Inhibrx: Tinanggap ng FDA ang BLA para sa ozekibart, itinakda ang PDUFA sa Abril 14, 2027

Tinanggap ng FDA ang BLA para sa ozekibart sa conventional chondrosarcoma at itinakda ang petsa ng layunin ng PDUFA sa Abril 14, 2027. Ang pagtanggap ng filing ay naglilipat sa asset mula sa clinical development patungo sa regulatory review. Plano rin ng kumpanya ang isang pulong sa FDA sa Q4 2026 upang talakayin ang first-line CRC at accelerated pathways sa fourth-line CRC.

Mahahalagang fact

Na-file: Ago 13, 2026, 08:10 PM
Kaganapan: Tinanggap ang aplikasyon
Direksyon: Positibo
Kumpanya: INBXInhibrx
Asset: ozekibart
Pinagmulan: SEC 8-K
Kumpiyansa: May source
Kalendaryo: Desisyon ng FDA (PDUFA) · Abr 14, 2027 · Positibo

Sipi mula sa source

EX-99.1 2 exhibit99106302026.htm EX-99.1 Document Exhibit 99.1 Inhibrx Reports Second Quarter 2026 Financial Results San Diego, CA, August 13, 2026 – Inhibrx Biosciences, Inc. (Nasdaq: INBX) (“Inhibrx” or the “Company”) today reported financial results for the second quarter of 2026. The biopharmaceutical company has two programs in ongoing clinical trials. Recent Corporate Highlights and Upcoming Milestones • Oxford Loan Amendment. In July 2026, the Company entered into a second amendment to the Loan and Security Agreement (Second Amendment) with Oxford Finance LLC (Oxford), which provides for an additional $325.0 million in gross proceeds, (i) $100.0 million of which was funded upon execution of the amendment and (ii) up to an additional $225.0 million which, upon the Company’s reques

SEC 8-K