Day One Biopharmaceuticals

DAWNPhase 2

Brisbane, United Statesdayonebio.com

Founded in 2018, Day One Biopharmaceuticals is driven by a mission to creatively and intentionally develop new medicines for people of all ages with life-threatening diseases, starting from the urgent needs of children with cancer. The company achieved a landmark FDA approval in 2024 for OJEMDA™ in pediatric low-grade glioma (pLGG) and is actively expanding its pipeline through strategic acquisitions, such as Mersana Therapeutics. With a leadership team of seasoned oncology experts, Day One employs a nimble, patient-centric business model to identify, develop, and commercialize first- or best-in-class targeted oncology therapies.

Market Cap

$679.7M

Founded

2018

Employees

55+ (oncology professionals cited); likely 100-200 total

Focus

Small Molecules

DAWN · Stock Price

USD 6.5816.92 (-72.00%)

Historical price data

AI Company Overview

Technology Platform

A 'Search & Development' business model focused on identifying and accelerating promising clinical-stage or approved targeted therapies for both pediatric and adult cancers with high unmet need.

Pipeline Snapshot

8 drugs in pipeline, 1 in Phase 3

Drug	Indication	Stage
Tovorafenib + Chemotherapeutic Agent	Low-grade Glioma	Phase 3
Tovorafenib	Low-grade Glioma	Phase 2
Tovorafenib	Craniopharyngioma, Child	Phase 2
Tovorafenib	Melanoma	Phase 2
Tovorafenib + Tovorafenib Drug: Pimasertib	Melanoma	Phase 1

FDA Approved Drugs

OJEMDANDAApr 23, 2024

Opportunities

Significant opportunity to expand OJEMDA™ into adult BRAF-altered cancers and other pediatric indications.

The Emi-Le ADC program offers entry into the high-growth ADC therapeutic area.

The acquisition by Servier provides global scale and resources to accelerate the development of the entire pipeline.

Risk Factors

Commercial execution risk with first product launch; clinical development risk for novel ADC Emi-Le; integration risk from the Mersana acquisition; and deal completion risk regarding the proposed acquisition by Servier.

Heavy reliance on the pediatric oncology market, which has inherent trial complexity and smaller patient populations.

Competitive Landscape

Competes with off-label BRAF/MEK inhibitors in pLGG and will face competition in the crowded ADC space with Emi-Le. Differentiates through a dedicated pediatric-first development strategy, deep regulatory expertise, and a business model designed to accelerate treatments for all ages with equal urgency.

Publications

Patents

Pipeline

FDA Approvals