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Key Takeaways Harmony Biosciences reported about $261M in preliminary Q2 2026 Wakix net product revenues, up 30% Y/Y.HRMY reaffirmed 2026 net product revenue guidance of $1.0-$1.04B after a strong first half.HRMY advances pitolisant programs and named an interim finance chief after its CFO stepped down. Harmony Biosciences (HRMY - Free Report) 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.

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HRMY’s CFO Steps DownHarmony 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 BusinessHarmony 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 - Free Report) and Novavax (NVAX - Free Report) , 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%.

Key Takeaways Harmony Biosciences reaffirmed Wakix guidance of $1.0-$1.04 billion after 17% revenue growth.HRMY plans a 2026 NDA filing for Pitolisant GR and expects late-stage data in 2027.HRMY is advancing epilepsy and orexin-2 programs to reduce reliance on Wakix revenues. Harmony Biosciences Holdings, Inc. (HRMY - Free Report) is trying to turn a successful narcolepsy franchise into a broader neuroscience platform.

The transition is funded by Wakix, which still does most of the commercial work. The question for investors is whether that cash-generating base can keep expanding while newer pitolisant products and non-pitolisant assets move closer to commercial relevance.

Why Harmony Still Leans on WakixWakix remains Harmony’s core commercial engine. First-quarter 2026 net product revenues rose 17% year over year to $215.4 million, and the company reiterated full-year Wakix net revenue guidance of $1.0-$1.04 billion.

The franchise benefits from broad payer coverage, rising prescriber familiarity and a differentiated profile as the only non-scheduled option in narcolepsy. Harmony exited the first quarter with roughly 8,600 patients on therapy, compared with about 80,000 diagnosed U.S. narcolepsy patients. That gap leaves room for adoption if plan changes, prior authorizations and other access frictions ease.

How HRMY Is Extending PitolisantHarmony is using lifecycle management to make pitolisant matter beyond the current Wakix label. Pitolisant GR is a gastro-resistant, bioequivalent formulation designed to let patients start at a therapeutic dose without titration and potentially reduce gastrointestinal tolerability issues.

The company expects to submit the Pitolisant GR new drug application in the second quarter of 2026, with a target action date in the first quarter of 2027. Pitolisant HD is further behind but potentially broader, with phase III programs in narcolepsy and idiopathic hypersomnia targeting differentiated labels tied to fatigue and sleep inertia. Top-line data are expected in 2027, with a potential action date in 2028.

Harmony Builds a Broader CNS PipelineThe broader pipeline is meant to reduce Harmony’s dependence on one commercial asset. EPX-100 is enrolling in two global phase III registrational trials in rare epilepsies, including Lennox-Gastaut syndrome and Dravet syndrome.

Harmony also holds rights to EPX-200 and is advancing BP1.15205, also known as BP-205, an orexin-2 receptor agonist with phase I clinical pharmacokinetic, safety and tolerability data from the single-ascending-dose portion expected in mid-2026. The amorphous pitolisant opportunity, supported by a patent running to 2042, adds another route into broader central nervous system indications. Jazz Pharmaceuticals plc (JAZZ - Free Report)  remains an important reference point in sleep medicine through its oxybate franchise, while Axsome Therapeutics, Inc. (AXSM - Free Report)  is relevant because AXS-12 is being developed for narcolepsy. Their presence underscores why Harmony is building across commercial, late-stage, early-stage and discovery-stage assets.

What Could Limit HRMY UpsideThe main risk is concentration. Wakix still drives Harmony’s revenues, so any slowdown in patient starts, persistence, reimbursement or pricing could pressure growth. Seasonal first-quarter access headwinds were more pronounced in 2026, showing that demand does not fully remove operational friction.

Competition is another constraint. The sleep-wake market is becoming more crowded, including orexin-2 programs and other narcolepsy approaches. Generic risk also matters. Harmony has settled with six of seven abbreviated new drug application filers, but earlier entry remains a concern if pediatric exclusivity does not extend protection as expected.

How Harmony’s Ratings Fit This StoryHarmony’s setup looks balanced rather than a clean near-term momentum call. The stock currently carries a Zacks Rank #3 (Hold), which points to an in-line short-term earnings outlook rather than a clear buy or sell signal. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

The Style Scores tell a more nuanced story. HRMY has a VGM Score of A, a Value Score of A and a Growth Score of B, suggesting favorable valuation and business-growth characteristics. Its Momentum Score of D is the offset, indicating weaker trading momentum. A longer-term Neutral view fits that mix, as Wakix durability and pipeline optionality are meaningful, but access friction, competition and patent timing keep the growth story from being risk-free.