Journey Medical

Journey Medical Corporation announces FDA approval of Emrosi™ (Minocycline Hydrochloride Extended Release Capsules, 40 mg) for treating rosacea in adults, developed in collaboration with Dr. Reddy's Laboratories Ltd. Emrosi demonstrated superiority over standard-of-care treatment and placebo in Phase 3 trials, with no significant safety issues. Initial supply expected in Q1-Q2 2025, with a planned commercial launch in the U.S.

Journey Medical Corporation announced FDA approval of Emrosi™, a 40 mg Minocycline Hydrochloride Extended Release Capsule, for treating rosacea's inflammatory lesions in adults. Developed with Dr. Reddy’s Laboratories, Emrosi showed superiority over current treatments in Phase 3 trials, aiming for a 2025 U.S. market launch.

FDA to decide on Journey's rosacea drug DFD-29, Merus' bispecific antibody for NSCLC and PDAC, PTC's gene therapy Upstaza for AADC deficiency, and Autolus' CAR T therapy obe-cel for ALL by November 4, 6, 13, and 16 respectively.

FDA approves Emrosi (minocycline hydrochloride) for rosacea treatment in adults, developed by Journey Medical in collaboration with Dr. Reddy’s Laboratories. Emrosi demonstrated superiority over standard-of-care and placebo in Phase 3 trials, with initial U.S. supply expected in Q1-Q2 2025.

Journey Medical Corporation reported Q2 2024 revenues of $14.9M, a 14% increase from Q1 2024. The FDA is reviewing DFD-29 for rosacea, with a PDUFA date of November 4, 2024. The company reduced its net loss to $3.4M from $8.4M in Q2 2023 and achieved positive Adjusted EBITDA of $0.3M. Key appointments include Joseph M. Benesch as CFO and Michael C. Pearce to the Board.

Journey Medical (DERM) received FDA approval for Emrosi, developed with Dr. Reddy’s Laboratories (RDY), to treat rosacea's inflammatory lesions in adults. Supported by two Phase 3 trials, Emrosi outperformed Oracea(R) and placebo in efficacy and safety over 16 weeks.

Journey Medical's DERM shares rose after FDA approved Emrosi for rosacea treatment, supported by positive Phase 3 trial results. Emrosi outperformed Oracea and placebo, with U.S. market availability expected by early 2025. The company plans a dermatology-focused launch to establish Emrosi as a new standard of care.

Journey Medical Corporation announced FDA approval for Emrosi™, a treatment for rosacea's inflammatory lesions in adults, developed with Dr. Reddy’s Laboratories. Emrosi showed superiority in Phase 3 trials over current treatments, with no significant safety issues. Journey Medical plans a U.S. launch in 2025, aiming to establish Emrosi as a new standard of care.

DFD-29, a modified-release formulation by Journey Medical, shows higher dermal concentration than doxycycline, potentially impacting rosacea treatment. Rosacea affects millions, impacting self-esteem and social interactions. Journey Medical markets dermatological treatments, focusing on FDA-approved products.