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Day One Biopharmaceuticals, Inc. - DAWN STOCK NEWS

Welcome to our dedicated page for Day One Biopharmaceuticals news (Ticker: DAWN), a resource for investors and traders seeking the latest updates and insights on Day One Biopharmaceuticals stock.

Day One Biopharmaceuticals, Inc. (Nasdaq: DAWN) is a clinical-stage biopharmaceutical company dedicated to developing and commercializing targeted therapies for people of all ages with genetically defined cancers. Founded with a mission to address the significant unmet needs in pediatric cancer treatment, Day One's approach starts with the biology of childhood cancer to bring forward innovative therapies that benefit both children and adults.

The company’s lead product candidate, tovorafenib (OJEMDA™), is an investigational, oral, brain-penetrant, highly-selective type II RAF kinase inhibitor. Tovorafenib targets a key enzyme in the MAPK signaling pathway and is currently under evaluation in two pivotal clinical trials for pediatric low-grade glioma (pLGG). The FDA has granted it Breakthrough Therapy and Rare Pediatric Disease designations for the treatment of patients with pLGG harboring an activating RAF alteration. On April 23, 2024, the FDA approved OJEMDA for the treatment of patients 6 months of age and older with relapsed or refractory pLGG harboring a BRAF fusion or rearrangement, or BRAF V600 mutation, marking a significant milestone for Day One.

Additionally, pLGG is the most common brain tumor diagnosed in children, accounting for 30% - 50% of all central nervous system tumors in this population. The absence of approved therapies for most pLGG patients underscores the chronic and relentless nature of the disease, which can significantly impact the long-term quality of life. Day One's FIREFLY-1 and FIREFLY-2/LOGGIC trials are evaluating tovorafenib in both relapsed and front-line settings, aiming to revolutionize the treatment landscape for these young patients.

Day One's robust pipeline also includes pimasertib, an investigational, oral, highly-selective small molecule inhibitor of mitogen‐activated protein kinases 1 and 2 (MEK-1/-2). The company is actively exploring additional clinical opportunities that leverage its innovative approach to cancer treatment.

With a dedicated team and strong partnerships with leading clinical oncologists, families, and scientists, Day One aims to continuously advance its mission. The company is headquartered in Brisbane, California, and remains committed to its vision of making a significant difference from Day One for all patients living with cancer.

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Day One Biopharmaceuticals (DAWN) announced its fourth quarter and full year 2023 financial results, with a cash position of $366.3 million, Phase 2 FIREFLY-1 registrational data published in Nature Medicine, and upcoming PDUFA target action date for tovorafenib NDA set for April 30, 2024.
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Day One Biopharmaceuticals (DAWN) announced the appointments of Habib Dable and Dr. William Grossman to its Board of Directors. Both bring extensive experience in the healthcare industry and oncology, which will strengthen the company's board as they prepare for the potential launch of their first new medicine.
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Day One Biopharmaceuticals (Nasdaq: DAWN) announced that Dr. Jeremy Bender, CEO, will present at the 42nd Annual J.P. Morgan Healthcare Conference on January 8. A live webcast will be available on the company's website.
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Day One Biopharmaceuticals (Nasdaq: DAWN) announced the publication of the registrational Phase 2 FIREFLY-1 trial results evaluating the investigational agent tovorafenib in patients with BRAF-altered, relapsed or progressive pediatric low-grade glioma (pLGG) in Nature Medicine. Subsets of the data will also be presented today in two oral plenary presentations at the 2023 Society for Neuro-Oncology (SNO) Annual Meeting in Vancouver, Canada. The study results demonstrate promising evidence with respect to the impact of tovorafenib for children and young adults with BRAF-altered relapsed or progressive pLGG, a debilitating form of brain tumor that currently has no approved systemic therapies. The Phase 3 FIREFLY-2/LOGGIC randomized clinical trial is also evaluating tovorafenib frontline therapy for patients newly diagnosed with pLGG.
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Day One Biopharmaceuticals (Nasdaq: DAWN) will participate in a fireside chat at the Piper Sandler 35th Annual Healthcare Conference on November 28 at 11:30 a.m. EST. A live audio webcast of the discussion will be available on the Company’s website, with an archived replay for 30 days.
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Day One Biopharmaceuticals announced that the FDA has accepted the New Drug Application (NDA) for tovorafenib in relapsed or progressive pediatric low-grade glioma (pLGG) for Priority Review. The Prescription Drug User Fee Act (PDUFA) target action date is set for April 30, 2024. Day One also highlighted recent corporate achievements and financial results for the third quarter of 2023.
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Day One Biopharmaceuticals has announced that the FDA has accepted its New Drug Application for tovorafenib as a monotherapy in relapsed or progressive pediatric low-grade glioma (pLGG). The FDA has granted priority review and set a target action date of April 30, 2024. pLGG is the most common brain tumor in children with no approved therapy. The NDA is based on results from a Phase 2 trial, and the company may receive a priority review voucher.
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Day One Biopharmaceuticals submits NDA for tovorafenib as a monotherapy in relapsed or progressive pediatric low-grade glioma (pLGG)
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Day One Biopharmaceuticals has entered into an exclusive license agreement and research collaboration with Sprint Bioscience for its VRK1 program. VRK1 is a target involved in cell division and DNA damage repair, and its over-expression is linked to poor prognosis in various cancers. Day One will pay an upfront payment of $3 million to Sprint Bioscience and may make additional milestone payments of up to $313 million.
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Day One Biopharmaceuticals announces positive results from FIREFLY-1 trial, with an overall response rate (ORR) of 67% and clinical benefit rate (CBR) of 93% in patients with relapsed or progressive pediatric low-grade glioma (pLGG). The company has initiated the rolling submission of the tovorafenib New Drug Application (NDA) and expects to complete it by October 2023. Day One also completed a $172.5 million public offering, strengthening their balance sheet.
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FAQ

What is the current stock price of Day One Biopharmaceuticals (DAWN)?

The current stock price of Day One Biopharmaceuticals (DAWN) is $13.72 as of November 22, 2024.

What is the market cap of Day One Biopharmaceuticals (DAWN)?

The market cap of Day One Biopharmaceuticals (DAWN) is approximately 1.4B.

What is the primary focus of Day One Biopharmaceuticals?

Day One Biopharmaceuticals focuses on developing and commercializing targeted therapies for genetically defined cancers, primarily starting with pediatric patients.

What is tovorafenib (OJEMDA™)?

Tovorafenib, also known as OJEMDA™, is an investigational, oral, brain-penetrant, highly-selective type II RAF kinase inhibitor designed to treat pediatric low-grade glioma (pLGG) with specific genetic alterations.

What recent milestone has Day One Biopharmaceuticals achieved?

The FDA recently approved OJEMDA (tovorafenib) for treating relapsed or refractory pediatric low-grade glioma (pLGG) with BRAF alterations.

What are the main clinical trials involving tovorafenib?

Tovorafenib is being evaluated in the FIREFLY-1 and FIREFLY-2/LOGGIC trials, targeting relapsed and front-line treatment settings for pediatric low-grade glioma (pLGG).

What designations has tovorafenib received from the FDA?

Tovorafenib has received Breakthrough Therapy and Rare Pediatric Disease designations from the FDA for treating patients with pLGG harboring an activating RAF alteration.

Where is Day One Biopharmaceuticals located?

Day One Biopharmaceuticals is headquartered in Brisbane, California.

What is the company’s approach to cancer treatment?

Day One Biopharmaceuticals utilizes a unique approach starting from the biology of childhood cancer and collaborates with pediatric oncology investigators to develop therapies for patients of all ages.

What other products are in Day One’s pipeline?

Besides tovorafenib, Day One's pipeline includes pimasertib, an investigational, oral, highly-selective small molecule inhibitor of MEK-1 and MEK-2.

How does Day One Biopharmaceuticals support the pLGG community?

Day One Biopharmaceuticals offers the EveryDay Support From Day One™ program, providing insurance coverage support, financial assistance, medication shipping, and educational resources.

What impact does pLGG have on children?

Pediatric low-grade glioma (pLGG) can significantly affect a child’s health, causing issues like vision loss and motor dysfunction, and requiring long-term treatment with potential acute and life-long adverse effects.

Day One Biopharmaceuticals, Inc.

Nasdaq:DAWN

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1.38B
83.00M
16.98%
93.17%
17.87%
Biotechnology
Pharmaceutical Preparations
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United States of America
BRISBANE