Turn Therapeutics' Drug in the FDA Approval Process
This 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.
- Drug:
- GX-03
- Announced Date:
- June 1, 2026
- Indication:
- Atopic Dermatitis Treatment
Announcement
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.
AI Summary
Turn 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- Drug:
- GX-03
- Announced Date:
- May 27, 2026
- Indication:
- Atopic Dermatitis Treatment
Announcement
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.
AI Summary
Turn 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- Drug:
- GX-03
- Announced Date:
- November 11, 2025
- Indication:
- Atopic Dermatitis Treatment
Announcement
Turn Therapeutics announced it has been named as one of the "Five Novel Mechanisms Reshaping Atopic Dermatitis Treatment" by Patient Care Online Magazine.
AI Summary
Turn 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
As of now, Turn Therapeutics (TTRX) has not received any FDA approvals for its therapy in the last two years.
In the past two years, Turn Therapeutics (TTRX) has reported FDA regulatory activity for GX-03.
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."
Currently, Turn Therapeutics has one therapy (GX-03) targeting the following condition: Atopic Dermatitis Treatment.
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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:TTRX last updated on 6/1/2026 by MarketBeat.com Staff. We continuously monitor for new FDA events and market data.
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