相关临床试验
15
0 进行中
药物批准
0
批准总数
监管机构
0
监管机构数
成立时间
N/A
已完成
11
73.3%
终止
4
26.7%
暂无批准数据
- Sol-Gel Technologies received a Notice of Allowance for a method-of-use patent extending intellectual property protection for topical patidegib (SGT-610) until 2044, significantly strengthening the commercial potential of their lead candidate. - The company completed an oversubscribed underwritten offering raising gross proceeds of approximately $33.1 million from leading healthcare specialist investors to fund continued development of SGT-610. - The pivotal Phase 3 clinical trial of SGT-610 for Gorlin syndrome remains on track with top-line results anticipated in the fourth quarter of 2026. - Sol-Gel expanded its global commercialization strategy by signing an exclusive license agreement with Sun Pharmaceutical Industries for TWYNEO® in India, adding to eight previous agreements covering multiple territories.
- Sol-Gel Technologies announced that its Phase 1b proof-of-concept study of SGT-210 for Darier disease failed to demonstrate superiority over vehicle control in efficacy assessments. - The company has decided to discontinue development of SGT-210 for Darier disease and will instead pursue small feasibility studies in other areas where the drug's mechanistic rationale is stronger. - Sol-Gel will continue prioritizing its Phase 3 program of SGT-610 for Gorlin syndrome prevention and potential Phase 3 development in high-frequency basal cell carcinoma. - SGT-610 represents a potential first-in-class topical hedgehog pathway inhibitor that could become the first approved treatment for preventing BCCs in Gorlin syndrome patients.
- Over 22 pharmaceutical companies are actively developing 25+ pipeline drugs for basal cell neoplasms, the most common type of skin cancer characterized by slow growth and low metastatic potential. - Recent clinical milestones include Senhwa Biosciences completing Phase I trials for Silmitasertib with positive survival outcomes, and multiple companies reporting positive Phase II results for their respective candidates. - Leading late-stage candidates include Sol-Gel Technologies' Patidegib, a first-in-class topical hedgehog pathway inhibitor targeting Gorlin Syndrome and basal cell carcinomas. - The pipeline features diverse mechanisms of action including SMO protein inhibitors, tyrosine kinase inhibitors, and casein kinase II inhibitors, addressing the growing demand driven by rising UV exposure and aging populations.
- Sol-Gel Technologies has completed patient enrollment for its pivotal Phase 3 clinical trial of SGT-610, a topical hedgehog pathway inhibitor for preventing basal cell carcinomas in Gorlin syndrome patients. - SGT-610 could become the first approved therapy for preventing new BCC lesions in this rare genetic disorder, with the company targeting potential peak revenue exceeding $300 million annually. - The company's Phase 1b trial of SGT-210 for Darier disease continues despite recruitment challenges, with market potential estimated between $200-300 million. - Sol-Gel secured $16 million from selling U.S. rights to EPSOLAY and TWYNEO to Mayne Pharma, extending its cash runway into the first quarter of 2027.
- Protalix BioTherapeutics has appointed Gilad Mamlok as Senior Vice President and Chief Financial Officer, effective August 24, 2025, succeeding Eyal Rubin. - Mamlok brings three decades of experience in healthcare and technology companies, including roles at TytoCare, Sol-Gel Technologies, and Given Imaging. - The appointment comes as Protalix continues to advance its pipeline of plant cell-based therapeutic proteins, including approved products Elfabrio and taliglucerase alfa. - The company's proprietary ProCellEx platform represents the first FDA-approved protein production system using plant cell-based suspension expression technology.
• 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.
- 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.
- 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.
- 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'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.
