Day One Biopharmaceuticals

What Day One Biopharmaceuticals does

Day One Biopharmaceuticals is a commercial-stage biopharmaceutical company founded in 2018 and headquartered in South San Francisco (now operating from Brisbane, California as part of Servier Group) that develops and commercializes targeted therapies for cancer patients across age groups, with an initial focus on pediatric oncology. The company operates under a "Search & Development" strategy that identifies and advances breakthrough therapies — including repurposed assets and novel targeted compounds — faster than traditional drug development models. Its core approved product, OJEMDA (tovorafenib), is an oral, brain-penetrant, highly selective Type II RAF kinase inhibitor approved by the FDA in April 2024 for relapsed or refractory pediatric low-grade glioma (pLGG) harboring BRAF alterations in patients aged six months and older; it is the only FDA-approved monotherapy and the first EU-approved targeted therapy for this indication. Pipeline assets include Emi-Le (emiltatug ledadotin), a B7-H4-targeted antibody-drug conjugate acquired via the January 2026 Mersana Therapeutics acquisition, and DAY301, a potentially first-in-class PTK7-targeted ADC in-licensed from MabCare Therapeutics.

Day One generates revenue through two streams: U.S. net product sales of OJEMDA distributed via specialty pharmacy channels with support from the EveryDay Support From Day One patient assistance program, and licensing royalties and milestone payments from Ipsen, which holds ex-U.S. commercialization rights (with EU conditional marketing authorization secured in April 2026). FY2025 net product revenue reached $155.4M, up 172% year-over-year, and 2026 U.S. net product revenue guidance is $225-250M. The go-to-market motion is enterprise field sales supported by Medical Science Liaisons targeting neuro-oncologists, pediatric oncologists, and major pediatric cancer treatment centers, supplemented by patient advocacy partnerships (Momcology, Pediatric Brain Tumor Foundation, Children's Brain Tumor Foundation) and presence at major oncology conferences (ASCO, SNO, ISPNO, AACR).

Following the completion of the Servier acquisition on April 23, 2026, for approximately $2.5 billion ($21.50 per share), Day One now operates as a wholly-owned subsidiary of Servier Group, with its headquarters in Brisbane, California and continued focus on pediatric oncology, rare cancers, and an expanding ADC pipeline targeting adult and pediatric solid tumors. The company reported a cash position exceeding $440 million as of Q4 2025 prior to the acquisition close.

Name

Day One Biopharmaceuticals

Legal name

Day One Biopharmaceuticals, Inc.

Website

https://dayonebio.com

Company type

Public

Founded year

2018

Operating status

Acquired

Headcount range

101–250 employees

Short description

Day One Biopharmaceuticals is a commercial-stage biopharmaceutical company developing targeted therapies for cancer. Its FDA-approved drug OJEMDA treats pediatric low-grade glioma, with an expanding ADC pipeline. The company was acquired by Servier in April 2026 for approximately $2.5 billion.

Ownership category

akta.pro rank

Product category

Pediatric Oncology Pharmaceuticals

NAICS

Pharmaceutical Preparation Manufacturing (325412), Biological Product (except Diagnostic) Manufacturing (325414)

SIC

Pharmaceutical Preparations (2834), Biological Products, (No Disgnostic Substances) (2836)

akta.pro primary industry

Oncology Specialty Pharmaceuticals (HLAIACAA)

akta.pro secondary industries

Rare Pediatric & Congenital Disorder Therapies (HLAIAIAN), Rare Oncology & Hematologic Malignancy Therapies (HLAIAIAC), Neuro-oncology (HLAKAIAL)

Keywords

• Targeted cancer therapies
• Pediatric oncology drugs
• Kinase inhibitor treatments
• Antibody drug conjugates
• Specialty biopharmaceutical products

Headquarters

HQ city

South San Francisco

HQ country

United States

HQ region

North America

Offices1 record

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

Technology or R&D, Personnel, Marketing or Sales, Operations, Supply Chain

Revenue model

1. Product Sales - OJEMDA: Day One generates revenue through the sale of its FDA-approved drug OJEMDA (tovorafenib) for pediatric low-grade glioma. The company reported $155.4 million in net product revenue for full-year 2025, representing 172% year-over-year growth. Q4 2025 revenue was $52.8 million. The company projects 2026 U.S. net product revenue guidance of $225-250 million.
2. Licensing Royalties: Day One receives licensing revenue from Ipsen for ex-U.S. rights to OJEMDA (tovorafenib). Ipsen licensed the rights in 2024 and the drug received EU approval in April 2026, generating milestone payments and ongoing royalties.

Go-to-market motion1 record

Distribution channels1 record

Marketing channels4 records

Core offering

Day One Biopharmaceuticals develops and commercializes targeted therapies for life-threatening cancers with a primary focus on pediatric oncology. The company's lead product OJEMDA (tovorafenib) is an FDA-approved oral, brain-penetrant, highly-selective Type II RAF kinase inhibitor for pediatric low-grade glioma (pLGG) with BRAF alterations. Its pipeline also includes investigational antibody-drug conjugates (ADCs) Emi-Le (B7-H4-targeted) and DAY301 (PTK7-targeted) for adult and pediatric solid tumors.

Product overview

Day One Biopharmaceuticals is a commercial-stage biopharmaceutical company focused on developing and commercializing targeted therapies for cancer patients of all ages. The company's portfolio consists of FDA-approved OJEMDA (tovorafenib), a Type II RAF inhibitor for pediatric low-grade glioma, along with clinical-stage antibody drug conjugates Emi-Le (B7-H4-targeted) and DAY301 (PTK7-targeted) for treating various adult and pediatric solid tumors. The company operates under a Search & Development strategy to identify and advance breakthrough medicines for serious diseases with high unmet medical needs.

Differentiator

Problem solved

Functional benefit

Brands

• OJEMDA: FDA-approved targeted therapy for relapsed or refractory pediatric low-grade glioma (pLGG) with BRAF alterations. Contains the active ingredient tovorafenib.
• EveryDay Support From Day One

Products and services

• OJEMDA (tovorafenib) OJEMDA is an FDA-approved oral, brain-penetrant, highly-selective Type II RAF kinase inhibitor for treating relapsed or refractory pediatric low-grade glioma (pLGG) in patients 6 months and older with BRAF alterations. It targets the MAPK signaling pathway and is the only FDA-approved monotherapy for this indication, demonstrating a 71% overall response rate in clinical trials.
• Emi-Le (emiltatug ledadotin) Emi-Le is an investigational B7-H4-targeted antibody drug conjugate (ADC) with a drug-to-antibody ratio of 6 (DAR 6) and a proprietary payload. It demonstrated early anti-tumor activity in Phase 1 trials for adenoid cystic carcinoma (ACC) and other solid tumors.
• DAY301 DAY301 is a potentially first-in-class antibody drug conjugate (ADC) targeting protein tyrosine kinase 7 (PTK7), which is highly expressed on multiple adult and pediatric cancers including platinum-resistant ovarian cancer, triple negative breast cancer, non-small cell lung cancer, neuroblastoma, and osteosarcoma.

Quantifiable outcome

• 71% overall response rate per RANO-HGG criteria in Phase 2 FIREFLY-1 trial
• +2 more outcomes

Named customers2 records

Segments1 record

Ideal customer profiles2 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature3 records

Partnerships

Four partnerships are on record, tiered core.

• ServiercoreStrategic or Co-development Partner · 23 April 2026Servier completed acquisition of Day One Biopharmaceuticals in April 2026 for approximately $2.5 billion at $21.50 per share. The acquisition adds OJEMDA and Day One's pipeline of clinical-stage assets to Servier's oncology portfolio, supporting Servier's 2030 ambition to strengthen its position in rare cancers and pediatric oncology.
• Mersana TherapeuticscoreStrategic or Co-development Partner · 6 January 2026Day One completed acquisition of Mersana Therapeutics in January 2026 for $25 per share in cash plus a contingent value right worth up to $30.25 per share. The deal added Emi-Le (emiltatug ledadotin), a B7-H4-targeted ADC for adenoid cystic carcinoma, to Day One's pipeline. Approximately 60.57% of Mersana shares were tendered.
• IpsencoreOEM/ Whitelabel/ Licensing Partner · 1 January 2024Ipsen licensed the ex-U.S. rights to tovorafenib (OJEMDA) from Day One in 2024. This partnership enables global commercialization of the drug outside the United States. Ipsen secured EU marketing authorization for OJEMDA in April 2026 following positive CHMP opinion, making it the first targeted therapy for relapsed/refractory pLGG in the EU.
• MabCare TherapeuticscoreOEM/ Whitelabel/ Licensing PartnerDay One entered into a license agreement with MabCare Therapeutics for exclusive worldwide rights (excluding Greater China) to MTX-13, a novel ADC targeting PTK7, which became the DAY301 program. The ADC has shown antitumor activity in preclinical models and targets multiple adult and pediatric cancers.

Scale indicators11 records

Recent moves9 records

Expansion highlights6 records

Broad incumbents

• AstraZeneca: Global biopharmaceutical company with a leading ADC franchise (Enhertu, in partnership with Daiichi Sankyo) and broad oncology portfolio — directly comparable broad incumbent with overlapping ADC technology and rare oncology ambitions.
• Mirati Therapeutics: Precision oncology company (acquired by Bristol Myers Squibb) that developed targeted therapies for genetically defined cancers — directly comparable precision oncology strategic peer that was itself acquired, illustrating the M&A exit path relevant to Day One.
• Bayer: Global pharmaceutical company with oncology assets including kinase inhibitors (Stivarga/regorafenib) and a presence in rare cancers — comparable broad incumbent with overlapping kinase-inhibitor portfolio.
• Servier: French privately-held global pharmaceutical company and Day One's acquirer, with a broad oncology and rare disease portfolio — comparable parent strategic fit and now integrates Day One's pediatric oncology assets into its own franchise.
• Roche / Genentech: Global oncology leader with a broad pediatric and adult oncology pipeline including targeted therapies — comparable broad incumbent with the scale, infrastructure, and clinical development capabilities to compete in rare oncology indications.

Direct peers

• Novartis: Major oncology player with dabrafenib (Tafinlar) and trametinib (Mekinist), BRAF/MEK inhibitors that are widely used in BRAF-altered cancers including off-label use in pediatric low-grade glioma — directly competitive with Day One's OJEMDA in the MAPK pathway space.
• BioMarin Pharmaceutical: Specialty biopharma focused on rare diseases with Breakthrough and Orphan designations, premium pricing, and direct-to-patient distribution — directly comparable rare-disease specialty pharma business model and regulatory strategy.
• SpringWorks Therapeutics: Commercial-stage rare disease and rare oncology biotech focused on pediatric and adult cancers, with a comparable model of developing targeted therapies for underserved indications — directly comparable specialty/rare oncology commercial-stage peer.
• Jazz Pharmaceuticals: Specialty biopharmaceutical company with a portfolio spanning rare oncology and neuroscience, operating a similar specialty distribution and rare disease commercial model to Day One's OJEMDA franchise.

Emerging players

• Erasca: Clinical-stage precision oncology company developing therapies targeting the MAPK pathway — directly overlaps with Day One's tovorafenib mechanism and competes in BRAF/RAS-driven tumor space.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat5 records

Key risks5 records

Key highlights8 records

Customer concentration

• Xx.com/dayonebio
• LinkedInlinkedin.com/company/dayonebio

Revenue estimate

Valuation estimate

Number of profiles

Profiles11 records

Subsidiaries1 record

Funding overview

Funding rounds5 records

Investors17 records

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A1 record

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about Day One Biopharmaceuticals