Turn Therapeutics (TTRX) FDA Approvals $6.33 +1.13 (+21.73%) Closing price 06/1/2026 04:00 PM EasternExtended Trading$6.32 -0.01 (-0.24%) As of 06/1/2026 07:56 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 Compare Share Share FDA Events Stock AnalysisAnalyst ForecastsChartCompetitorsEarningsFDA EventsHeadlinesInsider TradesOwnershipSEC FilingsShort InterestTrendsBuy This Stock Turn Therapeutics' Drug in the FDA Approval ProcessThis section highlights FDA-related milestones and regulatory updates for drugs developed by Turn Therapeutics (TTRX). Over the past two years, Turn Therapeutics has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as GX-03. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend. GX-03 FDA Regulatory Timeline and Events GX-03 is a drug developed by Turn Therapeutics for the following indication: Atopic Dermatitis Treatment. 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. Interim Analysis - June 1,2026Interim Analysis Phase 2Drug: GX-03Announced Date: June 1, 2026Indication: Atopic Dermatitis TreatmentAnnouncementTurn Therapeutics Inc announced interim analysis findings from the first 50 completed subjects enrolled in its ongoing randomized, double-blind, vehicle-controlled Phase 2 clinical trial evaluating GX-03 in adults with moderate-to-severe atopic dermatitis.AI SummaryTurn Therapeutics Inc. reported interim results from the first 50 patients in its ongoing Phase 2 trial of GX-03 for adults with moderate-to-severe atopic dermatitis. The study is randomized, double-blind, and vehicle-controlled. After four weeks, 92.6% of patients treated with GX-03 reached EASI-50, meaning at least a 50% drop in eczema severity. In the same period, 70.4% reached EASI-75 and 44.4% reached EASI-90. By eight weeks, 51.9% reached EASI-90, showing very strong skin improvement over time. No treatment-related serious side effects were seen in either group, and there were no treatment-related tolerability problems or dropouts. Based on the early data, the company refined its enrollment criteria, endpoint plan, and overall trial strategy. Turn Therapeutics said GX-03 continued to show a favorable safety and tolerability profile as the trial moves forward.Read AnnouncementPublication - May 27,2026Publication Drug: GX-03Announced Date: May 27, 2026Indication: Atopic Dermatitis TreatmentAnnouncementTurn Therapeutics Inc. announced the publication of a peer-reviewed research article in the Journal of Dermatological Treatment evaluating the effects of its lead program, GX-03, in an IL-36–associated inflammatory environment.AI SummaryTurn Therapeutics Inc. announced the publication of a peer-reviewed study in the Journal of Dermatological Treatment on its lead program, GX-03. The research examined how an extended-release topical polyhexanide treatment worked in a mouse model of Staphylococcus aureus-induced dermatitis linked to IL-36, a marker tied to inflammation. The study, titled “Effects of extended-release topical polyhexanide in a Staphylococcus aureus-induced murine dermatitis model characterized by IL-36 expression,” was co-authored by company CEO Bradley Burnam and Dr. Stephen Bresnick. Turn Therapeutics said the paper is the first in a planned series that will look at GX-03’s biological and clinical effects. The company also noted that a follow-up manuscript is already under review and will focus on how the treatment works at a deeper mechanistic level.Read AnnouncementProvided Update - November 11,2025Provided Update Drug: GX-03Announced Date: November 11, 2025Indication: Atopic Dermatitis TreatmentAnnouncementTurn Therapeutics announced it has been named as one of the "Five Novel Mechanisms Reshaping Atopic Dermatitis Treatment" by Patient Care Online Magazine.AI SummaryTurn Therapeutics announced it was named one of the "Five Novel Mechanisms Reshaping Atopic Dermatitis Treatment" by Patient Care Online Magazine. The company said its GX-03 topical technology earned the recognition as a top innovation in eczema care. CEO Bradley Burnam said IL-36 plays a key role in the inflammation behind atopic dermatitis, eczema and psoriasis. GX-03 is described as the first topical to target IL-36, potentially offering an alternative to systemic drugs and injectables. Company studies showed GX-03 can inhibit IL-36 alpha, IL-36 gamma, IL-31 and IL-4. Patient Care Online is an educational resource for office-based clinicians. Turn said it is advancing its pipeline and expects topline data from its lead severe eczema program in early 2026, aiming to bring a new topical option to patients in need.Read Announcement Turn Therapeutics FDA Events - Frequently Asked Questions Has Turn Therapeutics received FDA approval? As of now, Turn Therapeutics (TTRX) has not received any FDA approvals for its therapy in the last two years. What drugs has Turn Therapeutics submitted to the FDA? In the past two years, Turn Therapeutics (TTRX) has reported FDA regulatory activity for GX-03. What is the most recent FDA event for Turn Therapeutics? The most recent FDA-related event for Turn Therapeutics occurred on June 1, 2026, involving GX-03. The update was categorized as "Interim Analysis," with the company reporting: "Turn Therapeutics Inc announced interim analysis findings from the first 50 completed subjects enrolled in its ongoing randomized, double-blind, vehicle-controlled Phase 2 clinical trial evaluating GX-03 in adults with moderate-to-severe atopic dermatitis." What conditions do Turn Therapeutics' current drugs treat? Currently, Turn Therapeutics has one therapy (GX-03) targeting the following condition: Atopic Dermatitis Treatment. More FDA Event Resources from MarketBeat FDA Calendars Recent FDA Drug Approval Calendar Upcoming FDA Events & PDUFA Dates Calendar Companies With Recent FDA Events Actuate Therapeutics FDA EventsAprea Therapeutics FDA EventsAura Biosciences FDA EventsBriacell Therap FDA EventsCelcuity FDA EventsCellectar Biosciences FDA EventsCitius Pharmaceuticals FDA EventsCytokinetics FDA EventsAlpha Tau Medical FDA EventsEnlivex Therapeutics FDA EventsGreenwich LifeSciences FDA EventsImmuneering FDA EventsIovance Biotherapeutics FDA EventsJade Biosciences FDA EventsModerna FDA Events 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 Related Companies Cabaletta Bio FDA Events Candel Therapeutics FDA Events Altimmune FDA Events Gyre Therapeutics FDA Events Tectonic Therapeutic FDA Events Arvinas FDA Events Prothena FDA Events Contineum Therapeutics FDA Events Aquestive Therapeutics FDA Events Sutro Biopharma FDA Events Stock Lists Biotechnology StocksCompare Biotech StocksCompare Healthcare StocksCompare Pharmaceutical StocksHealthcare and Medical Stocks FDA progress for NASDAQ:TTRX last updated on 6/1/2026 by MarketBeat.com Staff. 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Interim Analysis - June 1,2026Interim Analysis Phase 2Drug: GX-03Announced Date: June 1, 2026Indication: Atopic Dermatitis TreatmentAnnouncementTurn Therapeutics Inc announced interim analysis findings from the first 50 completed subjects enrolled in its ongoing randomized, double-blind, vehicle-controlled Phase 2 clinical trial evaluating GX-03 in adults with moderate-to-severe atopic dermatitis.AI SummaryTurn Therapeutics Inc. reported interim results from the first 50 patients in its ongoing Phase 2 trial of GX-03 for adults with moderate-to-severe atopic dermatitis. The study is randomized, double-blind, and vehicle-controlled. After four weeks, 92.6% of patients treated with GX-03 reached EASI-50, meaning at least a 50% drop in eczema severity. In the same period, 70.4% reached EASI-75 and 44.4% reached EASI-90. By eight weeks, 51.9% reached EASI-90, showing very strong skin improvement over time. No treatment-related serious side effects were seen in either group, and there were no treatment-related tolerability problems or dropouts. Based on the early data, the company refined its enrollment criteria, endpoint plan, and overall trial strategy. Turn Therapeutics said GX-03 continued to show a favorable safety and tolerability profile as the trial moves forward.Read Announcement
Publication - May 27,2026Publication Drug: GX-03Announced Date: May 27, 2026Indication: Atopic Dermatitis TreatmentAnnouncementTurn Therapeutics Inc. announced the publication of a peer-reviewed research article in the Journal of Dermatological Treatment evaluating the effects of its lead program, GX-03, in an IL-36–associated inflammatory environment.AI SummaryTurn Therapeutics Inc. announced the publication of a peer-reviewed study in the Journal of Dermatological Treatment on its lead program, GX-03. The research examined how an extended-release topical polyhexanide treatment worked in a mouse model of Staphylococcus aureus-induced dermatitis linked to IL-36, a marker tied to inflammation. The study, titled “Effects of extended-release topical polyhexanide in a Staphylococcus aureus-induced murine dermatitis model characterized by IL-36 expression,” was co-authored by company CEO Bradley Burnam and Dr. Stephen Bresnick. Turn Therapeutics said the paper is the first in a planned series that will look at GX-03’s biological and clinical effects. The company also noted that a follow-up manuscript is already under review and will focus on how the treatment works at a deeper mechanistic level.Read Announcement
Provided Update - November 11,2025Provided Update Drug: GX-03Announced Date: November 11, 2025Indication: Atopic Dermatitis TreatmentAnnouncementTurn Therapeutics announced it has been named as one of the "Five Novel Mechanisms Reshaping Atopic Dermatitis Treatment" by Patient Care Online Magazine.AI SummaryTurn Therapeutics announced it was named one of the "Five Novel Mechanisms Reshaping Atopic Dermatitis Treatment" by Patient Care Online Magazine. The company said its GX-03 topical technology earned the recognition as a top innovation in eczema care. CEO Bradley Burnam said IL-36 plays a key role in the inflammation behind atopic dermatitis, eczema and psoriasis. GX-03 is described as the first topical to target IL-36, potentially offering an alternative to systemic drugs and injectables. Company studies showed GX-03 can inhibit IL-36 alpha, IL-36 gamma, IL-31 and IL-4. Patient Care Online is an educational resource for office-based clinicians. Turn said it is advancing its pipeline and expects topline data from its lead severe eczema program in early 2026, aiming to bring a new topical option to patients in need.Read Announcement
