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Former FDA chief Stephen Hahn joins Turn Therapeutics (Nasdaq: TTRX)

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(Moderate)
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(Neutral)
Form Type
8-K

Rhea-AI Filing Summary

Turn Therapeutics Inc. announced that it has appointed Stephen M. Hahn, M.D., former Commissioner of the U.S. Food and Drug Administration, as its executive clinical and regulatory lead. He will oversee clinical and regulatory strategy for GX-03, the company’s investigational topical therapy for moderate-to-severe atopic dermatitis, which is currently in a Phase 2 randomized controlled trial with topline results expected in mid-2026.

GX-03 is described as a first-in-class, non-systemic, topical cytokine‑modulating therapy aimed at key inflammatory pathways in eczema and other inflammatory skin diseases. Turn Therapeutics positions itself as a biotechnology company focused on targeted, localized therapies for inflammatory diseases with high unmet medical need.

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Item 7.01 Regulation FD Disclosure Disclosure
Material non-public information disclosed under Regulation Fair Disclosure, often investor presentations or guidance.
Item 9.01 Financial Statements and Exhibits Exhibits
Financial statements, pro forma financial information, and exhibit attachments filed with this report.
Employees at MD Anderson more than 21,000 employees MD Anderson Cancer Center workforce overseen during Hahn’s tenure
MD Anderson operating budget $5.2 billion Operating budget of MD Anderson Cancer Center during Hahn’s leadership role
FDA commissioner term 2019 to 2021 Period when Hahn served as 24th FDA Commissioner
Scientific publications more than 220 publications Peer-reviewed scientific papers authored by Stephen M. Hahn
GX-03 trial timing mid-2026 Expected timing for topline results from Phase 2 GX-03 trial
atopic dermatitis medical
"GX-03, the Company’s investigational topical therapy currently in a Phase 2 clinical trial for moderate-to-severe atopic dermatitis"
A chronic inflammatory skin condition, often called eczema, that causes dry, itchy, red patches and recurring flare-ups; think of it as a persistent rash that can come and go over a person’s life. It matters to investors because its chronic nature and large patient population create steady demand for treatments, influence drug development and approval decisions, affect healthcare costs and reimbursement, and can drive revenue and valuation shifts for companies working on therapies and diagnostics.
Phase 2 randomized controlled trial medical
"GX-03 is currently being evaluated in a Phase 2 randomized controlled trial, with topline results expected in mid-2026."
cytokine-modulating therapy medical
"GX-03 is a first-in-class, non-systemic, topical cytokine-modulating therapy in development for moderate-to-severe atopic dermatitis"
forward-looking statements regulatory
"Certain statements in this press release may constitute “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995."
Forward-looking statements are predictions or plans that companies share about what they expect to happen in the future, like estimating sales or profits. They matter because they help investors understand a company's outlook, but since they are based on guesses and assumptions, they can sometimes be wrong.
topical therapy medical
"GX-03, the Company’s investigational topical therapy currently in a Phase 2 clinical trial for moderate-to-severe atopic dermatitis"
A topical therapy is a medicine applied directly to the skin, eyes, or other body surfaces—think of it like painting a treatment onto the area that needs help rather than swallowing a pill. For investors, the delivery method matters because topical products often have lower systemic side effects, simpler manufacturing and distribution, and clear market niches, all of which can influence approval chances, pricing, patient adoption, and potential revenue streams.
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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

FORM 8-K

 

CURRENT REPORT

Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934

 

Date of Report (Date of earliest event reported): May 18, 2026

 

TURN THERAPEUTICS INC.

(Exact name of registrant as specified in its charter)

 

Delaware   001-42875   32-0456090
(State or other jurisdiction of
incorporation)
  (Commission File Number)   (IRS Employer
Identification Number)

 

250 N. Westlake Blvd., Westlake Village, California   91362
(Address of principal executive offices)   (Zip Code)

 

Registrant’s telephone number, including area code: (818) 564-4011

 

N/A

(Former name or former address, if changed since last report)

 

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

 

¨ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

 

¨ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

 

¨ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

 

¨ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

 

Securities registered pursuant to Section 12(b) of the Act:

 

Title of Each Class   Trading Symbol   Name of Each Exchange on Which Registered
Common Stock, par value $0.0001 per share   TTRX   The Nasdaq Stock Market LLC

 

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

 

Emerging growth company

 

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.

 

 

 

 

 

Item 7.01 Regulation FD Disclosure.

 

On May 18, 2026, Turn Therapeutics Inc. issued a press release (the “Press Release”). A copy of the Press Release is furnished as Exhibit 99.1 to this Current Report on Form 8-K.

 

The information in Item 7.01 of this Current Report on Form 8-K and the Press Release furnished as Exhibit 99.1 hereto shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such a filing.

 

Item 9.01 Financial Statements and Exhibits.

 

(d) Exhibits

 

Exhibit No.   Description
99.1   Press Release, dated May 18, 2026
104   Cover Page Interactive Data File (embedded within the Inline XBRL document)

 

1

 

 

SIGNATURES

 

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

 

  TURN THERAPEUTICS INC.
Date: May 18, 2026  
   
  By: /s/ Bradley Burnam
  Name: Bradley Burnam
  Title: Chief Executive Officer

 

2

 

Exhibit 99.1

 

 

 

FOR IMMEDIATE RELEASE

 

Turn Therapeutics Appoints Physician-Scientist and Former FDA Commissioner, Dr. Stephen M. Hahn, as Executive Clinical and Regulatory Lead 

 

Dr. Hahn Brings Unparalleled Clinical and Regulatory Expertise to Support Advancement

of GX-03 for Moderate-to-Severe Atopic Dermatitis and Pipeline Indications 

 

Westlake Village, Calif. -- May 18, 2026 - Turn Therapeutics Inc. (Nasdaq: TTRX), a clinical-stage biotechnology company developing targeted, localized therapies for inflammatory skin diseases, today announced the appointment of Stephen M. Hahn, M.D., former Commissioner of the U.S. Food and Drug Administration (FDA), to oversee the clinical and regulatory strategy for GX-03, the Company’s investigational topical therapy currently in a Phase 2 clinical trial for moderate-to-severe atopic dermatitis (eczema). 

 

“Patients with inflammatory skin diseases still lack adequate treatment options, especially therapies that work well without causing significant systemic effects. GX-03 represents a differentiated approach focused on treating inflammation directly at the site of disease, potentially offering an important new localized treatment option,” said Stephen Hahn. “This mission is deeply personal for me. My own family has struggled with atopic dermatitis, and I know firsthand how difficult and frustrating it can be. Throughout my career, I have remained focused on advancing therapies that are both scientifically rigorous and truly meaningful for patients. I look forward to working with the Turn Therapeutics team to help bring this potential therapy forward responsibly and urgently.”

 

“There are very few people in this industry who combine scientific rigor, regulatory expertise, and genuine compassion for patients the way Dr. Hahn does,” said Bradley Burnam, Chief Executive Officer of Turn Therapeutics. “His interest in treatment options for inflammatory skin disease is not just professional, it is personal, and you can see that in the way he approaches this work. Beyond his extraordinary experience leading major clinical and regulatory organizations, he brings a level of thoughtfulness, integrity, and patient focus. We are incredibly fortunate to have him helping guide our path forward.”

 

About Dr. Stephen M. Hahn

 

Stephen M. Hahn, M.D., is a physician, biotechnology executive, and former Commissioner of the U.S. Food and Drug Administration with decades of leadership experience spanning clinical medicine, regulatory science, healthcare operations, and medical product development. As the 24th FDA Commissioner from 2019 to 2021, Dr. Hahn oversaw both COVID and non-COVID regulatory activities, including therapeutics, vaccines, diagnostics, medical devices, and clinical trials.

 

Prior to joining the FDA, Dr. Hahn served as Chief Medical Executive, Deputy President, and Chief Operating Officer at MD Anderson Cancer Center, where he helped oversee one of the world’s leading academic medical centers with more than 21,000 employees and a $5.2 billion operating budget. He also held senior academic and clinical leadership positions at MD Anderson and the University of Pennsylvania’s Perelman School of Medicine. In the biotechnology sector, Dr. Hahn has served in executive leadership roles including CEO-Partner at Flagship Pioneering and Chief Executive Officer of Harbinger Health. He has extensive experience in clinical research and medical product development, including topical therapies, and has authored more than 220 peer-reviewed scientific publications.

 

Dr. Hahn earned his M.D. from Temple University and his B.A. in Biology from Rice University. He completed his internal medicine residency at University of California, San Francisco, and his fellowship and residency training at the National Cancer Institute in Bethesda, Maryland.

 

###

 

 

 

 

About GX-03 

 

GX-03 is a first-in-class, non-systemic, topical cytokine-modulating therapy in development for moderate-to-severe atopic dermatitis (eczema). By stabilizing the cutaneous microenvironment and modulating epithelial danger sensing, GX-03 is designed to address IL-36, IL-4, IL-13, and IL-31 signaling through upstream prevention rather than downstream, systemic suppression. GX-03 is currently being evaluated in a Phase 2 randomized controlled trial, with topline results expected in mid-2026. 

 

About Turn Therapeutics 

 

Turn Therapeutics is a biotechnology company focused on developing innovative, precision therapies that target the underlying causes of inflammatory diseases with high unmet needs. Its lead investigational therapy, GX-03, is a first-in-class, non-systemic topical inhibitor currently in development for the treatment of moderate-to-severe atopic dermatitis. This therapy is designed to modulate key inflammatory pathways involved in eczema and other inflammatory dermatological conditions. 

 

Forward-Looking Statement

 

Certain statements in this press release may constitute “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. All statements, other than statements of historical fact, contained in this press release are forward-looking statements. Forward-looking statements contained in this press release may be identified by the use of words such as “anticipate,” “believe,” “contemplate,” “could,” “estimate,” “expect,” “intend,” “seek,” “may,” “might,” “plan,” “potential,” “predict,” “project,” “suggest,” “target,” “aim,” “should,” “will,” “would,” or the negative of these words or other similar expressions, although not all forward-looking statements contain these words. Forward-looking statements are based on Turn Therapeutics’ current expectations and are subject to inherent uncertainties, risks, and assumptions that are difficult to predict, including risks related to the success of development programs, and the Company’s ability to execute its strategic plan. Further, certain forward-looking statements are based on assumptions as to future events that may not prove to be accurate. For a further discussion of risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to the business of Turn Therapeutics in general, see the risk disclosures in the Company’s filings with the Securities and Exchange Commission (the “SEC”), including the Company’s Annual Report on Form 10-K for the year ended December 31, 2025, filed with the SEC on March 31, 2026. All such forward-looking statements speak only as of the date they are made, and Turn Therapeutics undertakes no obligation to update or revise these statements, whether as a result of new information, future events, or otherwise.

 

Investor Relations / Media Contact 

Sasha Damouni 

Damouni Group LLC 

Sasha@damounigroup.com 

 

# # #

 

 

 

FAQ

What leadership change did Turn Therapeutics (TTRX) announce on May 18, 2026?

Turn Therapeutics appointed former FDA Commissioner Stephen M. Hahn, M.D., as its executive clinical and regulatory lead. He will guide clinical and regulatory strategy for GX-03 and support advancement of the company’s pipeline in inflammatory skin diseases.

What is GX-03 in Turn Therapeutics (TTRX) pipeline and what disease does it target?

GX-03 is a first-in-class, non-systemic topical cytokine-modulating therapy in development for moderate-to-severe atopic dermatitis. It aims to stabilize the skin microenvironment and modulate inflammatory signaling involved in eczema and other inflammatory dermatologic conditions.

What is the current clinical status of GX-03 at Turn Therapeutics (TTRX)?

GX-03 is currently being evaluated in a Phase 2 randomized controlled trial for moderate-to-severe atopic dermatitis. The company states that topline results from this trial are expected in mid-2026, providing an important clinical readout for the program.

What relevant experience does Dr. Stephen Hahn bring to Turn Therapeutics (TTRX)?

Dr. Hahn is a physician and former FDA Commissioner with decades of experience in clinical medicine, regulatory science, and product development. He previously held senior leadership roles at MD Anderson Cancer Center and in biotechnology, and has authored more than 220 peer‑reviewed publications.

How does Turn Therapeutics (TTRX) describe its business focus?

Turn Therapeutics describes itself as a biotechnology company developing innovative, precision therapies that target underlying causes of inflammatory diseases with high unmet need. Its lead investigational therapy, GX-03, focuses on localized, non-systemic treatment for moderate-to-severe atopic dermatitis.

What forward-looking statements does Turn Therapeutics (TTRX) highlight in this announcement?

The company notes that statements about development program success and execution of strategic plans are forward-looking. It emphasizes that such statements involve risks and uncertainties and refers investors to risk disclosures in its Annual Report on Form 10-K for the year ended December 31, 2025.

Filing Exhibits & Attachments

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