Inhibrx Biosciences: Ozekibart için BLA'yı 2. çeyrek 2026'da sunmayı planlıyor

Inhibrx Biosciences announced plans to submit a biologics license application (BLA) to the U.S. Food and Drug Administration for ozekibart in the second quarter of 2026. This follows positive topline results from the registrational trial of ozekibart in chondrosarcoma, where it met its primary endpoint.

Temel olgular

Bildirildi: 13 Kas 2025 23:00
Olay: Başvuru yapıldı
Yön: Olumlu
Şirket: INBXInhibrx
Varlık: ozekibart
Kaynak: SEC 8-K
Güvenilirlik: Kaynaklı

Kaynak alıntısı

EX-99.1 2 exhibit99109302025.htm EX-99.1 Document Exhibit 99.1 Inhibrx Reports Third Quarter 2025 Financial Results San Diego, CA, November 14, 2025 – Inhibrx Biosciences, Inc. (Nasdaq: INBX) (“Inhibrx” or the “Company”) today reported financial results for the third quarter of 2025. Following the completion of the sale of INBRX-101 (the “101 Transaction”) by Inhibrx, Inc. (the “Former Parent”) to Sanofi S.A. and the Former Parent’s concurrent spin-off of the Inhibrx business in May 2024, the biopharmaceutical company now has two programs in ongoing clinical trials. Recent Corporate Highlights On October 23, 2025, Inhibrx announced positive topline results from its registrational trial of ozekibart (INBRX-109) in chondrosarcoma and provided an update on its colorectal cancer and Ewing sarcoma expansion cohorts. • Ozekibart met its primary endpoint in chondrosarcoma, demonstrating a statistically significant and clinically meaningful improvement in median progression-free survival compared to placebo. • Key secondary endpoints reinforce the primary benefit, demonstrating meaningful improvements in disease control and patient quality of life. • Inhibrx plans to submit to the U.S. Food and Drug Administration a biologics license application in the second quarter of 2026. • Interim data from expansion cohorts in patients with colorectal cancer and Ewing sarcoma demonstrate high response and disease control rates in difficult-to-treat, heavily pretreated patients. Financial Res

SEC 8-K