Journey Medical Corporation Announces Publication of Clinical Trial Results Assessing the Impact of Emrosi™ (DFD-29) on Microbial Flora of Healthy Adults in the Journal of Drugs in Dermatology

Rhea-AI Summary

Journey Medical (Nasdaq: DERM) reported publication (Dec 10, 2025) of Phase 1 results for Emrosi (DFD-29) in the Journal of Drugs in Dermatology.

The multicenter, randomized, double-blind study enrolled 60 healthy adults (2:1 DFD-29:placebo), dosing once daily for 16 weeks. The trial met all three primary microbiological endpoints: no significant change in skin, GI, or vaginal microbiota; no detectable minocycline resistance; and no emergence of opportunistic organisms. No significant safety issues were reported. Emrosi (40 mg minocycline modified-release: 10 mg immediate + 30 mg extended) is FDA-approved in the U.S. for inflammatory rosacea lesions in adults.

Positive

• Phase 1 trial met all three primary microbiological endpoints
• No detectable microbiome changes after 16 weeks
• No development of minocycline antibiotic resistance observed
• Well tolerated; no significant safety issues in 60 adults

Negative

• None.

Key Figures

Treatment duration 16 weeks DFD-29 administration period in Phase 1 trial

Emrosi dose 40 mg Minocycline Hydrochloride Modified-Release daily oral dose

Immediate release dose 10 mg Immediate release component of Emrosi capsule

Extended release dose 30 mg Extended release component of Emrosi capsule

Subjects enrolled 60 healthy adults Total enrollment in DFD-29-CD-006 Phase 1 trial

Male subjects 30 males Gender breakdown in Phase 1 trial

Female subjects 30 females Gender breakdown in Phase 1 trial

Randomization ratio 2:1 DFD-29 vs placebo allocation in Phase 1 study

Market Reality Check

$7.70 Last Close

Volume Volume 219,437 is 1.06x the 20-day average of 206,605, indicating typical trading interest ahead of this update. normal

Technical Price at $8.13 is above the 200-day MA of $7.08 and sits 13.51% below the 52-week high of $9.40.

Peers on Argus

DERM declined 0.85% while peers were mixed: CTOR up 13.73%, IRWD up 4.03%, BIOA up 2.73%, and SXTC and OGI down. Moves do not indicate a unified sector trend.

Historical Context

Date	Event	Sentiment	Move	Catalyst
Nov 12	Q3 2025 earnings	Positive	+0.3%	Reported revenue growth, Emrosi launch contribution and narrowed net loss.
Nov 05	Earnings preview	Neutral	-1.8%	Announcement of Q3 2025 results date and conference call logistics.
Oct 08	Investor conferences	Neutral	-0.4%	Participation in two October 2025 investor conferences in New York.
Sep 03	Investor conferences	Neutral	-2.4%	Plans to attend September 2025 investor conferences with meetings and talks.
Aug 18	Investor presentation	Neutral	+0.7%	Upcoming Emerging Growth Conference presentation and corporate overview.

Pattern Detected

Recent earnings and conference headlines have generally produced modest price moves, with no strong pattern of large reactions to news.

Recent Company History

Over the last few months, Journey Medical has focused on investor outreach and the commercial ramp of Emrosi. Q3 2025 results on Nov 12 showed higher revenues and narrowed losses, with a small positive price reaction. Multiple conference participations in August–October 2025 drew only minor share price changes. Against this backdrop, publication of Phase 1 microbiome safety data adds clinical support for Emrosi’s profile rather than marking a major strategic shift.

Market Pulse Summary

This announcement adds supportive Phase 1 data showing Emrosi (DFD-29) met all three primary microbiological objectives over 16 weeks in 60 healthy adults, with no significant safety issues or detectable microbiome disruption. Combined with previously published Phase 3 efficacy results and existing FDA approval for rosacea, it strengthens the drug’s long-term safety narrative. Investors may watch future prescriptions, additional safety follow-up, and upcoming financial reports to assess Emrosi’s commercial and clinical durability.

Key Terms

randomized medical

"is a multicenter, randomized, double-blind, placebo-controlled, parallel group study"

Randomized means participants or units in a study are assigned to different groups by chance rather than by choice, like flipping a coin to decide who gets a new treatment and who gets a comparison. For investors, randomized designs matter because they reduce bias and make results more trustworthy, so outcomes from randomized studies carry more weight when assessing regulatory approval, commercial prospects, and the risk that trial results will change a company’s valuation.

double-blind medical

"multicenter, randomized, double-blind, placebo-controlled, parallel group study"

A double-blind process means that neither the people conducting an activity nor the people involved know certain key details, such as who is receiving a treatment or a placebo. This approach helps prevent bias from influencing the results, making the outcome more trustworthy. For investors, it ensures that decisions or judgments are based on unbiased information rather than preconceived opinions or expectations.

placebo-controlled medical

"randomized, double-blind, placebo-controlled, parallel group study that enrolled"

"Placebo-controlled" describes a testing method where one group receives the actual treatment or intervention, while another group receives a harmless, inactive version called a placebo. This approach helps determine whether the real treatment has genuine effects beyond psychological expectations. For investors, understanding this ensures confidence that reported benefits are real and not influenced by bias or false perceptions.

ClinicalTrials.gov regulatory

"Additional information... can be found on ClinicalTrials.gov using the identifier"

clinicaltrials.gov is a publicly accessible U.S. government database that lists details, timelines and status updates for medical studies testing drugs, devices or procedures. For investors it acts like a public calendar and scoreboard—showing when trials start, are delayed, or report results—so it helps gauge a company’s development progress, regulatory risk and potential value impact before official earnings or approvals are announced.

AI-generated analysis. Not financial advice.

Clinical trial achieved all three primary objectives with no significant safety issues being reported

Results indicate that Emrosi can be safely used for up to 16 weeks with no detectable impact on skin, GI tract or vaginal microbiota

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

SCOTTSDALE, Ariz., Dec. 10, 2025 (GLOBE NEWSWIRE) -- Journey Medical Corporation (Nasdaq: DERM) (“Journey Medical”), 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 announced that results from the Phase 1 clinical trial (DFD-29-CD-006) assessing the impact of low-dose oral minocycline (“DFD-29” or commercially known as “Emrosi™) on skin, gastrointestinal (“GI”) and vaginal microflora in healthy adults were published in the Journal of Drugs in Dermatology, a leading peer-reviewed publication in clinical dermatology. The clinical trial also assessed the safety and tolerability of the treatment. The results indicate that DFD-29 administration for 16 weeks had no detectable effects on skin, GI tract or vaginal microflora and it was well tolerated in healthy adults, supporting its use as a therapeutic option for patients with moderate-to-severe rosacea.

“We are very pleased to see these important data published in the Journal of Drugs in Dermatology,” said Claude Maraoui, Co-Founder, President and Chief Executive Officer of Journey Medical. “This peer-reviewed validation reinforces the differentiated profile of Emrosi as an effective, low-dose oral treatment for rosacea that does not meaningfully disrupt the normal microbiota or contribute to antibiotic resistance. These results, along with the robust safety and efficacy data seen throughout all of our clinical trials, further support Emrosi’s potential for long-term use and underscore our commitment to bringing safe, innovative dermatology treatments to patients.”

DFD-29-CD-006 is a multicenter, randomized, double-blind, placebo-controlled, parallel group study that enrolled 60 healthy, adult subjects (30 males and 30 females) in a 2:1 randomization between DFD-29 and placebo. Treatment was administered once daily orally over 16 weeks. Microbiological samples were collected from the skin (forehead), stool and vagina at multiple timepoints through the study. The study achieved all primary microbiological endpoints:

1. No significant change in the normal microbiome of the skin, vagina, or gastrointestinal tract.
2. No noticeable development of antibiotic resistance to minocycline.
3. No significant emergence of opportunistic organisms compared to treatment with placebo.

There were no significant safety issues noted during the study. Additional information on the DFD-29 Phase 1 clinical trial can be found on ClinicalTrials.gov using the identifier NCT05597462.

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 did Journey Medical (DERM) announce on December 10, 2025 about Emrosi?

Publication of Phase 1 results showing no microbiome disruption, no resistance, and good tolerability over 16 weeks.

How many subjects and what duration was the DFD-29 Phase 1 study (NCT05597462)?

The study enrolled 60 healthy adults in a 2:1 randomization and dosed once daily for 16 weeks.

Did the Emrosi (DFD-29) trial show antibiotic resistance development?

No; the trial reported no noticeable development of minocycline resistance compared with placebo.

What microbiological sites were tested in the DFD-29 study for DERM's Emrosi?

Microbiological sampling was performed on the skin (forehead), stool, and vaginal specimens at multiple timepoints.

Is Emrosi approved and what is its formulation and indication?

Emrosi is FDA-approved in the U.S. as 40 mg minocycline modified-release (10 mg immediate + 30 mg extended) for inflammatory rosacea lesions in adults.