08:20 AM EDT, 05/21/2024 (MT Newswires) -- Bristol-Myers Squibb ( BMY ) said Tuesday that the US Food and Drug Administration has reassigned the Prescription Drug User Fee Act goal date of the Biologics License Application for the subcutaneous formulation of Opdivo co-formulated with Halozyme's recombinant human hyaluronidase.

The PDUFA goal date is now expected Dec. 29, 2024, compared with Feb. 28, 2025 previously, the company said.

The application is based on results from a late-stage trial of the subcutaneous formulation of nivolumab to evaluate and demonstrate noninferior pharmacokinetics, efficacy, and consistent safety versus its intravenous formulation.

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