Day One Biopharma (DAWN) Reports Encouraging 3-Year Follow-Up Findings from Key Phase 2 FIREFLY-1 Trial of OJEMDA (Tovorafenib)
Written by Emily J. Thompson, Senior Investment Analyst
Updated: Dec 16 2025
0mins
Should l Buy DAWN?
Source: Yahoo Finance
Company Overview: Day One Biopharmaceuticals Inc. (NASDAQ: DAWN) is recognized for its potential to double in value by 2026, with a Buy rating maintained by analyst Soumit Roy from JonesTrading.
Clinical Trial Results: The company announced updated three-year follow-up results from the Phase 2 FIREFLY-1 trial of OJEMDA (tovorafenib), showing no new safety signals and confirming previously reported positive outcomes.
FDA Approval: Tovorafenib, a Type II RAF kinase inhibitor, is FDA-approved for treating pediatric patients with specific types of low-grade glioma, based on its response rate and duration of response.
Investment Perspective: While DAWN is seen as a promising investment, the article suggests that certain AI stocks may offer better upside potential and lower risk, encouraging readers to explore other investment opportunities.
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Analyst Views on DAWN
Wall Street analysts forecast DAWN stock price to rise
9 Analyst Rating
8 Buy
1 Hold
0 Sell
Strong Buy
Current: 11.000
Low
16.00
Averages
24.13
High
34.00
Current: 11.000
Low
16.00
Averages
24.13
High
34.00
About DAWN
Day One Biopharmaceuticals, Inc. is a commercial-stage biopharmaceutical company focused on developing and commercializing targeted therapies for people of all ages with life-threatening diseases. It partners with clinical oncologists, families, and scientists to identify, acquire, and develop cancer treatments. Its commercial product, OJEMDA (tovorafenib), is an oral, brain-penetrant, selective type II rapidly accelerated fibrosarcoma (RAF) kinase inhibitor. OJEMDA is used for the treatment of patients over six months of age and older with relapsed or refractory pLGG harboring a BRAF fusion or rearrangement, or BRAF V600 mutation. Its pipeline product candidates include DAY301 and Emi-Le (emiltatug ledadotin). DAY301 is a novel Antibody Drug Conjugate, or ADC, targeting protein-tyrosine kinase 7, or PTK7. Emi-Le (emiltatug ledadotin) is a novel antibody drug conjugate (ADC) targeting the B7-H4 protein in clinical development to treat the rare cancer adenoid cystic carcinoma (ACC).
About the author
Emily J. Thompson
Emily J. Thompson, a Chartered Financial Analyst (CFA) with 12 years in investment research, graduated with honors from the Wharton School. Specializing in industrial and technology stocks, she provides in-depth analysis for Intellectia’s earnings and market brief reports.
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- Debt Burden Concerns: With over $17.6 billion in long-term debt reported in Q3 2025, Lumen faces significant financial challenges, and while the divestiture may alleviate some pressure, the company's ongoing transformation could complicate its recovery and stock performance outlook.
See More
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- Identifying Investment Opportunities: Mahn advised investors to focus on long-term growth, particularly the AI boom, with trillions expected in infrastructure investments by 2030, emphasizing the potential of companies supporting this growth, such as data center cooling and power providers.
- Stability and Yield: He mentioned Comfort Systems USA Inc., recently added to the S&P 500, and Duke Energy Corp., trading at 17X forward earnings with a 3.7% dividend yield, as solid choices for stability in turbulent markets.
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- 2026 Growth Projections: The company anticipates U.S. net product revenue for OJEMDA to range between $225 million and $250 million in 2026, representing a 53% year-over-year growth at the midpoint, reflecting optimism about future market demand and product performance.
- Cash Reserves: As of December 31, 2025, prior to the acquisition of Mersana, Day One had approximately $441.1 million in cash, cash equivalents, and short-term investments (unaudited), providing robust financial support for expansion and R&D initiatives.
- Stock Price Reaction: Day One's stock surged by 22.43% to $10.945, indicating positive market sentiment regarding the company's growth potential, particularly following the acquisition of Mersana, which may enhance its product portfolio and competitive positioning.
See More
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- Biopharma Surge: Day One Biopharmaceuticals Inc (NASDAQ:DAWN) shares surged 20% to $10.77 after reporting a projected 2025 OJEMDA net product revenue of $155.4 million, a 172% year-over-year increase, highlighting strong market demand and growth potential.
- FDA Response Impact: Atara Biotherapeutics Inc (NASDAQ:ATRA) shares plummeted 53% to $6.41 following a Complete Response Letter from the FDA citing concerns over clinical trial adequacy, raising investor worries about the company's future prospects.
- Sector Sentiment Fluctuations: Financial stocks dipped by 1.1% while consumer staples rose by 1%, reflecting differing investor confidence across sectors, which may influence future investment strategies and market trends.
See More
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- Revenue Outlook Boost: Day One Biopharmaceuticals Inc reported preliminary 2025 OJEMDA net product revenue of $155.4 million, up 172% year-over-year, indicating robust growth potential in the biopharmaceutical sector that may attract more investor interest.
- Market Dynamics: Amid a broader decline in U.S. stocks, Wheels Up Experience Inc saw its shares jump 30.2% to $0.89, suggesting a market reassessment of its business model, potentially providing support for future financing and expansion.
- Increased Demand for Safe Assets: Growing concerns about Federal Reserve independence have led investors to shift towards safe-haven assets like gold, driving up precious metals stocks, which reflects market sensitivity to economic uncertainties and a preference for secure investments.
See More
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- Significant Revenue Growth: Day One Biopharmaceuticals reported approximately $52.8 million in net product revenue for OJEMDA in Q4 2025, totaling $155.4 million for the year, which represents a remarkable 172% year-over-year increase driven by rising patient demand and prescription volumes.
- Optimistic 2026 Outlook: The company projects U.S. OJEMDA net product revenue between $225 million and $250 million for 2026, reflecting a midpoint growth of 53%, indicating a strategic commitment to establishing the product as the standard of care and expanding its global market presence.
- Clinical Trial Progress: Day One expects to complete enrollment in the pivotal Phase 3 FIREFLY-2 trial in the first half of 2026, with mid-2027 data readout anticipated, positioning the company for potential approval in 2028, thereby solidifying its market position in treating pediatric low-grade glioma.
- Strong Financial Position: As of December 31, 2025, Day One reported approximately $441.1 million in cash and short-term investments, which, while preliminary, underscores the company's robust financial foundation for ongoing investments and research and development efforts.
See More
