Halozyme Discloses That Bristol Myers Squibb Received Updated Action Date From U.S. FDA For Subcutaneous Nivolumab Co-Formulated with ENHANZE (Halozyme's Proprietary Recombinant Human Hyaluronidase Enzyme); The Updated Goal Date Is December 29, 2024
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Halozyme announced that Bristol Myers Squibb received an updated FDA action date of December 29, 2024, for the Biologics License Application for subcutaneous nivolumab co-formulated with Halozyme's ENHANZE. The application is based on Phase 3 trial results showing noninferior pharmacokinetics, efficacy, and safety compared to the intravenous formulation.
May 21, 2024 | 11:55 am
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POSITIVE IMPACT
Bristol Myers Squibb's subcutaneous nivolumab with Halozyme's ENHANZE received an updated FDA action date. Positive Phase 3 results could lead to approval, enhancing BMY's product portfolio.
The updated FDA action date and positive Phase 3 trial results for the subcutaneous formulation of nivolumab could lead to approval, enhancing Bristol Myers Squibb's product portfolio.
CONFIDENCE 85
IMPORTANCE 60
RELEVANCE 70
POSITIVE IMPACT
Halozyme's proprietary enzyme ENHANZE is part of the subcutaneous nivolumab formulation, which has received an updated FDA action date. Positive Phase 3 results could lead to approval, benefiting Halozyme.
The updated FDA action date and positive Phase 3 trial results for the subcutaneous formulation of nivolumab with ENHANZE could lead to approval, benefiting Halozyme significantly.
CONFIDENCE 90
IMPORTANCE 70
RELEVANCE 80