Core Insights - Harmony Biosciences Holdings, Inc. (HRMY) shares increased by 12.7% to close at $29.6, supported by strong trading volume, contrasting with a 1.8% loss over the past four weeks [1][2] Financial Performance - The company reported preliminary third-quarter 2025 revenues for the Wakix (pitolisant) franchise at approximately $239 million, marking a 29% year-over-year increase [2] - Harmony Biosciences raised its revenue guidance for 2025 to a range of $845-$865 million, up from the previous estimate of $820-$860 million [2] - The expected quarterly earnings per share (EPS) for the upcoming report is $0.83, reflecting a year-over-year change of +5.1%, with revenues anticipated at $220.95 million, an 18.8% increase from the previous year [3] Market Sentiment - The consensus EPS estimate for Harmony Biosciences has remained unchanged over the last 30 days, indicating that stock price movements may not sustain without trends in earnings estimate revisions [4] - The stock currently holds a Zacks Rank of 3 (Hold), indicating a neutral outlook [5] Industry Context - Harmony Biosciences operates within the Zacks Medical - Biomedical and Genetics industry, alongside Oculis Holding AG (OCS), which saw a 0.7% increase in its stock price recently and has returned 19.6% over the past month [5]

Core Insights - Harmony Biosciences Holdings, Inc. (HRMY) shares fell by 16.56% on September 24 following the announcement of the failure of the late-stage RECONNECT study for ZYN002 in Fragile X syndrome (FXS) [1][2] - The RECONNECT study was a randomized, double-blind, placebo-controlled trial aimed at assessing the efficacy and safety of ZYN002, a transdermal gel cannabidiol for patients aged 3 to under 30 years with FXS [1][2] - The study did not meet its primary endpoint of improving social avoidance, attributed to a higher-than-expected placebo response rate [2] Company Performance - Year-to-date, HRMY has experienced a 22.2% decline, contrasting with a 5.3% gain in the industry [3] - The company's lead drug, Wakix (pitolisant), generated revenues of $200.5 million in the second quarter [5][7] - HRMY plans to initiate phase III registrational trials for a high dose of pitolisant in narcolepsy and idiopathic hypersomnia in the fourth quarter of 2025 [5][7] Pipeline Expansion - HRMY has broadened its pipeline into rare epilepsy through the acquisition of Epygenix Therapeutics, adding EPX-100 and EPX-200 to its portfolio [6][7] - EPX-100 is currently in phase III registrational trials for Dravet Syndrome and Lennox-Gastaut Syndrome, while EPX-200 is in the pre-IND phase for developmental and epileptic encephalopathies [6]