SPARC enters definitive agreement to monetise rare paediatric disease PRV, unlocking capital for R&D and strategic growth
If approved, the move would significantly broaden the use of KEYTRUDA and KEYTRUDA QLEX in combination with Padcev
A decision is expected by August 17, 2026 under the Prescription Drug User Fee Act timeline
The investigational therapy, ifinatamab deruxtecan, is a potential first-in-class B7-H3 directed DXd antibody drug conjugate discovered by Daiichi Sankyo and jointly developed with Merck
Enhertu recently received Breakthrough Therapy Designation, accelerating development and review for this critical patient population
If approved, DTX401 would be the first treatment to address the disease at its root cause
Iberdomide has the potential to be the first approved CELMoD agent
HYMPAVZI is already approved in the US for patients 12 and older with hemophilia A without factor VIII inhibitors or hemophilia B without factor IX inhibitors
The FDA’s regulatory decision is expected in Q2 2026 under the Prescription Drug User Fee Act (PDUFA)
A PRV is a tradable voucher granted by the FDA to encourage the development of new treatments for rare pediatric diseases
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