Journey Medical, a subsidiary of Fortress Biotech, reported that the Phase 1 clinical trial of its low‑dose, modified‑release rosacea drug Emrosi (DFD‑29) has been completed and the results were published in the Journal of Drugs in Dermatology. The 60‑patient study found that 16 weeks of oral minocycline had no detectable impact on skin, gastrointestinal, or vaginal microbiota and was well tolerated, with no significant safety issues.
The safety profile reinforces Emrosi’s differentiated positioning. The drug received FDA approval in November 2024 for inflammatory rosacea lesions and has already achieved broad payer coverage—expanding from 54 million commercial lives in May to over 100 million in July. In Q3 2025, Emrosi contributed $4.9 million to Journey Medical’s net product revenues, with prescriptions up 146% sequentially, underscoring strong commercial traction.
Fortress Biotech’s Q3 2025 financials reflected the momentum from its dermatology portfolio. Total revenue rose to $17.6 million, a 20.5% year‑over‑year increase driven by $17.0 million in marketed dermatology products. Net income reached $3.7 million ($0.13 per share), a turnaround from a $15.0 million loss in Q3 2024, and the company expects to become sustainably EBITDA‑positive in Q4 2025.
Management emphasized the significance of the data. Journey Medical CEO Claude Maraoui said, “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.” Fortress Biotech’s leadership highlighted the broader pipeline and the company’s strategy to leverage its diversified model to generate long‑term value.
The global rosacea market was valued at $2.08 billion in 2024 and is projected to grow at a 7.1% CAGR through 2030. Emrosi is expected to reach peak annual net sales of over $200 million in the U.S. and $300 million worldwide, positioning Fortress as a key player in a market dominated by antibiotics.
The Phase 1 data support payer coverage decisions and may accelerate Emrosi’s U.S. launch. Combined with the company’s improving financials and expanding payer base, the results signal a strengthening commercial outlook for Fortress Biotech’s dermatology segment and reinforce confidence in its pipeline strategy.
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