FDA Approves BeOne Medicines' TEVIMBRA Combo for HER2-Positive Cancer

โดย Insider Monkey·US·Read original
Summary · why it matters

BeOne Medicines (NASDAQ:ONC) received FDA approval for TEVIMBRA in combination with ZIIHERA and chemotherapy as a first-line treatment for HER2-positive gastroesophageal adenocarcinoma, a cancer affecting over 31,000 Americans annually. The approval is based on Phase 3 data showing a median overall survival of 26.4 months, the longest reported for an immunotherapy-based regimen in this setting. The company also reported second-quarter revenue of $1.7 billion, up 30% year over year, and raised its full-year revenue guidance to $6.6–$6.8 billion. However, the CELESTIAL 301 trial failed to show statistical superiority on its primary endpoint, and the company faces biosimilar competition for XGEVA. Shares trade at a forward P/E of 46.73, reflecting high growth expectations.

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Biotech & Genomic Medicine▲ · 1 stocks
BeOne Medicines AG
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FDA approval for TEVIMBRA combo is a regulatory win for BeOne Medicines.

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