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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

1. Halozyme's technology aids Janssen's RYBREVANT SC formulation approval recommendation. 2. Positive CHMP opinion boosts prospects for HALO's ENHANZE drug delivery technology.

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Why Bullish?

The approval recommendation indicates a growing demand for HALO's technology. Past instances show that positive regulatory news often lifts stock prices in biotech firms.

How important is it?

The article significantly highlights HALO's technology role in major approvals, impacting its market position. Regulatory success closely correlates with financial gains in the biotech industry.

Why Long Term?

Successful applications can lead to enduring revenue streams. Similar past scenarios have shown sustained impacts following product approvals.

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JNJRYBREVANTLAZCLUZE
SAN DIEGO , Feb. 3, 2025 /PRNewswire/ -- Halozyme Therapeutics, Inc. (NASDAQ: HALO) (Halozyme) today announced that Janssen-Cilag International NV, a Johnson & Johnson company, received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency recommending an extension of marketing authorisation for a subcutaneous (SC) formulation of RYBREVANT® (amivantamab) in combination with LAZCLUZE® (lazertinib) for the first-line treatment of adult patients with advanced non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 L858R substitution mutations, and as a monotherapy for the treatment of adult patients with advanced NSCLC with activating EGFR exon 20 insertion mutations after failure of platinum-based therapy. "We are pleased that the subcutaneous formulation of amivantamab, which was developed with our ENHANZE drug delivery technology, was recommended for approval in Europe," said Dr. Helen Torley, president and chief executive officer of Halozyme.

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