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1,270 Results for "harmony biosciences.rss".
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Rare diseases
Harmony Freezes Cannabidiol Gel After Phase III Miss in Fragile X Syndrome
Harmony Biosciences has paused a mid-stage trial of ZYN002 in 22q11.2 deletion syndrome after the THC-free cannabinoid drug failed to significantly improve social avoidance in a late-stage study in fragile X Syndrome.
November 5, 2025
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2 min read
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Tristan Manalac
Rare diseases
Harmony Fails Pivotal Fragile X Syndrome Trial, Blames High Placebo Response
While Harmony management has not disclosed future plans for ZYN002, Jefferies analysts expect the asset to be shelved.
September 25, 2025
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1 min read
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Tristan Manalac
Neuroscience
Harmony’s Dravet Drug Halves Monthly Seizures in Late-Stage Study
The Phase III, open-label extension study suggests EPX-100 has a “positive” risk/benefit profile for the treatment of Dravet syndrome, analysts at H.C. Wainwright & Co. said Tuesday.
December 3, 2025
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2 min read
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Tristan Manalac
Press Releases
Harmony Biosciences to Present at the 44th Annual J.P. Morgan Healthcare Conference
January 7, 2026
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1 min read
Press Releases
Harmony Biosciences to Participate in Upcoming December 2025 Investor Conferences
November 19, 2025
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1 min read
Regulatory
FDA Kicks Down Harmony’s Bid to Push Wakix Into Idiopathic Hypersomnia
Despite the regulatory setback, analysts appear optimistic, noting that Harmony’s long-term prospects remain bright given the development of its high-dose formulation of its sleep-regulating drug Wakix.
February 20, 2025
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2 min read
·
Tristan Manalac
Press Releases
Ivonescimab’s Updated Label Shows Positive Dual Results in PFS and OS from HARMONi-A Study
January 7, 2026
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5 min read
Press Releases
Beacon Biosignals Announces Partnership with Harmony Biosciences to Advance Objective Clinical Endpoints in Hypersomnia Conditions Through Quantitative EEG
December 16, 2025
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3 min read
Press Releases
Harmony Biosciences Guides to Over $1 Billion in WAKIX® Revenue in 2026; Advancing Robust Late-Stage Pipeline With Potential for Long-term Value Creation
January 12, 2026
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19 min read
Press Releases
Harmony Biosciences Presents Clinically Meaningful Open-Label Extension Study Effectiveness Data for EPX-100 in Dravet Syndrome
December 9, 2025
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4 min read
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