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Harmony Biosciences (HRMY) investor relations material
Harmony Biosciences Cantor Global Healthcare Conference 2025 summary
Complete event summary combining all related documents: earnings call transcript, report, and slide presentation.
Leadership and company overview
Leadership team has extensive experience in both large pharma and biotech, emphasizing a preference for the dynamic biotech environment.
Company launched in 2017, focusing on growth through commercial success and pipeline expansion.
Pipeline includes late-stage, catalyst-rich assets in orphan and rare neurological disorders.
Pipeline and clinical development
Three main franchises: sleep/wake (Wakix and next-gen pitolisant), rare epilepsy (EPX-100 in phase 3 for Dravet and Lennox-Gastaut), and neurobehavioral (ZYN002 for Fragile X, phase 3 data imminent).
Pipeline includes eight assets across 13 programs, with up to six in phase 3 by year-end; each franchise targets $1–2 billion peak sales.
ZYN002 is a synthetic, transdermal gel targeting the endocannabinoid system for Fragile X; phase 3 Reconnect trial top-line data expected soon.
Phase 3 Reconnect trial focuses on patients with complete methylation of the FMR1 gene, aiming for a clinically meaningful and statistically significant improvement in social avoidance.
Positive data could lead to the first approved therapy for Fragile X and support expansion into related indications like 22q deletion syndrome.
Regulatory and market strategy
Consistent, positive interactions with the FDA and EMA, with global rights to ZYN002.
Plans to file for approval in both the US and Europe if phase 3 data are positive.
Market opportunity for Fragile X estimated at 80,000 US patients, with 60–70% fully methylated.
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