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2026-10-21 07:49 4d ago
2026-10-21 02:46 4d ago
Harmony Biosciences čelí riziku patentového sporu s AET
HRMY Harmony Biosciences Holdings
FMP Stock News 90
Original source text
SummaryHarmony Biosciences is rated Buy with a 12-month price target of $43, reflecting strong cash generation and WAKIX growth.HRMY's valuation is supported by WAKIX's robust performance, cash reserves, and limited downside if patents hold through 2030.Key risks include the pending AET patent litigation and management turnover, with significant near-term binary events ahead.Pipeline assets and new formulations offer optionality, but current price largely reflects WAKIX and cash, making position sizing critical.Tom Werner/DigitalVision via Getty Images

Harmony Biosciences (HRMY) is the kind of stock I find easiest to think about in options terms. The company closed at $37.95 on Friday. At that price, you're buying three things at once.

The first

40 Followers

Analyst’s Disclosure: I/we have no stock, option or similar derivative position in any of the companies mentioned, and no plans to initiate any such positions within the next 72 hours. I wrote this article myself, and it expresses my own opinions. I am not receiving compensation for it (other than from Seeking Alpha). I have no business relationship with any company whose stock is mentioned in this article.

Seeking Alpha's Disclosure: Past performance is no guarantee of future results. No recommendation or advice is being given as to whether any investment is suitable for a particular investor. Any views or opinions expressed above may not reflect those of Seeking Alpha as a whole. Seeking Alpha is not a licensed securities dealer, broker or US investment adviser or investment bank. Our analysts are third party authors that include both professional investors and individual investors who may not be licensed or certified by any institute or regulatory body.
2026-10-16 14:25 9d ago
2026-10-16 09:15 9d ago
Akcie Harmony Biosciences vzrostly díky tržbám přípravku Wakix
HRMY Harmony Biosciences Holdings
FMP Stock News 90
Original source text
Key Takeaways Harmony Biosciences shares rise 27.6% in six months, fueled by strong Wakix demand and pipeline progress.Wakix sales climb 24% to $476.7 million in the first half of 2026, supporting $1.0-$1.04B revenue target.Pipeline advances in BP-205 and EPX-100 offer growth opportunities. The going has been strong for Harmony Biosciences Holdings, Inc.  (HRMY - Free Report) over the past six months. Shares of this pharmaceutical company have surged 27.6% over the said time frame against the industry’s decline of 2.2%. The stock has also outperformed the sector and the S&P 500 Index during this period.

HRMY’s robust rally has been driven by better-than-expected quarterly results, which can be attributed to robust demand for lead drug Wakix (pitolisant) and encouraging pipeline progress.

HRMY Outperforms Industry, Sector and S&P 500 Index
Image Source: Zacks Investment Research

Against this backdrop, a closer evaluation of the company’s strengths and weaknesses can help assess its attractiveness as an investment opportunity.

Wakix Drives HRMY’s Strong Revenue GrowthSustained demand for lead drug Wakix, approved for excessive daytime sleepiness in adults with narcolepsy, is driving top-line growth for the company.

Sales of the drug totaled $476.7 million in the first half of 2026, up 24% from the first half of 2025.

The average patient count rose by 450 to 8,950 in the second quarter. The growth can be attributed to strong demand for Wakix, effective commercial execution and the drug’s broad clinical utility.

With approximately 80,000 diagnosed narcolepsy patients in the United States, Wakix has significant market potential to support continued revenue growth.

HRMY remains on track to achieve its 2026 Wakix revenue guidance of $1.0-$1.04 billion.

Planned franchise expansions include gastro-resistant pitolisant tablets, with a potential launch in the first half of 2027, and high-dose pitolisant, which is being evaluated in phase III studies for narcolepsy and idiopathic hypersomnia.

Additional opportunities include a phase III study on Wakix in Prader-Willi syndrome, with top-line data expected in mid-2027.

These initiatives could broaden pitolisant's reach, extend its commercial life and support future revenue growth.

However, patent litigation and potential generic competition remain important risks.

Pipeline Progress Offers Additional Growth OpportunitiesBeyond Wakix, Harmony is advancing a diversified pipeline that could create new growth drivers.

BP-205, an investigational orexin-2 receptor agonist, is a key asset, with phase I single ascending-dose data demonstrating favorable pharmacokinetics, a half-life of approximately 25 hours and a generally favorable safety and tolerability profile.

Its potential for rapid onset and once-daily dosing supports further development, with multiple ascending-dose data expected in the fourth quarter of 2026 and phase II studies across multiple central nervous system indications scheduled to begin in mid-2027.

Meanwhile, EPX-100 (clemizole hydrochloride) is being evaluated in phase III studies for Lennox-Gastaut syndrome and Dravet syndrome, with top-line data expected in the first half of 2027.

Harmony also has $962.5 million in cash, cash equivalents and investments, providing financial flexibility to fund pipeline development and pursue business development opportunities. These programs offer meaningful long-term upside, although their commercial potential will depend on clinical outcomes and regulatory approvals.

HRMY: Valuation & EstimatesGoing by the price/sales ratio, shares currently trade at 1.98X forward sales, lower than its mean of 2.51X and the biotech industry’s value of 2.06X.

Image Source: Zacks Investment Research

The bottom-line estimate for 2026 has remained unchanged and the same for 2027 has increased 8 cents to $4.06, over the past 60 days.

Image Source: Zacks Investment Research

Invest in HRMYStrong Wakix growth, expanding pitolisant franchise, promising pipeline and solid liquidity position should maintain momentum for HRMY.

The company’s reaffirmed full-year revenue guidance of $1.0-$1.04 billion highlights Wakix’s commercial strength.

Planned launches of new pitolisant formulations and potential label expansions could further extend the franchise’s growth trajectory, while pipeline candidates BP-205 and EPX-100 offer additional long-term revenue opportunities.

HRMY’s ability to generate substantial revenues and earnings from its marketed product provides a foundation for continued investment in new growth opportunities, despite patent litigations.

However, competition in the narcolepsy market remains significant. Jazz Pharmaceuticals (JAZZ - Free Report) competes with Xywav, while Alkermes (ALKS - Free Report) markets Lumryz (following the acquisition of Avadel Pharmaceuticals plc), an extended-release sodium oxybate treatment for narcolepsy.

JAZZ reported strong growth in Xywav, with approximately 17,125 active patients on treatment at the end of the second quarter of 2026. Of these, around 11,275 had narcolepsy and 5,850 had idiopathic hypersomnia.

ALKS’s pipeline also includes alixorexton, Alkermes' novel, investigational, oral, selective orexin 2 receptor agonist in development for the treatment of narcolepsy type 1, narcolepsy type 2 and idiopathic hypersomnia.

Nevertheless, continued Wakix growth and the potential expansion of its product portfolio provide a favorable foundation for long-term growth. We recommend the stock to prospective investors, while existing shareholders should hold their positions, as we believe the company has further growth potential.

HRMY currently sports a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
 
2026-10-13 00:10 12d ago
2026-10-12 19:16 13d ago
Akcie Harmony Biosciences klesly po změně generálního ředitele
HRMY Harmony Biosciences Holdings
FMP Stock News 88
Original source text
Harmony Biosciences (HRMY -5.09%) is getting a new leader, but investors aren't happy about it. On news of a major C-Suite change, they eagerly sold shares in the pharmaceutical company to leave it with more than a 5% loss on Monday.

New boss incoming
That morning, Harmony announced that its current COO and member of its board, Peter Anastasiou, is to become CEO, effective Jan. 1, 2027. In a planned succession, he will replace the healthcare company's current chief, Jeffrey Dayno, who will stay with Harmony in an advisory role throughout that year.

Image source: Getty Images.

In the press release announcing the move, Harmony signaled a "steady as she goes" approach. The company stated that it will stick with its current strategic priorities, including further development of its molecule, pitolisant (approved by the Food and Drug Administration under the brand name Wakix for certain sleep disorders), and advancement of its pipeline.

In addition to detailing the CEO change, Harmony also reiterated its full-year net revenue guidance for Wakix. The drug should maintain its blockbuster status, with net revenue of $1 billion to $1.04 billion. The company added that its assumptions for hitting key commercial and pipeline milestones remain unchanged.

Premium Feature

Moneyball Superscore

74/100

Today's Change

(

-5.09

%) $

-2.05

Current Price

$

38.23

Rite of passage?
Personally, I'm not seeing much in that press release to be gloomy about.

That said, change can be hard for investors, particularly when an outgoing CEO has led a company to success -- as in the case of Dayno, who deserves significant credit in the development of Wakix (he was chief medical officer at the time). I'd probably take this opportunity to load up on the still high-potential Harmony at a discount.

Eric Volkman has no position in any of the stocks mentioned. The Motley Fool has no position in any of the stocks mentioned. The Motley Fool has a disclosure policy.
2026-09-03 16:54 1mo ago
2026-09-03 12:31 1mo ago
Harmony Biosciences ve 2. čtvrtletí překonala odhady díky Wakixu
HRMY Harmony Biosciences Holdings
FMP Stock News 78
Original source text
A month has gone by since the last earnings report for Harmony Biosciences Holdings, Inc. (HRMY - Free Report) . Shares have added about 12.1% in that time frame, outperforming the S&P 500.

Will the recent positive trend continue leading up to its next earnings release, or is Harmony Biosciences due for a pullback? Well, first let's take a quick look at its latest earnings report in order to get a better handle on the recent catalysts for Harmony Biosciences Holdings, Inc. before we dive into how investors and analysts have reacted as of late.

HRMY Q2 Earnings Beat Estimates on Strong Wakix Sales

Harmony Biosciences Holdings reported second-quarter 2026 earnings of $1.28 per share, up from 68 cents in the year-ago quarter. The figure surpassed the Zacks Consensus Estimate of 97 cents.

Quarterly revenues rose 30% year over year to $261.28 million and surpassed the Zacks Consensus Estimate of $253 million. Growth was driven by sustained demand for lead drug, Wakix (pitolisant), with the estimated average patient count increasing by 450 sequentially to 8,950.

HRMY Q2 Cost Analysis

Cost of products sold represented 24.2% of product revenues compared with 19% in the prior-year quarter, primarily due to new royalties tied to the Novitium license agreement.

Research and development expenses declined 7.1% to $46.6 million, reflecting the absence of a $15-million CiRC upfront payment recorded a year ago. Sales and marketing expenses increased 13.5% to $34.1 million due to the expansion of field-based teams.

General and administrative expenses decreased 17.3% to $28.1 million due to a charge related to an ANDA settlement in the second quarter of 2025.

Cash, cash equivalents and investments totaled $962.5 million as of June 30, 2026, up from $882.5 million as of 2025-end.

Harmony Pipeline Updates Highlight BP-205

In April 2024, the company expanded into orexin-based therapies through a sublicense agreement with Bioprojet for BP-205, an investigational orexin-2 receptor agonist being developed for narcolepsy and other central nervous system (CNS) disorders.

The agreement grants exclusive rights to develop, manufacture and commercialize BP-205 in the United States and Latin America.

Harmony reported favorable phase I single-ascending-dose data for BP-205, its orexin-2 receptor agonist. The candidate demonstrated a short time to maximum plasma concentration (30-75 minutes) and a mean half-life of approximately 25 hours, supporting the potential for rapid onset and once-daily dosing.

Exposure increased proportionally across the tested doses. BP-205 was generally safe and well tolerated, with no serious or severe treatment-emergent adverse events.

Multiple-ascending-dose data in healthy volunteers are expected in the fourth quarter of 2026. Harmony also plans to begin a phase Ib study in sleep-deprived healthy volunteers during the third quarter, with data expected in early 2027.

Phase II studies across multiple central nervous system indications are scheduled to begin in mid-2027.

HRMY Advances Pitolisant and Epilepsy Assets

The FDA accepted the new drug application for pitolisant GR, assigning a target action date of April 1, 2027. The gastro-resistant formulation is designed to reduce gastrointestinal side effects and allow patients to begin treatment at a therapeutic dose without titration.

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).

Phase III ONSTRIDE studies of high-dose pitolisant in narcolepsy and idiopathic hypersomnia remain underway, with top-line data expected in 2027. Top-line results are expected in mid-2027.

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.

The company also strengthened its rare epilepsy pipeline by acquiring Epygenix Therapeutics, gaining exclusive rights to develop EPX-100 (clemizole hydrochloride) for Dravet syndrome (DS) and Lennox-Gastaut syndrome (LGS).
EPX-100 is being evaluated in the phase III LIGHTHOUSE study for LGS and the ARGUS study for DS. Top-line results from both rare-epilepsy programs are expected in the first half of 2027, with potential regulatory action targeted for 2028.

Harmony Reiterates 2026 Revenue Outlook

Harmony reaffirmed its 2026 Wakix net revenue guidance of $1 billion to $1.04 billion.

Wakix net product revenues rose 21% sequentially in the second quarter, reflecting a rebound from the seasonal market-access headwinds that affected patient starts during the first quarter.

Management expects patient growth to continue steadily through the second half of the year, supported by the expanded commercial infrastructure.

The average patient increase was the second highest in the product’s seven-year commercial history. Four of the past five quarters generated more than 400 patient additions, indicating steady demand within the narcolepsy market.

Management attributed the strong performance to Wakix’s position as the only non-scheduled treatment option for narcolepsy. The product has payer coverage for more than 80% of covered lives and is used both as a standalone therapy and in combination with other narcolepsy therapies.

How Have Estimates Been Moving Since Then?It turns out, estimates revision have trended upward during the past month.

VGM ScoresAt this time, Harmony Biosciences has a great Growth Score of A, though it is lagging a lot on the Momentum Score front with a C. However, the stock has a grade of A on the value side, putting it in the top 20% for value investors.

Overall, the stock has an aggregate VGM Score of A. If you aren't focused on one strategy, this score is the one you should be interested in.

OutlookEstimates have been trending upward for the stock, and the magnitude of these revisions looks promising. Interestingly, Harmony Biosciences has a Zacks Rank #3 (Hold). We expect an in-line return from the stock in the next few months.

Performance of an Industry PlayerHarmony Biosciences belongs to the Zacks Medical - Biomedical and Genetics industry. Another stock from the same industry, Myriad Genetics (MYGN - Free Report) , has gained 2.5% over the past month. More than a month has passed since the company reported results for the quarter ended June 2026.

Myriad reported revenues of $190.7 million in the last reported quarter, representing a year-over-year change of -10.5%. EPS of -$0.25 for the same period compares with $0.05 a year ago.

For the current quarter, Myriad is expected to post a loss of $0.16 per share, indicating a change of 0% from the year-ago quarter. The Zacks Consensus Estimate has changed -118.2% over the last 30 days.

Myriad has a Zacks Rank #5 (Strong Sell) based on the overall direction and magnitude of estimate revisions. Additionally, the stock has a VGM Score of B.
2026-08-14 14:50 2mo ago
2026-08-14 10:05 2mo ago
Harmony Biosciences oznamuje rekord WAKIX a rozvoj pipeline
HRMY Harmony Biosciences Holdings
FMP Stock News 78
Original source text
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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2026-08-04 14:10 2mo ago
2026-08-04 09:51 2mo ago
Harmony Biosciences překonala odhady zisku i tržeb
HRMY Harmony Biosciences Holdings
FMP Stock News 78
Original source text
Harmony Biosciences Holdings, Inc. (HRMY - Free Report) came out with quarterly earnings of $1.28 per share, beating the Zacks Consensus Estimate of $0.97 per share. This compares to earnings of $0.68 per share a year ago. These figures are adjusted for non-recurring items.

This quarterly report represents an earnings surprise of +31.96%. A quarter ago, it was expected that this company would post earnings of $0.76 per share when it actually produced earnings of $0.55, delivering a surprise of -27.63%.

Over the last four quarters, the company has surpassed consensus EPS estimates just once.

Harmony Biosciences, which belongs to the Zacks Medical - Biomedical and Genetics industry, posted revenues of $261.28 million for the quarter ended June 2026, surpassing the Zacks Consensus Estimate by 3.46%. This compares to year-ago revenues of $200.49 million. The company has topped consensus revenue estimates three times over the last four quarters.

The sustainability of the stock's immediate price movement based on the recently-released numbers and future earnings expectations will mostly depend on management's commentary on the earnings call.

Harmony Biosciences shares have lost about 4.9% since the beginning of the year versus the S&P 500's gain of 11%.

What's Next for Harmony Biosciences?While Harmony Biosciences has underperformed the market so far this year, the question that comes to investors' minds is: what's next for the stock?

There are no easy answers to this key question, but one reliable measure that can help investors address this is the company's earnings outlook. Not only does this include current consensus earnings expectations for the coming quarter(s), but also how these expectations have changed lately.

Empirical research shows a strong correlation between near-term stock movements and trends in earnings estimate revisions. Investors can track such revisions by themselves or rely on a tried-and-tested rating tool like the Zacks Rank, which has an impressive track record of harnessing the power of earnings estimate revisions.

Ahead of this earnings release, the estimate revisions trend for Harmony Biosciences was favorable. While the magnitude and direction of estimate revisions could change following the company's just-released earnings report, the current status translates into a Zacks Rank #1 (Strong Buy) for the stock. So, the shares are expected to outperform the market in the near future. You can see the complete list of today's Zacks #1 Rank (Strong Buy) stocks here.

It will be interesting to see how estimates for the coming quarters and the current fiscal year change in the days ahead. The current consensus EPS estimate is $0.99 on $271.8 million in revenues for the coming quarter and $3.33 on $1.03 billion in revenues for the current fiscal year.

Investors should be mindful of the fact that the outlook for the industry can have a material impact on the performance of the stock as well. In terms of the Zacks Industry Rank, Medical - Biomedical and Genetics is currently in the top 42% of the 250 plus Zacks industries. Our research shows that the top 50% of the Zacks-ranked industries outperform the bottom 50% by a factor of more than 2 to 1.

Alvotech (ALVO - Free Report) , another stock in the same industry, has yet to report results for the quarter ended June 2026.

This company is expected to post quarterly loss of $0.06 per share in its upcoming report, which represents a year-over-year change of -142.9%. The consensus EPS estimate for the quarter has remained unchanged over the last 30 days.

Alvotech's revenues are expected to be $99.24 million, down 42.8% from the year-ago quarter.
2026-07-17 19:49 3mo ago
2026-07-17 15:26 3mo ago
Harmony Biosciences oznamuje 30% růst tržeb z Wakix
HRMY Harmony Biosciences Holdings
FMP Stock News 86
Original source text
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.

Image Source: Zacks Investment Research

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%.
2026-06-29 20:14 3mo ago
2026-06-29 14:41 3mo ago
Harmony Biosciences rozšiřuje Wakix do vzácných poruch
HRMY Harmony Biosciences Holdings
FMP Stock News 78
Original source text
Key Takeaways Harmony Biosciences is expanding pitolisant into idiopathic hypersomnia and rare disorders.HRMY is advancing Pitolisant GR and HD to improve dosing, tolerability and differentiation.HRMY is developing BP-205 and EPX-100 to broaden its neuroscience pipeline footprint. Harmony Biosciences Holdings, Inc. (HRMY - Free Report) is no longer only a Wakix revenue story. The company is using its sleep-wake franchise to fund a broader neuroscience strategy.

The central question is whether those emerging growth trends can turn pipeline investment into a more diversified business before competition and exclusivity risks pressure the core product.

Harmony Pushes Beyond One IndicationHarmony is working to extend pitolisant beyond its established narcolepsy base. Its late-stage clinical work includes idiopathic hypersomnia, Prader-Willi syndrome and myotonic dystrophy type 1.

That approach reflects a broader attempt to extract more value from an established mechanism across adjacent neurological settings. Rather than relying only on new patient starts in narcolepsy, HRMY is trying to build a wider clinical footprint around the same scientific foundation.

Why HRMY Is Chasing Better FormulationsPitolisant Gastro-Resistant and Pitolisant High-Dose are central to that lifecycle strategy. The gastro-resistant version is intended to allow patients to start at a therapeutic dose without titration, while potentially improving tolerability for patients prone to gastrointestinal symptoms.

The high-dose version targets a more differentiated label. Ongoing Phase III programs in narcolepsy and idiopathic hypersomnia are aimed at fatigue in narcolepsy and sleep inertia in idiopathic hypersomnia, with top-line data expected in 2027 and a target action date in 2028. For HRMY, formulation work is not just incremental. It is a way to defend the franchise and sharpen commercial positioning.

How Harmony Is Entering Orexin and Rare EpilepsyHarmony’s BP1.15205 program moves the company into orexin-2 receptor agonism, an emerging area in sleep-wake therapeutics. The candidate is being developed for narcolepsy and other potential indications, and Harmony has described BP-205 as a highly potent, selective orexin-2 receptor agonist with potential once-daily dosing.

The company is also moving deeper into rare epilepsy through EPX-100, or clemizole hydrochloride. EPX-100 is enrolling in two global Phase III registrational trials in Lennox-Gastaut syndrome and Dravet syndrome. Jazz Pharmaceuticals plc (JAZZ - Free Report) , which has exposure to rare sleep disorders and rare epilepsies, offers a useful comparison for how sleep and epilepsy franchises can sit within one neuroscience business.

Alkermes plc (ALKS - Free Report) , another neuroscience-focused peer, also highlights investor interest in central nervous system portfolios beyond single-product stories.

What Competition Means for HRMY’s FutureMore treatment development in narcolepsy and related disorders can help validate demand. A more active category may increase physician awareness, expand payer familiarity and reinforce the need for differentiated therapies.

The same trend also raises pressure. Multiple orexin-2 receptor agonists are moving toward approval or late-stage development, while Harmony’s BP-205 remains early. More choices could narrow the window for differentiation, increase payer scrutiny and make execution around access, positioning and persistence more important.

How Harmony’s Ratings Reflect These TrendsThe bottom line is that Harmony has credible growth trends, but the stock still needs proof that they can translate into broader revenue durability. Wakix remains the commercial engine, while pitolisant lifecycle programs, orexin science and rare epilepsy assets represent the next phase of the story.

HRMY carries a Zacks Rank #3 (Hold), which points to a more balanced short-term setup rather than a clear momentum call. Its Value Score of A and VGM Score of A suggest the stock screens well on valuation and combined style characteristics, while its Growth Score of B supports the view that fundamental expansion remains part of the case.

The Momentum Score of D tempers that message. Investors may need patience as the market waits for clearer evidence from Pitolisant GR, Pitolisant HD, BP-205 and EPX-100. The signals line up with a company investing into promising trends, but not yet with a stock that has fully earned a breakout narrative.
2026-06-29 20:14 3mo ago
2026-06-29 14:41 3mo ago
Harmony Biosciences potvrzuje výhled tržeb Wakix
HRMY Harmony Biosciences Holdings
FMP Stock News 78
Original source text
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.