Journey Medical (NASDAQ:DERM) shares are trading higher Monday after the company announced the U.S. Food and Drug Administration approved its Emrosi drug for the treatment of rosacea.

What Happened: The FDA has approved Journey Medical’s Emrosi, formerly known as DFD-29, for the treatment of inflammatory lesions of rosacea in adults. 

The approval was supported by positive data from the company’s two Phase 3 clinical trials, which met all co-primary and secondary endpoints. Journey Medical said Emrosi demonstrated statistically significant superiority over both the current standard-of-care treatment, Oracea, and placebo.

Journey Medical announced that it’s in the process of completing the manufacturing of Emrosi for the U.S. market. The company expects initial supply of the drug to be available late in the first quarter or early in the second quarter of 2025.

“With approval from the FDA, Journey Medical is proud to deliver Emrosi, a unique treatment option for the millions of patients in the U.S. suffering from rosacea,” said Claude Maraoui, co-founder, president and CEO of Journey Medical.

“Rosacea is a difficult to treat skin condition and based on the favorable results from our Phase 3 clinical trials, Emrosi has potential to become the best-in-class oral medication to treat the condition. Our seasoned dermatology-focused sales force is now preparing for a successful launch and to establish Emrosi as a new standard of care in the treatment of rosacea.”

Journey Medical said it intends to commercialize Emrosi in the U.S. with its dermatology-focused commercial organization. The company aims to execute a launch strategy to help push Emrosi toward becoming the new oral standard of care for adult rosacea patients.

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DERM Price Action: Journey Medical shares were up 3.40% at $6.38 at the time of publication, according to Benzinga Pro.

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