熱門資訊> 正文
Regeneron淋巴瘤疗法odronextamab再次被FDA拒绝
2025-08-02 02:45
- 再生元製藥公司(REGN) 0
- 纳比特(NA) 0
- 盛大科技(SDA) 0
- The U.S. Food and Drug Administration (FDA) has declined to approve Regeneron’s (NASDAQ:REGN) lymphoma therapy odronextamab for the second time, the company disclosed on Friday with its Q2 2025 financials.
- The U.S. pharma giant noted that the regulators sent a complete response letter regarding its Biologics License Application (BLA) following issues found during an inspection at a production site run by Catalent, which was recently acquired by Novo Nordisk (NVO).
- The CRL related to the bispecific antibody’s potential use as a late-line option for relapsed/refractory follicular lymphoma.
- In March 2024, the FDA declined to approve odronextamab as a late-line therapy for R/R follicular lymphoma and R/R diffuse large B-cell lymphoma due to concerns over enrollment status for the drug's confirmatory trials.
More on Regeneron Pharmaceuticals
- Regeneron Pharmaceuticals, Inc. (REGN) Q2 2025 Earnings Call Transcript
- Regeneron Pharmaceuticals: My Highest Conviction Pharma Pick For 2025
- Regeneron Pharmaceuticals Stock May Be Worth Buying Again - Rating Upgrade
- Regeneron outlines path to $17B Dupixent annual sales and initiates 10 Lynozyfic registrational trials amid robust Q2 growth
- Regeneron posts Q2 beat as new Eylea version outperforms
推薦文章
風險及免責提示：以上內容僅代表作者的個人立場和觀點，不代表華盛的任何立場，華盛亦無法證實上述內容的真實性、準確性和原創性。投資者在做出任何投資決定前，應結合自身情況，考慮投資產品的風險。必要時，請諮詢專業投資顧問的意見。華盛不提供任何投資建議，對此亦不做任何承諾和保證。
