Day One Biopharmaceuticals with a rating of Buy and set a new price target of $40.00
Goldman initiated coverage of Day One Biopharmaceuticals with a rating of Buy and set a new price target of $45.00
BofA Securities initiated coverage of Day One Biopharmaceuticals with a rating of Buy and set a new price target of $34.00