On September 24, 2025, Harmony Biosciences announced that its Phase 3 registrational trial of ZYN002 in Fragile X syndrome, the RECONNECT study, failed to meet its primary endpoint of improvement in social avoidance. The study evaluated the transdermal synthetic cannabidiol formulation in a late‑stage setting. The failure was attributed to a higher than expected placebo response rate, preventing the drug from demonstrating a statistically significant benefit over placebo.
The negative outcome represents a setback for Harmony’s rare‑neurobehavioral pipeline, as ZYN002 was positioned as a potential first‑in‑class therapy for Fragile X syndrome. The result may delay the company’s projected launch timeline and impact future revenue expectations.
In addition, a separate late‑stage trial of an experimental drug for a rare genetic disorder also failed to meet its main goal, further underscoring challenges in Harmony’s pipeline development. These combined setbacks highlight the risks associated with the company’s current clinical portfolio and may influence investor expectations regarding future product launches.
The content on BeyondSPX is for informational purposes only and should not be construed as financial or investment advice. We are not financial advisors. Consult with a qualified professional before making any investment decisions. Any actions you take based on information from this site are solely at your own risk.