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# Harmony Reports Disappointing Fragile X Data
- URL: https://www.fdaweb.com/harmony-reports-disappointing-fragile-x-data/
- Published: 2025-09-24T12:00:00.000Z
- Updated: 2026-09-14T15:22:37.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5159927

Harmony Biosciences says topline results from its Phase 3 registrational clinical trial (RECONNECT study) of ZYN002 in Fragile X syndrome (FXS) did not meet the primary endpoint of improvement in social avoidance primarily due to a higher-than-expected placebo response rate. “Although the study did not achieve its primary endpoint, the findings from this study provide valuable insights into Fragile X syndrome, a rare neurobehavioral condition with significant unmet medical need and no FDA-approved therapies,” the company says. “We will conduct a comprehensive analysis of the full dataset to better understand the results as part of our continued commitment to the Fragile X community.”

The company says the RECONNECT Study was a randomized, double-blind, placebo-controlled, multiple-center study designed to assess the efficacy and safety of ZYN002, a pharmaceutically manufactured cannabidiol administered as a transdermal gel to patients with FXS ages 3 to under 30 years old.

FXS is described by the company as a rare genetic disorder that is the leading known cause of both inherited intellectual disability and autism spectrum disorder. The disorder negatively affects synaptic function, plasticity and neuronal connections, and results in a spectrum of intellectual disabilities and behavioral symptoms, such as social avoidance and irritability.