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SCOTTSDALE, Ariz. - Journey Medical Corporation (NASDAQ:DERM), a commercial-stage pharmaceutical company valued at $106 million, announced the publication of positive results from two Phase 3 clinical trials for Emrosi™ (DFD-29), a treatment for moderate-to-severe papulopustular rosacea in adults. According to InvestingPro analysis, the company currently appears overvalued based on its Fair Value metrics, though it maintains a FAIR overall financial health score. The trials, published in the Journal of the American Medical Association - Dermatology, showed that Emrosi™ met all primary and secondary endpoints, demonstrating statistical superiority over both Oracea® (doxycycline) capsules and placebo.
The U.S. Food and Drug Administration (FDA) approved Emrosi™ in November 2024, with a market launch expected in early spring of 2025. This approval comes as the company faces revenue challenges, with InvestingPro data showing a 27.69% decline in revenue over the last twelve months. Emrosi™, also known as DFD-29, is a 40 mg Minocycline Hydrochloride Modified-Release Capsule, combining 10 mg immediate release and 30 mg extended release, administered once daily for 16 weeks.
In the Minocycline Versus Oracea® in Rosacea-1 (MVOR-1) and Minocycline Versus Oracea in Rosacea-2 (MVOR-2) trials, subjects were randomized to receive DFD-29, Oracea, or placebo. The co-primary endpoints were the proportion of subjects achieving Investigator’s Global Assessment (IGA) treatment success and the reduction in total inflammatory lesion count from baseline to Week 16. Secondary endpoints included the reduction in Clinician’s Erythema Assessment (CEA) score.
Results from MVOR-1 showed 65.0% IGA success in the DFD-29 group compared to 46.1% in the Oracea group and 31.2% in the placebo group. The DFD-29 group also exhibited a mean reduction of 21.3 lesions, significantly greater than both Oracea and placebo. MVOR-2 results were consistent, with 60.1% IGA success for DFD-29, and a mean lesion reduction of 18.0.
No significant safety issues were reported, with the number and severity of treatment emergent adverse events (TEAEs) similar across treatment groups. The most common adverse reaction was dyspepsia, and the medication should not be taken by patients with a history of hypersensitivity to tetracyclines.
Rosacea is estimated to affect over 16 million Americans and 415 million people worldwide, often impacting self-confidence and social interactions. Journey Medical Corporation, founded by Fortress Biotech, Inc. (NASDAQ:FBIO), focuses on marketing FDA-approved prescription pharmaceutical products for dermatological conditions. Despite recent market volatility showing a 9.38% decline over the past week, the stock has demonstrated strong momentum with a 36.06% return over the past year. Analysts maintain a positive outlook, with price targets ranging from $9 to $11. Get deeper insights and access to comprehensive financial analysis through InvestingPro, which offers exclusive ProTips and detailed research reports for over 1,400 US stocks.
This article is based on a press release statement from Journey Medical Corporation.
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