Press Releases April 29, 2026 09:08 AM

Silo Pharma’s PTSD Program Advances as FDA Fast-Tracks Psychedelic Therapies for PTSD

U.S. Federal Initiatives Accelerate Silo Pharma’s PTSD Program Amid Fast-Tracking of Psychedelic Therapies

By Derek Hwang
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SILO

Silo Pharma commends recent U.S. federal actions accelerating development and regulatory clarity for psychedelic-based therapies addressing PTSD and related mental health disorders, highlighting its own PTSD-focused drug candidate SPC-15. The FDA's investigational new drug clearance for noribogaine and upcoming psychedelic drug development guidance mark significant progress for the mental health therapeutics sector.

Silo Pharma’s PTSD Program Advances as FDA Fast-Tracks Psychedelic Therapies for PTSD
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Key Points

  • The U.S. government is advancing funding and regulatory efforts to fast-track psychedelic-based treatments for PTSD and substance use disorders, legitimizing Silo Pharma's approach.
  • Silo Pharma's PTSD program SPC-15 and other CNS disease assets position it to benefit from increased clinical and regulatory support in this emerging therapeutic area.
  • FDA’s issuance of priority vouchers and investigational drug clearances signals a favorable environment for psychedelic drug development, benefiting companies focused on mental health innovation.

Federal initiatives focused on PTSD and related conditions appears to validate need for new and novel approaches to mental health treatment

SARASOTA, Fla, April 29, 2026 (GLOBE NEWSWIRE) -- Silo Pharma, Inc. (NASDAQ: SILO), a developmental-stage biopharmaceutical company focused on novel therapeutics and drug delivery systems, today commends a wave of coordinated U.S. federal actions that are rapidly advancing the development of psychedelic-based therapeutics for mental health and substance use disorders. Building on last weekend’s executive initiative to fast-track these treatments, multiple agencies have taken meaningful steps this week to accelerate research, clinical progress, and regulatory clarity across the sector.

The Advanced Research Projects Agency for Health announced initial awardees under its EVIDENT program, including leading institutions such as Johns Hopkins University and other innovators focused on psychedelic science. Silo believes this funding validates its position on the growing importance of data-driven approaches to treating complex neurological and psychiatric conditions.

In parallel, the U.S. Food and Drug Administration granted investigational new drug (IND) clearance to DemeRx NB for its noribogaine candidate targeting alcohol use disorder, highlighting continued expansion of clinical-stage programs in the mental health space.

“We are witnessing a coordinated and accelerating shift at the federal level,” said Silo CEO Eric Weisblum. “From funding and clinical advancement to regulatory prioritization, in our opinion the foundation is being laid for a new generation of therapies that could transform how we treat PTSD and related disorders.”

The FDA issued three Commissioner’s National Priority Vouchers to Compass Pathways, Usona Institute, and Transcend Therapeutics, underscoring a clear intent to accelerate high-impact therapies. Notably, the inclusion of a PTSD-relevant program further signals a strong institutional focus on addressing urgent unmet needs among veterans and broader patient populations. Additionally, the organization confirmed that final guidance for psychedelic drug development will be published imminently, a long-anticipated milestone expected to provide critical clarity for sponsors and researchers navigating clinical and regulatory pathways.

About Silo Pharma, Inc.

Silo Pharma is a diversified developmental-stage biopharmaceutical and cryptocurrency treasury company. Its therapeutic focus is on addressing underserved conditions, including stress-induced psychiatric disorders, chronic pain, and central nervous system (CNS) diseases. The Company’s portfolio includes innovative programs such as SPC-15 for PTSD, SP-26 for fibromyalgia and chronic pain, and preclinical assets targeting Alzheimer’s disease. Silo’s research is conducted in collaboration with leading universities and laboratories. silopharma.com

Forward Looking Statements

This news release contains “forward-looking statements” within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995. These statements are identified using words “could”, “believe”, “anticipate”, “intend”, “estimate”, “expect”, “may”, “continue”, “predict”, “potential”, and similar expressions that are intended to identify forward-looking statements. Such statements involve known and unknown risks, uncertainties, and other factors that could cause the actual results of the Company to differ materially from the results expressed or implied by such statements, including statements about the intended use of proceeds from the offering, changes to anticipated sources of revenues, future economic and competitive conditions, difficulties in developing the Company’s technology platforms, retaining and expanding the Company’s customer base, fluctuations in consumer spending on the Company’s products and other factors. Accordingly, although the Company believes that the expectations reflected in such forward-looking statements are reasonable, there can be no assurance that such expectations will prove to be correct. The Company disclaims any obligations to publicly update or release any revisions to the forward-looking information contained in this press release, whether as a result of new information, future events, or otherwise, after the date of this press release or to reflect the occurrence of unanticipated events except as required by law.

Contact

(800) 705-0120
investors@silopharma.com


Risks

  • Silo Pharma is a developmental-stage company with inherent risks in clinical trial success and technology development which could delay or prevent commercialization.
  • Regulatory environments for psychedelic therapies remain evolving and uncertain; final FDA guidance might impose unexpected requirements impacting development timelines.
  • The competitive landscape includes multiple institutions and companies receiving similar federal support, potentially diluting Silo Pharma’s market opportunity.

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