Shares of Harmony Biosciences (HRMY) surged 5.02% on Tuesday, following the company's strong fourth-quarter earnings release and updates on its pipeline progress and patent protection for its lead drug pitolisant.
The biopharmaceutical company focused on rare neurological diseases reported Q4 net product revenue of $201.3 million, beating estimates of $201 million. Its adjusted earnings of $1.08 per share also exceeded the consensus forecast of $0.74. For full year 2024, Harmony's net product revenue grew 23% year-over-year to $714.7 million, driven by continued strong demand for its narcolepsy drug WAKIX (pitolisant).
Harmony provided 2025 net revenue guidance in the range of $820-860 million, reflecting its confidence in WAKIX achieving over $1 billion in sales from the narcolepsy indication alone. The company also announced reaching a settlement with Novogen Pharma regarding its generic pitolisant challenge, allowing Novogen to launch its generic version from January 2030 or earlier under certain circumstances. This outcome reinforced the strength of Harmony's intellectual property for pitolisant.
On the pipeline front, Harmony remains on track to initiate two Phase 3 trials for its high-dose pitolisant formulation in the fourth quarter of 2025, targeting narcolepsy and idiopathic hypersomnia indications. Top-line data from these studies is anticipated in 2027, with potential approval in 2028. The company is also expecting top-line results in Q3 2025 from the Phase 3 RECONNECT study evaluating its transdermal synthetic cannabidiol ZYN002 in Fragile X syndrome, with prospects of becoming the first approved treatment for this rare genetic disorder.
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