Ideaya Biosciences Announced The FDA Clearance Of An Investigational New Drug Application To Initiate GSK-sponsored Phase 1/2 Trial To Evaluate GSK101 (IDE705) In Combination With Niraparib For Tumors With BRCA Or Other Homologous Recombination Mutations
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Ideaya Biosciences has announced FDA clearance of an Investigational New Drug application to initiate a GSK-sponsored Phase 1/2 trial for GSK101 (IDE705) in combination with Niraparib for tumors with BRCA or other homologous recombination mutations. IDEAYA will receive a $7 million milestone payment upon IND acceptance, and potential future aggregate milestones of up to $950 million related to GSK101 Pol Theta inhibitors.
August 21, 2023 | 10:03 am
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NEUTRAL IMPACT
GlaxoSmithKline is sponsoring the Phase 1/2 trial for GSK101 (IDE705) in combination with Niraparib for tumors with BRCA or other homologous recombination mutations.
As the sponsor of the Phase 1/2 trial, GlaxoSmithKline is investing in the development of GSK101 (IDE705). However, the financial implications of the IND clearance are more directly relevant to IDEAYA Biosciences.
CONFIDENCE 90
IMPORTANCE 60
RELEVANCE 80
POSITIVE IMPACT
IDEAYA Biosciences will receive a $7 million milestone payment upon IND acceptance, and potential future aggregate milestones of up to $950 million related to GSK101 Pol Theta inhibitors.
The FDA clearance of the IND application is a significant regulatory milestone for IDEAYA Biosciences. The $7 million milestone payment will provide immediate financial benefit, and the potential for up to $950 million in future milestones presents a substantial revenue opportunity.
CONFIDENCE 90
IMPORTANCE 80
RELEVANCE 100