OJEMDA™ (tovorafenib)
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Day One Announces New OJEMDA™ (tovorafenib) Data to be Presented in Oral Session at the 2025 Society for Neuro-Oncology (SNO) Annual Meeting
Globenewswire· 2025-11-10 12:00
Core Insights - Day One Biopharmaceuticals is set to present new data on OJEMDA (tovorafenib) demonstrating durable responses and clinical stability in pediatric low-grade glioma (pLGG) patients at the Society for Neuro-Oncology (SNO) meeting [1][3] Company Overview - Day One Biopharmaceuticals focuses on developing targeted therapies for life-threatening diseases, particularly in pediatric cancer, addressing a critical unmet need in therapeutic development [11][12] - The company is based in Brisbane, California, and aims to redefine cancer drug development for all ages [11][12] Product Information - Tovorafenib (OJEMDA) is a Type II RAF kinase inhibitor approved for treating patients aged 6 months and older with relapsed or refractory pLGG harboring BRAF alterations [4][6] - The drug has received Breakthrough Therapy and Rare Pediatric Disease designations from the FDA, indicating its potential significance in treating pLGG [6] Clinical Trial Insights - The pivotal Phase 2 FIREFLY-1 trial evaluated tovorafenib in 137 patients, showing an overall response rate (ORR) of 67% and a median duration of response (DOR) of 16.6 months [8] - The trial results indicate sustained efficacy and long-term response in patients, reinforcing the clinical evidence for OJEMDA's differentiated profile [3][8] Pediatric Low-Grade Glioma Context - Pediatric low-grade glioma is the most common brain tumor in children, with significant incidence rates in the US and Europe, and BRAF alterations are present in over 50% of cases [9] - The condition often requires long-term treatment due to its chronic nature and the profound side effects associated with both the tumor and its treatment [9]
Day One Biopharmaceuticals pany(DAWN) - 2025 Q1 - Earnings Call Presentation
2025-05-06 20:33
Financial Performance - Since launch, OJEMDA net product revenue reached $87.7 million[10, 14] - In Q1 2025, OJEMDA net product revenue was $30.5 million[10, 14, 19] - Q1 2025 saw a $3 million (+11%) increase in U S net product revenue compared to Q4 2024[14, 19] - Total revenue for Q1 2025 was $30.8 million[29] - The company holds a strong financial position with $473 million in cash[10, 29] - Net loss for the company was ($360) million[29] Commercial Performance - Cumulative prescriptions since launch totaled 2,571[14, 21] - Prescription growth in Q1 2025 was driven by new patient starts and continued therapy among on-label patients[21] Market Opportunity - Priority 1 centers manage approximately 4,000 estimated patients[24] - Priority 2 centers manage approximately 5,000 estimated patients[24] - Priority 3 centers manage approximately 4,000 estimated patients[24]
XOMA Royalty Completes Sale of Kinnate Pipeline Assets
Newsfilter· 2025-04-14 11:30
Core Viewpoint - XOMA Royalty Corporation has successfully sold its remaining Kinnate pipeline assets for up to $270 million in upfront and milestone payments, along with royalties on future commercial sales [1][2] Group 1: Financial Details - The total potential financial benefit from the sale includes up to $270 million in upfront and milestone payments, plus royalties on commercial sales at rates ranging from low single digits to mid-teens [1] - Holders of Kinnate Contingent Value Rights (CVRs) will receive 85% of all related payments made to XOMA Royalty prior to April 2, 2029 [2] Group 2: Company Background - XOMA Royalty Corporation operates as a biotechnology royalty aggregator, acquiring future economic rights associated with therapeutic candidates licensed to pharmaceutical or biotechnology companies [3] - The company provides non-dilutive, non-recourse funding to sellers, enabling them to advance their internal drug candidates or for general corporate purposes [3] Group 3: Current Portfolio - As of the date of the press release, XOMA Royalty's milestone and royalty portfolio includes commercial assets such as VABYSMO®, OJEMDA™, MIPLYFFA™, XACIATO™, IXINITY®, and DSUVIA® [6]