
Core Insights - Silo Pharma, Inc. has completed dosing in a large animal study requested by the FDA for its lead asset SPC-15, with results expected in 60 days [1] - The company is confident in the safety and therapeutic delivery of SPC-15 and is on track to submit an investigational new drug (IND) application [2] - Silo plans to utilize the FDA's 505(b)(2) regulatory pathway for SPC-15, which could expedite clinical timelines and reduce development costs [3] Company Overview - Silo Pharma is a developmental stage biopharmaceutical company focused on addressing underserved conditions, including stress-induced psychiatric disorders, chronic pain, and CNS diseases [5] - The company's portfolio includes innovative programs such as SPC-15 for PTSD, SP-26 for fibromyalgia, and preclinical assets targeting Alzheimer's disease and multiple sclerosis [5] - Silo collaborates with leading universities and laboratories for its research initiatives [5] Product Details - SPC-15 is an intranasal serotonin 5-HT4 receptor agonist aimed at treating stress-induced psychiatric disorders like PTSD and anxiety [4] - The drug has potential eligibility for the FDA's streamlined 505(b)(2) regulatory pathway, which may accelerate its approval process [4] - Silo Pharma has exclusive global rights for the development and commercialization of SPC-15 in collaboration with Columbia University [4]