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Dual-action approach combining 5-HT4R Agonist (SPC-15) and NMDAR antagonist demonstrates enhanced efficacy in preclinical study for managing severe conditions
Proposal submitted for FDA 505(b)(2) regulatory pathway for SPC-15 approval Advancing path to IND submission for first-in-human trials SARASOTA, FL, Sept. 10, 2024 (GLOBE NEWSWIRE) -- Silo Pharma, Inc. (Nasdaq: SILO) (“Silo” or the “Company”), a developmental stage biopharmaceutical company focused on developing novel formulations and drug delivery systems for traditional therapeutics and psychedelic treatments, today announced the completion of a pre-Investigational New Drug (pre-IND) meeting with the U.S. Food and Drug Administration (FDA) regarding the Company's development plan for SPC-15, an intranasal prophylactic treatment for post-traumatic stress disorder (PTSD) and stress-induced anxiety disorder.
Clinical roadmap unveiled for novel and proprietary intranasal PTSD treatment SARASOTA, FL, June 04, 2024 (GLOBE NEWSWIRE) -- Silo Pharma, Inc. (Nasdaq: SILO) (“Silo” or the “Company”), a developmental stage biopharmaceutical company focused on developing novel formulations and drug delivery systems for traditional therapeutics and psychedelic treatments, today announced its submission of a pre-Investigational New Drug (pre-IND) briefing package and meeting request to the U.S. Food and Drug Administration (FDA) for SPC-15, Silo's intranasal prophylactic treatment for post-traumatic stress disorder (PTSD) and stress-induced anxiety disorder. Pre-clinical data indicate that SPC-15 has additive benefits for combating stress-induced pathophysiology, both at the behavioral and neural levels.
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