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FDA Approves Journey Medical's Emrosi™ for Rosacea Treatment

• The FDA has approved Emrosi™ (minocycline hydrochloride extended-release capsules, 40 mg) for treating inflammatory lesions of rosacea in adults. • Journey Medical anticipates launching Emrosi™ in late Q1 or early Q2 of 2025, expanding their dermatology-focused product portfolio. • Clinical data presented at the 44th Fall Clinical Dermatology Conference highlighted Emrosi's higher dermal concentration compared to doxycycline. • The approval marks a significant advancement in rosacea treatment, addressing a prevalent dermatological condition.

Journey Medical Corporation (Nasdaq: DERM) has received FDA approval for Emrosi™ (minocycline hydrochloride extended-release capsules, 40 mg) for the treatment of inflammatory lesions of rosacea in adults. The company announced the approval on November 4, 2024, marking a significant milestone in their focus on dermatological treatments.

Clinical Data and Formulation

Emrosi™ is a modified-release formulation of minocycline designed to provide higher dermal concentrations compared to traditional doxycycline treatments. Data presented at the 44th Fall Clinical Dermatology Conference demonstrated that DFD-29 (40 mg), the formulation now approved as Emrosi™, achieves higher dermal concentrations than doxycycline from Day 1 onward at a similar dose. This is expected to translate into a clinically meaningful impact for patients with rosacea.

Commercial Launch

Journey Medical anticipates launching Emrosi™ in late Q1 or early Q2 of 2025. The company plans to host a conference call on February 5, 2025, to discuss the U.S. commercial launch plan for Emrosi™.

Journey Medical's Portfolio

Journey Medical Corporation is a commercial-stage pharmaceutical company focused on selling and marketing FDA-approved prescription pharmaceutical products for dermatological conditions. The addition of Emrosi™ will further strengthen their portfolio in addressing common skin conditions.

Financial Highlights

In addition to the FDA approval, Journey Medical reported total revenues of $14.6 million for the third quarter ended September 30, 2024. The company's focus on strategic acquisitions and product development continues to drive growth in the dermatology space.
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Reference News

[1]
Journey Medical Corporation (DERM)
finance.yahoo.com · Feb 28, 2025

Journey Medical Corporation announced FDA approval of Emrosi™ for rosacea treatment, with a Q1/Q2 2025 launch. Q3 2024 r...

[4]
Journey Medical Corporation to Host Conference Call to Discuss U.S. Commercial Launch ...
biospace.com · Jan 23, 2025

Journey Medical Corporation announced a conference call on February 5, 2025, to update on Emrosi™'s commercial launch fo...

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