INBX: FDA menerima BLA untuk ozekibart; PDUFA ditetapkan 14 April 2027

FDA telah menerima pengajuan BLA untuk ozekibart (INBRX-109) pada kondisi kondrosarkoma konvensional yang tidak dapat direseksi atau metastasis tanpa masalah tinjauan pengajuan yang teridentifikasi. Tanggal target PDUFA 14 April 2027 telah ditetapkan, menetapkan timeline regulasi untuk potensi persetujuan.

Fakta utama

Diajukan: 15 Jun 2026, 20.06
Peristiwa: Permohonan diterima
Arah: Positif
Perusahaan: INBXInhibrx
Aset: ozekibart
Sumber: SEC 8-K
Keyakinan: Bersumber
Kalender: Keputusan FDA (PDUFA) · 14 Apr 2027 · Positif

Kutipan sumber

inhibrx-20260615 FALSE 0002007919 0002007919 2026-06-15 2026-06-15 UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): June 15, 2026 INHIBRX BIOSCIENCES, INC. (Exact name of registrant as specified in its charter) Delaware 001-42031 99-0613523 (State or other jurisdiction of incorporation) (Commission File Number) (IRS Employer Identification No.) 11025 N. Torrey Pines Road , Suite 140 La Jolla , CA 92037 (Address of Principal Executive Offices and Zip Code) Registrant’s telephone number, including area code: ( 858 ) 795-4220 Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the

SEC 8-K