Grünenthal has successfully completed a Phase I trial for its proprietary nociceptin receptor (NOP) agonist, demonstrating safety and tolerability in 113 healthy volunteers. The company plans to advance the novel pain therapy into a Phase II trial later this year, with results expected in the second half of 2027.
Vertex completed the rolling BLA submission for povetacicept in IgA nephropathy after positive Phase 3 RAINIER interim data. The company plans to use a Priority Review Voucher to accelerate FDA review.
The FDA approved 46 novel drugs in 2025, down from 50 in 2024. Small molecules accounted for 31 approvals (67%), with oncology leading at nine approvals. Large molecules contributed 15 approvals (33%), spanning ADCs, bispecifics, and subcutaneous delivery innovations.
