Journey Medical Corporation Announces Emrosi™ Data Analysis to be Presented at the Society of Dermatology Physician Associates (SDPA) 2025 Annual Summer Dermatology Conference

Rhea-AI Summary

Journey Medical Corporation announced new data analysis from Phase 3 trials of Emrosi (DFD-29) for treating moderate-to-severe papulopustular rosacea will be presented at SDPA 2025. The analysis showed Emrosi's efficacy is independent of patient body weight, based on two trials (MVOR-1 and MVOR-2) with 653 total participants. The drug demonstrated superior efficacy compared to both placebo and doxycycline, with success rates up to 75.5% in IGA treatment outcomes. As the lowest FDA-approved oral minocycline dose that doesn't require weight-based adjustments, Emrosi showed significant improvements in inflammatory lesion counts across all weight categories while maintaining a favorable safety profile.

Insights

Pharmaceutical Industry Analyst

Emrosi's body weight-independent efficacy strengthens Journey Medical's competitive position in the $1B+ rosacea market.

Journey Medical's Emrosi (minocycline HCl) demonstrated a significant clinical advantage over both placebo and doxycycline in treating moderate-to-severe papulopustular rosacea, regardless of patient body weight. This is a meaningful differentiator in the prescription rosacea market.

The Phase 3 data showed Emrosi achieved 56-76% treatment success versus 28-35% for placebo and 28-51% for doxycycline across both weight categories. The reduction in inflammatory lesion count was also superior with Emrosi, showing ~17-22 lesion reduction compared to ~11-13 for placebo and ~14-15 for doxycycline.

The body weight independence is particularly valuable because it:

• Eliminates dosing calculation errors
• Simplifies prescription decisions for physicians
• Reduces potential barriers to adoption
• Positions the drug competitively against weight-dependent alternatives

As the lowest oral dose of minocycline approved by the FDA with weight-independent dosing, Emrosi has potential to capture significant market share in the rosacea treatment landscape, estimated at over $1 billion annually. The favorable safety profile mentioned, combined with superior efficacy to the current standard of care (doxycycline), positions Emrosi to potentially become a first-line therapy for moderate-to-severe rosacea.

Journey Medical's commercial strategy of making Emrosi available through specialty pharmacy chains aligns with distribution patterns for similar dermatological medications, ensuring appropriate market access for this newly approved treatment.

Emrosi™ (DFD-29; 40 mg Minocycline Hydrochloride Modified-Release Capsules, 10 mg immediate release and 30 mg extended release) demonstrated efficacy independent of body weight differences when treating rosacea

SCOTTSDALE, Ariz., June 20, 2025 (GLOBE NEWSWIRE) -- Journey Medical Corporation (Nasdaq: DERM) (“Journey Medical” or “the Company”, “we”, or “our”), a commercial-stage pharmaceutical company that primarily focuses on selling and marketing U.S. Food and Drug Administration (“FDA”) approved prescription pharmaceutical products for the treatment of dermatological conditions, today announced that a data analysis from two Phase 3 multicenter clinical trials, evaluating Emrosi™ for the treatment of moderate-to-severe papulopustular rosacea in adults will be presented at the Society of Dermatology Physician Associates (SDPA) 2025 Summer Dermatology Conference taking place June 25-29 in Washington, DC. The analysis determined that differences in body weight did not affect the efficacy of Emrosi in the two Phase 3 trials, which supported its November 2024 FDA approval.

“This analysis demonstrated that Emrosi is body weight independent, which means it can be prescribed without regard to the patient's body weight. This is an important attribute, as it avoids the potential for errors in dose calculations,” said Julie Harper, MD, past president of the American Acne & Rosacea society (AARS) and Owner of the Dermatology and Skin Care Center of Birmingham, AL. “If doses were to be calculated based on body weight, the wide range of body weights in the real world would pose a challenge.”

Subjects in the double-blind, placebo-controlled Minocycline Versus Oracea^® in Rosacea-1 (“MVOR-1”) and Minocycline Versus Oracea in Rosacea-2 (“MVOR-2”) Phase 3 clinical trials were randomized in a 3:3:2 ratio to treatment with Emrosi, doxycycline 40 mg, or placebo once daily for 16 weeks. The coprimary efficacy endpoints were: 1) the proportion of participants demonstrating Investigator’s Global Assessment (“IGA”) treatment success with Emrosi vs. placebo; and 2) reductions in total inflammatory lesion counts with Emrosi vs. placebo. Comparisons between Emrosi and doxycycline were secondary endpoints. Sub-group analyses were conducted in patients with body weight less than or equal to the median body weight (≤MBW) and in patients with body weight greater than the median body weight (>MBW).

Of the 653 participants enrolled, 323 were randomized in MVOR-1 (including 246 [76.5%] women) and 330 were randomized in MVOR-2 (including 249 [75.5%] women). The median body weight at baseline was 83.5 kg in MVOR-1 and 83.0 kg in MVOR-2.

Table 1: Efficacy Results from the Subgroup Analysis based on Body Weight of Participants

Endpoint	Baseline Body Weight	MVOR-1 (N=323)						MVOR-2 (N=330)
		Emrosi (n=122)		Doxycycline (n=121)		Placebo (n=80)		Emrosi (n=123)		Doxycycline (n=125)		Placebo (n=82)
Proportion of Subjects with IGA Treatment Success at Week 16	≤ Median	75.5%		51.0%		28.2%		58.2%		28.1%		29.7%
	> Median	56.3%		46.9%		35.3%		65.0%		33.9%		22.6%
Change from Baseline in Total Inflammatory Lesion Count at Week 16	≤ Median	-20.4 (10.7)		-15.0 (7.3)		-11.7 (10.0)		-17.7 (8.7)		-14.5 (10.7)		-12.0 (8.8)
	> Median	-22.1 (11.7)		-14.7 (10.6)		-12.5 (8.5)		-17.1 (7.8)		-14.9 (10.1)		-10.7 (11.1)

Emrosi showed superior efficacy on both co-primary endpoints, in both the body weight categories, compared to placebo and doxycycline. Emrosi was generally well tolerated, with no notable between-group differences in the frequency or severity of reported adverse events.

“These compelling Phase 3 results reinforce the potential of Emrosi to become a new standard of care for patients with rosacea. Emrosi is the lowest oral dose of minocycline approved by the FDA that is a body weight–independent formulation, enabling physicians to prescribe confidently without the need for dose adjustments,” said Claude Maraoui, Co-Founder, President, and CEO of Journey Medical Corporation. “Demonstrating statistically significant and clinically meaningful improvements over both placebo and the current standard of care, regardless of body weight, Emrosi represents a major step forward in managing this chronic and often frustrating skin condition. We are proud to bring forward this FDA-approved treatment that offers patients faster, more effective treatment with a favorable safety profile.”

Emrosi is available by prescription at specialty pharmacy chains.

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 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,” “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^TM, 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 are the key findings from Journey Medical's Emrosi Phase 3 trials for rosacea treatment?

The Phase 3 trials showed Emrosi's efficacy is independent of body weight, with success rates up to 75.5% in IGA treatment outcomes and superior results compared to both placebo and doxycycline in treating moderate-to-severe papulopustular rosacea.

How does Emrosi (DERM) differ from other rosacea treatments?

Emrosi is the lowest FDA-approved oral minocycline dose that doesn't require weight-based adjustments, making it easier for physicians to prescribe without calculating doses based on patient weight.

What were the main endpoints in Journey Medical's MVOR-1 and MVOR-2 trials?

The trials' coprimary endpoints were the proportion of participants showing Investigator's Global Assessment treatment success and reductions in total inflammatory lesion counts, comparing Emrosi versus placebo.

How many participants were involved in Journey Medical's Emrosi clinical trials?

The Phase 3 trials included 653 total participants, with 323 randomized in MVOR-1 (76.5% women) and 330 in MVOR-2 (75.5% women).

When will Journey Medical present the Emrosi data analysis?

The data analysis will be presented at the Society of Dermatology Physician Associates (SDPA) 2025 Summer Dermatology Conference, taking place June 25-29 in Washington, DC.