12:37 PM EDT, 07/23/2025 (MT Newswires) -- GSK (GSK) said the US Food and Drug Administration extended the review period for its biologics license application for Blenrep combinations to treat relapsed or refractory multiple myeloma.

The new Prescription Drug User Fee Act action date is Oct. 23, giving the FDA additional time to evaluate new information in support of the application, GSK said Wednesday in a statement.

The application for Blenrep combinations is supported by Phase III trials showing progression-free and overall survival benefits over standard therapies, with safety and tolerability profiles consistent those of the individual agents, GSK said.

GSK shares rose 2.6% in recent Wednesday trading.

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