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Medicus Pharma gets FDA backing to advance skin cancer patch
Proactiveinvestors NA· 2025-09-29 12:14
About this content About Ian Lyall Ian Lyall, a seasoned journalist and editor, brings over three decades of experience to his role as Managing Editor at Proactive. Overseeing Proactive's editorial and broadcast operations across six offices on three continents, Ian is responsible for quality control, editorial policy, and content production. He directs the creation of 50,000 pieces of real-time news, feature articles, and filmed interviews annually. Prior to Proactive, Ian helped lead the business outpu ...
Medicus Pharma Ltd. Receives Positive Feedback From the Food and Drug Adminstration (FDA) Type C Meeting Supporting the Development of Skinject
Accessnewswire· 2025-09-29 11:30
The FDA agrees that the Company may follow 505(b)(2) regulatory pathway to non-invasively treat basal cell carcinoma (BCC) of the skin using dissolvable Doxorubicin-containing Microneedle arrays (D-MNA) representing ~$2 billion in potential market opportunity The Company plans to complete patient recruitment for SKNJCT-003 before the end of Q4 2025 and to request End-of-Phase 2 (EOP2) with the FDA in Q1 2026 PHILADELPHIA, PENNSYLVANIA / ACCESS Newswire / September 29, 2025 / Medicus Pharma Ltd. (NASDAQ:MDCX ...
Stonegate Capital Partners Initiates Coverage on Medicus Pharma Ltd. (MDCX)
Newsfile· 2025-09-24 13:26
Stonegate Capital Partners Initiates Coverage on Medicus Pharma Ltd. (MDCX)September 24, 2025 9:26 AM EDT | Source: Reportable, Inc. Dallas, Texas--(Newsfile Corp. - September 24, 2025) - Medicus Pharma Ltd. (NASDAQ: MDCX): Stonegate Capital Partners initiates their coverage on Medicus Pharma Ltd. (NASDAQ: MDCX). Medicus advanced several strategic initiatives in 2Q25 as it builds a diversified portfolio of clinical and pre-clinical assets. The Company completed the acquisition of Antev Limited ...
Medicus Pharma Ltd. To Present at Brookline Capital Markets
Accessnewswire· 2025-09-24 11:30
The Company will provide an update on its novel Doxorubicin containing Microneedle Array (D-MNA) treatment to non-invasively treat basal cell carcinoma of the skin (BCC) and development of Teverelix, a next generation GnRH Antagonist as a first in class market product for Acute Urinary Retention (AURr) and high CV risk Prostate Cancer D-MNA and Teverelix collectively represent ~$8 billion in potential market opportunity PHILADELPHIA, PA / ACCESS Newswire / September 24, 2025 / Medicus Pharma Ltd. (NASDAQ:MD ...
Medicus Pharma closes Antev acquisition, expands skin cancer trial - ICYMI
Proactiveinvestors NA· 2025-09-20 13:30
About this content About Emily Jarvie Emily began her career as a political journalist for Australian Community Media in Hobart, Tasmania. After she relocated to Toronto, Canada, she reported on business, legal, and scientific developments in the emerging psychedelics sector before joining Proactive in 2022. She brings a strong journalism background with her work featured in newspapers, magazines, and digital publications across Australia, Europe, and North America, including The Examiner, The Advocate, ...
Medicus Pharma secures $8M in non-dilutive debenture financing
Proactiveinvestors NA· 2025-09-18 13:20
About this content About Emily Jarvie Emily began her career as a political journalist for Australian Community Media in Hobart, Tasmania. After she relocated to Toronto, Canada, she reported on business, legal, and scientific developments in the emerging psychedelics sector before joining Proactive in 2022. She brings a strong journalism background with her work featured in newspapers, magazines, and digital publications across Australia, Europe, and North America, including The Examiner, The Advocate, ...
Medicus Pharma Ltd. Announces $8.0 Million Non-Dilutive Debenture Financing
Accessnewswire· 2025-09-18 11:30
The Company plans to use the proceeds to accelerate the development of Teverelix, a next generation GnRH Antagonist, as a first in class market product for Acute Urinary Retention (AURr) and high CV risk Prostate Cancer collecting representing ~ $6 billion in potential market opportunity PHILADELPHIA, PA / ACCESS Newswire / September 18, 2025 / Medicus Pharma Ltd. (NASDAQ:MDCX) ("Medicus" or the "Company"), a biotech/life sciences company focused on advancing the clinical development programs of novel and d ...
Medicus Pharma closes Antev acquisition; sees $6B market potential
Proactiveinvestors NA· 2025-09-02 13:33
公司背景 - 资深记者Sean Mason拥有20年加拿大和美国股票研究及写作经验 毕业于多伦多大学历史与经济学专业 通过加拿大证券课程 曾任职于Investors Digest of Canada、Stockhouse和SmallCapPowercom等机构 [1] - Proactive为全球投资受众提供快速、可获取、信息丰富且可操作的商业与金融新闻内容 所有内容由经验丰富的新闻记者团队独立制作 [1] 业务覆盖 - 新闻团队覆盖全球主要金融和投资中心 在伦敦、纽约、多伦多、温哥华、悉尼和珀斯设有办事处及演播室 [2] - 专注于中小型市值市场 同时更新蓝筹公司、大宗商品及广泛投资领域动态 服务活跃的私人投资者群体 [2] - 报道领域包括生物技术与制药、采矿与自然资源、电池金属、石油与天然气、加密货币以及新兴数字和电动汽车技术等市场 [3] 技术应用 - 积极采用前瞻性技术 人类内容创作者具备数十年专业经验 同时运用技术辅助和增强工作流程 [4] - 偶尔使用自动化及软件工具(包括生成式AI) 但所有发布内容均经过人工编辑和创作 符合内容生产和搜索引擎优化最佳实践 [5]
Medicus Pharma nears FDA milestone in cancer trial - ICYMI
Proactiveinvestors NA· 2025-08-30 16:28
临床试验进展 - 针对皮肤基底细胞癌的2期概念验证试验已完成90名患者中超过75%的随机分组 预计年底前完成全部患者入组[1][4][7] - 研究九处美国临床中心和两处欧洲中心患者招募进度超预期 可能无需启用英国中心即可完成年度目标[7] - 公司已请求与美国食品药品监督管理局举行Type C会议 就关键试验设计方案寻求指导 并确认快速通道资格认定[2][4][5] 监管沟通与合作 - 美国食品药品监督管理局已接受Type C会议请求 将在本季度结束前提供进一步指导 显示监管机构对项目的积极态度[5][6] - 通过提前与监管机构对齐方案 可提升股东资本使用效率 避免后续临床开发出现重大偏差[6] 财务与战略布局 - 截至6月30日公司现金余额达1130万美元 为临床项目提供充足资金支持[8] - 正在完成对英国Aim公司的收购 预计本月末完成交易 同时探索与Helix Nano合作开发耐热疫苗[8] 市场前景 - 皮肤基底细胞癌作为最常见皮肤癌症 代表150亿美元市场规模 非侵入性治疗替代方案存在巨大市场机会[6]
Medicus Pharma Ltd. Provides Update on Doxorubicin Containing Novel Microneedle Array (D-MNA) Clinical Development Program for the Treatment of Basal Cell Carcinoma (BCC) of the Skin and Reports Second Quarter 2025 Financial Highlights
Newsfile· 2025-08-21 11:30
临床开发进展 - 美国FDA已接受公司Type C会议请求 旨在讨论D-MNA产品开发路径并寻求快速通道资格 预计2025年第三季度末前获得FDA书面回复 [1][2] - SKNJCT-003二期临床研究已完成90名计划患者中超过75%的随机分组 该研究在美国9个临床中心开展 采用随机双盲安慰剂对照设计 设置100μg低剂量组和200μg高剂量组 [3][4][8] - 一期研究SKNJCT-001显示D-MNA在所有13名患者中安全性良好 无剂量限制性毒性或严重不良事件 其中6名结节型BCC患者达到完全病理缓解 [5][6][7] - 2025年3月中期分析显示超过60%的临床清除率 当时已完成60名目标患者中50%以上随机分组 [8] - 在阿联酋启动SKNJCT-004研究 计划在4个临床中心对36名患者进行随机分组 由克利夫兰诊所阿布扎比分院牵头 [9] 战略合作与收购 - 2025年6月签署最终协议收购英国临床阶段生物技术公司Antev 获得新一代GnRH拮抗剂Teverelix 用于心血管高风险晚期前列腺癌患者 [10][18] - 2025年8月与波士顿生物技术公司HelixNano签署非约束性谅解备忘录 共同开发热稳定mRNA传染病疫苗 结合双方mRNA平台与微针阵列递送技术 [11] 财务表现 - 第二季度通过融资交易和权证行使获得1150万美元净收益 现金及等价物从第一季度末400万美元增至970万美元 [13] - 总运营费用600万美元 较2024年同期360万美元增长 研发费用140万美元 行政管理费用460万美元 [13] - 净亏损620万美元 较2024年同期360万美元扩大 反映临床开发加速和战略投入增加 [13] - 完成公开发行单位融资700万美元 [13] 公司治理 - 2025年8月内部人士行使145,000份股票期权 行权价格0.84美元和2.87美元 出于税务和财务规划目的 [12] - 管理层表示公司基本面强劲 资产负债表呈积极趋势 内部人士行权后有意持有股份显示对公司前景乐观 [15]