Silo Pharma partners with Allucent for FDA IND application on SPC-15 for PTSD, aiming for 2026 clinical trial submission.
Quiver AI Summary
Silo Pharma, Inc. has appointed Allucent, a global clinical research organization, to assist in its preparations for submitting an investigational new drug application (IND) to the FDA for its intranasal treatment SPC-15 aimed at addressing PTSD. The submission is anticipated in 2026, followed by a first-in-human clinical trial once FDA approval is obtained. Silo’s CEO, Eric Weisblum, emphasized the importance of this partnership in progressing the development of the therapy, which will focus on dose-ranging studies to evaluate the drug's pharmacokinetics and safety. The company plans to utilize the FDA's 505(b)(2) pathway to expedite clinical development, expecting preliminary results from relevant studies in early 2026. Silo Pharma is focused on innovative treatments for challenging medical conditions, collaborating with various universities and research facilities.
Potential Positives
- Silo Pharma has partnered with Allucent, a respected clinical research organization, to aid in the submission of its IND application for the Phase 1 clinical trial of SPC-15 for PTSD, enhancing the company's credibility and support in the clinical trial process.
- The expected submission of the IND in 2026 indicates that Silo Pharma is progressing towards critical clinical development milestones for its innovative PTSD treatment.
- Pursuing the FDA's 505(b)(2) accelerated regulatory pathway suggests a prioritized focus on advancing SPC-15 through the regulatory process, which could lead to faster market entry if successful.
Potential Negatives
- The press release emphasizes that the IND submission is not expected until 2026, indicating potential delays in bringing SPC-15 to clinical trials.
- The use of forward-looking statements highlights significant uncertainties regarding the development timeline and potential risks, which could negatively impact investor confidence.
- Silo Pharma's status as a "diversified developmental-stage" company may raise concerns among investors about its ability to execute and bring products to market effectively, particularly in the competitive biopharmaceutical landscape.
FAQ
What is Silo Pharma's latest announcement?
Silo Pharma announced its partnership with Allucent for the IND submission of SPC-15 to the FDA for PTSD treatment.
What is the purpose of SPC-15?
SPC-15 is an intranasal prophylactic treatment aimed at addressing PTSD symptoms.
When does Silo Pharma plan to submit the IND?
They expect to submit the IND in 2026, pending FDA approval.
Who is Allucent?
Allucent is a global CRO specializing in drug development solutions for biopharma and government clients.
What regulatory pathway will Silo pursue for SPC-15?
Silo intends to use the FDA's 505(b)(2) accelerated regulatory pathway for SPC-15’s clinical development.
Disclaimer: This is an AI-generated summary of a press release distributed by GlobeNewswire. The model used to summarize this release may make mistakes. See the full release here.
$SILO Insider Trading Activity
$SILO insiders have traded $SILO stock on the open market 1 times in the past 6 months. Of those trades, 1 have been purchases and 0 have been sales.
Here’s a breakdown of recent trading of $SILO stock by insiders over the last 6 months:
- ERIC WEISBLUM (Chief Executive Officer) purchased 10,000 shares for an estimated $4,329
To track insider transactions, check out Quiver Quantitative's insider trading dashboard.
$SILO Hedge Fund Activity
We have seen 9 institutional investors add shares of $SILO stock to their portfolio, and 10 decrease their positions in their most recent quarter.
Here are some of the largest recent moves:
- ANSON FUNDS MANAGEMENT LP added 952,381 shares (+inf%) to their portfolio in Q3 2025, for an estimated $657,142
- ADVISORSHARES INVESTMENTS LLC added 180,642 shares (+98.0%) to their portfolio in Q3 2025, for an estimated $124,642
- VIRTU FINANCIAL LLC added 107,786 shares (+inf%) to their portfolio in Q3 2025, for an estimated $74,372
- URSA FUND MANAGEMENT, LLC removed 37,500 shares (-100.0%) from their portfolio in Q3 2025, for an estimated $25,874
- CITADEL ADVISORS LLC removed 28,160 shares (-100.0%) from their portfolio in Q3 2025, for an estimated $19,430
- XTX TOPCO LTD removed 26,823 shares (-100.0%) from their portfolio in Q3 2025, for an estimated $18,507
- TWO SIGMA SECURITIES, LLC removed 26,748 shares (-61.9%) from their portfolio in Q3 2025, for an estimated $18,456
To track hedge funds' stock portfolios, check out Quiver Quantitative's institutional holdings dashboard.
Full Release
SARASOTA, FL, Nov. 17, 2025 (GLOBE NEWSWIRE) -- Silo Pharma, Inc. (Nasdaq: SILO) (“Silo” or “the Company), a diversified developmental-stage biopharmaceutical and cryptocurrency treasury company, today announced that it has selected Allucent, a global full-service clinical research organization (CRO), to support the Company’s final preparations and planned submission of its investigational new drug application (IND) to the FDA for a Phase 1 clinical trial of its intranasal prophylactic SPC-15 as a treatment for PTSD. The Company currently expects to submit the IND in 2026 and commence its first-in-human (FIH) SPC-15 trial subsequent to FDA approval.
“We believe that a partnership with Allucent, is a significant move forward in bringing our novel PTSD therapeutic to the clinic,” said Silo CEO Eric Weisblum. “With Allucent’s expertise, we believe our IND will provide a sound rationale for clinical development, beginning with protocols for dose-ranging studies to assess the pharmacokinetics and safety profile for SPC-15. We expect to receive positive preclinical results in these categories which should meet the FDA’s clinical trial standards.”
Data from an IND-enabling GLP (Good Laboratory Practice)-compliant toxicology and toxicokinetic study, along with findings from a drug-device study of the formulation-specific intranasal spray system used for SPC-15 drug delivery, are expected in early 2026. Silo intends to pursue the FDA’s 505(b)(2) accelerated regulatory pathway for clinical development of SPC-15.
About Silo Pharma
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 and multiple sclerosis. Silo’s research is conducted in collaboration with leading universities and laboratories.
silopharma.com
About Allucent
Allucent is on a mission to help bring new therapies to light by solving the distinct challenges faced by biopharma and government clients. A global provider of comprehensive drug development solutions, including consulting, clinical operations, biometrics, and clinical pharmacology across a range of therapeutic areas, Allucent brings more than 30 years of experience in over 60 countries. With an A-Team of former regulators, leading scientists, and clinical experts, Allucent’s individualized partnership approach delivers deep insights and hands-on expertise to help clients navigate the complexities of bringing innovative treatments to patients. Learn more at allucent.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 Silo Pharma, Inc. (“Silo” or “the Company”) to differ materially from the results expressed or implied by such statements, including 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
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