Day One Biopharmaceuticals reported preliminary 2025 net product revenue of $155.4 million for its flagship drug OJEMDA, a 172 % increase from the $55.5 million earned in 2024. The jump reflects a sharp rise in U.S. commercial sales driven by growing physician adoption and expanded patient access in the relapsed or refractory pediatric low‑grade glioma market, where OJEMDA remains the sole approved targeted therapy.
The company lifted its 2026 U.S. net product revenue guidance to $225 million–$250 million, up from the $145 million–$150 million range it had set for 2025. The higher outlook signals management’s confidence that OJEMDA demand will continue to accelerate, bolstered by the upcoming FIREFLY‑2 Phase 3 data expected in mid‑2027 and the company’s expanding pipeline following the acquisition of Mersana Therapeutics, which adds the adenoid cystic carcinoma candidate Emi‑Le.
OJEMDA’s market dominance is reinforced by real‑world evidence showing sustained efficacy and safety, which has encouraged broader prescribing. The Mersana acquisition not only diversifies Day One’s product portfolio but also provides additional revenue streams that could offset the high operating losses typical of a growth‑stage biopharma, while the company’s cash position of roughly $441 million supports continued investment in research and commercialization.
CEO Jeremy Bender highlighted the “steady uptake” of OJEMDA and expressed optimism about the front‑line data from FIREFLY‑2, noting that the company is “poised to deliver on our mission and on our growth aspirations.” He also emphasized the company’s solid financial footing, which will enable ongoing investment in high‑potential pipeline assets such as Emi‑Le and DAY301.
The announcement was well received by investors, who viewed the revenue beat and upward guidance as evidence of strong commercial execution and a robust pipeline. The company’s guidance reflects a 53 % year‑over‑year growth expectation for 2026, underscoring management’s confidence in sustained demand and the potential impact of forthcoming clinical data.
Looking ahead, Day One plans to complete enrollment for FIREFLY‑2 in the first half of 2026, with a data readout slated for mid‑2027. The company also expects Phase 1 data for Emi‑Le by mid‑2026 and for DAY301 in the second half of 2026, positioning it to broaden its therapeutic reach beyond pediatric low‑grade glioma.
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