Harmony Biosciences Archives

FRAXA Q&A Webinar with Dr. Elizabeth Berry-Kravis on the Harmony RECONNECT Trial

Fragile X Research Q&A: Dr. Berry-Kravis on the RECONNECT Trial

October 2, 2025

Fragile X Research Q&A with Dr. Berry-Kravis on RECONNECT results, placebo effects, outcome measures, methylation, and research directions for families.

RECONNECT Trial Results: ZYN002 Does Not Meet Primary Endpoint in Fragile X

September 24, 2025

Harmony Biosciences announced that the Phase 3 RECONNECT trial of ZYN002 in Fragile X syndrome failed to meet its primary endpoint.

Fragile X Research Update: A Turning Point for Treatments and Curative Approaches

September 17, 2025

Fragile X research is at a turning point. FRAXA is funding ASO therapy and CRISPR-based gene reactivation to target the root cause of Fragile X.

#teamwally gathered in matching Fragile X shirts for a group photo during a family fundraiser

#teamwally: Help Find a Cure for Fragile X Syndrome

May 9, 2025

Join #teamwally in supporting Fragile X research. Read Wally’s inspiring journey and help fund a future of hope and breakthroughs for kids like him.

Support the FRAXA Schutz Family Campaign & #teamwally Campaign

November 11, 2024

Join the Schutz family in their journey with Fragile X syndrome. Discover Wally’s inspiring progress, the impact of clinical research, and how donations to FRAXA fuel hope for breakthroughs to support families affected by Fragile X.

Understanding Anxiety in Fragile X: Insights from Dr. Carrie Buchanan’s Webinar

August 1, 2024

Dr. Carrie Buchanan shares strategies to manage anxiety in individuals with Fragile X syndrome, including non-pharmacological treatments and medication options.

Exploring Advances Fragile X Research: Comprehensive Webinar Highlights – May 2024

June 22, 2024

Learn about new FRAXA grants, key clinical trials, and scientific updates that are shaping the future of Fragile X syndrome. Webinar presented by Mike Tranfaglia and Katie Clapp.

Harmony Biosciences Phase 3 Clinical Trial (RECONNECT) with At-Home Option

May 20, 2024

Harmony Biosciences’ RECONNECT Phase 3 trial of ZYN002 offered an at-home participation option. Unfortunately the trial reported negative results.

Your Support on Giving Tuesday 2023 is Transforming Research

November 29, 2023

Thanks to 191 donors, FRAXA raised $333,517 on #GivingTuesday 2023—advancing research and hope for Fragile X families.

An Update from Harmony Biosciences on Giving Tuesday

November 28, 2023

Harmony Biosciences completed its acquisition of Zynerba Pharmaceuticals. This message is from Jeffrey M. Dayno, M.D. Harmony’s President and CEO.

ASOs and Fragile X: Addressing the Most Asked Questions

August 16, 2023

Explore the potential of ASOs in treating Fragile X syndrome & FXTAS. Dive into a comprehensive Q&A addressing key questions and breakthrough findings.

The Endocannabinoid System and Fragile X Syndrome

July 6, 2023

This project will examine how CBD and other drugs targeting the endocannabinoid system affect hyperexcitable Fragile X neurons to identify new treatment strategies.

Clinical Trial Results Reported for Phase 3 CONNECT-FX Study of Zygel™

November 29, 2022

Results have just been published from Zynerba Pharmaceuticals’s phase 3 clinical trial of Zygel™ in the Journal of Neurodevelopmental Disorders. In this trial, 212 children and adolescents aged 3 to 17 years were given Zygel or placebo for 12 weeks.

World Fragile X Day Is Lighting the Way for Fragile X Research

August 8, 2022

On July 22, 383 landmarks worldwide lit up for World Fragile X Day—shining bright to raise awareness and celebrate research progress.

2021 FRAXA Awards – Recognizing Perseverance and Dedication

July 22, 2021

In conjunction with World Fragile X Day 2021, FRAXA Research Foundation is proud to recognize its annual award recipients. This year’s recipients exemplify the perseverance and dedication that has made FRAXA a global leader in Fragile X research for nearly 30 years. We are fortunate to partner with these individuals on research, community support and awareness efforts.

Pivotal Phase 3 Trial of Zygel in Severe Fragile X Possible This Year

May 17, 2021

Zynerba Pharmaceuticals reported receiving advice from the U.S. Food and Drug Administration (FDA) on the design of an upcoming Phase 3 clinical trial meant to confirm previous trial findings supporting Zygel as a cannabidiol treatment in a specific subset of Fragile X syndrome patients. The new trial, called RECONNECT, is expected to launch before October, and will mainly enroll children and adolescents with a complete (100%) methylation of FMR1, the gene mutated in Fragile X.

Pharmacotherapeutic Effects of Cannabidiol (CBD) in Fragile X syndrome (FXS) and Autism Spectrum disorder (ASD)

May 6, 2021

This study tested CBD (cannabidiol) treatment in male and female Fragile X mice to learn how and why it works and whether gender affects responses to CDB treatment.

Zygel May Improve Behavior in Children With Severe Fragile X, Trial Data Suggest

October 22, 2020

Zynerba presented clinical trial results for Zygel at a recent neurology conference. Zygel, an experimental cannabidiol (CBD) gel, may reduce behavioral abnormalities in children with Fragile X syndrome who have more severe disease.