Day One Announces Preliminary 2025 OJEMDA™ Net Product Revenue And Provides 2026 Net Product Revenue Guidance

Rhea-AI Summary

Day One (Nasdaq: DAWN) reported preliminary unaudited 2025 OJEMDA net product revenue of $155.4 million, a 172% year-over-year increase, with Q4 2025 revenue of $52.8 million (~37% QoQ growth) and 1,394 prescriptions in Q4. The company provided 2026 OJEMDA U.S. net product revenue guidance of $225–$250 million (midpoint ≈ 53% YoY growth). As of Dec 31, 2025, prior to the Mersana acquisition, Day One held approximately $441.1 million of cash, cash equivalents, and short-term investments (unaudited). Key near-term milestones include completing Phase 3 FIREFLY-2 enrollment in 1H 2026 (mid-2027 readout) and planned Phase 1 data for Emi-Le by mid-2026 and DAY301 in 2H 2026.

Positive

• 2025 revenue of $155.4M (+172% YoY)
• Q4 2025 revenue of $52.8M (~37% QoQ growth)
• 2026 guidance $225–$250M (midpoint ≈ 53% YoY growth)
• Cash position of ~$441.1M as of Dec 31, 2025 (pre-acquisition)

Negative

• Preliminary 2025 results are unaudited and subject to adjustment
• Projected approval timing is contingent on FIREFLY-2 enrollment completion and a mid-2027 readout

News Market Reaction

+26.73% 2.9x vol

22 alerts

+26.73% News Effect

+16.0% Peak in 10 hr 35 min

+$246M Valuation Impact

$1.17B Market Cap

2.9x Rel. Volume

On the day this news was published, DAWN gained 26.73%, reflecting a significant positive market reaction. Argus tracked a peak move of +16.0% during that session. Our momentum scanner triggered 22 alerts that day, indicating elevated trading interest and price volatility. This price movement added approximately $246M to the company's valuation, bringing the market cap to $1.17B at that time. Trading volume was elevated at 2.9x the daily average, suggesting notable buying interest.

Data tracked by StockTitan Argus on the day of publication.

Key Figures

2025 OJEMDA revenue: $155.4 million YoY revenue growth: 172% 2026 OJEMDA guidance: $225–$250 million +5 more

8 metrics

2025 OJEMDA revenue $155.4 million Preliminary full-year 2025 net product revenue (unaudited)

YoY revenue growth 172% 2025 OJEMDA net product revenue vs. 2024

2026 OJEMDA guidance $225–$250 million Projected 2026 U.S. net product revenue range

Q4 2025 OJEMDA revenue $52.8 million Preliminary fourth-quarter 2025 net product revenue (unaudited)

Q4 2025 prescriptions 1,394 prescriptions OJEMDA prescription volume during fourth quarter 2025

2026 growth at midpoint 53% YoY Implied OJEMDA U.S. revenue growth at midpoint of 2026 guidance

Year-end 2025 cash $441.1 million Cash, cash equivalents, and short-term investments as of Dec 31, 2025 (unaudited)

FIREFLY-2 data timing Mid-2027 readout Pivotal Phase 3 OJEMDA trial in first-line pLGG

Market Reality Check

Price: $12.34 Vol: Volume 1,211,724 is at 0....

low vol

$12.34 Last Close

Volume Volume 1,211,724 is at 0.55x the 20-day average of 2,206,015, suggesting muted activity ahead of the update. low

Technical Shares at $8.94 are trading above the 200-day MA of $7.44, while still 33.92% below the 52-week high of $13.53.

Peers on Argus

DAWN was down 3.35% pre-announcement, while peers were mixed: AVBP and TNGX up 3...

DAWN was down 3.35% pre-announcement, while peers were mixed: AVBP and TNGX up 3.32% and 3.98%, KURA, PRAX, and VIR down between 1.2% and 3.09%. With no peers in the momentum scanner and only one peer headline today, trading appears more company-specific than part of a broad sector move.

Historical Context

5 past events · Latest: Jan 06 (Positive)

Pattern 5 events

Date	Event	Sentiment	Move	Catalyst
Jan 06	Acquisition completion	Positive	+1.1%	Closed Mersana deal, adding Emi-Le ADC to Day One’s pipeline.
Dec 16	Conference appearance	Neutral	-0.2%	Announced upcoming J.P. Morgan Healthcare Conference presentation.
Nov 24	Clinical data update	Positive	+4.2%	Reported three-year FIREFLY-1 OJEMDA data with durable efficacy.
Nov 18	Conference participation	Neutral	-3.0%	Participation in Piper Sandler healthcare conference fireside chat.
Nov 13	Acquisition announcement	Positive	-14.4%	Announced Mersana acquisition with CVR structure and defined milestones.

Pattern Detected

News tied to OJEMDA clinical data and completed M&A has generally aligned with modestly positive price reactions, while the initial Mersana acquisition announcement coincided with a notable selloff.

Recent Company History

Over the past few months, Day One has focused on expanding its OJEMDA franchise and pipeline. On Nov 13, 2025, it agreed to acquire Mersana, adding the Emi‑Le ADC program, which coincided with a -14.41% move. Updated three‑year FIREFLY‑1 data on Nov 24, 2025 saw shares rise 4.23%. Completion of the Mersana acquisition on Jan 6, 2026 was followed by a modest 1.05% gain. Today’s revenue and guidance update builds directly on these commercial and clinical foundations.

Market Pulse Summary

The stock surged +26.7% in the session following this news. A strong positive reaction aligns with t...

Analysis

The stock surged +26.7% in the session following this news. A strong positive reaction aligns with the company’s reported fundamentals, including preliminary 2025 OJEMDA revenue of $155.4 million and projected 2026 U.S. revenue of $225–$250 million, implying 53% growth at the midpoint. Historical data show favorable responses to OJEMDA clinical updates, though past M&A announcements have triggered volatility, suggesting that execution on guidance and integration milestones could determine how durable such a move becomes.

Key Terms

pediatric low-grade glioma, pLGG, phase 3, phase 1, +4 more

8 terms

pediatric low-grade glioma medical

"standard of care (SOC) in 2L pediatric low-grade glioma (pLGG)"

Pediatric low-grade glioma is a slow-growing brain tumor found in children and teenagers that originates from the brain’s support cells and is generally less aggressive than high-grade tumors. It matters to investors because development or approval of diagnostics, drugs, or devices for these tumors can create steady, long‑term revenue opportunities and affect clinical trial timelines, regulatory risk and reimbursement — similar to investing in a product that serves an ongoing maintenance need rather than a one-time fix.

pLGG medical

"uptake of OJEMDA in relapsed or refractory pLGG, and by the opportunities"

Pediatric low-grade glioma (PLGG) is a group of typically slow-growing brain tumors that occur in children and can cause long-term neurological problems. For investors, PLGG matters because it represents a defined patient population with significant medical need and limited effective treatments, so positive clinical trial results or regulatory approvals for new therapies can materially affect a company’s value, much like unlocking a new product line for a small business.

phase 3 medical

"Complete enrollment in the pivotal Phase 3 FIREFLY-2 clinical trial in first-line pLGG"

Phase 3 is the late-stage clinical testing step for a new drug or medical treatment, where the product is given to large groups of patients to confirm effectiveness, monitor side effects, and compare it to standard care. Successful Phase 3 results are often the final scientific hurdle before regulators decide on approval and market launch—like passing a final exam before graduation—and can sharply change a company's valuation and future revenue prospects.

phase 1 medical

"Advance Emi-Le program by delivering Phase 1 clinical data by mid-2026"

Phase 1 is the first stage of testing a new drug or medical treatment in people, focused primarily on safety, how the body handles the product, and finding a tolerated dose. Think of it as a short, tightly controlled experiment with a small group to check for dangerous side effects before wider testing; for investors it is an early milestone that reduces some uncertainty but still carries high risk and potential for both big value changes and setbacks.

antibody drug conjugate medical

"DAY301, a PTK7-targeted antibody drug conjugate (ADC), in the second half"

An antibody drug conjugate is a targeted medical treatment that combines a special antibody with a powerful drug, allowing precise delivery of the medicine directly to cancer cells or other harmful cells in the body. For investors, it represents a sophisticated approach to therapy that could improve treatment effectiveness and reduce side effects, potentially leading to significant growth opportunities in the biotech and pharmaceutical sectors.

adc medical

"DAY301, a PTK7-targeted antibody drug conjugate (ADC), in the second half"

An antibody-drug conjugate (ADC) is a targeted cancer medicine that pairs an antibody that recognizes specific markers on tumor cells with a potent cell-killing drug, connected so the toxic payload is delivered directly to the cancer. For investors, ADCs matter because successful ADCs can improve patient outcomes and reduce side effects compared with traditional chemotherapy, shaping clinical trial success, regulatory approval chances, commercial demand, and a company’s valuation much like a guided missile versus a general bomb.

standard of care medical

"support continued OJEMDA adoption as standard of care (SOC) in 2L pediatric"

Standard of care is the accepted medical treatment or clinical approach that most qualified doctors would use for a given condition today, based on available evidence, guidelines and common practice. For investors, it acts like the baseline product customers expect: a new therapy or device must match or improve on the standard of care to win market share, gain reimbursement and limit legal or regulatory risk.

soc medical

"support continued OJEMDA adoption as standard of care (SOC) in 2L pediatric"

Standard of care (often abbreviated SOC) is the treatment or management approach that is widely accepted and used by medical professionals for a particular disease or condition. For investors, SOC provides the benchmark against which new therapies, devices, or clinical results are judged—like comparing a new car to the current most popular model; a product that meaningfully outperforms the SOC can win market share and drive revenue, while failure to beat or match it limits commercial potential.

AI-generated analysis. Not financial advice.

Preliminary 2025 net product revenue of $155.4 million, representing 172% year-over-year growth; OJEMDA 2026 U.S. net product revenue projected to be $225 - $250 million

Company to present on corporate progress and priorities for 2026 during J.P. Morgan Healthcare Conference, January 12th at 5:15 pm PT (8:15 pm ET)

BRISBANE, Calif., Jan. 11, 2026 (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 the release of preliminary unaudited 2025 OJEMDA™ net product revenue, cash and investments at year-end and provided 2026 OJEMDA net product revenue guidance ahead of the company’s scheduled presentation tomorrow at the 44th Annual J.P. Morgan Healthcare Conference at 5:15 pm PT (8:15 pm ET).

“Following remarkable commercial and clinical progress in 2025 and the strategic acquisition of Mersana and our new pipeline program Emi-Le (emiltatug ledadotin), we’re entering 2026 poised to deliver on our mission and on our growth aspirations,” said Jeremy Bender, Ph.D., chief executive officer of Day One. “I’m thrilled by the steady uptake of OJEMDA in relapsed or refractory pLGG, and by the opportunities for future patient impact we expect from the clinical data for OJEMDA in front line pLGG and for Emi-Le and DAY301. Our solid financial position will continue to enable us to invest in future programs that have strong potential to become important new medicines.”

2025 OJEMDA Commercial Performance

• OJEMDA net product revenue was approximately $52.8 million and $155.4 million for the fourth quarter and full year 2025, respectively (unaudited)
• ~37% QoQ growth compared to Q3 2025; ~172% YoY growth vs. 2024, driven by momentum in patient demand, with prescription volumes increasing to 1,394 during the fourth quarter
• 2026 OJEMDA U.S. net product revenue is projected to be between $225 million and $250 million, representing 53% year-over-year growth at the midpoint
  

2026 Corporate Priorities and Key Milestones

OJEMDA

• Deliver on 2026 OJEMDA net product revenue guidance, with a focus on increasing persistency and driving new patient starts to support continued OJEMDA adoption as standard of care (SOC) in 2L pediatric low-grade glioma (pLGG)
• Extend the OJEMDA commercial opportunity beyond the U.S. with global expansions via our partner
• Complete enrollment in the pivotal Phase 3 FIREFLY-2 clinical trial in first-line pLGG in the first half of 2026, enabling a mid-2027 data readout and a potential approval in 2028
  

PIPELINE

• Advance Emi-Le program by delivering Phase 1 clinical data by mid-2026 and progressing toward registration
• Provide initial data from the Phase 1a clinical trial for DAY301, a PTK7-targeted antibody drug conjugate (ADC), in the second half of 2026

Corporate Update
As of December 31, 2025, prior to the acquisition of Mersana, Day One had approximately $441.1 million of cash, cash equivalents, and short-term investments (unaudited). The 2025 net product revenues and cash, cash equivalents and short-term investments position included in this release are preliminary and are therefore subject to adjustment. The preliminary net product revenue results are based on management’s initial analysis of operations for the year ended December 31, 2025. The Company expects to issue full financial results for the fourth-quarter and full-year 2025 in February 2026.

J.P. Morgan Presentation Details
Dr. Jeremy Bender, chief executive officer, will present during the 44^th Annual J.P. Morgan Healthcare Conference on Monday, January 12 at 5:15 pm PT (8:15 pm ET). 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 following the live presentation.

About Day One Biopharmaceuticals
Day One Biopharmaceuticals is a commercial-stage biopharmaceutical company that believes when it comes to pediatric cancer, we can do better. The Company was founded to address a critical unmet need: the dire lack of therapeutic development in pediatric cancer. Inspired by “The Day One Talk” that physicians have with patients and their families about an initial cancer diagnosis and treatment plan, Day One aims to re-envision cancer drug development and redefine what’s possible for all people living with cancer—regardless of age—starting from Day One.

Day One partners with leading clinical oncologists, families, and scientists to identify, acquire, and develop important targeted cancer treatments. The Company’s pipeline includes tovorafenib (OJEMDA™), DAY301, and following the recently announced acquisition of Mersana Therapeutics, Emi-Le (emiltatug ledadotin), a novel antibody drug conjugate (ADC) targeting the B7-H4 protein in clinical development to treat the rare cancer adenoid cystic carcinoma (ACC).

Day One is based in Brisbane, California. For more information, please visit www.dayonebio.com or find the Company on LinkedIn or X.

Cautionary Note Regarding Forward-Looking Statements
This press release contains “forward-looking” statements within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995, including, but not limited to: Day One’s ability to grow revenue from OJEMDA, plans to develop and commercialize cancer therapies and its pipeline and the impact of Emi-Le and DAY301, and statements regarding its net product revenues, cash, cash equivalents and short-term investments. Statements including words such as “believe,” “plan,” “continue,” “expect,” “will,” “develop,” “signal,” “potential,” or “ongoing” and statements in the future tense are forward-looking statements. These forward-looking statements involve risks and uncertainties, as well as assumptions, which, if they do not fully materialize or prove incorrect, could cause our results to differ materially from those expressed or implied by such forward-looking statements.

Forward-looking statements are subject to risks and uncertainties that may cause Day One’s actual activities or results to differ significantly from those expressed in any forward-looking statement, including risks and uncertainties in this press release and other risks set forth in our filings with the Securities and Exchange Commission, including risks related to the ability to realize the anticipated benefits of the Mersana acquisition, including the possibility that the expected benefits from the acquisition will not be realized or will not be realized within the expected time period; the risk that the businesses will not be integrated successfully; disruption from the transaction making it more difficult to maintain business and operational relationships; negative effects of the consummation of the acquisition on the market price of Day One’s common stock and/or operating results; significant transaction costs; unknown liabilities, Day One’s ability to develop, obtain and retain regulatory approval for or commercialize any product candidate, Day One’s ability to protect intellectual property, the potential impact of global business or macroeconomic conditions, including as a result of inflation, government shutdowns, rising interest rates, instability in the global banking system, geopolitical conflicts and the sufficiency of Day One’s cash, cash equivalents and investments to fund its operations. These forward-looking statements speak only as of the date hereof and Day One specifically disclaims any obligation to update these forward-looking statements or reasons why actual results might differ, whether as a result of new information, future events or otherwise, except as required by law.

DAY ONE MEDIA
media@dayonebio.com

DAY ONE INVESTORS
LifeSci Advisors, PJ Kelleher
pkelleher@lifesciadvisors.com

FAQ

What were Day One (DAWN) preliminary OJEMDA net product revenues for 2025?

Day One reported preliminary unaudited 2025 OJEMDA net product revenue of $155.4 million.

How much revenue did OJEMDA generate in Q4 2025 for DAWN?

OJEMDA net product revenue for Q4 2025 was approximately $52.8 million.

What is Day One's 2026 OJEMDA U.S. net product revenue guidance (DAWN)?

The company projects $225–$250 million in U.S. OJEMDA net product revenue for 2026 (midpoint ≈ 53% YoY growth).

What cash did Day One report at year-end 2025 prior to the Mersana acquisition?

As of December 31, 2025, Day One had approximately $441.1 million of cash, cash equivalents, and short-term investments (unaudited).

When does Day One expect a FIREFLY-2 data readout and potential approval for OJEMDA?

The company expects to complete FIREFLY-2 enrollment in 1H 2026, enabling a mid-2027 data readout and a potential approval in 2028.

When will Day One report clinical data for Emi-Le and DAY301 (DAWN)?

Emi-Le Phase 1 clinical data are expected by mid-2026, and initial DAY301 Phase 1a data are expected in the second half of 2026.