Sol-Gel and Mayne Pharma Announce $16 Million Deal for EPSOLAY and TWYNEO Rights in the U.S.
• Sol-Gel Technologies has entered into a $16 million agreement with Mayne Pharma for the sale and exclusive license of U.S. rights to dermatology products EPSOLAY and TWYNEO, extending the company's cash runway into Q1 2027.
• The transaction allows Sol-Gel to focus resources on its promising SGT-610 program for Gorlin syndrome, which has completed 80% patient recruitment for Phase III trials with top-line results expected in Q4 2026.
• Based on recent market research, Sol-Gel estimates SGT-610's U.S. market potential between $400-500 million annually as the first potential preventative treatment for basal cell carcinomas in Gorlin syndrome patients.
Androgenetic Alopecia Pipeline Shows Promise with Over 100 Therapies in Development
• DelveInsight's latest report reveals a robust pipeline for androgenetic alopecia with 80+ companies developing 100+ therapeutic candidates across various clinical stages.
• Key emerging treatments include KX-826 from Kintor Pharma and Clascoterone from Cassiopea, which could significantly expand options beyond the current FDA-approved minoxidil and finasteride.
• Recent clinical trial results from companies like Veradermics, Chong Kun Dang, and Pelage Pharmaceuticals demonstrate increasing R&D investment in addressing this common condition affecting up to 50% of both men and women.
Rosacea Therapeutics Pipeline Shows Promise with Emerging Therapies
• Over 25 companies are developing novel rosacea treatments, indicating a robust pipeline.
• Key emerging therapies like Epsolay, M 1220, and BMX-010 are expected to significantly impact the rosacea market.
• Sol-Gel Technologies and Maruho Co., Ltd. are among the leading companies in developing advanced-stage rosacea drugs.
• Recent regulatory approvals, such as Zydus Lifesciences' metronidazole topical cream, offer new treatment options.
FDA Approves Emrosi (Minocycline Hydrochloride) for Rosacea Treatment in Adults
• The FDA has approved Emrosi (minocycline hydrochloride) as a 40mg extended-release capsule for treating inflammatory lesions of rosacea in adults.
• Emrosi demonstrated statistically significant superiority over Oracea and placebo in Phase 3 trials, showing success in Investigator’s Global Assessment and lesion reduction.
• Journey Medical anticipates launching Emrosi in early 2025, positioning it as a potential best-in-class oral medication for rosacea with a favorable safety profile.
• Emrosi's extended-release formulation delivers minocycline steadily, mitigating drug level fluctuations and improving tolerability for patients with rosacea.
Sol-Gel Technologies Receives Nasdaq Extension to Regain Compliance
• Sol-Gel Technologies received a 180-day extension from Nasdaq to regain compliance with the minimum bid price rule, now until May 19, 2025.
• The extension was granted based on Sol-Gel meeting other Nasdaq listing requirements and its plan to rectify the bid price deficiency.
• Sol-Gel may implement a reverse stock split, if necessary, to meet the minimum bid price of $1.00 per share for at least ten consecutive business days.
• Sol-Gel is focused on developing and commercializing treatments for skin diseases, including SGT-610 for Gorlin syndrome.
Sol-Gel Technologies Advances SGT-610 for Gorlin Syndrome and SGT-210 for Darier Disease
• Sol-Gel's Phase 3 clinical trial of SGT-610 for Gorlin Syndrome is actively enrolling patients across 40 clinical sites, with topline results expected in H2 2026.
• A proof-of-concept study for SGT-210 in Darier disease is ongoing, with plans to file a Phase 2 IND in Q2 2025, targeting a market with significant unmet needs.
• Sol-Gel shareholders approved Mori Arkin as interim CEO, effective January 1, 2025, succeeding founder Dr. Alon Seri-Levy, who will remain as a consultant.
• The company reported Q3 2024 revenues of $5.4 million, primarily from licensing agreements, and anticipates its cash resources will fund operations into Q1 2026.
Rosacea Therapeutics: Emerging Therapies and Market Outlook
• Over 25 companies are actively involved in developing novel rosacea treatments, indicating a robust pipeline.
• Key emerging therapies like Epsolay, M 1220, and BMX-010 are expected to significantly impact the rosacea market in the coming years.
• Sol-Gel Technologies and Maruho Co., Ltd. are among the leading companies in advancing rosacea drug candidates through clinical development.
• Recent regulatory approvals, such as Zydus Lifesciences' metronidazole topical cream, provide additional treatment options for rosacea patients.
Rosacea Pipeline Analysis 2024: Insights into Therapeutics Development
The 2024 Rosacea Pipeline Analysis report by DelveInsight highlights the ongoing clinical development activities and growth prospects in the Rosacea Therapeutics Market. It details the involvement of over 25 key pharma and biotech companies, including Sol-Gel Technologies, in developing more than 25 pipeline drugs. The report covers various stages of clinical development, mechanisms of action, and molecule types, offering a comprehensive overview of the current and future landscape of Rosacea treatment.
FDA Approves Epsolay for Inflammatory Lesions of Rosacea
• The FDA has approved Epsolay, a 5% encapsulated benzoyl peroxide cream, for treating inflammatory lesions of rosacea in adults.
• Clinical trials showed Epsolay reduced inflammatory lesions by nearly 70% after 12 weeks, compared to 38-46% with the vehicle cream.
• Almost 50% of patients achieved an IGA score of 0/1 at 12 weeks, indicating clear or almost clear skin, compared to placebo.
• Epsolay utilizes microencapsulation technology to slowly release benzoyl peroxide, potentially reducing skin irritation.
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