Obsidian Therapeutics' Drug in the FDA Approval Process
This section highlights FDA-related milestones and regulatory updates for drugs developed by Obsidian Therapeutics (OBX).
Over the past two years, Obsidian Therapeutics has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
OBX-115. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
OBX-115 FDA Regulatory Events
OBX-115 is a drug developed by Obsidian Therapeutics for the following indication: in Advanced Melanoma.
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:
- OBX-115
- Announced Date:
- August 5, 2026
- Indication:
- in Advanced Melanoma
Announcement
Obsidian Therapeutics, Inc. announced the first patient has been enrolled in the registration-enabling cohort of the Phase 1/2 Agni-01 multicenter study of amsokigene autoleucel (amsoki-cel, formerly OBX-115), an engineered TIL cell therapy armored with pharmacologically regulatable membrane-bound IL15 (mbIL15), in patients with immune checkpoint inhibitor (ICI)-resistant advanced or metastatic melanoma.
AI Summary
Obsidian Therapeutics announced that the first patient has been enrolled in the registration-enabling cohort of the Phase 1/2 Agni-01 multicenter trial. The study is evaluating amsokigene autoleucel (amsoki-cel, formerly OBX-115), an engineered tumor-infiltrating lymphocyte (TIL) therapy for people with advanced or metastatic melanoma whose disease has resisted immune checkpoint inhibitors (ICIs).
Amsoki-cel is designed with pharmacologically regulatable membrane-bound interleukin-15 (mbIL15). This feature is intended to support the activity and expansion of therapeutic T cells while allowing treatment effects to be controlled with medication. The new enrollment marks progress toward generating the clinical evidence needed for potential registration. Obsidian is also studying amsoki-cel in non-small cell lung cancer through Agni-01, with Phase 1 data expected in the first half of 2027.
Read Announcement
Obsidian Therapeutics FDA Events - Frequently Asked Questions
As of now, Obsidian Therapeutics (OBX) has not received any FDA approvals for its therapy in the last two years.
In the past two years, Obsidian Therapeutics (OBX) has reported FDA regulatory activity for OBX-115.
The most recent FDA-related event for Obsidian Therapeutics occurred on August 5, 2026, involving OBX-115. The update was categorized as "Enrollment Update," with the company reporting: "Obsidian Therapeutics, Inc. announced the first patient has been enrolled in the registration-enabling cohort of the Phase 1/2 Agni-01 multicenter study of amsokigene autoleucel (amsoki-cel, formerly OBX-115), an engineered TIL cell therapy armored with pharmacologically regulatable membrane-bound IL15 (mbIL15), in patients with immune checkpoint inhibitor (ICI)-resistant advanced or metastatic melanoma."
Currently, Obsidian Therapeutics has one therapy (OBX-115) targeting the following condition: in Advanced Melanoma.
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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
FDA progress for NASDAQ:OBX last updated on 8/5/2026 by MarketBeat.com Staff. We continuously monitor for new FDA events and market data.
