IDEAYA Biosciences Reveals Clearance Of Investigational New DrugApplication With FDA For Initiation Of Phase 1 Clinical Trial To Evaluate Werner Helicase Development Candidate IDE275
Portfolio Pulse from Suganya Shanmugam
IDEAYA Biosciences has received FDA clearance for a Phase 1 clinical trial of IDE275, a Werner Helicase development candidate. The trial will focus on patients with MSI-High tumors. IDEAYA will receive a $7 million payment for IND acceptance and potential future milestones up to $950 million. The company has a 50/50 US profit share and an 80/20 global R&D cost share with GSK.
October 28, 2024 | 10:02 am
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POSITIVE IMPACT
GSK is involved in a partnership with IDEAYA for the development of IDE275, sharing global R&D costs and US profits. The FDA clearance for the trial is a positive development.
GSK's partnership with IDEAYA in the development of IDE275, including cost and profit sharing, means the FDA clearance is a positive development for GSK, potentially enhancing its pipeline.
CONFIDENCE 85
IMPORTANCE 70
RELEVANCE 50
POSITIVE IMPACT
IDEAYA Biosciences received FDA clearance for a Phase 1 trial of IDE275, with a $7M payment for IND acceptance and potential milestones up to $950M. The trial targets MSI-High tumors.
The FDA clearance for the Phase 1 trial is a significant milestone for IDEAYA, potentially leading to substantial future payments and profit sharing. This news is likely to positively impact IDYA's stock price in the short term.
CONFIDENCE 95
IMPORTANCE 90
RELEVANCE 100