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Harmony Biosciences NASDAQ: HRMY highlighted record quarterly performance for its narcolepsy treatment WAKIX and outlined development plans across its orexin, epilepsy and pitolisant lifecycle-management programs during Piper Sandler’s virtual CNS Symposium.

Peter Anastasiou, the company’s chief operating officer, said WAKIX’s seventh year on the market continued to demonstrate its role in narcolepsy treatment and the company’s commercial capabilities. He said the product’s performance supports investment in pipeline programs, including BP-205, and provides flexibility for potential business-development transactions.

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BP-205 Data Support Broad Orexin Development Plans
Chief Medical Officer Kumar Budur discussed initial clinical findings for BP-205, an orexin 2 receptor agonist being developed for narcolepsy and potentially other central nervous system indications. He described BP-205 as having a novel chemical scaffold, high potency and selectivity, and preclinical safety findings that did not indicate hepatotoxicity or cardiotoxicity concerns.

Harmony reported results from a randomized, double-blind, placebo-controlled single-ascending-dose study in 72 healthy volunteers. Doses ranged from 0.2 milligrams to 6 milligrams. Budur said the study showed a time to maximum concentration of 30 to 75 minutes, dose-proportional exposure across the evaluated range and a half-life of approximately 25 hours.

The company believes those pharmacokinetic characteristics could support once-daily dosing. Budur said once-daily administration could be beneficial for patient convenience and adherence, while the longer half-life could help maintain wakefulness later in the day.

In the single-ascending-dose study, reported adverse events included headache in approximately 10% of participants, fatigue in 4% and diarrhea in 3%. The company said it did not observe cardiovascular, hepatic or visual disturbances. Harmony has completed dosing in a multiple-ascending-dose study, where it observed target-engagement adverse events including insomnia and polyuria. Budur said insomnia was neither severe nor sustained, and no visual adverse events had been seen in the multiple-ascending-dose dataset to date.

Harmony expects to disclose the full multiple-ascending-dose dataset in the fourth quarter. It has opened an investigational new drug application in the U.S. and plans to begin a sleep-deprived healthy-volunteer study, with top-line data expected in early 2027.

Anastasiou said Harmony and partner Bioprojet intend to pursue a broad orexin strategy, potentially including a portfolio of orexin agonists. The company is evaluating potential uses in cognition, attention, mood and fatigue, in addition to narcolepsy and idiopathic hypersomnia. Harmony intends to initiate multiple Phase II studies for BP-205 in mid-2027, though it did not identify the specific indications.

EPX-100 Program Targets Dravet and Lennox-Gastaut Syndromes
Harmony also discussed EPX-100, or clemizole hydrochloride, which is in Phase III development for Dravet syndrome and Lennox-Gastaut syndrome. Anastasiou said the epilepsy markets remain characterized by polypharmacy and continued unmet need for both seizure control and tolerability.

According to Budur, prior open-label extension data in Dravet syndrome showed a median 50% reduction in countable motor seizures over 28 days among patients exposed to clemizole hydrochloride for at least six months. He said 50% of patients experienced a 50% reduction in seizure frequency. The patients were taking at least four antiseizure medicines, with clemizole used as adjunctive therapy.

The company said clemizole’s reported tolerability profile has not indicated a need for echocardiogram or liver-function monitoring. Budur said diarrhea, occurring in approximately 2% of patients, was the only adverse event of note in the data previously presented. Harmony plans to present an additional data cut at the American Epilepsy Society meeting later this year.

Harmony expects top-line data from its Phase III Dravet and Lennox-Gastaut studies in 2027 and anticipates a potential approval in 2028. The company said clemizole is administered twice daily, compared with three-times-daily dosing for bexicaserin, though Budur said comparative efficacy, safety and tolerability will need to be evaluated as additional data emerge.

Pitolisant Formulations Aim to Expand Treatment Options
Harmony also outlined plans for gastro-resistant and higher-dose formulations of pitolisant. The company has an April 27 PDUFA date for pitolisant GR, a gastro-resistant formulation intended to potentially reduce gastrointestinal side effects and allow patients to begin treatment at a therapeutic 17.8-milligram dose rather than titrating from a subtherapeutic dose.

Anastasiou said gastrointestinal symptoms are common among narcolepsy patients and may not necessarily be related to therapy. If approved, Harmony expects to use its existing sales force, marketing organization, specialty-pharmacy network and patient-support hub to commercialize the product. He added that the company has filed utility patents that could provide exclusivity into the 2040s.

Pitolisant HD, an optimized higher-dose formulation, is being evaluated in separate Phase III studies in narcolepsy and idiopathic hypersomnia. Harmony is studying doses up to 60 milligrams of pitolisant hydrochloride. The company expects top-line data in 2027 and a potential PDUFA in 2028.

Budur said the narcolepsy study will also assess fatigue, while the idiopathic hypersomnia study will assess sleep inertia. Anastasiou noted that idiopathic hypersomnia is not currently an indication for WAKIX, making it a potential new patient population for the company.

About Harmony Biosciences (NASDAQ:HRMY)Harmony Biosciences Holdings, Inc is a commercial‐stage biopharmaceutical company focused on developing and delivering therapies for people with rare neurological and endocrine diseases. Founded in 2017 and headquartered in Plymouth Meeting, Pennsylvania, Harmony Biosciences went public in 2020 and trades on the Nasdaq under the ticker HRMY. The company's mission centers on identifying and advancing medicines that address critical unmet needs in patient populations underserved by existing treatments.

The company's flagship product is WAKIX (pitolisant), the first and only histamine H3 receptor antagonist/inverse agonist approved by the U.S.

This instant news alert was generated by narrative science technology and financial data from MarketBeat in order to provide readers with the fastest reporting and unbiased coverage. Please send any questions or comments about this story to [email protected].

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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.