Obsidian Therapeutics (OBX) FDA Approvals $17.75 +0.25 (+1.43%) Closing price 09/18/2026 04:00 PM EasternExtended Trading$17.68 -0.07 (-0.42%) As of 09/18/2026 07:30 PM Eastern Extended trading is trading that happens on electronic markets outside of regular trading hours. This is a fair market value extended hours price provided by Massive. Learn more. Add Share Share FDA Events Stock AnalysisAnalyst ForecastsChartFDA EventsSEC Filings Obsidian Therapeutics' Drug in the FDA Approval ProcessThis 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. Enrollment Update - August 5,2026Enrollment Update Phase 1/2Drug: OBX-115Announced Date: August 5, 2026Indication: in Advanced MelanomaAnnouncementObsidian 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 SummaryObsidian 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 Has Obsidian Therapeutics received FDA approval? As of now, Obsidian Therapeutics (OBX) has not received any FDA approvals for its therapy in the last two years. What drugs has Obsidian Therapeutics submitted to the FDA? In the past two years, Obsidian Therapeutics (OBX) has reported FDA regulatory activity for OBX-115. What is the most recent FDA event for Obsidian Therapeutics? 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." What conditions do Obsidian Therapeutics' current drugs treat? Currently, Obsidian Therapeutics has one therapy (OBX-115) targeting the following condition: in Advanced Melanoma. 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Enrollment Update - August 5,2026Enrollment Update Phase 1/2Drug: OBX-115Announced Date: August 5, 2026Indication: in Advanced MelanomaAnnouncementObsidian 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 SummaryObsidian 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
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