SILO (Silo Pharma, Inc.) PDUFA Date | FDA Catalyst & Approval Status

Jul 21, 2026

Silo Pharma's subsidiary, QwikAgents, has joined the NVIDIA Developer Program to enhance its AI agent platform. This partnership will provide access to NVIDIA's AI software ecosystem, which is expected to accelerate the development of autonomous AI solutions for enterprise customers. The platform aims to automate complex workflows and support scalable operations.

Jun 29, 2026

SILOFDA Updates

Silo Pharma Advances SPC-15 PTSD Therapeutic with Drug-Device Robustness Study Ahead of Planned FDA Type C Meeting Request

Silo Pharma has engaged Resyca to conduct a robustness study for its SPC-15 PTSD treatment. This study aims to evaluate the performance of a nasal spray delivery system designed to enhance drug delivery to the brain. The data from this study will support Silo's upcoming FDA Type C meeting to discuss regulatory guidance for its clinical trial strategy.

Jun 23, 2026

Silo Pharma Reports Positive Stability Data for SPC-15 PTSD Treatment, Advancing Program Toward First-in-Human Clinical Trial

Silo Pharma has reported positive stability data for its investigational drug SPC-15, which is aimed at treating PTSD. The stability tests confirmed the drug's integrity over nine months, supporting its advancement towards a first-in-human clinical trial. The company is preparing for an IND submission, highlighting its commitment to cGMP standards.

Jun 18, 2026

▲ +5.3%on this newsshared move

Silo Pharma Regains Compliance with Nasdaq Minimum Bid Price Requirement

Silo Pharma has announced that it has regained compliance with Nasdaq's minimum bid price requirement as of June 17, 2026. The company continues to trade on the Nasdaq Capital Market, and CEO Eric Weisblum expressed confidence in their progress towards a first-in-human clinical trial for their lead drug targeting PTSD. Silo Pharma is focused on developing innovative therapeutics for various psychiatric and CNS disorders.

May 7, 2026

Silo Pharma is advancing its investigational drug SPC-15 for Post-Traumatic Stress Disorder (PTSD), with an IND application planned for 2025. The company anticipates data from preclinical studies in the next 30 to 90 days, which will influence the timing of their FDA submission. SPC-15, a novel intranasal therapy, could address a significant unmet medical need as no new PTSD drugs have been approved in nearly 25 years. The company is confident in its potential and is pursuing the FDA's expedited review options to facilitate quicker access to clinical trials.

Jun 25, 2025

Silo Pharma, Inc. has partnered with AmplifyBio to conduct a large animal GLP study of its lead asset, SPC-15, an intranasal treatment for PTSD. This study aims to support the upcoming IND application for human trials. Previous studies indicate that SPC-15 has favorable absorption characteristics, and success in this study could significantly advance its development. The collaboration between Silo and AmplifyBio has been ongoing since 2022, contributing to the progress of SPC-15 through various pre-clinical phases.

Jun 7, 2024

Silo Pharma, Inc. has announced promising results from a study indicating a new drug formulation that could enhance remission and reduce relapse in depression patients. This formulation reportedly improves mood stability without the side effects often seen with existing antidepressants. Silo's CEO emphasized the significance of these findings for potentially treating millions of individuals affected by depression. The company continues to prioritize its SPC-15 program for PTSD while exploring these positive developments.

May 14, 2024

SILOConferences/Events

Silo Pharma to Participate in FDA Meeting Exploring Emerging Therapeutic Interest in Ketamine

Silo Pharma, Inc. has announced its participation in an FDA-hosted meeting on June 27, 2024, focused on ketamine as a treatment for emerging therapeutic interests. The company's CEO and a scientific advisor are expected to engage with various stakeholders, including clinicians and researchers. Silo's lead candidate, SPC-15, aims to treat PTSD and anxiety. Another candidate, SP-26, is an injectable implant designed for chronic pain. Silo Pharma aims to address gaps in treatment options for these conditions.

Silo Pharma’s SP-26 Ketamine Implant Demonstrates Successful Drug Delivery

Silo Pharma announced a positive update on their SP-26 ketamine implant, designed for chronic pain and fibromyalgia treatment. Recent testing has confirmed the successful loading of ketamine into the implants while maintaining structural integrity. The company believes that this implantable drug delivery system could offer sustained relief for chronic conditions, potentially qualifying for an expedited FDA approval. Silo plans to progress into further testing of the ketamine formulation to assess its release and effectiveness.

Feb 1, 2024

SILOFDA Updates

Silo Pharma Announces Pipeline Prioritization for 2024 Targeting Mental Health, Chronic Pain, and Neurology

Silo Pharma, Inc. has announced its strategic focus for 2024, prioritizing the clinical development of its lead drug program, SPC-15, aimed at treating PTSD. The company plans to submit a Pre-Investigational New Drug Application to the FDA while working on additional therapeutic programs targeting chronic pain and Alzheimer's disease. Significant advancements include an innovative non-opioid treatment for fibromyalgia and collaborations with prestigious research institutions. Silo's approach utilizes the FDA's 505(b)(2) regulatory pathway, which may streamline the approval process for its promising drug candidates.

Silo Pharma has announced an exclusive license agreement with Medspray Pharma BV for its innovative soft mist nasal spray technology, which will be used for the delivery of SPC-15, a novel drug for PTSD and other disorders. This partnership was established following successful feasibility studies. The exclusive rights cover multiple conditions including anxiety disorders and Alzheimer's disease, potentially enhancing Silo’s research and development efforts. SPC-15, a serotonin 4 receptor agonist, may qualify for FDA's accelerated approval pathway if clinical trials are successful.

Nov 8, 2023

Silo Pharma to Initiate Dose-Ranging Study of Novel Intranasal Therapeutic SPC-15 for the Treatment of PTSD

Silo Pharma, Inc. announced its plans to begin a dose-ranging study of SPC-15, a novel intranasal therapeutic for treating PTSD. The study aims to identify the maximum tolerated dose and assess pharmacokinetics in small animals before advancing to human trials. The collaboration with AmplifyBio includes a six- to eight-week study period. If successful, SPC-15 may pursue approval through the FDA's 505(b)(2) pathway. Completion of this study is a strategic step toward initiating Phase 1 clinical trials.

Silo Pharma, Inc. has been granted U.S. Patent 16/825,371 for its drug SPU-21, aimed at treating rheumatoid arthritis by selectively targeting inflamed synovial tissue. The patent strengthens the company's intellectual property around SPU-21, which has demonstrated effectiveness in preclinical models in slowing down arthritic progression. This development underscores Silo Pharma's focus on merging traditional therapeutics with psychedelic research to address various medical conditions. The rheumatic market is projected to be highly lucrative, with expectations of generating significant revenues in the coming years.

Silo Pharma, Inc. has announced a share repurchase program with authorization to buy back up to $1 million of its common stock. The decision was made by the company's board of directors, highlighting their commitment to enhancing shareholder value amid favorable capital market conditions. The program will be conducted within the framework of regulatory requirements and company discretion concerning liquidity and market conditions. Silo Pharma specializes in merging traditional therapeutics with psychedelic research for mental health indications.

Jan 10, 2023

Silo Pharma Advances Clinical Study Analyzing Effects of Psilocybin on Inflammation

Silo Pharma has reported progress on a clinical study in collaboration with UCSF that explores the effects of psilocybin on inflammation in patients with Parkinson's disease, bipolar disorder, and chronic pain. The study involves targeted patient populations and includes several dosing sessions with psilocybin, aimed at understanding its mechanism of action. Data collection for the Parkinson's segment is set to conclude by the end of February 2023, with other patient groups following later. This research could position psilocybin as a therapeutic option for inflammatory disorders.

Dec 30, 2022

ENGLEWOOD CLIFFS, NJ , Sept. 15, 2022 (GLOBE NEWSWIRE) -- Silo Pharma, Inc. (OTCQB: SILO) (“the Company”), a developmental stage biopharmaceutical company focused on merging traditional therapeutics with psychedelic research, announced today that it will effect a 1-for-50 reverse

Jul 27, 2022

Silo Pharma Announces Positive Results from its Topically Administered Formulation of Ketamine

Silo shows reversal of allodynia and hyperalgesia using its selected formulation and partnered, patented delivery system ENGLEWOOD CLIFFS, N.J, July 27, 2022 (GLOBE NEWSWIRE) -- Silo Pharma, Inc . (OTCQB: SILO), a development-stage biopharmaceutical company today announced that

Uppercut Brands, Inc. Changes Name to Silo Pharma, Inc.; reflecting Company's Emerging Focusing on the Development and Commercialization of Psychedelic/Psilocybin-based Drug Therapies Early Entrant, Addressing Massive Market Opportunity for Psychedelic Drug Therapies for a Wi

Jun 3, 2015