CHMP Issues Positive Opinion for Subcutaneous RYBREVANT®(amivantamab) Co-Formulated with ENHANZE® for the Treatment of Patients with Advanced EGFR-Mutated Non-Small Cell Lung Cancer
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The Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion for the subcutaneous formulation of RYBREVANT® (amivantamab) co-formulated with ENHANZE® for treating advanced EGFR-mutated non-small cell lung cancer. This development involves Halozyme Therapeutics, Inc. and Janssen-Cilag International NV, a Johnson & Johnson company.
February 03, 2025 | 12:45 pm
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Halozyme Therapeutics, Inc. announced a positive CHMP opinion for a subcutaneous formulation of RYBREVANT® using their ENHANZE® technology, potentially boosting their market presence in Europe.
The positive CHMP opinion is a significant regulatory milestone that could lead to expanded use of Halozyme's ENHANZE® technology in Europe, potentially increasing revenue and market presence. This is likely to have a positive short-term impact on Halozyme's stock price.
CONFIDENCE 90
IMPORTANCE 70
RELEVANCE 80