Harmony Biosciences Jumps on Positive Drug Study Results
Shares rise after pivotal study for a new formulation of its narcolepsy drug WAKIX meets primary goals, paving the way for a 2026 regulatory filing.
Shares of Harmony Biosciences (NASDAQ: HRMY) climbed in morning trading after the pharmaceutical company announced positive results from a pivotal study for a new formulation of its flagship narcolepsy drug, WAKIX (pitolisant).
The stock rose approximately 2.8% to $34.31 on Monday following the news that its new gastro-resistant (GR) version of pitolisant met the primary goals in a pivotal bioequivalence study. The results are a critical step toward securing regulatory approval and extending the commercial life of the company’s primary revenue driver.
Harmony’s WAKIX is the first and only FDA-approved treatment for excessive daytime sleepiness in adult patients with narcolepsy that is not scheduled as a controlled substance. The development of a new formulation is a key part of the company's strategy to enhance the product's profile and protect its market position. The company confirmed that the 17.8mg dose of the new formulation was bioequivalent to the existing 17.8mg WAKIX tablets.
“We are very pleased to have demonstrated bioequivalence for pitolisant GR which, along with the positive findings from our dosing optimization study, confirms its potential as a differentiated next-generation treatment option for narcolepsy patients,” said Kumar Budur, Harmony's Chief Medical and Scientific Officer, in a statement reported by StreetInsider.
A separate dosing study suggested an additional clinical benefit: patients were able to successfully start treatment at the therapeutic dose, potentially removing the need for dose titration. The company reported no new safety or tolerability issues across the studies.
The successful study clears the path for Harmony to submit a New Drug Application (NDA) to the U.S. Food and Drug Administration, which it plans to do in early 2026. This timeline targets a Prescription Drug User Fee Act (PDUFA) date, the deadline for the FDA to decide on the application, in the first quarter of 2027.
From a commercial standpoint, the new formulation could be significant. Harmony has filed utility patent applications for the gastro-resistant version that, if granted, could provide market exclusivity for the product until 2044. This would substantially extend the lifecycle of its core asset well beyond the patent expiry of the original WAKIX formulation.
The market is responding to both the clinical and financial implications of the news. With a market capitalization of nearly $2 billion, Harmony's reliance on WAKIX means that pipeline developments related to the drug are closely watched by investors. The company posted strong third-quarter 2025 results, with revenues of $239.5 million beating analyst forecasts.
Wall Street sentiment appears supportive of the company's strategy. Following the announcement, analysts at Oppenheimer reiterated their “Outperform” rating on the stock with a $62 price target, forecasting that WAKIX sales could surpass $1 billion by 2026, according to Investing.com. The consensus among analysts is a "Moderate Buy," with an average price target of $45.55.