Day One | Advancing Targeted Therapies

Our treatments have the potential to save lives, our pipeline aims to protect futures and our commitment aspires to elevate what can be achieved in oncology.

Product Candidate

Therapeutic Area

Pre-Clinical Pre-CN
Ph 1 Phase 1
Ph 2 Phase 2
Ph 3/Reg Phase 3 / Registrational
Approved Approved

Tovorafenib Type II RAF inhibitor

OJEMDA™ brand name
in US¹

BRAF-altered
Relapsed pLGG

Approved

Therapeutic Area: BRAF-altered
Relapsed pLGG

Progress: Phase 2

Clinical Trial: FIREFLY-1 (pivotal Phase 2)

FIREFLY-1 (pivotal Phase 2)

Front-line
RAF-altered pLGG

Therapeutic Area: Front-line
RAF-altered pLGG

Progress: Phase 3

Clinical Trial: FIREFLY-2 (pivotal Phase 3)

FIREFLY-2 (pivotal Phase 3)

Pimasertib MEK 1/2 inhibitor

MAPK-altered
solid tumors ^†
(combination with tovorafenib)

Therapeutic Area: MAPK-altered
solid tumors ^†
(combination with tovorafenib)

Progress: Phase 1

Clinical Trial: FIRELIGHT-1^††

FIRELIGHT-1^††

VRK1 Program VRK1 inhibitor

Pediatric and adult cancers

Therapeutic Area: Pediatric and adult cancers

Progress: Pre-Clinical

Clinical Trial:

PreCN

The safety and efficacy of investigational agents and/or investigational uses of approved products have not been established.

¹ OJEMDA has received accelerated approval by the U.S. Food and Drug Administration.
^† Pimasertib Phase 1 dose escalation and expansion trial previously completed.
^†† Includes patients ≥12 years of age.
^§ Research collaboration and license agreement with Sprint Bioscience for exclusive worldwide rights to a research-stage program targeting VRK1.

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Pipeline

A pipeline for the future.

Our treatments have the potential to save lives, our pipeline aims to protect futures and our commitment aspires to elevate what can be achieved in oncology.

The safety and efficacy of investigational agents and/or investigational uses of approved products have not been established.

See our progress in motion.

You are now leaving the Day One Biopharmaceuticals Corporate Website

Pipeline

A pipeline for the future.

Our treatments have the potential to save lives, our pipeline aims to protect futures and our commitment aspires to elevate what can be achieved in oncology.

The safety and efficacy of investigational agents and/or investigational uses of approved products have not been established.

See our progress in motion.

You are now leaving the Day One Biopharmaceuticals Corporate Website

OJEMDA - Now Approved