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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.
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Cantor Global Healthcare Conference 2025 summary4 Sep, 2025

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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Q3 202528 Oct, 2025
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Frequently asked questions

Harmony Biosciences Holdings, Inc. is a commercial-stage pharmaceutical company that develops and sells novel therapies for people with rare diseases. It offers Naurex, an investigational drug to treat depression; Wakix, an oral treatment for excessive sleepiness; SPRITAM rapidly disintegrated tablets to treat nighttime seizures; and EVKOTEBO for prevention of recurrent seizures in people with partial-onset epilepsy. The company was formerly known as Axsome Therapeutics, Inc. and changed its name to Harmony Biosciences Holdings, Inc. in January 2019. Harmony Biosciences Holdings, Inc. was founded in 2017and is headquartered in Plymouth Meeting, Pennsylvania.

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