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Day One Biopharmaceuticals

🇺🇸United States
Ownership
Public
Employees
155
Market Cap
$1.3B
Website
http://www.dayonebio.com
Introduction

Day One Biopharmaceuticals, Inc. operates as a holding company. The firm through its subsidiary develops and commercializes targeted therapies for patients of all ages with genetically defined cancers. Its products include DAY101 and pimsertib. The company was founded by Julie Grant and Samuel Blackman in November 2018 and is headquartered in Brisbane, CA.

Day One Biopharmaceuticals Appoints Michael Vasconcelles as Head of R&D to Drive Pipeline Expansion

Day One Biopharmaceuticals has appointed Michael Vasconcelles, M.D., as Head of Research and Development, bringing over 25 years of oncology research and development expertise to the company.

XOMA Royalty Expands Portfolio to Over 120 Assets, Reports Financial Results for 2024

• XOMA Royalty doubled its portfolio to over 120 royalty assets through five strategic transactions in 2024, strengthening its position as a biotech royalty aggregator. • The company completed two whole company acquisitions and celebrated FDA approvals for Day One's OJEMDA™ (tovorafenib) and Zevra's MIPLYFFA™ (arimoclomol), generating significant milestone payments. • Despite reporting a net loss of $13.8 million for 2024, XOMA Royalty received $46.3 million in cash receipts and maintains over $100 million in cash, positioning it for sustainable cashflow from royalties.

FDA Approves FoundationOne CDx as Companion Diagnostic for Tovorafenib in Pediatric Low-Grade Glioma

• The FDA has approved FoundationOne CDx as a companion diagnostic for tovorafenib (Ojemda) in pediatric low-grade glioma (pLGG) patients with specific BRAF alterations. • FoundationOne CDx detects BRAF fusions, rearrangements, and V600 mutations, enabling precise identification of pLGG patients who may benefit from tovorafenib treatment. • Tovorafenib received accelerated approval in April 2024 for relapsed/refractory BRAF-altered pLGG, supported by a 67% overall response rate in the FIREFLY-1 trial. • This approval marks Foundation Medicine’s first companion diagnostic indication exclusively supporting pediatric patients, enhancing precision medicine in pediatric oncology.

FDA Approvals in 2024: Novel Therapies for MASH, WHIM Syndrome, Pediatric Glioma, MDS, and Bladder Cancer

The FDA approved Madrigal's Rezdiffra, the first treatment for metabolic dysfunction-associated steatohepatitis (MASH), addressing a significant unmet need in liver disease.

Industry Leaders Unite to Tackle Patient Recruitment Challenges in Rare Disease Clinical Trials

• Over 80% of U.S. clinical trials fail to meet patient enrollment timelines, highlighting the significant challenges in rare disease research and patient recruitment. • Leading pharmaceutical companies including Biogen, Astellas Pharma, and Novo Nordisk are collaborating to address patient recruitment obstacles through innovative strategies and enhanced diversity initiatives. • The Patient Recruitment for Rare Disease Trials Summit brings together experts to explore solutions for patient engagement, data sharing, and fair compensation while maintaining trial integrity.

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