Ami Fadia

Ashwani Verma

David Amsellem

Graig Suvannavejh

Charles Duncan

David Hoang

Jason Gerberry

Danielle Brill

Patrick Trucchio

Corinne Jenkins

Corinne Johnson

François Brisebois

Jay Olson

John Gregory Dean

Luis Santos

Pavan Patel

Pete Stavropoulos

- Harmony Biosciences Holdings, Inc. announced on **September 24, 2025**, that its **Phase 3 RECONNECT Study** of **ZYN002** for **Fragile X syndrome (FXS)** **did not meet its primary endpoint**.  **[1802665_0001104659-25-092776_hrmy-20250924xex99d1.htm:0]** **[1802665_0001104659-25-092776_hrmy-20250924x8k.htm:1]** 
- The study's failure was primarily attributed to a **higher than expected placebo response rate**.  **[1802665_0001104659-25-092776_hrmy-20250924xex99d1.htm:0]** **[1802665_0001104659-25-092776_hrmy-20250924x8k.htm:1]** 
- Despite this setback, the company confirmed it is on track to initiate **Phase 3 trials for pitolisant HD** in narcolepsy and idiopathic hypersomnia in **Q4 2025**, emphasizing its late-stage pipeline.  **[1802665_0001104659-25-092776_hrmy-20250924xex99d1.htm:0]**

Harmony Biosciences' ZYN002 Phase 3 Study Fails Primary Endpoint

Harmony Biosciences Holdings (HRMY)