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 ...

Summary of Grace Therapeutics Conference Call Company Overview - **Company**: Grace Therapeutics, Inc. (NasdaqCM:GRCE) - **Focus**: Development of GTX-104, an intravenous formulation of amlodipine targeting subarachnoid hemorrhage (SAH), a rare disease with high morbidity and mortality rates [2][3][4] Core Points and Arguments - **Current Standard of Care**: Amlodipine, an oral calcium channel blocker, has significant clinical liabilities, including high first-pass metabolism and hypotension issues [2][5][6][9] - **Innovative Solution**: GTX-104 aims to address the shortcomings of oral amlodipine by providing a novel aqueous formulation for intravenous administration, enhancing dose compliance and hypotension management [3][10][19] - **Clinical Trial Success**: The pivotal Phase 3 trial (STRY1) demonstrated: - 20% fewer clinically significant hypotensive events with GTX-104 compared to oral amlodipine - 95% or higher dose compliance in 55% of patients on IV versus only 8% on oral [15][19] - 30% of patients on IV showed good recovery compared to oral [15][18] - **Regulatory Pathway**: The FDA accepted the New Drug Application (NDA) for GTX-104 with a PDUFA goal date of April 23, 2026, following a successful pre-NDA meeting [17][25] Market Potential - **Target Market**: Approximately 50,000 cases of SAH annually in the U.S., treated primarily in about 250 hospitals [20][21] - **Commercial Strategy**: A focused sales force of 15 to 20 individuals will be deployed to market GTX-104, leveraging a strong patent portfolio that includes seven years of market exclusivity and multiple formulation patents extending to 2042 [21][22] Financial Position - **Cash Reserves**: $20 million reported at the end of June, with additional potential proceeds from warrants expected to support operations through the anticipated approval and into revenue generation in 2027 [22][23] Additional Important Insights - **Patient Demographics**: SAH primarily affects younger populations, with an average patient age of less than 60 years and a higher incidence in women [5][17] - **Clinical Need**: The unmet clinical need is significant, as many patients are unconscious and unable to swallow, complicating the administration of oral medications [6][10] - **Pharmaco-economic Benefits**: The IV formulation demonstrated a reduction in ICU length of stay by 1.5 days and a 50% reduction in ICU readmissions compared to oral therapy, highlighting its cost-effectiveness [15][16][19] This summary encapsulates the key points from the Grace Therapeutics conference call, emphasizing the company's innovative approach to treating a critical condition, its strong clinical data, and the promising market opportunity ahead.

Core Insights - Silo Pharma, Inc. is developing SPC-15, an intranasal prophylactic targeting Post-Traumatic Stress Disorder (PTSD), with plans to submit an Investigational New Drug (IND) application by the end of 2025 [1][4] - The company anticipates receiving preclinical study data for SPC-15 within 30 to 90 days, which will inform the IND application process [1][4] - SPC-15 aims to address a significant unmet need in the PTSD treatment market, as there have been no new drug approvals for PTSD in nearly 25 years, despite the condition affecting approximately 3.9% of the global population [6] Company Overview - Silo Pharma is a developmental stage biopharmaceutical company focused on novel therapeutics for underserved conditions, including stress-induced psychiatric disorders and chronic pain [8] - The company collaborates with Columbia University for preclinical studies and holds exclusive global rights for the development and commercialization of SPC-15 [7][8] - Silo Pharma's portfolio includes other programs targeting fibromyalgia, chronic pain, Alzheimer's disease, and multiple sclerosis [8] Drug Development Process - The final studies for SPC-15 include a Good Laboratory Practice-compliant toxicology study and a large animal safety study requested by the FDA [2] - The company plans to utilize the FDA's 505(b)(2) regulatory pathway for SPC-15, which could expedite the approval process and reduce development costs [5] - If the IND application is approved, Silo Pharma could initiate a Phase 1 clinical trial for SPC-15 by the end of 2026 [4]