Harmony Biosciences' Phase 3 ZYN002 trial in Fragile X syndrome fails primary endpoint

Harmony Biosciences Holdings, Inc.

RECONNECT study did not meet primary endpoint of improvement in social avoidance; higher than expected placebo response cited.
Study enrolled 215 patients aged 3 to <30 years; 1:1 randomization to ZYN002 or placebo over 18 weeks.
CEO Jeffrey Dayno reaffirms late-stage pipeline; Phase 3 trials for pitolisant HD in narcolepsy and idiopathic hypersomnia on track for Q4 2025.
Company describes itself as profitable and self-funding biotech with strong cash generation.
Fragile X syndrome has no FDA-approved therapies; company will conduct comprehensive data analysis.

item 7.01item 9.01

This headline and bullets were generated automatically by deepseek-v4-flash:cloud@v2 from the public filing. Read the source on SEC.gov before relying on any specific claim. Not investment advice. See methodology for how this pipeline works.