Day One Biopharmaceuticals Stock Price, News & Analysis

Day One Biopharmaceuticals, Inc. (Nasdaq: DAWN) is a commercial-stage biopharmaceutical company in the pharmaceutical preparation manufacturing industry. The company is dedicated to developing and commercializing targeted therapies for people of all ages with life-threatening diseases, with a particular focus on pediatric cancer. Day One states that it was founded to address a critical unmet need: the lack of therapeutic development in pediatric cancer, and it aims to re-envision cancer drug development starting from the moment of diagnosis, often referred to as the “Day One Talk” between physicians, patients, and families.

According to multiple company disclosures, Day One partners with clinical oncologists, families, and scientists to identify, acquire, and develop targeted cancer treatments. The company’s pipeline includes tovorafenib (OJEMDA™), DAY301, and, following the acquisition of Mersana Therapeutics, Emi-Le (emiltatug ledadotin). Day One is based in Brisbane, California, and its common stock trades on the Nasdaq Global Select Market under the symbol DAWN.

Core business focus

Day One describes itself as a biopharmaceutical company dedicated to targeted therapies for genetically defined and other life-threatening cancers. Earlier descriptions emphasized genetically defined cancers and an initial focus on pediatric patients, and more recent communications highlight an expansion into adult oncology while maintaining a focus on rare cancers. The company’s approach centers on targeted agents that address specific molecular alterations or targets in cancer, and on building a pipeline of such therapies through internal development and acquisitions.

Key products and pipeline

The company’s pipeline, as described in its news releases, includes the following programs:

• Tovorafenib (OJEMDA™): An oral Type II RAF kinase inhibitor. Company communications describe it as a Type II RAF kinase inhibitor of mutant BRAF V600, wild-type BRAF, and wild-type CRAF kinases. Tovorafenib, marketed as OJEMDA in the U.S., is indicated for patients 6 months of age and older with relapsed or refractory pediatric low-grade glioma (pLGG) or low-grade glioma harboring a BRAF fusion or rearrangement, or BRAF V600 mutation. The indication is approved under accelerated approval based on response rate and duration of response, with continued approval potentially contingent on confirmatory trials.
• DAY301: Described by the company as a PTK7-targeted antibody-drug conjugate (ADC). Day One reports that DAY301 is being evaluated in a Phase 1a/1b clinical trial, with active enrollment in the Phase 1a portion.
• Emi-Le (emiltatug ledadotin): A clinical-stage ADC added to the pipeline through the acquisition of Mersana Therapeutics. Company releases describe Emi-Le as a novel ADC targeting the B7-H4 protein, in clinical development to treat adenoid cystic carcinoma (ACC), a rare cancer often arising in the salivary gland and characterized by high unmet medical need.

Earlier third-party descriptions also refer to DAY101, described as an oral, brain-penetrant, highly selective type II pan-RAF kinase inhibitor. Subsequent company communications refer to tovorafenib/OJEMDA as the key RAF inhibitor program, and to DAY301 and Emi-Le as antibody-drug conjugate programs.

Clinical development and indications

Day One’s development work around tovorafenib/OJEMDA is centered on pediatric low-grade glioma with specific BRAF alterations. Company press releases and SEC filings describe the pivotal FIREFLY-1 Phase 2 trial in patients aged 6 months to 25 years with relapsed or refractory BRAF-altered pLGG. Updated three-year data reported by the company include overall response rate, duration of response, progression-free survival, and exploratory analyses such as time-to-next-treatment and treatment-free intervals. These data have been presented at scientific meetings such as the Society for Neuro-Oncology Annual Meeting.

Tovorafenib is also being evaluated in the FIREFLY-2/LOGGIC Phase 3 trial as front-line therapy for patients aged 6 months to 25 years with pLGG harboring BRAF fusion, rearrangement, or BRAF V600 mutation. Company communications note that enrollment in this pivotal trial is progressing, with completion targeted in a future period. In addition, tovorafenib has received regulatory designations from the U.S. Food and Drug Administration and the European Commission, including Breakthrough Therapy, Rare Pediatric Disease, and Orphan Drug designations for certain glioma indications, and it has been evaluated under priority review.

For DAY301, Day One reports that it is conducting a Phase 1a/1b clinical trial as a PTK7-targeted ADC program. For Emi-Le, the company notes that early Phase 1 data in adenoid cystic carcinoma have shown anti-tumor activity and that it views the program as having potential for a defined patient population without approved therapies or a clear standard of care.

Commercialization and revenue sources

Day One identifies itself as a commercial-stage company, with OJEMDA net product revenue reported in its financial press releases and 8-K filings. The company reports U.S. net product revenue from OJEMDA and has also disclosed license revenue from ex-U.S. commercial rights for tovorafenib. Financial updates describe growth in net product revenue, prescription volumes, and guidance for future OJEMDA net product revenue. The company has also disclosed cash, cash equivalents, and short-term investment balances, and has used existing cash resources to finance acquisitions such as the purchase of Mersana Therapeutics.

In addition to product revenue, Day One has reported license revenue related to ex-U.S. rights for tovorafenib and has previously recognized a gain from the sale of a priority review voucher. These elements, as described in company financial statements, contribute to its overall revenue profile alongside research and development and selling, general, and administrative expenses.

Corporate transactions and growth strategy

Day One’s growth strategy, as reflected in its disclosures, includes internal development of targeted therapies and portfolio expansion through acquisitions and partnerships. A notable transaction is the acquisition of Mersana Therapeutics, completed in January 2026 following a tender offer and statutory merger. Through this transaction, Mersana became a direct wholly owned subsidiary of Day One, and Mersana’s common stock was delisted from Nasdaq. The acquisition added Emi-Le as a second novel ADC to Day One’s clinical pipeline.

Company communications describe the Mersana acquisition as aligned with Day One’s mission and as a way to expand into adult oncology while maintaining a focus on rare cancers. Day One has also referenced prior collaborations, such as a terminated research collaboration and license agreement with Sprint Bioscience AB for a VRK1 program, indicating ongoing portfolio review and prioritization.

Regulatory and scientific engagement

Day One regularly communicates clinical and corporate updates through press releases, conference presentations, and SEC filings. The company has presented data at meetings such as the Society for Neuro-Oncology and the American Society of Clinical Oncology, and participates in investor and industry conferences including the J.P. Morgan Healthcare Conference and the Piper Sandler Healthcare Conference.

Its SEC filings on Form 8-K frequently attach press releases and corporate presentations as exhibits, covering clinical trial updates, financial results, and material agreements such as the Mersana merger agreement. These filings also document regulatory designations and trial outcomes for tovorafenib, including response rates, durations of response, and safety profiles from FIREFLY-1.

Stock listing and regulatory status

Day One Biopharmaceuticals’ common stock is registered under Section 12(b) of the Securities Exchange Act of 1934 and trades on the Nasdaq Global Select Market under the symbol DAWN, as noted in its 8-K filings. The filings list the company’s jurisdiction of incorporation as Delaware. There is no indication in the provided materials of delisting or deregistration for DAWN; instead, the filings describe ongoing reporting of financial results and material events.

Location and sector

The company reports its principal location as Brisbane, California, and operates within the broader manufacturing sector under the pharmaceutical preparation manufacturing industry classification. Its activities, as described in company communications, span discovery, clinical development, regulatory engagement, commercialization of oncology therapies, and corporate development transactions.

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