FDA Events for Inhibrx Biosciences (INBX)
This section highlights FDA-related milestones and regulatory updates for drugs developed by Inhibrx Biosciences (INBX).
Over the past two years, Inhibrx Biosciences has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
INBRX-109. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
INBRX-109 - FDA Regulatory Timeline and Events
INBRX-109 is a drug developed by Inhibrx Biosciences for the following indication: Conventional Chondrosarcoma.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- INBRX-109
- Announced Date:
- January 21, 2025
- Indication:
- Conventional Chondrosarcoma
Announcement
Inhibrx Biosciences, Inc. announced preliminary efficacy and safety data from the Phase 1 trial of ozekibart (INBRX-109) in combination with FOLFIRI for the treatment of advanced or metastatic, unresectable colorectal adenocarcinoma (CRC).
AI Summary
Inhibrx Biosciences announced encouraging preliminary data from its Phase 1 trial evaluating ozekibart (INBRX-109) with FOLFIRI in patients with advanced or metastatic, unresectable colorectal adenocarcinoma. In the trial, 10 of 13 patients were evaluated using RECIST v1.1 criteria. Among these patients, there was one complete response, three partial responses, and six cases of stable disease. Durable disease control lasting 180 days or more was observed in nearly half of the patients, with a median progression-free survival of 7.85 months. Notably, responses were seen even in patients who had undergone multiple prior lines of therapy, including those who had previously failed FOLFIRI. The reported treatment-related adverse events were generally mild to moderate. Based on these promising results, Inhibrx is now expanding the trial to a larger, more uniform patient group to further assess ozekibart’s efficacy and safety.
Read Announcement
Inhibrx Biosciences FDA Events - Frequently Asked Questions
As of now, Inhibrx Biosciences (INBX) has not received any FDA approvals for its therapy in the last two years.
In the past two years, Inhibrx Biosciences (INBX) has reported FDA regulatory activity for INBRX-109.
The most recent FDA-related event for Inhibrx Biosciences occurred on January 21, 2025, involving INBRX-109. The update was categorized as "Efficacy and Safety Data," with the company reporting: "Inhibrx Biosciences, Inc. announced preliminary efficacy and safety data from the Phase 1 trial of ozekibart (INBRX-109) in combination with FOLFIRI for the treatment of advanced or metastatic, unresectable colorectal adenocarcinoma (CRC)."
Currently, Inhibrx Biosciences has one therapy (INBRX-109) targeting the following condition: Conventional Chondrosarcoma.
More FDA Event Resources from MarketBeat
FDA Event Stage Terminology & Abbreviation Guide
- NDA: New Drug Application
- ANDA: Abbreviated New Drug Application
- sNDA: Supplemental New Drug Application
- BLA: Biologics License Application
- sBLA: Supplemental Biologics License Application
- FDA Approved: Approved by the FDA
- EMA: European Medicines Agency
- CE Mark: European Union Certification
- NMPA: China National Medical Products Administration
- MHLW: Japanese Ministry of Health
- FDA Meeting: Consultation with FDA
- Pre-IND: Pre-Investigational New Drug Meeting
- Breakthrough Therapy: Special FDA designation for promising therapies
- Fast Track: Accelerated FDA approval pathway
- Orphan Drug: Designation for rare disease treatments
- RPD: Rare Pediatric Disease Designation
- RMAT: Regenerative Medicine Advanced Therapy
- DSMB Review: Data Safety Monitoring Board Review
- IDMC Review: Independent Data Monitoring Committee
- MAA: MHRA Marketing Authorization Application
- RTF: Refusal to File (Rejected Application)
- 510(k): FDA Clearance for Medical Devices
- Rolling Submission: Staggered regulatory review process
This page (NASDAQ:INBX) was last updated on 7/12/2025 by MarketBeat.com Staff
