Silo Pharma Advances SPC-15 PTSD Therapeutic with Drug-Device Robustness Study Ahead of Planned FDA Type C Meeting Request
Rhea-AI Summary
Silo Pharma (Nasdaq: SILO) engaged drug-device partner Resyca to run a robustness study on the microchip-based Soft-Mist nasal spray delivering SPC-15, its lead intranasal prophylactic PTSD treatment.
The 30-day study will test device performance and SPC-15 formulation stability and is expected to support a planned FDA Type C meeting and IND/Phase 1 strategy under a previously aligned 505(b)(2) pathway.
Positive
- Robustness study initiated for SPC-15 nose-to-brain nasal spray over 30 days
- Study data expected to support planned FDA Type C meeting request for SPC-15
- Prior FDA pre-IND alignment on streamlined 505(b)(2) regulatory pathway for SPC-15
Negative
- None.
News Market Reaction – SILO
In the Jun 30 session, SILO gained 0.32%, reflecting a mild positive market reaction. Argus tracked a peak move of +34.2% during that session. Argus tracked a trough of -10.9% from its starting point during tracking. Our momentum scanner triggered 8 alerts that day, indicating moderate trading interest and price volatility. Trading volume was very high at 3.1x the daily average, suggesting strong buying interest.
Data tracked by StockTitan Argus on the day of publication.
Key Figures
Historical Context
| Date | Event | Sentiment | 24h Move | Catalyst |
|---|---|---|---|---|
| Jun 23 | Clinical stability data | Positive | +3.7% | Positive nine‑month stability data for SPC-15 supporting IND-enabling CMC requirements. |
| Jun 18 | Nasdaq compliance | Positive | +5.3% | Regained compliance with Nasdaq minimum bid price, removing near-term listing overhang. |
| May 07 | TBI patent filing | Positive | -0.2% | Provisional patent filing for ibogaine-based therapeutic targeting traumatic brain injury. |
| Apr 29 | PTSD program update | Positive | +1.3% | PTSD program positioned amid broader federal moves fast-tracking psychedelic PTSD therapies. |
| Apr 22 | AI expansion deal | Neutral | -16.9% | Acquisition of Qwikagents.ai assets to expand into AI agent market alongside SPC-15. |
24h Move is the share-price change in the day after each event; other market factors may also have contributed.
SILO has generally reacted positively to clinical and regulatory progress, with a notable selloff on its AI diversification news.
Key Terms
nose-to-brain medical
blood-brain barrier medical
505(b)(2) regulatory
AI-generated analysis. How Rhea-AI works. Not financial advice.
Study designed to evaluate performance and formulation stability of proprietary nose-to-brain delivery system
SARASOTA, FLA., June 29, 2026 (GLOBE NEWSWIRE) -- Silo Pharma (Nasdaq: SILO) (“Silo” or “the Company”), a diversified developmental-stage biopharmaceutical company with a therapeutic focus on addressing underserved conditions, including stress-induced psychiatric disorders, chronic pain, and central nervous system (CNS) diseases, today announced that it has engaged its drug-device development partner Resyca to conduct a robustness study evaluating the microchip-based nasal spray system used for nose-to-brain delivery of SPC-15, the Company’s lead intranasal prophylactic treatment for post-traumatic stress disorder (PTSD).
“We believe this robustness study represents another important step toward initiating our first-in-human clinical program for SPC-15,” said Eric Weisblum, Chief Executive Officer of Silo Pharma. “Together with our previously completed preclinical studies, these data are expected to support our planned FDA Type C meeting request, where we intend to obtain regulatory guidance on our IND strategy and Phase 1 clinical trial design.”
Resyca's patented Soft-Mist Nasal Spray system is designed for targeted nose-to-brain drug delivery, enabling molecules to bypass the blood-brain barrier. Silo believes this approach has the potential to increase drug concentrations in the brain while reducing systemic exposure, potentially enabling faster therapeutic onset and an improved safety profile. Drug-device robustness testing is a standard component of combination-product development and is intended to demonstrate consistent device performance and formulation stability prior to clinical evaluation. Silo’s robustness study will evaluate device performance consistency during expected use and assess formulation stability of SPC-15 formulations (lead and placebo) over a 30-day period.
The U.S. Food and Drug Administration’s (FDA) IND Type C meeting is a formal interaction with the FDA to obtain regulatory feedback on drug development programs outside of standard milestone meetings. In a previous pre-IND meeting with the FDA, Silo successfully aligned with the FDA on the streamlined 505(b)(2) regulatory pathway for approval of SPC-15.
About Silo Pharma, Inc.
Silo Pharma is a diversified developmental-stage biopharmaceutical company with a therapeutic focus 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 post-traumatic stress disorder (PTSD), SP-26 for fibromyalgia and chronic pain, and a preclinical asset 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 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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investors@silopharma.com
