Turn Therapeutics (TTRX) FDA Approvals $5.20 -0.11 (-2.07%) Closing price 04:00 PM EasternExtended Trading$5.20 0.00 (-0.10%) As of 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 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. 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 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 May 27, 2026, involving GX-03. The update was categorized as "Publication," with the company reporting: "Turn 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." What conditions do Turn Therapeutics' current drugs treat? Currently, Turn Therapeutics has one therapy (GX-03) targeting the following condition: Atopic Dermatitis Treatment. 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FDA EventsAgenus FDA EventsAkari Therapeutics FDA EventsBioCardia FDA EventsBioXcel Therapeutics FDA EventsCogent Biosciences 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 Candel Therapeutics FDA Events Tectonic Therapeutic FDA Events Aquestive Therapeutics FDA Events Sutro Biopharma FDA Events Contineum Therapeutics FDA Events Prothena FDA Events Immix Biopharma FDA Events Aura Biosciences FDA Events Avalo Therapeutics FDA Events Shattuck Labs FDA Events Stock Lists Biotechnology StocksCompare Biotech StocksCompare Healthcare StocksCompare Pharmaceutical StocksHealthcare and Medical Stocks FDA progress for NASDAQ:TTRX last updated on 5/27/2026 by MarketBeat.com Staff. 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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
