HRMY Posts Preliminary Q2 Revenues, Announces CFO Transition

Harmony Biosciences HRMY announced preliminary second-quarter 2026 results.

The company registered a record $261 million in net product revenues from its lead drug, Wakix (pitolisant).

Wakix received FDA approval in August 2019 to treat excessive daytime sleepiness (EDS) in adults with narcolepsy and was launched in the United States in November 2019. In October 2020, the FDA expanded its approval to include the treatment of cataplexy in adults with narcolepsy.

Revenues increased 30% year over year and 21% sequentially from the first quarter, reflecting continued strong demand and solid commercial execution.

Encouraged by its first-half performance, the company reiterated its full-year 2026 net product revenue guidance of $1.0 billion to $1.04 billion, signaling confidence in sustained growth for the remainder of the year.

Harmony is scheduled to report its complete second-quarter 2026 financial results and provide a business update on Aug. 4, 2026.

Shares of HRMY have lost 10.4% year to date against the industry’s 1.7% gain.

Image Source: Zacks Investment Research

HRMY’s CFO Steps Down

Harmony announced that chief financial officer (CFO) Glenn Reicin has stepped down, effective July 16, 2026, to pursue other opportunities.

The company appointed Stephen Mollichella, currently senior vice president and controller, as interim principal financial officer while it conducts a search for a permanent CFO.

HRMY’s Efforts to Strengthen Business

Harmony is pursuing label expansion opportunities for pitolisant beyond narcolepsy, targeting rare neurological disorders such as Prader-Willi syndrome (PWS) and myotonic dystrophy type 1 (DM1).

The company is conducting the phase III TEMPO study in PWS, supported by FDA alignment, which has the potential to serve as the registrational trial and support the company’s efforts to seek pediatric exclusivity for pitolisant.

The FDA granted Orphan Drug designation to pitolisant for the treatment of PWS in 2024.

In DM1, phase II data demonstrated meaningful improvements in EDS and fatigue, supporting further development.

Wakix has also expanded into the pediatric narcolepsy market, with FDA approval for EDS in 2024.

In February 2026, the FDA also approved Wakix for the treatment of cataplexy in patients six years and older with narcolepsy, providing additional long-term growth opportunities for the franchise.

Meanwhile, Harmony is advancing two next-generation formulations of pitolisant to strengthen and extend this franchise.

The company is on track to submit a new drug application for pitolisant GR (gastro-resistant) shortly. A decision from the FDA is expected in the first quarter of 2027. The formulation features an enteric coating designed to reduce gastrointestinal side effects, allowing patients to start treatment at a therapeutic dose without titration. Harmony has filed utility patents that could extend the pitolisant franchise into the 2040s.

HRMY is also developing pitolisant HD (high dose) to further expand the franchise. Phase III studies are underway in narcolepsy (ONSTRIDE 1) and idiopathic hypersomnia (ONSTRIDE 2), with top-line data expected in 2027. The enhanced formulation is designed to improve efficacy through optimized pharmacokinetics, an enteric coating and a higher dose, while supporting differentiated labeling for fatigue in narcolepsy and sleep inertia in idiopathic hypersomnia. Utility patents for Pitolisant HD have also been filed, supporting franchise protection into the 2040s.

HRMY’s Zacks Rank and Other Stocks to Consider 

HRMY currently carries a Zacks Rank #1 (Strong Buy). A couple of other top-ranked stocks from the sector are Liquidia Corporation LQDA and Novavax NVAX, each sporting a Rank #1 at present. You can see the complete list of today’s Zacks #1 Rank stocks here.

Over the past 60 days, estimates for Liquidia’s 2026 earnings per share (EPS) have increased from $2.97 to $3.02. Over the same period, EPS estimates for 2027 have also increased from $4.81 to $4.92. LQDA shares have skyrocketed more than 118.3% year to date.

Liquidia’s earnings beat estimates in three of the trailing four quarters and missed in the remaining one, with the average surprise being 54.40%.

Over the past 60 days, estimates for Novavax’s 2026 loss per share have narrowed from 20 cents to 19 cents. Over the same period, loss per share estimates for 2027 have narrowed from 31 cents to 25 cents. NVAX shares have gained nearly 22.7% year to date.

Novavax’s earnings beat estimates in each of the trailing four quarters, with the average surprise being 305.24%.
 


 

7 Best Stocks for the Next 30 Days

Just released: Experts distill 7 elite stocks from the current list of 220 Zacks Rank #1 Strong Buys. They deem these tickers "Most Likely for Early Price Pops."

Since 1988, the full list has beaten the market more than 2X over with an average gain of +23.9% per year. So be sure to give these hand picked 7 your immediate attention. 

Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report

This article originally published on Zacks Investment Research (zacks.com).

Zacks Investment Research

Source Zacks-com