Fortress Biotech

Mustang Bio receives FDA Orphan Drug Designation for MB-108, an HSV-1 oncolytic virus for malignant glioma. Preclinical data supports combining MB-108 with MB-101 CAR-T cell therapy to treat recurrent glioblastoma, with ongoing Phase 1 trials showing MB-108 is active and well-tolerated.

Mustang Bio receives FDA Orphan Drug Designation for MB-108 (HSV-1 oncolytic virus) for malignant glioma treatment. MB-108 is active and well-tolerated in recurrent glioblastoma patients in ongoing Phase 1 trials. Preclinical data support combining MB-108 with MB-101 (IL13Rα2‐targeted CAR-T cell therapy) to potentially optimize clinical results.

DelveInsight's 'Rosacea Pipeline Insight, 2024' report highlights 25+ key companies developing 25+ pipeline drugs for Rosacea, with therapies in various stages of clinical development. Key companies include Sol-Gel Technologies, Maruho Co., Ltd., AOBiome LLC, and others. Emerging therapies like Epsolay, M 1220, and BMX-010 are expected to impact the market. Regulatory approvals and collaborations are noted, such as Sol-Gel Technologies' agreement with Searchlight Pharma Inc. and Zydus Lifesciences' FDA approval for Metronidazole Topical cream.

Journey Medical announced FDA approval of Emrosi™ for rosacea treatment, highlighting its potential as a best-in-class oral medication. Supported by positive Phase 3 trial results, Emrosi showed superiority over current treatments. Journey Medical plans a U.S. launch in 2025, aiming to establish Emrosi as a new standard of care for rosacea.

Journey Medical announces FDA approval of Emrosi™ (Minocycline Hydrochloride Extended Release Capsules, 40 mg) for treating rosacea in adults, developed with Dr. Reddy's Laboratories Ltd. Emrosi demonstrated superiority over standard-of-care and placebo in Phase 3 trials, with initial U.S. market supply expected in Q1 or Q2 2025.

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 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 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.