Fortress Biotech’s Majority-Controlled Subsidiary, Journey Medical Corporation, Receives FDA Approval for Emrosi™ for Rosacea Treatment

Fortress Biotech, Inc. (NASDAQ: FBIO) announced through its majority-controlled subsidiary, Journey Medical Corporation, that the U.S. Food and Drug Administration (FDA) has approved Emrosi™ (Minocycline Hydrochloride Extended Release Capsules, 40mg) for treating inflammatory lesions of rosacea in adults.

Developed by Journey Medical in collaboration with Dr. Reddy’s Laboratories, Ltd., Emrosi (also known as DFD-29) is currently under manufacturing for the U.S. market. Initial supply is expected to be accessible in either late Q1 or early Q2 of 2025. Journey Medical plans to market Emrosi in the United States with its specialized dermatology-focused commercial unit.

The approval of Emrosi follows positive results from Journey Medical’s Phase 3 clinical trials for rosacea treatment. The trials successfully met primary and secondary endpoints, demonstrating Emrosi’s statistical superiority over existing treatments such as Oracea® 40mg capsules and a placebo in terms of Investigator’s Global Assessment treatment success.

Fortress Biotech provided a cautionary note regarding forward-looking statements, underscoring the unpredictable nature of regulatory approvals, product development programs, and other contingencies that could impact actual results.

Given the uncertainties involved, Fortress Biotech emphasized its commitment to shareholder value, navigating growth strategies, and adhering to necessary regulatory standards. The company disclaimed any obligation to update forward-looking statements, highlighting an awareness of potential fluctuations in expectations.

Fortress Biotech remains dedicated to advancing innovative treatments in the medical field, with Emrosi’s approval marking a significant milestone in the company’s pursuit of effective therapies.

No further information was disclosed in the report regarding financial details or subsequent developments related to this specific approval.

This article was generated by an automated content engine and was reviewed by a human editor prior to publication. For additional information, read Fortress Biotech’s 8K filing here.

Fortress Biotech Company Profile

Fortress Biotech, Inc, a biopharmaceutical company, develops dermatology, pharmaceutical, and biotechnology products in the United States. The company markets dermatology products, such as Qbrexza a medicated cloth towelette for the treatment of primary axillary hyperhidrosis; Accutane capsules for severe recalcitrant nodular acne; Amzeeq for severe acne vulgaris; Zilxi, a topical foam; Exelderm cream and solution for topical use; Targadox an oral doxycycline drug for adjunctive therapy for severe acne; Luxamend; sulconazole nitrate cream and solution for tinea cruris and tinea corporis; and doxycycline hyclate tablet.