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 company pioneering targeted therapies for pediatric and adult cancers with genetic drivers. This page aggregates official press releases, regulatory filings, and verified news about DAWN's innovative oncology pipeline, including FDA-approved OJEMDA for pediatric low-grade glioma and investigational candidates like PTK7-targeting DAY301.
Investors and researchers will find updates on clinical trial progress, partnership announcements, and scientific developments. Content categories include earnings reports, research collaborations, regulatory milestones, and therapeutic pipeline advancements. All materials are sourced directly from company communications or reputable financial/medical publications.
Bookmark this page for structured access to DAWN's latest developments in precision oncology. Check regularly for updates on their mission to transform cancer treatment through genetically targeted therapies.
Day One (Nasdaq: DAWN) reported three-year follow-up data from the Phase 2 FIREFLY-1 trial of OJEMDA (tovorafenib) in relapsed/refractory pediatric low-grade glioma (data cutoff June 6, 2025; median study duration 40.6 months).
Key results in 76 evaluable patients: overall response rate 53%, median duration of response 19.4 months, median PFS 16.6 months, and median time-to-next-treatment 42.6 months. Of 39 patients entering treatment-free observation, 77% remained off therapy ≥12 months. No new safety signals; Grade ≥3 events (≥5%) listed.
Day One (Nasdaq: DAWN) announced management will participate in a fireside chat at the Piper Sandler 37th Annual Healthcare Conference on Tuesday, December 2, 2025 at 4:00 p.m. EST.
A live webcast will be available via the Events section of the Day One Media & Investors page, and an archived replay will be available for 30 days after the live event.
Day One (NASDAQ: DAWN) signed a definitive merger agreement to acquire Mersana Therapeutics for $25 per share cash plus one non-tradable CVR, with total consideration up to $55.25 per share and an approximate equity value at closing of $129 million (total deal value up to ~$285 million). The acquisition adds emiltatug ledadotin (Emi-Le), an antibody‑drug conjugate targeting B7-H4, which showed early anti-tumor activity in an ongoing Phase 1 study for adenoid cystic carcinoma type‑1 (ACC‑1).
Milestone CVR payments total up to $30.25 per share tied to clinical, regulatory, and sales milestones. Day One expects to fund the transaction with existing cash and aims to close by end of January 2026, subject to regulatory approvals and customary conditions.
Day One (Nasdaq: DAWN) will present new long‑term data for OJEMDA (tovorafenib) from the registrational Phase 2 FIREFLY-1 trial at the 30th SNO Annual Meeting on November 23, 2025. The oral presentation reports >36‑month follow‑up in patients aged 6 months–25 years with relapsed or progressive pediatric low‑grade glioma and will include treatment‑free interval (TFI) data disclosed for the first time.
The presentation covers once‑weekly oral monotherapy after completion of a full course of 26 cycles (~24 months); an earlier data cut is in the abstract and updated results will be shown at the meeting in Honolulu.
Day One (Nasdaq: DAWN) reported third quarter 2025 results with accelerating commercial performance of OJEMDA and strengthened financial position. Q3 OJEMDA net product revenue was $38.5M, up 15% sequentially; YTD U.S. OJEMDA revenue was $102.6M, +89% versus 2024. Quarterly TRx reached 1,256 and new patient starts rose 19% sequentially. The company raised full-year 2025 OJEMDA revenue guidance to $145–$150M. R&D spend was $31.4M and SG&A $28.1M in Q3; net loss was $19.7M. Cash, cash equivalents and short-term investments totaled $451.6M as of Sep 30, 2025. Three-year FIREFLY-1 data will be presented Nov 23, 2025.
Day One Biopharmaceuticals (Nasdaq: DAWN) will report its third quarter 2025 financial results on Tuesday, November 4, 2025.
The company will host a live conference call and webcast on Nov. 4, 2025 at 4:30 p.m. ET to discuss results and corporate progress. Live audio will be available in the Events section of Day One's Media & Investors page, and an archived replay will be accessible for 30 days after the event.
Day One Biopharmaceuticals (NASDAQ:DAWN) reported strong Q2 2025 financial results, with OJEMDA net product revenue of $33.6 million, representing a 310% increase year-over-year and 10% quarter-over-quarter growth. The company provided full-year 2025 OJEMDA revenue guidance of $140-150 million.
Key highlights include OJEMDA prescriptions exceeding 1,000 in Q2 2025 (up 346% YoY), appointment of Dr. Michael Vasconcelles as Head of R&D, and continued progress in clinical trials. The company ended Q2 with $453.1 million in cash and reported a net loss of $30.3 million. R&D expenses decreased to $36.1 million from $92.1 million in Q2 2024, primarily due to prior year's MabCare license payment.
Day One Biopharmaceuticals (NASDAQ: DAWN), a company focused on developing targeted therapies for life-threatening diseases, has scheduled its Q2 2025 financial results conference call and webcast for Tuesday, August 5, 2025, at 4:30 p.m. ET.
The event will include a discussion of financial results and corporate updates. Investors can access the live webcast through Day One's Events page, and a replay will be available for 30 days following the presentation.
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