Isotretinoin

Journey Medical's Emrosi, a new minocycline hydrochloride capsule, has received FDA approval for treating rosacea's inflammatory lesions in adults. Despite concerns over the lack of a redness reduction claim and competition from generic Oracea, Journey's CEO Claude Maraoui anticipates Emrosi's strong market position and potential $300 million annual sales, with a launch planned for Q1-Q2 2025.

FDA approves Journey Medical's Emrosi, a 40mg minocycline hydrochloride extended-release capsule, for rosacea treatment. Developed with Dr Reddy's Laboratories, Emrosi met all co-primary and secondary endpoints in Phase III trials, outperforming placebo and Galderma's Oracea. Journey Medical aims to establish Emrosi as a new standard of care, with initial US market supply expected in H1 2025. This move challenges Galderma's dominance in the rosacea market, as highlighted by GlobalData's 2022 report.

Pseudo acne fulminans is a rare dermatological condition arising during isotretinoin treatment, particularly in severe inflammatory acne patients. It is characterized by sudden nodule and ulcerative lesions, typically occurring in teenaged boys and men within the first month of treatment. Miranti presented two cases highlighting the importance of careful monitoring, dosage adjustments, and proactive scar management. Prevention involves starting high-risk patients on low isotretinoin doses combined with prednisone, and post-treatment includes topical retinoids and advanced scar treatments.

Lake Street Capital Markets initiated coverage on Journey Medical Corp. with a Buy rating and a $9.00 price target, highlighting DFD-29's potential. The analyst anticipates DFD-29 will dominate its category and turn AEBITDA positive in 2025. Journey Medical reported Q2 net product revenue of $14.9 million, exceeding expectations, and DFD-29's PDUFA date is set for November 4, 2024. The company plans to discontinue Amino and reduce sales territories, aiming for portfolio expansion.