Journey Medical Corporation Reports Combined Emrosi™ (DFD-29) Phase 3 Clinical Trial Efficacy Data Analysis Presented at the 2025 Fall Clinical Dermatology Conference

Rhea-AI Summary

Journey Medical (Nasdaq: DERM) presented pooled Phase 3 efficacy data for Emrosi (DFD-29) at the 2025 Fall Clinical Dermatology Conference on October 24, 2025. The pooled analysis of MVOR-1 and MVOR-2 included 653 subjects randomized 3:3:2 and compared once-daily DFD-29, Oracea (doxycycline 40 mg) and placebo over 16 weeks.

Key results: IGA success 62.7% for DFD-29 vs 39.0% for Oracea and 28.2% for placebo (P<0.001 each). Mean inflammatory lesion change at week 16: -19.2 for DFD-29 vs -14.8 Oracea and -11.3 placebo (P<0.001 each). The company reported no major safety issues or serious adverse events related to study drug.

Positive

• IGA success 62.7% for DFD-29 at week 16
• -19.2 mean inflammatory lesion reduction with DFD-29 at week 16
• Statistically superior to Oracea and placebo (P<0.001 for comparisons)
• 653 subjects pooled across two randomized Phase 3 trials

Negative

• None.

Insights

Clinical-Regulatory Strategist

Pooled Phase 3 data show Emrosi (DFD-29) achieved clear, statistically significant superiority versus Oracea and placebo in IGA success and lesion reduction at week 16.

The pooled analysis covers 653 subjects randomized 3:3:2 across two identical Phase 3 trials (MVOR-1 and MVOR-2). At week 16, DFD-29 reached 62.7% IGA treatment success versus 39.0% for Oracea and 28.2% for placebo, with p<0.001 for both comparisons. Mean inflammatory lesion reductions were -19.2 for DFD-29, -14.8 for Oracea and -11.3 for placebo, again p<0.001 versus both comparators. The trials met all co-primary and secondary endpoints and reported no major safety issues or serious adverse events related to study drug.

These results establish a clear efficacy advantage on the two trial endpoints reported: IGA success and lesion count change. The safety summary states comparable incidence and severity of treatment-emergent adverse events across arms. Key items to watch in the near term include broader safety data breakdowns by subgroup, full adverse‑event tables, and real‑world uptake following commercial availability through specialty pharmacies; expect those details in forthcoming full poster materials or conference proceedings from the 2025 Fall Clinical Dermatology Conference (Oct 23–26).

FDA-approved Emrosi (40 mg Minocycline Hydrochloride Modified-Release Capsules, 10 mg immediate release and 30 mg extended release) is available in the United States for the treatment of inflammatory lesions of rosacea in adults

DFD-29 demonstrated superior efficacy in IGA success rates and inflammatory lesion counts versus both placebo and doxycycline (P<0.001 for all comparisons)

Poster Presented on Efficacy of Oral DFD-29, a Low-Dose Minocycline Formulation, in Patients with Rosacea: A Pooled Analysis of Two Phase 3 Trials

SCOTTSDALE, Ariz., Oct. 24, 2025 (GLOBE NEWSWIRE) -- Journey Medical Corporation (“Journey Medical” or “the Company”) (Nasdaq: DERM), a commercial-stage pharmaceutical company primarily focused on selling and marketing U.S. Food and Drug Administration (“FDA”)-approved prescription pharmaceutical products for the treatment of dermatological conditions, today presented efficacy data from a pooled analysis of the two Phase 3 multicenter, randomized, double-blind, parallel-group, active-comparator and placebo-controlled clinical trials, Minocycline Versus Oracea^® in Rosacea-1 (“MVOR-1”) and Minocycline Versus Oracea in Rosacea-2 (“MVOR-2”), evaluating DFD-29 (40 mg Minocycline Hydrochloride Modified-Release Capsules, 10 mg immediate release and 30 mg extended release) (or “Emrosi™”) for the treatment of inflammatory lesions of rosacea in adults, at the 2025 Fall Clinical Dermatology Conference taking place October 23-26, 2025, in Las Vegas, NV.

“These combined Phase 3 results, demonstrating Emrosi’s statistical superiority over both Oracea and placebo in achieving Investigator’s Global Assessment (“IGA”) treatment success and reducing total inflammatory lesion count, reaffirm the strong efficacy and safety profile that have established Emrosi as an important treatment option for patients with rosacea,” said Claude Maraoui, Co-Founder, President, and CEO of Journey Medical Corporation. “As we expand Emrosi’s reach and adoption, these data strengthen our position in the growing dermatology market and underscore our commitment to delivering clinically proven therapies that improve patient outcomes. We believe Emrosi has the potential to become the standard of care for rosacea.”

Combined Phase 3 Clinical Result Highlights

In the Phase 3 study, 62.7% of subjects treated with DFD-29 achieved IGA treatment success, compared with 39.0% in the Oracea group and 28.2% in the placebo group. The differences between the DFD-29 and both Oracea and placebo were statistically significant, each with a p-value of <0.001. The DFD-29 group also experienced a mean reduction of 19.2 inflammatory lesions from baseline to week 16, versus reductions of 14.8 lesions with Oracea and 11.3 lesions with placebo (p < 0.001 for each comparison).

Combined Phase 3 Clinical Results Summary

	Combined MVOR-1 and MVOR-2 Analysis
	IGA Success at Week 16		Inflammatory Lesion Change at Week 16
DFD-29 (40 mg)	62.7%		-19.2
Oracea (40 mg)	39.0%		-14.8
Placebo	28.2%		-11.3
P-value: DFD-29 versus Oracea	P<0.001		P<0.001
P-value: DFD-29 versus Placebo	P<0.001		P<0.001

A total of 653 subjects across two Phase 3 clinical trials were randomized in a 3:3:2 ratio to receive once-daily treatment with DFD-29, Oracea (Doxycycline Capsules, 40 mg) or placebo for 16 weeks. The primary objective of both studies was to evaluate the safety and efficacy of DFD-29 compared to placebo for the treatment of papulopustular rosacea, with a secondary objective of comparing DFD-29 to Oracea. Both trials met all co-primary and secondary endpoints, demonstrating that DFD-29 was statistically superior to Oracea and placebo in achieving IGA treatment success and reducing total inflammatory lesion count from baseline to week 16. DFD-29 was well tolerated, with no major safety issues or serious adverse events related to the study drug reported in either trial (MVOR-1 and MVOR-2). The incidence and severity of treatment-emergent adverse events (“TEAEs”) were comparable across all treatment groups.

Emrosi is available by prescription at specialty pharmacy chains.

Oracea^® is a registered trademark of Galderma Holdings, S.A. Société Anonyme.

About Rosacea
Rosacea is a chronic, relapsing, inflammatory skin condition that most commonly presents with symptoms such as deep facial redness, acne-like inflammatory lesions (papules and pustules) and spider veins (telangiectasia). According to The National Rosacea Society, it is estimated that rosacea affects over 16 million Americans and as many as 415 million people worldwide. Rosacea is most frequently seen in adults between 30 and 50 years of age. Surveys conducted by The National Rosacea Society report that more than 90 percent of rosacea patients said their condition had lowered their self-confidence and self-esteem, and 41 percent stated that it had caused them to avoid public contact or cancel social engagements. Among rosacea patients with severe symptoms, 88 percent said the disorder had adversely affected their professional interactions, and 51 percent said they had missed work because of their condition.

Important Safety Information
Indication: EMROSI™ is indicated for the treatment of inflammatory lesions (papules and pustules) of rosacea in adults. Adverse Events: The most common adverse reaction reported by ≥1% of subjects treated with EMROSI and more frequently than in subjects receiving placebo was dyspepsia. Contraindications: EMROSI should not be taken by patients who have a history of hypersensitivity to any of the tetracyclines. Warnings/Precautions: Cases of anaphylaxis, serious skin reactions (e.g., Stevens-Johnson syndrome), erythema multiforme, and drug rash with eosinophilia and systemic symptoms (DRESS) syndrome have been reported postmarketing with minocycline use in patients with acne. If DRESS syndrome is recognized, discontinue EMROSI immediately. Use during the second and third trimesters of pregnancy, infancy and childhood up to the age of 8 years may cause permanent discoloration of the teeth and reversible inhibition of bone growth. Discontinue EMROSI use if Antibiotic-Associated Colitis occurs. Discontinue EMROSI if liver injury is suspected. Patients experiencing light-headedness, dizziness or vertigo should be cautioned about driving vehicles or operating heavy machinery. Clinical manifestations include headache, blurred vision, diplopia, and vision loss. Discontinue EMROSI immediately if symptoms occur. Symptoms may be manifested by fever, rash, arthralgia, and malaise. Discontinue EMROSI immediately if symptoms occur. Patients should minimize or avoid exposure to natural or artificial sunlight while using EMROSI. Tetracycline-class antibiotics are known to cause hyperpigmentation. EMROSI may induce hyperpigmentation in many organs, including nails, bone, skin, eyes, thyroid, visceral tissue, oral cavity, sclerae and heart valves. Because of the potential for drug-resistant bacteria to develop during the use of EMROSI, use EMROSI only as indicated. If superinfection occurs, discontinue EMROSI and institute appropriate therapy. Perform periodic laboratory evaluations of organ systems, including hematopoietic, renal and hepatic studies. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

For full prescribing information, please visit www.emrosi.com.

About Journey Medical Corporation
Journey Medical Corporation (Nasdaq: DERM) (“Journey Medical”) is a commercial-stage pharmaceutical company that primarily focuses on the selling and marketing of FDA-approved prescription pharmaceutical products for the treatment of dermatological conditions through its efficient sales and marketing model. The Company currently markets eight branded FDA-approved prescription drugs that help treat and heal common skin conditions. The Journey Medical team comprises industry experts with extensive experience in developing and commercializing some of dermatology’s most successful prescription brands. Journey Medical is located in Scottsdale, Arizona and was founded by Fortress Biotech, Inc. (Nasdaq: FBIO). Journey Medical’s common stock is registered under the Securities Exchange Act of 1934, as amended, and it files periodic reports with the U.S. Securities and Exchange Commission (“SEC”). For additional information about Journey Medical, visit www.journeymedicalcorp.com.

Forward-Looking Statements
This press release may contain “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. As used below and throughout this press release, the words “the Company”, “we”, “us” and “our” may refer to Journey Medical. Such statements include, but are not limited to, any statements relating to our growth strategy and product development programs and any other statements that are not historical facts. The words “anticipate,” “believe,” “continue.” “estimate,” “may,” “expect,” “will,” “could,” “project,” “intend,” “potential” and similar expressions are generally intended to identify forward-looking statements. Forward-looking statements are based on management’s current expectations and are subject to risks and uncertainties that could negatively affect our business, operating results, financial condition and stock price. Factors that could cause actual results to differ materially from those currently anticipated include: the fact that our products and product candidates are subject to time and cost intensive regulation and clinical testing and as a result, may never be successfully developed or commercialized; a substantial portion of our sales derive from products that may become subject to third-party generic competition, the introduction of new competitor products, or an increase in market share of existing competitor products, any of which could have a significant adverse impact on our operating income; we operate in a heavily regulated industry, and we cannot predict the impact that any future legislation or administrative or executive action may have on our operations; our revenue is dependent mainly upon sales of our dermatology products and any setback relating to the sale of such products could impair our operating results; competition could limit our products’ commercial opportunity and profitability, including competition from manufacturers of generic versions of our products; the risk that our products do not achieve broad market acceptance, including by government and third-party payors; our reliance third parties for several aspects of our operations; our dependence on our ability to identify, develop, and acquire or in-license products and integrate them into our operations, at which we may be unsuccessful; the dependence of the success of our business, including our ability to finance our company and generate additional revenue, on the successful commercialization of our recently approved product, Emrosi™, and any future product candidates that we may develop, in-license or acquire; clinical drug development is very expensive, time consuming, and uncertain and our clinical trials may fail to adequately demonstrate the safety and efficacy of our current or any future product candidates; our competitors could develop and commercialize products similar or identical to ours; risks related to the protection of our intellectual property and our potential inability to maintain sufficient patent protection for our technology and products; our business and operations would suffer in the event of computer system failures, cyber-attacks, or deficiencies in our or our third parties’ cybersecurity; the substantial doubt about our ability to continue as a going concern; the effects of major public health issues, epidemics or pandemics on our product revenues and any future clinical trials; our potential need to raise additional capital; Fortress controls a voting majority of our common stock, which could be detrimental to our other shareholders; as well as other risks described in Part I, Item 1A, “Risk Factors,” in our Annual Report on Form 10-K for the year ended December 31, 2024, subsequent Reports on Form 10-Q, and our other filings we make with the SEC. We expressly disclaim any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in our expectations or any changes in events, conditions or circumstances on which any such statement is based, except as may be required by law, and we claim the protection of the safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995.

Company Contact:
Jaclyn Jaffe
(781) 652-4500
ir@jmcderm.com

Media Relations Contact:
Tony Plohoros
6 Degrees
(908) 591-2839
tplohoros@6degreespr.com    

FAQ

What were the pooled Phase 3 IGA success rates for Emrosi (DFD-29) in 2025 (DERM)?

The pooled IGA success at week 16 was 62.7% for DFD-29, versus 39.0% for Oracea and 28.2% for placebo.

How much did Emrosi (DFD-29) reduce inflammatory lesions versus Oracea in the Phase 3 pooled analysis?

Mean inflammatory lesion change at week 16 was -19.2 for DFD-29 versus -14.8 for Oracea (P<0.001).

How many patients were included in the pooled DFD-29 Phase 3 analysis reported October 24, 2025?

A total of 653 subjects were randomized across the two Phase 3 trials (MVOR-1 and MVOR-2).

Did the Phase 3 trials report any serious safety issues for Emrosi (DFD-29)?

No major safety issues or serious adverse events related to the study drug were reported; TEAE incidence and severity were comparable across groups.

What was the study duration and randomization for the DFD-29 Phase 3 trials in 2025?

Subjects received once-daily treatment for 16 weeks and were randomized in a 3:3:2 ratio to DFD-29, Oracea, or placebo.