The European Medicines Agency Has Validated The Extension Application To Introduce Subcutaneous Administration For Bristol Myers Squibb's Opdivo (Nivolumab) And A New Strength (600 Mg/Vial) Across Multiple Previously Approved Adult Solid Tumor Indications
Portfolio Pulse from Benzinga Newsdesk
The European Medicines Agency has validated Bristol Myers Squibb's application to introduce a subcutaneous administration for Opdivo (Nivolumab) and a new strength (600 mg/vial) for multiple previously approved adult solid tumor indications. This validation is based on results from the CheckMate -67T Phase 3 trial.
June 21, 2024 | 11:03 am
News sentiment analysis
Sort by:
Descending
POSITIVE IMPACT
The European Medicines Agency has validated Bristol Myers Squibb's application for a subcutaneous formulation of Opdivo and a new strength (600 mg/vial) for multiple solid tumor indications. This is based on the CheckMate -67T Phase 3 trial results.
The validation by the European Medicines Agency is a significant regulatory milestone for Bristol Myers Squibb. It could lead to increased adoption and sales of Opdivo in the European market, positively impacting BMY's stock price in the short term.
CONFIDENCE 90
IMPORTANCE 80
RELEVANCE 100