Harmony Biosciences (NASDAQ:HRMY – Get Free Report) and Sonoma Pharmaceuticals (NASDAQ:SNOA – Get Free Report) are both healthcare companies, but which is the better business? We will compare the two businesses based on the strength of their profitability, valuation, institutional ownership, dividends, risk, analyst recommendations and earnings.
Institutional and Insider Ownership 86.2% of Harmony Biosciences shares are owned by institutional investors. Comparatively, 1.9% of Sonoma Pharmaceuticals shares are owned by institutional investors. 11.0% of Harmony Biosciences shares are owned by insiders. Comparatively, 1.0% of Sonoma Pharmaceuticals shares are owned by insiders. Strong institutional ownership is an indication that large money managers, endowments and hedge funds believe a stock is poised for long-term growth.
Profitability This table compares Harmony Biosciences and Sonoma Pharmaceuticals’ net margins, return on equity and return on assets.
Net Margins Return on Equity Return on Assets Harmony Biosciences 18.88% 20.06% 14.15% Sonoma Pharmaceuticals -10.33% -21.41% -6.08% Analyst Ratings This is a breakdown of recent ratings and recommmendations for Harmony Biosciences and Sonoma Pharmaceuticals, as reported by MarketBeat.com. Sell Ratings Hold Ratings Buy Ratings Strong Buy Ratings Rating Score Harmony Biosciences 1 5 5 0 2.36 Sonoma Pharmaceuticals 1 0 0 0 1.00 Harmony Biosciences presently has a consensus price target of $47.11, suggesting a potential upside of 11.51%. Given Harmony Biosciences’ stronger consensus rating and higher possible upside, equities analysts plainly believe Harmony Biosciences is more favorable than Sonoma Pharmaceuticals.
Risk & Volatility Harmony Biosciences has a beta of 0.93, meaning that its stock price is 7% less volatile than the S&P 500. Comparatively, Sonoma Pharmaceuticals has a beta of 1.31, meaning that its stock price is 31% more volatile than the S&P 500.
Earnings & Valuation This table compares Harmony Biosciences and Sonoma Pharmaceuticals”s revenue, earnings per share and valuation.
Gross Revenue Price/Sales Ratio Net Income Earnings Per Share Price/Earnings Ratio Harmony Biosciences $868.45 million 2.83 $158.69 million $3.08 13.72 Sonoma Pharmaceuticals $19.53 million 0.32 -$3.17 million ($1.22) -1.09 Harmony Biosciences has higher revenue and earnings than Sonoma Pharmaceuticals. Sonoma Pharmaceuticals is trading at a lower price-to-earnings ratio than Harmony Biosciences, indicating that it is currently the more affordable of the two stocks.
Summary Harmony Biosciences beats Sonoma Pharmaceuticals on 13 of the 14 factors compared between the two stocks.
(Get Free Report)
Harmony Biosciences Holdings, Inc., a commercial-stage pharmaceutical company, focuses on developing and commercializing therapies for patients with rare and other neurological diseases in the United States. The company offers WAKIX (pitolisant), a molecule with a novel mechanism of action for the treatment of excessive daytime sleepiness in adult patients with narcolepsy. It also offers HBS-102, a melanin-concentrating hormone receptor 1 for MCH neurons. The company was formerly known as Harmony Biosciences II, Inc. and changed its name to Harmony Biosciences Holdings, Inc. in February 2020. Harmony Biosciences Holdings, Inc. was incorporated in 2017 and is headquartered in Plymouth Meeting, Pennsylvania.
About Sonoma Pharmaceuticals (Get Free Report)
Sonoma Pharmaceuticals, Inc., develops and produces stabilized hypochlorous acid (HOCl) products for wound care, animal health care, eye care, oral care, and dermatological conditions in the United States, Latin America, Europe, Asia, and internationally. The company offers Regenacyn, a prescription scar gel; Pediacyn, a pediatric dermatology and wound care product for over-the-counter (OTC) use; Epicyn, an Antimicrobial Facial Cleanser; Levicyn, an HOCl based prescription and OTC product to use and relieve skin irritations, lacerations, abrasions, and burns; Celacyn, a scar management gel; and SebuDerm to manage and relieve the burning, itching, erythema, scaling, and pain associated with seborrhea and seborrheic dermatitis. It also provides Gramaderm for the treatment of topical mild to moderate acne; Microcyn, a HOCl-based topical line of products designed to stimulate expedited healing by targeting a wide range of pathogens; Ocucyn eyelid and eyelash cleanser; Microdacyn60 oral care solution for the treatment of mouth and throat infections; and Podiacyn, a foot care product. In addition, the company offers MicrocynAH, an HOCl-based solution designed to relieve common symptoms of hot spots, scratches, skin rashes post-surgical sites, and irritated animal skin for healing; MicrocynVS, a veterinarian-strength animal care product used in vet clinics and animal hospitals; Nanocyn, a hospital-grade disinfectant; Acuicyn, an antimicrobial prescription solution for the treatment of blepharitis and the daily hygiene of eyelids and lashes; MucoClyns for the use in emergencies and safe to use on mucous membranes, cuts, abrasions, burns, and body surfaces; Endocyn root canal irrigation solutions; and Sinudox for nasal irrigation. The company was formerly known as Oculus Innovative Sciences, Inc. and changed its name to Sonoma Pharmaceuticals, Inc. in December 2016. Sonoma Pharmaceuticals, Inc. was incorporated in 1999 and is based in Boulder, Colorado.
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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.
PLYMOUTH MEETING, Pa., Sept. 03, 2026 (GLOBE NEWSWIRE) -- Harmony Biosciences Holdings, Inc. (Nasdaq: HRMY) today announced that it will present encore data from the company’s investigation of EPX-100 (clemizole hydrochloride) at the 16th European Epilepsy Congress being held from September 5-9, in Athens, Greece.
The company is investigating EPX-100 for the treatment of Dravet syndrome and Lennox-Gastaut syndrome in the ongoing ARGUS and LIGHTHOUSE trials, respectively. These trials are currently enrolling, and more information can be found at argustrial.com and lighthouselgsstudy.com.
Poster presentation details are listed below:
Abstract Title: EPX-100 as Adjunctive Therapy in Patients with Dravet Syndrome: Preliminary Results From the Open-Label Extension Phase of the ARGUS Study
Poster #: P0342Date/Time: September 6, from 2:00-3:00 pm EEST Abstract Title: A Drug-Drug Interaction Study of EPX-100 (Clemizole Hydrochloride) With Clinical Probe Substrates for Selected CYP EnzymesPoster #: P0331Date/Time: September 6, from 2:00-3:00 pm EEST About Clemizole Hydrochloride (EPX-100)
EPX-100, clemizole hydrochloride, is under development for the treatment of Dravet syndrome (DS) and Lennox-Gastaut syndrome (LGS). EPX-100 acts by targeting central 5-hydroxytryptamine receptors to modulate serotonin signaling. The drug candidate is administered orally twice a day in a liquid formulation and has been developed based on a proprietary phenotype-based zebrafish drug screening platform. DS is caused by a loss of function mutation in the SCN1A gene, and scn1 mutant zebrafish replicate the genetic etiology and phenotype observed in the majority of individuals with DS. The scn1Lab mutant zebrafish model that expresses voltage gated sodium channels has been used for high-throughput screening of compounds that modulate Nav1.1 in the central nervous system.
About Dravet Syndrome
Dravet syndrome (DS) is a severe and progressive epileptic encephalopathy that begins in infancy and causes significant impact on patient functioning. DS begins in the first year of life and is characterized by high seizure frequency and severity, intellectual disability, and a risk of sudden unexpected death in epilepsy. Approximately 85% of Dravet syndrome cases are caused by de novo loss-of-function (LOF) mutations in SCN1A gene, which codes for a voltage-gated sodium channel. DS has an estimated incidence rate of 1:15,700.
About Lennox-Gastaut Syndrome
Lennox-Gastaut syndrome (LGS) is a rare and drug-resistant epileptic encephalopathy characterized by onset in children between 3-5 years of age. The underlying cause of LGS is unknown and can be related to a wide range of factors including genetic differences and structural differences in the brain. As a result, patients experience multiple seizure types, including atonic seizures, and developmental, cognitive, and behavioral issues. LGS affects approximately 48,000 patients in the U.S.
About Harmony Biosciences
Harmony Biosciences is a pharmaceutical company dedicated to developing and commercializing innovative therapies for patients with rare neurological diseases who have unmet medical needs. Driven by novel science, visionary thinking, and a commitment to those who feel overlooked, Harmony Biosciences is nurturing a future full of therapeutic possibilities that may enable patients with rare neurological diseases to truly thrive. Established by Paragon Biosciences, LLC, in 2017 and headquartered in Plymouth Meeting, Pa., we believe that when empathy and innovation meet, a better future can begin; a vision evident in the therapeutic innovations we advance, the culture we cultivate, and the community programs we foster. For more information, please visit www.harmonybiosciences.com.
Canada Pension Plan Investment Board acquired a new position in shares of Harmony Biosciences Holdings, Inc. (NASDAQ:HRMY – Free Report) in the 2nd quarter, according to its most recent disclosure with the SEC. The fund acquired 33,200 shares of the company’s stock, valued at approximately $1,209,000. Canada Pension Plan Investment Board owned about 0.06% of Harmony Biosciences at the end of the most recent quarter.
Other institutional investors and hedge funds have also recently modified their holdings of the company. BlackRock Inc. purchased a new stake in Harmony Biosciences during the 2nd quarter worth about $258,583,000. SG Americas Securities LLC boosted its position in shares of Harmony Biosciences by 109.9% during the 1st quarter. SG Americas Securities LLC now owns 2,018,174 shares of the company’s stock worth $56,529,000 after acquiring an additional 1,056,507 shares in the last quarter. Armistice Capital LLC purchased a new position in shares of Harmony Biosciences in the 4th quarter valued at about $18,710,000. AQR Capital Management LLC increased its holdings in shares of Harmony Biosciences by 128.9% in the 4th quarter. AQR Capital Management LLC now owns 813,889 shares of the company’s stock valued at $30,456,000 after acquiring an additional 458,321 shares during the last quarter. Finally, Arrowstreet Capital Limited Partnership increased its holdings in shares of Harmony Biosciences by 42.8% in the 3rd quarter. Arrowstreet Capital Limited Partnership now owns 1,295,381 shares of the company’s stock valued at $35,701,000 after acquiring an additional 388,472 shares during the last quarter. Institutional investors and hedge funds own 86.23% of the company’s stock.
Harmony Biosciences Stock Performance NASDAQ HRMY opened at $39.38 on Tuesday. The firm has a market cap of $2.29 billion, a P/E ratio of 12.79, a P/E/G ratio of 0.36 and a beta of 0.96. Harmony Biosciences Holdings, Inc. has a 52-week low of $25.52 and a 52-week high of $40.87. The business’s 50-day moving average price is $37.00 and its 200 day moving average price is $32.80. The company has a quick ratio of 3.45, a current ratio of 3.48 and a debt-to-equity ratio of 0.13.
Harmony Biosciences (NASDAQ:HRMY – Get Free Report) last posted its quarterly earnings data on Tuesday, August 4th. The company reported $1.28 EPS for the quarter, beating the consensus estimate of $0.96 by $0.32. Harmony Biosciences had a return on equity of 20.06% and a net margin of 18.88%.The firm had revenue of $261.28 million during the quarter, compared to the consensus estimate of $250.77 million. During the same period in the prior year, the business earned $0.92 EPS. The firm’s revenue was up 30.3% compared to the same quarter last year. On average, equities research analysts expect that Harmony Biosciences Holdings, Inc. will post 3.77 earnings per share for the current year. Wall Street Analysts Forecast Growth HRMY has been the subject of several recent analyst reports. Wall Street Zen upgraded Harmony Biosciences from a “buy” rating to a “strong-buy” rating in a research note on Sunday, August 16th. Mizuho increased their price target on shares of Harmony Biosciences from $50.00 to $51.00 and gave the company an “outperform” rating in a research note on Friday, July 31st. Weiss Ratings raised shares of Harmony Biosciences from a “hold (c)” rating to a “hold (c+)” rating in a report on Monday, August 17th. UBS Group restated a “neutral” rating and set a $37.00 price objective on shares of Harmony Biosciences in a research report on Wednesday, August 5th. Finally, Deutsche Bank Aktiengesellschaft restated a “hold” rating and issued a $39.00 target price on shares of Harmony Biosciences in a report on Wednesday, August 5th. Five investment analysts have rated the stock with a Buy rating, five have assigned a Hold rating and one has given a Sell rating to the stock. According to MarketBeat, Harmony Biosciences currently has a consensus rating of “Hold” and a consensus target price of $47.11.
Check Out Our Latest Research Report on HRMY
Harmony Biosciences Company Profile (Free Report)
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.
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PLYMOUTH MEETING, Pa., Aug. 27, 2026 (GLOBE NEWSWIRE) -- Harmony Biosciences Holdings, Inc. (Nasdaq: HRMY), today announced that Harmony's management team will participate in a fireside chat at the 2026 Cantor Global Healthcare Conference in New York, N.Y., on Thursday, September 10, 2026, at 10:20 a.m., E.T.
A webcast of the fireside chat will be available on the investor page of the Harmony Biosciences website at https://ir.harmonybiosciences.com/.
About Harmony Biosciences
Harmony Biosciences is a pharmaceutical company dedicated to developing and commercializing innovative therapies for patients with rare neurological diseases who have unmet medical needs. Driven by novel science, visionary thinking, and a commitment to those who feel overlooked, Harmony Biosciences is nurturing a future full of therapeutic possibilities that may enable patients with rare neurological diseases to truly thrive. Established by Paragon Biosciences, LLC, in 2017 and headquartered in Plymouth Meeting, Pa., we believe that when empathy and innovation meet, a better future can begin; a vision evident in the therapeutic innovations we advance, the culture we cultivate, and the community programs we foster. For more information, please visit www.harmonybiosciences.com.
Aurora Investment Counsel acquired a new position in Harmony Biosciences Holdings, Inc. (NASDAQ:HRMY – Free Report) in the 2nd quarter, according to the company in its most recent disclosure with the Securities & Exchange Commission. The fund acquired 65,148 shares of the company’s stock, valued at approximately $2,372,000. Harmony Biosciences accounts for approximately 1.2% of Aurora Investment Counsel’s portfolio, making the stock its 22nd largest holding. Aurora Investment Counsel owned about 0.11% of Harmony Biosciences at the end of the most recent reporting period.
Other hedge funds also recently bought and sold shares of the company. Nebula Research & Development LLC grew its position in Harmony Biosciences by 2.0% during the second quarter. Nebula Research & Development LLC now owns 17,403 shares of the company’s stock valued at $550,000 after buying an additional 348 shares during the period. The Manufacturers Life Insurance Company raised its holdings in Harmony Biosciences by 2.4% in the 2nd quarter. The Manufacturers Life Insurance Company now owns 22,686 shares of the company’s stock worth $717,000 after purchasing an additional 532 shares during the period. Mirae Asset Global Investments Co. Ltd. raised its holdings in Harmony Biosciences by 25.9% in the 4th quarter. Mirae Asset Global Investments Co. Ltd. now owns 2,799 shares of the company’s stock worth $105,000 after purchasing an additional 575 shares during the period. Allworth Financial LP lifted its position in Harmony Biosciences by 286.7% during the fourth quarter. Allworth Financial LP now owns 812 shares of the company’s stock valued at $30,000 after purchasing an additional 602 shares in the last quarter. Finally, PNC Financial Services Group Inc. lifted its position in Harmony Biosciences by 30.3% during the fourth quarter. PNC Financial Services Group Inc. now owns 2,663 shares of the company’s stock valued at $100,000 after purchasing an additional 619 shares in the last quarter. Hedge funds and other institutional investors own 86.23% of the company’s stock.
Harmony Biosciences Stock Up 2.8% HRMY opened at $39.93 on Thursday. The company has a market capitalization of $2.33 billion, a PE ratio of 12.96, a price-to-earnings-growth ratio of 0.36 and a beta of 0.96. The firm has a 50-day simple moving average of $36.19 and a two-hundred day simple moving average of $32.71. The company has a quick ratio of 3.45, a current ratio of 3.48 and a debt-to-equity ratio of 0.13. Harmony Biosciences Holdings, Inc. has a 52 week low of $25.52 and a 52 week high of $40.87.
Harmony Biosciences (NASDAQ:HRMY – Get Free Report) last issued its earnings results on Tuesday, August 4th. The company reported $1.28 earnings per share (EPS) for the quarter, topping the consensus estimate of $0.96 by $0.32. The firm had revenue of $261.28 million for the quarter, compared to analysts’ expectations of $250.77 million. Harmony Biosciences had a return on equity of 20.06% and a net margin of 18.88%.The business’s revenue was up 30.3% compared to the same quarter last year. During the same period in the previous year, the firm posted $0.92 earnings per share. Analysts forecast that Harmony Biosciences Holdings, Inc. will post 3.77 earnings per share for the current fiscal year. Wall Street Analyst Weigh In A number of brokerages recently issued reports on HRMY. HC Wainwright reiterated a “buy” rating and set a $55.00 price objective on shares of Harmony Biosciences in a research note on Thursday, July 16th. Oppenheimer restated an “outperform” rating and set a $70.00 target price on shares of Harmony Biosciences in a research note on Tuesday, August 4th. Wall Street Zen raised shares of Harmony Biosciences from a “buy” rating to a “strong-buy” rating in a report on Sunday. Truist Financial upped their price target on shares of Harmony Biosciences from $29.00 to $34.00 and gave the stock a “hold” rating in a research report on Wednesday, August 5th. Finally, Deutsche Bank Aktiengesellschaft reissued a “hold” rating and issued a $39.00 price objective on shares of Harmony Biosciences in a research note on Wednesday, August 5th. Four analysts have rated the stock with a Buy rating, five have assigned a Hold rating and one has given a Sell rating to the company. According to MarketBeat, the stock currently has a consensus rating of “Hold” and a consensus target price of $45.50.
Get Our Latest Research Report on HRMY
Harmony Biosciences Profile (Free Report)
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.
Further Reading Five stocks we like better than Harmony Biosciences Bloom Energy’s AI Surge Meets a Valuation Reality Check Target Is Winning Shoppers Back—Can the Rally Reach $180? IonQ’s Space Contract Points to a New Frontier for Quantum Investors Is Apple’s AI Strategy Smarter Than Skeptics Think? Want to see what other hedge funds are holding HRMY? Visit HoldingsChannel.com to get the latest 13F filings and insider trades for Harmony Biosciences Holdings, Inc. (NASDAQ:HRMY – Free Report).
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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.
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California State Teachers Retirement System raised its position in shares of Harmony Biosciences Holdings, Inc. (NASDAQ:HRMY – Free Report) by 40.9% in the first quarter, according to the company in its most recent 13F filing with the SEC. The institutional investor owned 57,928 shares of the company’s stock after purchasing an additional 16,821 shares during the quarter. California State Teachers Retirement System owned about 0.10% of Harmony Biosciences worth $1,623,000 as of its most recent SEC filing.
Several other hedge funds also recently modified their holdings of the company. Empowered Funds LLC lifted its holdings in shares of Harmony Biosciences by 29.6% in the first quarter. Empowered Funds LLC now owns 110,375 shares of the company’s stock valued at $3,092,000 after buying an additional 25,222 shares during the period. Quantinno Capital Management LP grew its holdings in Harmony Biosciences by 11.1% during the first quarter. Quantinno Capital Management LP now owns 13,634 shares of the company’s stock worth $382,000 after acquiring an additional 1,361 shares during the period. SummitTX Capital L.P. acquired a new position in Harmony Biosciences during the first quarter worth about $300,000. Lazard Asset Management LLC grew its holdings in Harmony Biosciences by 8.7% during the first quarter. Lazard Asset Management LLC now owns 33,806 shares of the company’s stock worth $947,000 after acquiring an additional 2,703 shares during the period. Finally, OMERS ADMINISTRATION Corp raised its position in Harmony Biosciences by 144.2% in the first quarter. OMERS ADMINISTRATION Corp now owns 30,990 shares of the company’s stock worth $868,000 after acquiring an additional 18,300 shares in the last quarter. 86.23% of the stock is currently owned by institutional investors and hedge funds.
Harmony Biosciences Trading Up 0.6% NASDAQ:HRMY opened at $39.77 on Thursday. The company has a quick ratio of 3.45, a current ratio of 3.48 and a debt-to-equity ratio of 0.13. Harmony Biosciences Holdings, Inc. has a 1-year low of $25.52 and a 1-year high of $40.87. The firm has a market capitalization of $2.32 billion, a price-to-earnings ratio of 12.91, a price-to-earnings-growth ratio of 0.37 and a beta of 0.96. The stock has a fifty day simple moving average of $35.66 and a 200 day simple moving average of $32.65.
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Harmony Biosciences (NASDAQ:HRMY – Get Free Report) last posted its quarterly earnings data on Tuesday, August 4th. The company reported $1.28 earnings per share (EPS) for the quarter, topping the consensus estimate of $0.96 by $0.32. Harmony Biosciences had a return on equity of 20.06% and a net margin of 18.88%.The firm had revenue of $261.28 million for the quarter, compared to the consensus estimate of $250.77 million. During the same quarter in the previous year, the company earned $0.92 EPS. The business’s revenue for the quarter was up 30.3% compared to the same quarter last year. Sell-side analysts forecast that Harmony Biosciences Holdings, Inc. will post 3.77 earnings per share for the current year.
Wall Street Analysts Forecast Growth A number of equities research analysts have weighed in on HRMY shares. Mizuho upped their price target on shares of Harmony Biosciences from $50.00 to $51.00 and gave the company an “outperform” rating in a report on Friday, July 31st. Zacks Research raised shares of Harmony Biosciences from a “hold” rating to a “strong-buy” rating in a research note on Monday, July 13th. HC Wainwright reiterated a “buy” rating and issued a $55.00 target price on shares of Harmony Biosciences in a report on Thursday, July 16th. Needham & Company LLC increased their target price on shares of Harmony Biosciences from $45.00 to $50.00 and gave the company a “buy” rating in a research note on Tuesday, August 4th. Finally, Weiss Ratings upgraded shares of Harmony Biosciences from a “hold (c-)” rating to a “hold (c)” rating in a report on Tuesday, June 23rd. One investment analyst has rated the stock with a Strong Buy rating, four have given a Buy rating, four have assigned a Hold rating and one has given a Sell rating to the stock. According to MarketBeat.com, the company has an average rating of “Moderate Buy” and a consensus price target of $45.50.
Check Out Our Latest Research Report on HRMY
Harmony Biosciences Company Profile (Free Report)
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.
Featured Articles Five stocks we like better than Harmony Biosciences GE Vernova’s AI Power Boom Faces a Profit Test Cardinal Health Earnings: Can Perfection Get Priced In Twice? Nebius’ Q2 Beat Shows the AI Bottleneck Is Capacity, Not Demand Legacy Jet Builders Stall While Embraer Accelerates to New Highs Want to see what other hedge funds are holding HRMY? Visit HoldingsChannel.com to get the latest 13F filings and insider trades for Harmony Biosciences Holdings, Inc. (NASDAQ:HRMY – Free Report).
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Key Takeaways Healthcare demand and demographic trends support BTSG, HRMY, UNH and NVCR.HRMY is backed by earnings growth and higher estimate revisions.UNH and NVCR pair improving earnings outlooks with defensive demand. The healthcare sector has quietly regained momentum in 2026, with the benchmark State Street Health Care Select Sector SPDR ETF (XLV) advancing 7.1% year to date as of Aug. 6. Investors have increasingly turned to the sector for its defensive characteristics amid periodic market volatility, while long-term structural drivers continue to reinforce confidence. Unlike highly cyclical industries, healthcare benefits from relatively stable demand, making it an attractive option for investors seeking resilience during uncertain economic conditions. BrightSpring Health Services, Inc. (BTSG - Free Report) , Harmony Biosciences Holdings, Inc. (HRMY - Free Report) , UnitedHealth Group Incorporated (UNH - Free Report) and NovoCure Limited (NVCR - Free Report) are four stocks that have benefited.
Structural Growth Drivers Remain IntactThe sector continues to enjoy favorable long-term fundamentals supported by rising health awareness, rapid technological innovation and the healthcare needs of an aging global population. Advances in medical technology, diagnostics and treatment options are improving patient outcomes while expanding growth opportunities across the industry. Investor interest has also been supported by stronger capital flows into healthcare-focused funds, particularly those with exposure to biotechnology, reflecting optimism about future innovation despite the industry's inherent volatility.
Policy and Earnings Challenges PersistDespite these strengths, healthcare faces several headwinds. Regulatory uncertainty remains, with potential changes to Affordable Care Act subsidies, Medicaid funding, pharmaceutical pricing policies and tariffs creating uncertainty for future profitability. In addition, healthcare's projected earnings growth trails that of high-growth sectors such as information technology, consumer discretionary and industrials, making it less appealing for investors focused primarily on aggressive earnings expansion.
Defensive Appeal Supports Long-Term OutlookEven with policy risks and comparatively modest earnings expectations, healthcare remains an important component of a diversified portfolio. Its defensive demand profile, supported by essential medical services and demographic trends, can help cushion portfolios during periods of economic weakness. While fluctuations in consumer purchasing power and volatility within certain healthcare subsectors may weigh on sentiment from time to time, the sector's combination of stability, innovation and long-term demand continues to support a constructive investment outlook for 2026.
Our ChoicesThe stocks below flaunt a Zacks Rank #1 (Strong Buy) or Rank #2 (Buy). The search was also narrowed down with a VGM Score of A or B. Here, V stands for Value, G for Growth and M for Momentum. The score is a weighted combination of these three metrics. Such a score allows you to eliminate the negative aspects of stocks and select winners. You can see the complete list of today’s Zacks #1 Rank stocks here.
BrightSpring Health Services provides home and community-based healthcare through pharmacy, clinical, rehabilitation and supportive care services, serving Medicare, Medicaid and insured patients across the United States. BTSG’s expected earnings growth rate for the current year is 78%. The Zacks Consensus Estimate for its current-year earnings has improved 6.6% over the past 60 days. This Zacks Rank #1 company has a VGM Score of A.
Harmony Biosciences develops and commercializes therapies for rare neurological diseases, with treatments for narcolepsy and a pipeline targeting sleep disorders, epilepsy and other rare neurological conditions in the United States. HRMY’s expected earnings growth rate for the current year is 22.9%. The Zacks Consensus Estimate for its current-year earnings has increased 4.1% over the past 60 days. This Zacks Rank #1 company has a VGM Score of A.
UnitedHealth Group provides healthcare benefits, pharmacy services, care delivery, healthcare technology and data solutions, serving individuals, employers, government programs and healthcare providers in the United States and internationally. UNH’s expected earnings growth rate for the current year is 20.4%. The Zacks Consensus Estimate for its current-year earnings has increased 7.5% over the past 60 days. This Zacks Rank #1 company has a VGM Score of A.
NovoCure develops and commercializes tumor treating fields devices for solid tumor cancers, while advancing clinical research across multiple cancer types in markets worldwide. NVCR’s expected earnings growth rate for the next year is 41.8%. The Zacks Consensus Estimate for its current-year earnings has increased 21.9% over the past 60 days. This Zacks Rank #2 company has a VGM Score of A.
Bottom LineHealthcare continues to offer a compelling blend of defensive stability and long-term growth potential, supported by demographic trends and medical innovation. While regulatory uncertainty remains a key risk, fundamentally strong companies with improving earnings outlooks and favorable estimate revisions, such as these four picks, are well-positioned to benefit from the sector's steady momentum.
Harmony Biosciences (NASDAQ:HRMY) reported second-quarter net revenue of $261.3 million, up 30% from the prior-year period and 21% sequentially, as sales of its narcolepsy treatment WAKIX rebounded from seasonal market-access pressures earlier in the year.
The company reiterated its 2026 net revenue guidance of $1 billion to $1.04 billion. Net income for the quarter rose to $75.4 million, or $1.28 per diluted share, from $39.8 million, or $0.68 per diluted share, a year earlier.
Management also disclosed early clinical data for BP-205, an orexin-2 receptor agonist in development for sleep-wake and potentially broader central nervous system indications. The company plans to report multiple-ascending-dose data for the candidate in the fourth quarter and expects top-line data from a sleep-deprived healthy-volunteer study in early 2027.
WAKIX Growth and Commercial Initiatives Chief Executive Officer Jeffrey Dayno said WAKIX generated record quarterly net revenue and remained on track to surpass $1 billion in annual revenue. He said the second-quarter performance marked a rebound from elevated insurance-plan changes, plan switching and premium increases that delayed some patient starts during the first quarter.
Chief Commercial Officer Adam Zaeske said WAKIX reached an estimated average of 8,950 patients during the quarter, an increase of about 450 patients from the first quarter. He described the increase as the highest second-quarter patient gain in the brand’s history and its second-largest quarterly gain overall.
Zaeske said WAKIX benefits from its position as the only non-scheduled treatment option for narcolepsy, as well as broad payer coverage representing more than 80% of covered lives. Harmony estimated that approximately 170,000 people have narcolepsy, with diagnosis rates below 50% and WAKIX penetration at roughly 20%.
During the quarter, the company completed the deployment of an expanded commercial organization, increasing its field sales, remote sales and field reimbursement presence by about 20%. Harmony also launched an online prescribing portal and made changes to its reimbursement-support process, which Zaeske said were helping patients secure treatment faster and with higher success rates.
BP-205 Phase I Data and Development Plans Harmony reported results from the single-ascending-dose portion of a Phase I study of BP-205 in 72 healthy volunteers. The randomized, double-blind, placebo-controlled trial evaluated single doses ranging from 0.2 milligrams to 6 milligrams across nine cohorts.
Chief Medical and Scientific Officer Kumar Budur said BP-205 demonstrated rapid absorption, with time to maximum concentration ranging from 30 to 75 minutes, and a mean half-life of approximately 25 hours across dose groups. He said the profile could support once-daily dosing and sustained effects through the day and into the early evening.
The company reported dose-proportional exposure across maximum concentration and area-under-the-curve measures, with no reported age- or gender-related differences in pharmacokinetic parameters. No serious or severe treatment-emergent adverse events were reported in the single-dose study, according to Harmony, and the company said it observed no cardiovascular, hepatic or visual abnormalities.
The most common adverse events were headache in approximately 10% of participants, fatigue in about 4%, and diarrhea in about 3%, Budur said.
Management characterized BP-205 as a potential best-in-class orexin-2 receptor agonist, citing its potency and selectivity. Budur said the compound showed more than 600-fold selectivity for orexin-2 receptors over orexin-1 receptors and more than 1,000-fold selectivity over more than 100 other receptors studied preclinically.
During the question-and-answer session, Budur said preliminary multiple-ascending-dose findings included transient insomnia and polyuria, which he described as potential mechanism-related effects. He said neither was serious nor sustained, while noting that the company would provide a fuller dataset in the fourth quarter.
Harmony said its U.S. investigational new drug application for BP-205 is open and that it expects to begin a Phase Ib trial in sleep-deprived healthy volunteers in the third quarter. The company expects the study to provide its first efficacy signals for the drug. It plans to initiate Phase II trials in multiple CNS indications in mid-2027.
Pipeline Updates and Patent Strategy Harmony said the FDA accepted its new drug application for pitolisant GR for full review, assigning a target action date of April 1, 2027. The formulation is designed to allow patients to begin at a therapeutic dose of 17.8 milligrams without titration and to reduce the potential for gastrointestinal adverse events.
The company is also advancing pitolisant HD in two Phase III registrational studies: ONSTRIDE-1 in narcolepsy and ONSTRIDE-2 in idiopathic hypersomnia. Top-line data are expected in 2027, with a potential FDA action in 2028, according to management.
For its other late-stage programs, Harmony said top-line data from its TEMPO study in Prader-Willi syndrome are now expected in mid-2027, delayed because of challenges enrolling patients meeting the study’s sleepiness criteria. The company also expects mid-2027 data from Phase III studies of EPX-100 in Dravet syndrome and Lennox-Gastaut syndrome.
Chief Operating Officer Peter Anastasiou said Harmony had settled with six of seven abbreviated new drug application filers related to WAKIX. The remaining litigation involves AET Pharma US, including disputes over the company’s polymorph and method-of-use patents. Closing arguments in the ANDA litigation are scheduled for Oct. 22, he said.
Harmony and Novitium also filed a separate infringement lawsuit in April against AET Pharma US and Sandoz involving a patent for an amorphous form of pitolisant hydrochloride. Anastasiou said the company believes its intellectual property estate supports WAKIX exclusivity through March 2030, including anticipated pediatric exclusivity.
Financial Position and Business Development Interim Principal Financial Officer Stephen Mollichella said cost of products sold rose to 24.2% of net revenue from 19% a year earlier, primarily due to new royalties tied to Harmony’s Novitium license agreement. Total operating expenses declined to $108.8 million from $114.2 million, largely because the prior-year quarter included a $15 million upfront payment to CIRC.
Harmony ended the quarter with $962.5 million in cash equivalents and investments and $155 million in debt. Management said it expects continued strong cash generation but intends to use capital for pipeline investment and business development.
Anastasiou said the company is evaluating acquisitions and licensing opportunities, primarily for assets with potential revenue contributions between 2028 and 2032, with a focus on sleep-wake disorders, epilepsy, rare CNS conditions and broader CNS markets.
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.
Key Takeaways HRMY beat Q2 earnings and revenue estimates as Wakix demand lifted sales 30% year over year. Harmony reaffirmed 2026 Wakix revenue guidance as patient growth and broad payer coverage supported demand. HRMY advanced BP-205 and pitolisant programs while expanding its rare epilepsy pipeline with EPX-100. Harmony Biosciences Holdings, Inc. (HRMY - Free Report) 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.
Shares gained 8.9% following the results. Year to date, shares of HRMY have risen 3.6% compared with the industry’s 0.8% gain.
Image Source: Zacks Investment Research
HRMY Q2 Cost AnalysisCost 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-205In 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 AssetsThe 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 OutlookHarmony 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’s0020position as the only nonscheduled 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.
Our Take on HRMY’s Q2 PerformanceHRMY delivered a strong second quarter, beating earnings and revenue estimates on robust demand for Wakix, while reaffirming its full-year revenue outlook. The company continues to generate healthy cash flows, providing ample resources to advance its pipeline.
Wakix remains the key growth driver, supported by rising patient additions, broad payer coverage and its differentiated profile as the only non-scheduled treatment for narcolepsy.
While Harmony remains heavily dependent on Wakix, its expanding pipeline, strong balance sheet and multiple near-term regulatory and clinical catalysts strengthen its long-term growth outlook.
HRMY’s Zacks Rank and Other Stocks to ConsiderHRMY currently sports 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 Zacks 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 increased from $4.81 to $5.31.
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 is unchanged at 20 cents. Over the same period, loss per share estimates for 2027 have narrowed from 26 cents to 25 cents.
Novavax’s earnings beat estimates in each of the trailing four quarters, with the average surprise being 305.24%.
SummaryHarmony Biosciences Holdings, Inc. has now elevated BP-205, its orexin-2 receptor agonist, to lead the pipeline.HRMY management has become even more specific about business development—exactly the kind of thing I thought was missing earlier.My updated valuation suggests most of the improvement is now reflected in the stock. I am, therefore, upgrading HRMY from Sell to Hold.Looking for a portfolio of ideas like this one? Members of The Total Pharma Tracker get exclusive access to our subscriber-only portfolios. Learn More » J Studios/DigitalVision via Getty Images
In April, I argued that despite Harmony Biosciences Holdings, Inc. (HRMY) having one excellent asset, it had failed to use the cash generated by Wakix to build or acquire a credible second growth
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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.
Investors seek growth stocks to capitalize on above-average growth in financials that help these securities grab the market's attention and produce exceptional returns. However, it isn't easy to find a great growth stock.
By their very nature, these stocks carry above-average risk and volatility. Moreover, if a company's growth story is over or nearing its end, betting on it could lead to significant loss.
However, the Zacks Growth Style Score (part of the Zacks Style Scores system), which looks beyond the traditional growth attributes to analyze a company's real growth prospects, makes it pretty easy to find cutting-edge growth stocks.
Our proprietary system currently recommends Harmony Biosciences Holdings, Inc. (HRMY - Free Report) as one such stock. This company not only has a favorable Growth Score, but also carries a top Zacks Rank.
Studies have shown that stocks with the best growth features consistently outperform the market. And for stocks that have a combination of a Growth Score of A or B and a Zacks Rank #1 (Strong Buy) or 2 (Buy), returns are even better.
While there are numerous reasons why the stock of this company is a great growth pick right now, we have highlighted three of the most important factors below:
Earnings GrowthEarnings growth is arguably the most important factor, as stocks exhibiting exceptionally surging profit levels tend to attract the attention of most investors. For growth investors, double-digit earnings growth is highly preferable, as it is often perceived as an indication of strong prospects (and stock price gains) for the company under consideration.
While the historical EPS growth rate for Harmony Biosciences is 10.7%, investors should actually focus on the projected growth. The company's EPS is expected to grow 22.8% this year, crushing the industry average, which calls for EPS growth of 15.2%.
Cash Flow GrowthWhile cash is the lifeblood of any business, higher-than-average cash flow growth is more important and beneficial for growth-oriented companies than for mature companies. That's because, growth in cash flow enables these companies to expand their businesses without depending on expensive outside funds.
Right now, year-over-year cash flow growth for Harmony Biosciences is 9%, which is higher than many of its peers. In fact, the rate compares to the industry average of 5.2%.
While investors should actually consider the current cash flow growth, it's worth taking a look at the historical rate too for putting the current reading into proper perspective. The company's annualized cash flow growth rate has been 32.4% over the past 3-5 years versus the industry average of 4.4%.
Promising Earnings Estimate RevisionsBeyond the metrics outlined above, investors should consider the trend in earnings estimate revisions. A positive trend is a plus here. Empirical research shows that there is a strong correlation between trends in earnings estimate revisions and near-term stock price movements.
There have been upward revisions in current-year earnings estimates for Harmony Biosciences. The Zacks Consensus Estimate for the current year has surged 2.1% over the past month.
Bottom LineWhile the overall earnings estimate revisions have made Harmony Biosciences a Zacks Rank #1 stock, it has earned itself a Growth Score of B based on a number of factors, including the ones discussed above.
You can see the complete list of today's Zacks #1 Rank (Strong Buy) stocks here.
This combination positions Harmony Biosciences well for outperformance, so growth investors may want to bet on it.
Harmony Biosciences NASDAQ: HRMY reported second-quarter net revenue of $261.3 million, up 30% from the prior-year period and 21% sequentially, as sales of its narcolepsy treatment WAKIX rebounded from seasonal market-access pressures earlier in the year.
The company reiterated its 2026 net revenue guidance of $1 billion to $1.04 billion. Net income for the quarter rose to $75.4 million, or $1.28 per diluted share, from $39.8 million, or $0.68 per diluted share, a year earlier.
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Management also disclosed early clinical data for BP-205, an orexin-2 receptor agonist in development for sleep-wake and potentially broader central nervous system indications. The company plans to report multiple-ascending-dose data for the candidate in the fourth quarter and expects top-line data from a sleep-deprived healthy-volunteer study in early 2027.
WAKIX Growth and Commercial Initiatives Chief Executive Officer Jeffrey Dayno said WAKIX generated record quarterly net revenue and remained on track to surpass $1 billion in annual revenue. He said the second-quarter performance marked a rebound from elevated insurance-plan changes, plan switching and premium increases that delayed some patient starts during the first quarter.
Chief Commercial Officer Adam Zaeske said WAKIX reached an estimated average of 8,950 patients during the quarter, an increase of about 450 patients from the first quarter. He described the increase as the highest second-quarter patient gain in the brand’s history and its second-largest quarterly gain overall.
Zaeske said WAKIX benefits from its position as the only non-scheduled treatment option for narcolepsy, as well as broad payer coverage representing more than 80% of covered lives. Harmony estimated that approximately 170,000 people have narcolepsy, with diagnosis rates below 50% and WAKIX penetration at roughly 20%.
During the quarter, the company completed the deployment of an expanded commercial organization, increasing its field sales, remote sales and field reimbursement presence by about 20%. Harmony also launched an online prescribing portal and made changes to its reimbursement-support process, which Zaeske said were helping patients secure treatment faster and with higher success rates.
BP-205 Phase I Data and Development Plans Harmony reported results from the single-ascending-dose portion of a Phase I study of BP-205 in 72 healthy volunteers. The randomized, double-blind, placebo-controlled trial evaluated single doses ranging from 0.2 milligrams to 6 milligrams across nine cohorts.
Chief Medical and Scientific Officer Kumar Budur said BP-205 demonstrated rapid absorption, with time to maximum concentration ranging from 30 to 75 minutes, and a mean half-life of approximately 25 hours across dose groups. He said the profile could support once-daily dosing and sustained effects through the day and into the early evening.
The company reported dose-proportional exposure across maximum concentration and area-under-the-curve measures, with no reported age- or gender-related differences in pharmacokinetic parameters. No serious or severe treatment-emergent adverse events were reported in the single-dose study, according to Harmony, and the company said it observed no cardiovascular, hepatic or visual abnormalities.
The most common adverse events were headache in approximately 10% of participants, fatigue in about 4%, and diarrhea in about 3%, Budur said.
Management characterized BP-205 as a potential best-in-class orexin-2 receptor agonist, citing its potency and selectivity. Budur said the compound showed more than 600-fold selectivity for orexin-2 receptors over orexin-1 receptors and more than 1,000-fold selectivity over more than 100 other receptors studied preclinically.
During the question-and-answer session, Budur said preliminary multiple-ascending-dose findings included transient insomnia and polyuria, which he described as potential mechanism-related effects. He said neither was serious nor sustained, while noting that the company would provide a fuller dataset in the fourth quarter.
Harmony said its U.S. investigational new drug application for BP-205 is open and that it expects to begin a Phase Ib trial in sleep-deprived healthy volunteers in the third quarter. The company expects the study to provide its first efficacy signals for the drug. It plans to initiate Phase II trials in multiple CNS indications in mid-2027.
Pipeline Updates and Patent Strategy Harmony said the FDA accepted its new drug application for pitolisant GR for full review, assigning a target action date of April 1, 2027. The formulation is designed to allow patients to begin at a therapeutic dose of 17.8 milligrams without titration and to reduce the potential for gastrointestinal adverse events.
The company is also advancing pitolisant HD in two Phase III registrational studies: ONSTRIDE-1 in narcolepsy and ONSTRIDE-2 in idiopathic hypersomnia. Top-line data are expected in 2027, with a potential FDA action in 2028, according to management.
For its other late-stage programs, Harmony said top-line data from its TEMPO study in Prader-Willi syndrome are now expected in mid-2027, delayed because of challenges enrolling patients meeting the study’s sleepiness criteria. The company also expects mid-2027 data from Phase III studies of EPX-100 in Dravet syndrome and Lennox-Gastaut syndrome.
Chief Operating Officer Peter Anastasiou said Harmony had settled with six of seven abbreviated new drug application filers related to WAKIX. The remaining litigation involves AET Pharma US, including disputes over the company’s polymorph and method-of-use patents. Closing arguments in the ANDA litigation are scheduled for Oct. 22, he said.
Harmony and Novitium also filed a separate infringement lawsuit in April against AET Pharma US and Sandoz involving a patent for an amorphous form of pitolisant hydrochloride. Anastasiou said the company believes its intellectual property estate supports WAKIX exclusivity through March 2030, including anticipated pediatric exclusivity.
Financial Position and Business Development Interim Principal Financial Officer Stephen Mollichella said cost of products sold rose to 24.2% of net revenue from 19% a year earlier, primarily due to new royalties tied to Harmony’s Novitium license agreement. Total operating expenses declined to $108.8 million from $114.2 million, largely because the prior-year quarter included a $15 million upfront payment to CIRC.
Harmony ended the quarter with $962.5 million in cash equivalents and investments and $155 million in debt. Management said it expects continued strong cash generation but intends to use capital for pipeline investment and business development.
Anastasiou said the company is evaluating acquisitions and licensing opportunities, primarily for assets with potential revenue contributions between 2028 and 2032, with a focus on sleep-wake disorders, epilepsy, rare CNS conditions and broader CNS markets.
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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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.
WAKIX® Net Revenue Grew 30% Year over Year to $261.3 Million for Second Quarter 2026; Estimated Average Patients Increased 450 to 8,950; Reiterates 2026 WAKIX Net Revenue Guidance of $1.0 Billion to $1.04 Billion
Phase 1 SAD Data for BP-205 Demonstrate Favorable PK and Safety/Tolerability Profiles; Phase 1 MAD Data Expected in Q4 2026
BP-205 IND Open in US; Initiating Phase 1b Study in Sleep-Deprived Healthy Volunteers in Q3; Data Expected Early 2027
Initiating Phase 2 Trials for BP-205 in Mid-2027 to Evaluate Multiple CNS Indications
Pitolisant GR NDA Accepted in July; Target PDUFA Date April 1, 2027
Pitolisant HD On Track for Phase 3 Topline Data in 2027 and Target PDUFA Date in 2028
Conference Call and Webcast Today at 8:30 a.m. ET
PLYMOUTH MEETING, Pa., Aug. 04, 2026 (GLOBE NEWSWIRE) -- Harmony Biosciences Holdings, Inc. (Nasdaq: HRMY) today reported Q2 2026 net revenue for WAKIX® (pitolisant) of $261.3 million, delivering 30% year-over-year growth in its seventh year on the market. These results underscore continued strong demand for WAKIX, disciplined commercial execution across the franchise and sustained momentum through the first half of 2026. Average patients for the quarter were approximately 8,950, an increase in average patients of 450. WAKIX remains on track to achieve full-year net revenue guidance of $1.0 billion to $1.04 billion.
The Company also announced encouraging single ascending dose (SAD) data from its Phase 1 study of BP-205, demonstrating favorable pharmacokinetic (PK) and safety/tolerability profiles that reinforce Harmony’s conviction in BP-205 as a potential best-in-class orexin-2 receptor (OX2R) agonist. These data support Harmony’s robust orexin development strategy, including initiating Phase 2 studies beginning in mid-2027 to evaluate multiple CNS indications.
“Our record second-quarter revenue reflects sustained demand for WAKIX and keeps us firmly on track to deliver over $1 billion in revenue this year. With this strong foundation, we are aggressively advancing our pipeline, with our orexin-2 agonist BP-205 as the centerpiece, that we believe can create significant long-term value for both patients and shareholders,” said Jeffrey M. Dayno, MD, President and Chief Executive Officer of Harmony Biosciences. “The Phase 1 clinical PK and safety/tolerability data for BP-205 that we shared today, together with pre-clinical data demonstrating the highest potency of any orexin-2 agonist currently in the clinic, reinforce our conviction that BP-205 has the potential to be the best-in-class orexin-2 agonist with broad clinical utility across multiple CNS indications.”
Bruce C. Corser, MD, Medical Director of the Sleep Management Institute, said, “The Phase 1 single ascending dose pharmacokinetic and safety/tolerability data for BP-205 are compelling. The potential for rapid onset of action and once-daily dosing, along with a favorable safety/tolerability profile, exceptional potency and high selectivity, suggests that BP-205 may have potential clinical utility in indications beyond orexin deficiency. I look forward to following the continued clinical development of this program.”
Key Drivers of Value Creation
Continued WAKIX Growth in an Evolving Market
Second Quarter 2026 Net Product Revenue for WAKIX
Net product revenue for the quarter ended June 30, 2026, was $261.3 million, representing 30% growth vs 2Q25 Estimated average number of patients grew 450 to 8,950 in Q2, which is the 2nd highest average patient growth everExecuted expansion of field sales, remote sales, field reimbursement and patient outreach teams with all roles hired, trained and fully deployed in 2QLaunched online portal and changes to reimbursement support process to enable patients to secure WAKIX faster and with higher success rate On Track to Achieve 2026 WAKIX Net Revenue Guidance of $1.0 Billion to $1.04 Billion
Advance a Robust, Self-Funded Pipeline
Orexin-2 receptor agonist BP-205 (BP1.15205) is Harmony’s OX2R agonist discovered by Teijin Pharma and developed in partnership with Bioprojet. It is designed to deliver a differentiated profile through its high potency, excellent selectivity, favorable safety/tolerability, and a predictable PK profile with the potential for once-a-day dosing. It is the most potent OX2R agonist currently in clinical development.
Phase 1 SAD topline data in healthy volunteers support Best-in-Class potential A short time to maximum plasma concentration (Tmax) in the range of 30 to 75 minutes Potential for rapid onset of efficacy Mean half-life (T1/2) of approximately 25h across dose groups Supports once-a-day dosing and potential for durable efficacy throughout the day and into the early evening Dose proportional exposure in maximum observed plasma concentration (Cmax) and area under the curve (AUC) Predictable systemic exposure across the doses tested No age or gender differences in PK parameters Supports no dose adjustment for elderly or female patients Generally safe and well tolerated with no serious or severe TEAEs No cardiovascular, hepatic or visual abnormalitiesThe most common AEs were headache, fatigue, and diarrhea in approximately 10%, 4%, and 3% of the participants, respectively Next steps in BP-205 development Multiple ascending dose (MAD) data in healthy volunteers expected in Q4US IND open; initiate Phase 1b study in sleep-deprived healthy volunteers in Q3; data expected in early 2027 Commitment to investing in robust development program for BP-205
Initiating Phase 2 studies to evaluate multiple potential CNS indications in mid-2027 Pitolisant GR (Gastro-resistant) Tablets: On track to launch in 1H 2027
NDA accepted by FDA in July; target PDUFA date of April 1, 2027 Designed with enteric coating meant to reduce the potential for GI side effects in patients with narcolepsy, 80 – 90% of whom experience GI symptoms as part of their diseaseEnables patients to initiate treatment at a therapeutic dose without titration, an important clinical differentiation Utility patents filed to extend pitolisant franchise into the 2040s Pitolisant HD (high dose): Opportunity to extend the pitolisant franchise with differentiated labeling
Phase 3 registrational clinical trials ongoing in narcolepsy (ONSTRIDE 1) and idiopathic hypersomnia (IH) (ONSTRIDE 2) Topline data expected in 2027; anticipated PDUFA date in 2028Enhanced formulation with optimized PK profile, enteric coating and higher dose to drive greater efficacyDifferentiated labeling: fatigue in narcolepsy and sleep inertia in IH Utility patents filed to extend pitolisant franchise into the 2040s WAKIX (pitolisant): Phase 3 trial in PWS (TEMPO)
Topline data expected in mid-2027 and anticipated PDUFA date in 2028On track for pediatric exclusivity: completion of TEMPO study fulfills the second and last requirement agreed with FDA for WAKIX pediatric exclusivity, which would provide for an additional six months of regulatory exclusivity for WAKIX Exploring amorphous form of pitolisant to pursue broader CNS indications
This opportunity is based on the exclusive license to Novitium’s issued amorphous pitolisant patent with protection until 2042Current efforts focused on formulation optimization, new modes of delivery, and an ongoing Phase 1 PK study EPX-100 (clemizole hydrochloride)
Actively enrolling in two Global Phase 3 registrational trials in rare epilepsies: Lennox-Gastaut syndrome (LGS) – the LIGHTHOUSE StudyDravet syndrome (DS) – the ARGUS Study Topline data expected in 1H 2027 and anticipated PDUFA dates in 2028 Emphasis on Business Development
Focused on opportunities with revenue potential in 2028–2032Prioritizing assets in Phase 3, in-registration, or on-marketTherapeutic areas of interest include Sleep/Wake, Epilepsy, Rare/Orphan CNS, and broader CNS indicationsSupported by a strong balance sheet and clear conviction to execute on strategic business development opportunitiesStrong liquidity position of $962.5 million in cash, cash equivalents, and investments as of June 30, 2026 Protect the Pitolisant Franchise
Strong IP Protection/Exclusivity: Harmony’s pitolisant IP estate is multi-layered (formulations, methods of use, next-gen applications) and supports WAKIX exclusivity to March 2030 (inclusive of 6-months of pediatric exclusivity), with potential protection of the franchise through other formulations into the 2040s via additional patents/applicationsANDA Settlements: Settled with 6 of the 7 ANDA filersOngoing Litigation: AET ANDA litigation for “polymorph” (‘197) and “method of use” (‘947) patents: The bench trial concluded, the post-trial briefs are public, and the judge has called for closing arguments from both sides on October 22, 2026Harmony Biosciences and Novitium filed a patent infringement lawsuit in April against AET Pharma US and AET’s marketing partner Sandoz, alleging infringement of patents covering an amorphous form of pitolisant hydrochloride (‘920) Second Quarter 2026 Financial Results
Harmony Biosciences reported net product revenue of $261.3 million for the quarter ended June 30, 2026, compared to $200.5 million for the same period in 2025, representing 30% year-over-year growth. This performance reflects continued strong demand for WAKIX within the large narcolepsy market opportunity (approximately 80,000 diagnosed patients in the U.S.), disciplined commercial execution across the franchise and the product's broad clinical utility. The continued success of WAKIX has been driven by strong demand and commercial execution. Based on our results for the first half of 2026, WAKIX remains on track to achieve full-year net revenue of $1.0 billion to $1.04 billion.
Cost of product sold was $63.2 million in the second quarter of 2026, or 24.2% as a percentage of net product revenue, as compared to $38.2 million, or 19.0%, for the same quarter in 2025, representing a 66% increase. The increase in cost of product sold as a percentage of net product revenue was primarily driven by new royalties related to the Novitium license agreement.
Net income for the second quarter was $75.4 million, or $1.28 per diluted share, compared to $39.8 million, or $0.68 per diluted share, for the same quarter in 2025.
Harmony’s operating expenses include the following:
Research and Development expenses were $46.6 million in the second quarter of 2026, as compared to $50.2 million for the same quarter in 2025, representing a 7% decrease; this was primarily driven by a $15.0 million up-front payment related to the agreement with CiRC that was entered into during the second quarter of 2025, for which there was no corresponding amount in the current year period;Sales and Marketing expenses were $34.1 million in the second quarter of 2026, as compared to $30.1 million for the same quarter in 2025, representing a 13% increase, primarily driven by the expansion of our field-based teams;General and Administrative expenses were $28.1 million in the second quarter of 2026, as compared to $33.9 million for the same quarter in 2025, representing a 17% decrease; this was primarily driven by a charge related to an ANDA settlement in the second quarter of 2025, for which there was no corresponding amount in the current year period; andTotal Operating expenses were $108.8 million in the second quarter of 2026, as compared to $114.2 million for the same quarter in 2025, representing a 5% decrease As of June 30, 2026, Harmony had cash, cash equivalents and investments of $962.5 million, compared to $882.5 million as of December 31, 2025.
2026 Net Product Revenue Guidance
Reiterated 2026 WAKIX net revenue guidance of $1.0 billion to $1.04 billion.
Conference Call Today at 8:30 a.m. ET
Harmony is hosting its second quarter 2026 financial results conference call and webcast today, beginning at 8:30 a.m. Eastern Time. The live and replay webcast of the call will be available on the investor relations page of our website https://ir.harmonybiosciences.com/.
To participate in the live call by phone, dial: 800-347-6865 (primary) or 203-518-9757 (alternate); conference ID is HRMYQ226.
About Harmony Biosciences
Harmony Biosciences is a pharmaceutical company dedicated to developing and commercializing innovative therapies for patients with rare neurological diseases who have unmet medical needs. Driven by novel science, visionary thinking, and a commitment to those who feel overlooked, Harmony Biosciences is nurturing a future full of therapeutic possibilities that may enable patients with rare neurological diseases to truly thrive. Established by Paragon Biosciences, LLC, in 2017 and headquartered in Plymouth Meeting, Pa., we believe that when empathy and innovation meet, a better future can begin; a vision evident in the therapeutic innovations we advance, the culture we cultivate, and the community programs we foster. For more information, please visit www.harmonybiosciences.com.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including statements regarding our full year 2026 net product revenue, expectations for the growth and value of WAKIX, our planned and ongoing clinical trials and expected timing of data readouts, anticipated regulatory milestones, our future results of operations and financial position, business strategy, products, prospective products, product approvals, and the plans and objectives of management for future operations. These statements are neither promises nor guarantees, but involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements, including, but not limited to, the following: our commercialization efforts and strategy for WAKIX; the rate and degree of market acceptance and clinical utility of pitolisant in additional indications, if approved, and any other product candidates we may develop or acquire, if approved, including EPX-100, Pitolisant GR and BP-205; our research and development plans, including our plans to explore the therapeutic potential of pitolisant in additional indications; our ongoing and planned clinical trials; our ability to expand the scope of our license agreements with Bioprojet Société Civile de Recherche (“Bioprojet”); the availability of favorable insurance coverage and reimbursement for WAKIX; the timing of, and our ability to obtain, regulatory approvals for pitolisant for other indications as well as any other product candidates; our estimates regarding expenses, future revenue, capital requirements and additional financing needs; our ability to identify, acquire and integrate additional products or product candidates with significant commercial potential that are consistent with our commercial objectives; our commercialization, marketing and manufacturing capabilities and strategy; significant competition in our industry; our intellectual property position; loss or retirement of key members of management; failure to successfully execute our growth strategy, including any delays in our planned future growth; our failure to maintain effective internal controls; the impact of government laws and regulations; volatility and fluctuations in the price of our common stock; the significant costs and required management time as a result of operating as a public company; the fact that the price of Harmony's common stock may be volatile and fluctuate substantially; statements related to our intended share repurchases and repurchase timeframe; and macroeconomic effects and changes in market conditions, including the impact of tariffs, inflation and the risk of recession. These and other important factors discussed under the caption "Risk Factors" in our Annual Report on Form 10-K filed with the Securities and Exchange Commission (the "SEC") on February 24, 2026 and our other filings with the SEC could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. Any such forward-looking statements represent management's estimates as of the date of this press release. While we may elect to update such forward-looking statements at some point in the future, we disclaim any obligation to do so, even if subsequent events cause our views to change.
HARMONY BIOSCIENCES HOLDINGS, INC. AND SUBSIDIARIESUNAUDITED CONDENSED CONSOLIDATED
STATEMENTS OF OPERATIONS AND COMPREHENSIVE INCOME
(In thousands, except share and per share data)
Three Months Ended June 30, Six Months Ended June 30, 2026 2025 2026 2025 Net product revenue $261,280 $200,489 $476,667 $385,222 Cost of product sold 63,198 38,153 107,710 70,147 Gross profit 198,082 162,336 368,957 315,075 Operating expenses: Research and development 46,596 50,159 115,979 84,699 Sales and marketing 34,120 30,073 65,814 60,784 General and administrative 28,050 33,924 60,557 65,167 Total operating expenses 108,766 114,156 242,350 210,650 Operating income 89,316 48,180 126,607 104,425 Other expense, net (53) (193) (180) (469)Interest expense (3,070) (3,646) (6,304) (7,482)Interest income 7,072 5,296 12,829 10,340 Income before income taxes 93,265 49,637 132,952 106,814 Income tax expense (17,834) (9,861) (25,033) (21,478)Net income $75,431 $39,776 $107,919 $85,336 Unrealized (loss) income on investments (314) (6) (1,073) 173 Comprehensive income $75,117 $39,770 $106,846 $85,509 EARNINGS PER SHARE: Basic $1.30 $0.69 $1.86 $1.49 Diluted $1.28 $0.68 $1.84 $1.46 Weighted average number of shares of common stock - basic 57,933,818 57,469,775 57,876,756 57,390,298 Weighted average number of shares of common stock - diluted 58,755,359 58,427,134 58,769,504 58,468,717 HARMONY BIOSCIENCES HOLDINGS, INC. AND SUBSIDIARIES
UNAUDITED CONDENSED CONSOLIDATED BALANCE SHEETS
(In thousands, except share and per share data) June 30, December 31, 2026 2025ASSETS CURRENT ASSETS: Cash and cash equivalents $549,769 $752,502Investments, short-term 118,022 22,838Trade receivables, net 110,995 96,787Inventory, net 6,360 5,357Prepaid expenses 19,311 16,014Other current assets 9,877 13,516Total current assets 814,334 907,014NONCURRENT ASSETS: Investments, long-term 294,668 107,127Intangible assets, net 77,496 89,418Deferred tax asset 156,765 149,699Other noncurrent assets 29,821 18,373Total noncurrent assets 558,750 364,617TOTAL ASSETS $1,373,084 $1,271,631LIABILITIES AND STOCKHOLDERS’ EQUITY CURRENT LIABILITIES: Trade payables $21,684 $17,693Accrued compensation 12,091 18,443Accrued expenses 169,128 191,039Current portion of long-term debt 20,000 20,000Other current liabilities 11,167 4,957Total current liabilities 234,070 252,132NONCURRENT LIABILITIES: Long-term debt, net 133,961 143,663Other noncurrent liabilities 5,810 5,618Total noncurrent liabilities 139,771 149,281TOTAL LIABILITIES 373,841 401,413COMMITMENTS AND CONTINGENCIES (Note 13) STOCKHOLDERS’ EQUITY: Common stock—$0.00001 par value; 500,000,000 shares authorized at June 30, 2026 and December 31, 2025, respectively; 58,120,695 and 57,726,170 shares issued and outstanding at June 30, 2026 and December 31, 2025, respectively 1 1Additional paid in capital 731,147 708,968Accumulated other comprehensive (loss) income (727) 346Retained earnings 268,822 160,903TOTAL STOCKHOLDERS’ EQUITY 999,243 870,218TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY $1,373,084 $1,271,631 Harmony Biosciences Investor Contact:
Brennan Doyle
484-566-3685 [email protected]
Harmony Biosciences Media Contact:
Cate McCanless
202-641-6086 [email protected]
Investors looking for stocks in the Medical - Biomedical and Genetics sector might want to consider either Harmony Biosciences Holdings, Inc. (HRMY) or Acadia Pharmaceuticals (ACAD). But which of these two stocks presents investors with the better value opportunity right now?
Here at Zacks, our focus is on the proven Zacks Rank system, which emphasizes earnings estimates and estimate revisions to find great stocks. Nevertheless, we are always paying attention to the latest value, growth, and momentum trends to underscore strong picks.
Considering these trends, value investing is clearly one of the most preferred ways to find strong stocks in any type of market. Value investors use tried-and-true metrics and fundamental analysis to find companies that they believe are undervalued at their current share price levels.
In addition to the Zacks Rank, investors looking for stocks with specific traits can utilize our Style Scores system. Of course, value investors will be most interested in the system's "Value" category. Stocks with "A" grades for Value and high Zacks Ranks are among the best value stocks available at any given moment.
One company to watch right now is Harmony Biosciences (HRMY - Free Report) . HRMY is currently sporting a Zacks Rank #1 (Strong Buy), as well as a Value grade of A.
Investors should also recognize that HRMY has a P/B ratio of 2.42. The P/B is a method of comparing a stock's market value to its book value, which is defined as total assets minus total liabilities. This company's current P/B looks solid when compared to its industry's average P/B of 3.55. Over the past year, HRMY's P/B has been as high as 4.20 and as low as 2.23, with a median of 2.87.
Value investors also love the P/S ratio, which is calculated by simply dividing a stock's price with the company's sales. This is a popular metric because sales are harder to manipulate on an income statement, so they are often considered a better performance indicator. HRMY has a P/S ratio of 2.31. This compares to its industry's average P/S of 6.57.
Finally, we should also recognize that HRMY has a P/CF ratio of 9.34. This data point considers a firm's operating cash flow and is frequently used to find companies that are undervalued when considering their solid cash outlook. This company's current P/CF looks solid when compared to its industry's average P/CF of 9.70. HRMY's P/CF has been as high as 16.61 and as low as 9.07, with a median of 11.73, all within the past year.
These figures are just a handful of the metrics value investors tend to look at, but they help show that Harmony Biosciences is likely being undervalued right now. Considering this, as well as the strength of its earnings outlook, HRMY feels like a great value stock at the moment.
Harmony Biosciences (HRMY) is evolving from a single-product firm into a self-funded neuroscience platform, leveraging robust WAKIX growth. WAKIX posted 30% Q1 revenue growth, supporting a strong balance sheet with $710 million net cash and funding for pipeline expansion. HRMY trades at a deep valuation discount, reflecting market fears of WAKIX cash flow erosion post-2030 and underappreciated pipeline potential.
Key Takeaways HRMY is among 16 screened stocks meeting low P/B, valuation, liquidity and growth criteria.General Motors qualified after meeting value screens, including low P/B, P/E, P/S and PEG metrics.HPE joined the list with a Value Score of B and projected 3-5-year EPS growth of 32.0%. Price-to-book ratio, or P/B ratio, is essentially the ratio of stock price to book value, i.e., how much an investor needs to pay for each dollar of book value of a stock. It is calculated by dividing the current closing price of the stock by the latest quarter's book value per share.
In value investing, it is a common practice to pick stocks that are cheap but fundamentally strong. There are a number of investment styles for finding great stocks at attractive values.
While considering valuation metrics, though price-to-earnings and price-to-sales are the first choices, the P/B ratio is also emerging as a convenient tool for identifying low-priced stocks that have high-growth prospects.
Here’s the formula of P/B ratio:
P/B ratio = market capitalization/book value of equity.
This metric can help identify attractively priced stocks with upside potential. Some such stocks are Harmony Biosciences Holdings (HRMY - Free Report) , Invesco (IVZ - Free Report) , General Motors (GM - Free Report) , Hewlett Packard Enterprise (HPE - Free Report) and Quanex Building Products (NX - Free Report) . Let us understand the concept of book value.
What is Book Value?There are several ways in which book value can be defined. Book value is the total value that would be left over, according to the company’s balance sheet, if it went bankrupt immediately. In other words, this is what shareholders would theoretically receive if a company liquidated all its assets after paying off all its liabilities.
It is calculated by subtracting total liabilities from the total assets of a company. In most cases, this equates to common stockholders’ equity on the balance sheet. However, depending on the company’s balance sheet, intangible assets should also be subtracted from total assets to determine book value.
Book Value Per Share = (Total Assets – Total Liabilities) ÷ Number of Outstanding Shares
Understanding P/B RatioBy comparing the book value of equity to its market price, we get an idea of whether a company is under- or overpriced. Like P/E or P/S ratios, it is always better to compare the P/B ratio within industries.
A P/B ratio of less than one means that the stock is trading at less than its book value or the stock is undervalued and, therefore, a good buy. Conversely, a stock with a ratio greater than one can be interpreted as being overvalued or relatively expensive.
For example, a stock with a P/B ratio of 2 means that we pay $2 for every $1 of book value. Thus, the higher the P/B, the more expensive the stock.
But there is a warning. A P/B ratio of less than one can also mean that the company is earning weak or even negative returns on its assets or that the assets are overstated. In such a case, the stock should be shunned because it may be destroying shareholder value. Conversely, the stock’s price may be significantly high — thereby pushing the P/B ratio to more than one — in the likely case that it has become a takeover target, a good enough reason to own the stock.
Moreover, the P/B ratio is not without limitations. It is useful for businesses like finance, investments, insurance and banking or manufacturing companies with many liquid/tangible assets on the books. However, it can be misleading for firms with significant R&D expenditure, high debt, service companies, or those with negative earnings.
In any case, the ratio is not particularly relevant as a standalone number. One should analyze other ratios like P/E, P/S and debt to equity before arriving at a reasonable investment decision.
Screening ParametersPrice to Book (Common Equity) less than X-Industry Median: A lower P/B compared with the industry average implies that there is enough room for the stock to gain.
Price to Sales less than X-Industry Median: The P/S ratio determines how much the market values every dollar of the company’s sales/revenues — a lower ratio than the industry makes the stock attractive.
Price to Earnings using F(1) estimate less than X-Industry Median: The P/E ratio (F1) values a company based on its current share price relative to its estimated earnings per share — a lower ratio than the industry is considered better.
PEG less than 1: PEG links the P/E ratio to the future growth rate of the company. The PEG ratio portrays a more complete picture than the P/E ratio. A value of less than 1 indicates that the stock is undervalued, and investors need to pay less for a stock that has bright earnings growth prospects.
Current Price greater than or equal to $5: They must all be trading at a minimum of $5 or higher.
Average 20-Day Volume greater than or equal to 100,000: substantial trading volume ensures that the stock is easily tradable.
Zacks Rank less than or equal to #2:Zacks Rank #1 (Strong Buy) or 2 (Buy) stocks are known to outperform irrespective of the market environment.
Value Score equal to A or B: Our research shows that stocks with a Value Score of A or B, when combined with a Zacks Rank #1 or 2, offer the best opportunities in the value investing space.
5 Low Price-to-Book StocksHere are five of the 16 stocks that qualified for the screening:
Delaware-based Harmony Biosciences is a neuroscience company developing and commercializing therapies for sleep/wake disorders and rare neurological diseases.
Harmony Biosciences currently has a Value Score of A and a Zacks Rank #1. HRMY has a projected 3-5-year EPS growth rate of 32.6%. You can see the complete list of today’s Zacks #1 Rank stocks here.
Headquartered in Atlanta, GA, Invesco Ltd. operates as an independent investment manager and offers a wide range of investment products and services.
IVZ has a Zacks Rank #2 and a Value Score of A. Invesco has a projected 3-5-year EPS growth rate of 22.02%.
Detroit, MI-based General Motors is one of the world’s largest automakers. General Motors, along with its strategic partners, produces, sells and services cars, trucks and parts under four core brands — Chevrolet, Buick, GMC and Cadillac. General Motors assembles passenger cars, crossover vehicles, light trucks, sport-utility vehicles, vans and other vehicles.
GM currently has a Zacks Rank #2 and a Value Score of A. The company has a projected 3-5-year EPS growth rate of 16.5%.
Headquartered in Houston, TX, Hewlett Packard Enterprise is a global enterprise technology company. It provides hardware, software and services that help businesses store, process and manage data across on-premise, cloud and edge environments. The company serves enterprises, governments, telecom operators and financial institutions in more than 150 countries.
Hewlett Packard currently has a Zacks Rank #1 and a Value Score of B. The company has a projected 3-5-year EPS growth rate of 32.0%
Houston, TX-based Quanex Building Products is an industry-leading manufacturer of components sold to original equipment manufacturers in the building products industry.
NX currently has a Value Score of A and a Zacks Rank #2. Quanex Building Products has a projected 3-5-year EPS growth rate of 14.0%.
The market expects Harmony Biosciences Holdings, Inc. (HRMY - Free Report) to deliver a year-over-year increase in earnings on higher revenues when it reports results for the quarter ended June 2026. This widely-known consensus outlook is important in assessing the company's earnings picture, but a powerful factor that might influence its near-term stock price is how the actual results compare to these estimates.
The stock might move higher if these key numbers top expectations in the upcoming earnings report, which is expected to be released on August 4. On the other hand, if they miss, the stock may move lower.
While management's discussion of business conditions on the earnings call will mostly determine the sustainability of the immediate price change and future earnings expectations, it's worth having a handicapping insight into the odds of a positive EPS surprise.
Zacks Consensus EstimateThis company is expected to post quarterly earnings of $0.97 per share in its upcoming report, which represents a year-over-year change of +42.7%.
Revenues are expected to be $252.54 million, up 26% from the year-ago quarter.
Estimate Revisions TrendThe consensus EPS estimate for the quarter has been revised 0.76% higher over the last 30 days to the current level. This is essentially a reflection of how the covering analysts have collectively reassessed their initial estimates over this period.
Investors should keep in mind that an aggregate change may not always reflect the direction of estimate revisions by each of the covering analysts.
Price, Consensus and EPS Surprise
Earnings WhisperEstimate revisions ahead of a company's earnings release offer clues to the business conditions for the period whose results are coming out. Our proprietary surprise prediction model -- the Zacks Earnings ESP (Expected Surprise Prediction) -- has this insight at its core.
The Zacks Earnings ESP compares the Most Accurate Estimate to the Zacks Consensus Estimate for the quarter; the Most Accurate Estimate is a more recent version of the Zacks Consensus EPS estimate. The idea here is that analysts revising their estimates right before an earnings release have the latest information, which could potentially be more accurate than what they and others contributing to the consensus had predicted earlier.
Thus, a positive or negative Earnings ESP reading theoretically indicates the likely deviation of the actual earnings from the consensus estimate. However, the model's predictive power is significant for positive ESP readings only.
A positive Earnings ESP is a strong predictor of an earnings beat, particularly when combined with a Zacks Rank #1 (Strong Buy), 2 (Buy) or 3 (Hold). Our research shows that stocks with this combination produce a positive surprise nearly 70% of the time, and a solid Zacks Rank actually increases the predictive power of Earnings ESP.
Please note that a negative Earnings ESP reading is not indicative of an earnings miss. Our research shows that it is difficult to predict an earnings beat with any degree of confidence for stocks with negative Earnings ESP readings and/or Zacks Rank of 4 (Sell) or 5 (Strong Sell).
How Have the Numbers Shaped Up for Harmony Biosciences?For Harmony Biosciences, the Most Accurate Estimate is higher than the Zacks Consensus Estimate, suggesting that analysts have recently become bullish on the company's earnings prospects. This has resulted in an Earnings ESP of +14.14%.
On the other hand, the stock currently carries a Zacks Rank of #1.
So, this combination indicates that Harmony Biosciences will most likely beat the consensus EPS estimate.
Does Earnings Surprise History Hold Any Clue?Analysts often consider to what extent a company has been able to match consensus estimates in the past while calculating their estimates for its future earnings. So, it's worth taking a look at the surprise history for gauging its influence on the upcoming number.
For the last reported quarter, it was expected that Harmony Biosciences would post earnings of $0.76 per share when it actually produced earnings of $0.55, delivering a surprise of -27.63%.
The company has not been able to beat consensus EPS estimates in any of the last four quarters.
Bottom LineAn earnings beat or miss may not be the sole basis for a stock moving higher or lower. Many stocks end up losing ground despite an earnings beat due to other factors that disappoint investors. Similarly, unforeseen catalysts help a number of stocks gain despite an earnings miss.
That said, betting on stocks that are expected to beat earnings expectations does increase the odds of success. This is why it's worth checking a company's Earnings ESP and Zacks Rank ahead of its quarterly release. Make sure to utilize our Earnings ESP Filter to uncover the best stocks to buy or sell before they've reported.
Harmony Biosciences appears a compelling earnings-beat candidate. However, investors should pay attention to other factors too for betting on this stock or staying away from it ahead of its earnings release.
Expected Results of an Industry PlayerAmong the stocks in the Zacks Medical - Biomedical and Genetics industry, Krystal Biotech, Inc. (KRYS - Free Report) , is soon expected to post earnings of $1.7 per share for the quarter ended June 2026. This estimate indicates a year-over-year change of +31.8%. This quarter's revenue is expected to be $119.05 million, up 24% from the year-ago quarter.
The consensus EPS estimate for Krystal Biotech has been revised 6.4% lower over the last 30 days to the current level. However, a higher Most Accurate Estimate has resulted in an Earnings ESP of +3.33%.
This Earnings ESP, combined with its Zacks Rank #4 (Sell), makes it difficult to conclusively predict that Krystal Biotech will beat the consensus EPS estimate. The company beat consensus EPS estimates in each of the trailing four quarters.
Stay on top of upcoming earnings announcements with the Zacks Earnings Calendar.
Harmony Biosciences (HRMY) was a big mover last session on higher-than-average trading volume. The latest trend in earnings estimate revisions might not help the stock continue moving higher in the near term.
July 21, 2026 08:05 ET | Source: Harmony Biosciences
PLYMOUTH MEETING, Pa., July 21, 2026 (GLOBE NEWSWIRE) -- Harmony Biosciences Holdings, Inc. (Nasdaq: HRMY) today announced that it will report second quarter 2026 financial results on Tuesday, August 4, 2026, before the open of the U.S. financial markets. Harmony will host a conference call and webcast on August 4, 2026, at 8:30 a.m. ET to discuss the results.
To participate in the call, please dial 800-347-6865 (domestic) or 203-518-9757 (international or alternate), and reference passcode HRMYQ226. It is recommended that you dial in at least 10 minutes prior to the call.
The live and replay webcast of the call will be available on the investor page of our website at https://ir.harmonybiosciences.com/.
About Harmony Biosciences
Harmony Biosciences is a pharmaceutical company dedicated to developing and commercializing innovative therapies for patients with rare neurological diseases who have unmet medical needs. Driven by novel science, visionary thinking, and a commitment to those who feel overlooked, Harmony Biosciences is nurturing a future full of therapeutic possibilities that may enable patients with rare neurological diseases to truly thrive. Established by Paragon Biosciences, LLC, in 2017 and headquartered in Plymouth Meeting, Pa, we believe that when empathy and innovation meet, a better future can begin; a vision evident in the therapeutic innovations we advance, the culture we cultivate, and the community programs we foster. For more information, please visit www.harmonybiosciences.com.
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%.
PLYMOUTH MEETING, Pa.--(BUSINESS WIRE)--Harmony Biosciences Holdings, Inc. (Nasdaq: HRMY) today announced preliminary, unaudited second quarter 2026 net product revenue for WAKIX® (pitolisant) of approximately $261 million, representing a new quarterly revenue record for the Company and growth of 30% year over year and 21% growth for Q2 over Q1. These results underscore continued strong demand for WAKIX, disciplined commercial execution across the franchise and sustained momentum through the fi.
Harmony Biosciences Holdings, Inc. (HRMY - Free Report) closed the last trading session at $34.81, gaining 2.9% over the past four weeks, but there could be plenty of upside left in the stock if short-term price targets set by Wall Street analysts are any guide. The mean price target of $44.33 indicates a 27.4% upside potential.
The average comprises 12 short-term price targets ranging from a low of $28.00 to a high of $85.00, with a standard deviation of $15.28. While the lowest estimate indicates a decline of 19.6% from the current price level, the most optimistic estimate points to a 144.2% upside. More than the range, one should note the standard deviation here, as it helps understand the variability of the estimates. The smaller the standard deviation, the greater the agreement among analysts.
While the consensus price target is a much-coveted metric for investors, solely banking on this metric to make an investment decision may not be wise at all. That's because the ability and unbiasedness of analysts in setting price targets have long been questionable.
However, an impressive consensus price target is not the only factor that indicates a potential upside in HRMY. This view is strengthened by the agreement among analysts that the company will report better earnings than what they estimated earlier. Though a positive trend in earnings estimate revisions doesn't give any idea as to how much the stock could surge, it has proven effective in predicting an upside.
Price, Consensus and EPS Surprise
Here's What You Should Know About Analysts' Price TargetsAccording to researchers at several universities across the globe, a price target is one of many pieces of information about a stock that misleads investors far more often than it guides. In fact, empirical research shows that price targets set by several analysts, irrespective of the extent of agreement, rarely indicate where the price of a stock could actually be heading.
While Wall Street analysts have deep knowledge of a company's fundamentals and the sensitivity of its business to economic and industry issues, many of them tend to set overly optimistic price targets. Are you wondering why?
They usually do that to drum up interest in shares of companies that their firms either have existing business relationships with or are looking to be associated with. In other words, business incentives of firms covering a stock often result in inflated price targets set by analysts.
However, a tight clustering of price targets, which is represented by a low standard deviation, indicates that analysts have a high degree of agreement about the direction and magnitude of a stock's price movement. While that doesn't necessarily mean the stock will hit the average price target, it could be a good starting point for further research aimed at identifying the potential fundamental driving forces.
That said, while investors should not entirely ignore price targets, making an investment decision solely based on them could lead to disappointing ROI. So, price targets should always be treated with a high degree of skepticism.
Here's Why There Could be Plenty of Upside Left in HRMYThere has been increasing optimism among analysts lately about the company's earnings prospects, as indicated by strong agreement among them in revising EPS estimates higher. And that could be a legitimate reason to expect an upside in the stock. After all, empirical research shows a strong correlation between trends in earnings estimate revisions and near-term stock price movements.
The Zacks Consensus Estimate for the current year has increased 1.7% over the past month, as one estimate has gone higher compared to no negative revision.
Moreover, HRMY currently has a Zacks Rank #1 (Strong Buy), which means it is in the top 5% of more than 4,000 stocks that we rank based on four factors related to earnings estimates. Given an impressive externally-audited track record, this is a more conclusive indication of the stock's potential upside in the near term. You can see the complete list of today's Zacks Rank #1 (Strong Buy) stocks here >>>> .
Therefore, while the consensus price target may not be a reliable indicator of how much HRMY could gain, the direction of price movement it implies does appear to be a good guide.
Investors interested in Medical - Biomedical and Genetics stocks are likely familiar with Harmony Biosciences Holdings, Inc. (HRMY - Free Report) and Amgen (AMGN - Free Report) . But which of these two companies is the best option for those looking for undervalued stocks? Let's take a closer look.
There are plenty of strategies for discovering value stocks, but we have found that pairing a strong Zacks Rank with an impressive grade in the Value category of our Style Scores system produces the best returns. The proven Zacks Rank puts an emphasis on earnings estimates and estimate revisions, while our Style Scores work to identify stocks with specific traits.
Currently, Harmony Biosciences Holdings, Inc. has a Zacks Rank of #1 (Strong Buy), while Amgen has a Zacks Rank of #3 (Hold). Investors should feel comfortable knowing that HRMY likely has seen a stronger improvement to its earnings outlook than AMGN has recently. But this is just one factor that value investors are interested in.
Value investors are also interested in a number of tried-and-true valuation metrics that help show when a company is undervalued at its current share price levels.
The Value category of the Style Scores system identifies undervalued companies by looking at a number of key metrics. These include the long-favored P/E ratio, P/S ratio, earnings yield, cash flow per share, and a variety of other fundamentals that help us determine a company's fair value.
HRMY currently has a forward P/E ratio of 10.91, while AMGN has a forward P/E of 16.25. We also note that HRMY has a PEG ratio of 0.33. This popular figure is similar to the widely-used P/E ratio, but the PEG ratio also considers a company's expected EPS growth rate. AMGN currently has a PEG ratio of 3.58.
Another notable valuation metric for HRMY is its P/B ratio of 2.26. The P/B ratio pits a stock's market value against its book value, which is defined as total assets minus total liabilities. For comparison, AMGN has a P/B of 21.17.
These metrics, and several others, help HRMY earn a Value grade of A, while AMGN has been given a Value grade of C.
HRMY stands above AMGN thanks to its solid earnings outlook, and based on these valuation figures, we also feel that HRMY is the superior value option right now.
Here at Zacks, our focus is on the proven Zacks Rank system, which emphasizes earnings estimates and estimate revisions to find great stocks. Nevertheless, we are always paying attention to the latest value, growth, and momentum trends to underscore strong picks.
Of these, perhaps no stock market trend is more popular than value investing, which is a strategy that has proven to be successful in all sorts of market environments. Value investors use tried-and-true metrics and fundamental analysis to find companies that they believe are undervalued at their current share price levels.
In addition to the Zacks Rank, investors looking for stocks with specific traits can utilize our Style Scores system. Of course, value investors will be most interested in the system's "Value" category. Stocks with "A" grades for Value and high Zacks Ranks are among the best value stocks available at any given moment.
One company value investors might notice is Harmony Biosciences (HRMY - Free Report) . HRMY is currently sporting a Zacks Rank #1 (Strong Buy) and an A for Value.
Investors should also recognize that HRMY has a P/B ratio of 2.42. The P/B ratio pits a stock's market value against its book value, which is defined as total assets minus total liabilities. This company's current P/B looks solid when compared to its industry's average P/B of 3.54. Over the past year, HRMY's P/B has been as high as 4.20 and as low as 2.23, with a median of 2.87.
Finally, our model also underscores that HRMY has a P/CF ratio of 9.34. This metric focuses on a firm's operating cash flow and is often used to find stocks that are undervalued based on the strength of their cash outlook. HRMY's current P/CF looks attractive when compared to its industry's average P/CF of 9.69. Within the past 12 months, HRMY's P/CF has been as high as 16.61 and as low as 9.07, with a median of 11.73.
These are only a few of the key metrics included in Harmony Biosciences's strong Value grade, but they help show that the stock is likely undervalued right now. When factoring in the strength of its earnings outlook, HRMY looks like an impressive value stock at the moment.
Here are three stocks with buy rank and strong value characteristics for investors to consider today, July 14:
Methanex Corporation (MEOH - Free Report) : This methanol and ammonia company carries a Zacks Rank #1, and has witnessed the Zacks Consensus Estimate for its current year earnings increasing nearly 14% over the last 60 days.
Methanex has a price-to-earnings ratio (P/E) of 5.62, compared with 12.40 for the industry. The company possesses a Value Score of A.
LATAM Airlines Group S.A. (LTM - Free Report) : This passenger and cargo airlines company carries a Zacks Rank #1, and has witnessed the Zacks Consensus Estimate for its current year earnings increasing 19.4% over the last 60 days.
LATAM Airlines has a price-to-earnings ratio (P/E) of 11.21, compared with 23.09 for the S&P 500. The company possesses a Value Score of A.
Harmony Biosciences Holdings, Inc. (HRMY - Free Report) : This commercial-stage pharmaceutical company carries a Zacks Rank #1, and has witnessed the Zacks Consensus Estimate for its next year earnings increasing 5.2% over the last 60 days.
Harmony Biosciences has a price-to-earnings ratio (P/E) of 11.31, compared with 23.09 for the S&P 500. The company possesses a Value Score of A.
You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Learn more about the Value score and how it is calculated here.
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.
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.
Key Takeaways Harmony Biosciences trades at 10.38X forward earnings, below industry and market averages.HRMY reiterated 2026 Wakix guidance despite missing earnings and revenue estimates in Q1.HRMY is advancing Pitolisant GR and HD programs while expanding rare epilepsy studies. Harmony Biosciences Holdings, Inc. (HRMY - Free Report) sits at an interesting point for investors. The stock looks inexpensive by several valuation measures, but the company depends heavily on Wakix for revenues.
That creates a balanced buy debate. HRMY has a profitable commercial franchise and a funded pipeline, yet recent misses keep the setup from looking one-sided.
Why HRMY Looks Cheap on PaperHRMY’s valuation profile is the clearest part of the bull case. The stock trades at 10.38X forward 12-month earnings, below 44.24X for the Zacks sub-industry, 21.22X for the Zacks sector and 20.9X for the S&P 500 index.
Other measures also look restrained. HRMY has a current-year price-to-earnings ratio of 11.08, a PEG ratio of 0.70, a price-to-sales ratio of 2.28 and a price-to-book ratio of 2.25. The discount reflects a business concentrated around one commercial product and exposed to future competition and generic risk.
Where Harmony Still Shows Operating StrengthHarmony still has operating support behind the valuation argument. In 2025, the company reported net product revenues of $868.5 million, up from $714.7 million in 2024. It also reiterated 2026 Wakix net revenue guidance of $1.0 billion to $1.04 billion.
The balance sheet adds flexibility. Harmony ended the first quarter of 2026 with $870.5 million in cash, cash equivalents and investments. Consensus estimates also imply growth, with sales projected at $1.009 billion in 2026 and $1.129 billion in 2027, while earnings are projected at $3.20 per share in 2026 and $3.64 per share in 2027.
Alkermes plc (ALKS - Free Report) gives investors another neuroscience peer to watch. Jazz Pharmaceuticals plc (JAZZ - Free Report) , with its sleep medicine presence, remains a relevant specialty pharma comparison.
Why Recent Results Raise CautionThe latest quarter introduced caution. Harmony reported earnings of 55 cents per share, below the Zacks Consensus Estimate of 76 cents and down from 78 cents in the year-ago period.
Net product revenues were $215.4 million, up 17% year over year, but they missed the Zacks Consensus Estimate of $222 million. The company exited the quarter with roughly 8,600 patients on therapy.
Management cited seasonal market access headwinds, including plan changes, prior authorizations and premium resets, that delayed starts. This pattern occurs in the first quarter, but it was more pronounced this year.
Spending also moved higher. Research and development expenses more than doubled to $69.3 million, reflecting pipeline expansion and licensing transactions. That spending could pay off, but it raises the execution bar.
What Could Re-Rate HRMY StockA stronger stock case starts with Wakix. Smooth progress toward the 2026 revenue target would help show that access friction is manageable and that the narcolepsy opportunity remains underpenetrated.
Pipeline execution is the second lever. Pitolisant GR is on track for an NDA submission in the second quarter, with a target action date in the first quarter of 2027. The formulation is designed to start patients at a therapeutic dose and potentially improve tolerability.
Pitolisant HD is another key program, with phase III studies in narcolepsy and idiopathic hypersomnia. Top-line data are anticipated in 2027, and a target action date is expected in 2028.
Investors will also watch whether pipeline spending can create future revenue streams. EPX-100 is enrolling in two phase III rare epilepsy studies, while amorphous pitolisant could open broader central nervous system indications.
How Harmony’s Ratings Shape the Buy DebateThe bottom line is that HRMY looks more like a valuation-driven watchlist candidate than a clean momentum buy. Low multiples and revenue growth are appealing, but recent misses and product concentration keep the risk-reward balanced.
The Neutral long-term view argues against an aggressive call. The stock currently carries a Zacks Rank #3 (Hold), which suggests a measured near-term setup rather than a clear signal for immediate outperformance. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
The Style Scores are more constructive on valuation and fundamentals. HRMY has a VGM Score of A, a Value Score of A and a Growth Score of B, supporting the case that the shares screen well for value and business expansion.
The Momentum Score of D is the offset. It suggests investors may need patience for the valuation case to work while the market waits for steadier execution and clearer pipeline progress.
Harmony Biosciences Holdings, Inc. (NASDAQ: HRMY - Get Free Report) has received an average rating of "Hold" from the twelve analysts that are presently covering the firm, MarketBeat Ratings reports. One investment analyst has rated the stock with a sell rating, six have issued a hold rating, four have given a buy rating and one has
PLYMOUTH MEETING, Pa.--(BUSINESS WIRE)--Harmony Biosciences Holdings, Inc. (Nasdaq: HRMY) today announced that Harmony's management team will participate in a fireside chat at the upcoming 25th Annual Needham Virtual Healthcare Conference on Monday, April 13, 2026, at 9:30 a.m. ET. A webcast of the fireside chat will be available on the investor page of the Harmony Biosciences website at https://ir.harmonybiosciences.com/. About Harmony Biosciences Harmony Biosciences is a pharmaceutical compan.
PLYMOUTH MEETING, Pa.--(BUSINESS WIRE)--Harmony Biosciences Holdings, Inc. (Nasdaq: HRMY) today announced the appointment of Peter Anastasiou as Chief Operating Officer and updates to its Board of Directors, including the appointment of Troy Ignelzi as a director and the nomination of Geno J. Germano as a director for election at Harmony's 2026 Annual Meeting of Shareholders. Mr. Anastasiou previously served on Harmony Biosciences' Board of Directors, where he contributed strategic insight acro.
PLYMOUTH MEETING, Pa.--(BUSINESS WIRE)--Harmony Biosciences Holdings, Inc. (Nasdaq: HRMY), today announced the appointment of Glenn Reicin as Chief Financial Officer, effective immediately, supporting Harmony's continued focus on strategic growth, financial strength, and long‑term value creation. Harmony is also reiterating its 2026 net product revenue guidance of $1.0 to $1.04 billion. Mr. Reicin is a seasoned biopharmaceutical executive with extensive experience across publicly traded and pri.
Harmony Biosciences (NASDAQ:HRMY) executives outlined 2026 priorities at Needham & Company’s Virtual Healthcare Conference, emphasizing continued growth for WAKIX and multiple late-stage pipeline readouts across sleep-wake and rare epilepsy indications.
WAKIX outlook and commercial execution President and CEO Jeffrey Dayno said Harmony is “on track to achieve over $1 billion in net revenue for WAKIX in its sixth year on the market,” describing the product as the company’s foundation for near- and long-term growth.
Chief Commercial Officer Adam Zaeske pointed to accelerating patient growth exiting 2025. While the company “typically see[s] patient additions of 100-400 patients a quarter,” Zaeske said the last three quarters saw “400-500 patient adds,” which he characterized as “really, really strong growth and momentum carrying us into 2026.” He attributed the performance to WAKIX’s differentiation as “the only non-scheduled treatment option available for patients,” along with broad access and ongoing refinements to sales execution, payer coverage, and patient support processes intended to speed time to dispense.
Looking ahead, Zaeske said Harmony expanded its commercial organization in the first quarter, increasing field sales, remote sales, and field reimbursement teams “on average of about 20%,” with hires in place and trained.
ANDA litigation and loss-of-exclusivity planning Fadia asked about an outstanding abbreviated new drug application (ANDA) filer. Dayno said Harmony has “settled with six of the seven ANDA filers” with loss of exclusivity (LOE) “to September of 2029,” and he added that pediatric exclusivity—“for which we’re on track to achieve”—would extend that to “March of 2030.”
On the ongoing trial process, Dayno said post-trial briefs were submitted the prior Thursday and the company cannot “predict the timing or the outcome.” He said Harmony remains focused both on completing settlement efforts and on advancing next-generation pitolisant programs.
Pitolisant franchise: GR and high-dose programs Dayno highlighted multiple pitolisant lifecycle initiatives. He said pitolisant GR (gastroresistant) is “on track for NDA submission this quarter,” with a target PDUFA date in “the first quarter of next year of 2027.”
Zaeske said the GR formulation is intended to improve the patient experience, noting that “80% of patients with narcolepsy have the potential for GI symptoms related to the disease.” He said the GR coating “adds to” WAKIX’s tolerability foundation and also enables patients to “start at a therapeutic dose” with “no titration required.” Zaeske added that Harmony’s distribution model allows it to recontact prior WAKIX patients who consented at initiation, potentially informing patients who discontinued for various reasons that a GR formulation is available. He said Harmony has “historically…thought about the GR as between $3 million and $500 million opportunity.”
For pitolisant high dose (HD), Zaeske described the strategy as “a totally new branded launch and a highly differentiated product,” combining the GR benefits with “up to 2x the approved dose of WAKIX” and pursuing “unique indications in narcolepsy and IH.” He said the company is running two phase III registrational trials—one in narcolepsy and one in idiopathic hypersomnia (IH)—with “target PDUFA dates both in 2028,” and said Harmony has discussed HD as “a billion-plus opportunity.”
Dayno added that HD is “a unique formulation” with “a different PK profile,” stating that “milligram for milligram, greater exposure” has been demonstrated, with safety margins “well beyond going two times the highest labeled dose.” He also said the GR and HD programs are designed to support potential new labeling in areas such as “fatigue in narcolepsy” and “sleep inertia in IH,” and that the company has “utility patents out through 2044” for both GR and HD.
New pitolisant formulation targeting fatigue Dayno and Chief Medical and Scientific Officer Kumar Budur discussed an additional pitolisant formulation obtained via an exclusive license backed by an issued patent “until 2042.” Budur said Harmony’s interest in fatigue stems from its “multidimensional” nature—emotional, physical, and cognitive—and argued the histaminergic mechanism, including downstream norepinephrine and serotonin effects, is “uniquely positioned to address all three aspects of fatigue.”
Budur cited Harmony’s phase II proof-of-concept study in type 1 myotonic dystrophy, where about 90% of patients have significant fatigue, saying pitolisant improved fatigue “in a clinically meaningful way” and showed a “dose response.” He also noted pitolisant is labeled in Europe for residual excessive daytime sleepiness in obstructive sleep apnea. Based on characteristics of the newly licensed formulation, Budur said Harmony prioritized fatigue in multiple sclerosis because fatigue is “very well characterized” in MS and affects a large proportion of patients. He said the company is “optimizing the formulation” and expects the next step to be a phase I pharmacokinetic study.
Orexin program and EPX-100 in rare epilepsies Management also addressed the evolving orexin landscape and Harmony’s own orexin receptor agonist, BP1.15205. Zaeske said physicians show interest in orexins based on efficacy but still have questions about tolerability and longer-term data, citing reported adverse events such as “pretty high rates of insomnia,” frequent urination, and visual disturbances. He said Harmony expects a “gradual approach” to adoption and argued that new brands in narcolepsy historically expand branded utilization rather than solely shift share, reflecting a polypharmacy treatment paradigm. Zaeske said WAKIX’s “exceptional safety and tolerability” and “extremely clean profile” support its role as an add-on therapy.
Budur said BP1.15205 is “the most potent orexin receptor agonist in clinical development,” describing potency at “0.015 nanomolar levels,” a novel chemical scaffold intended to avoid off-target issues seen with earlier compounds, and a preclinical profile supportive of “potentially once-a-day dosing.” Dayno said Harmony expects top-line data from a phase I single-ascending-dose PK study in healthy volunteers “mid-year,” followed by an IND submission “mid-year” and a sleep-deprived healthy volunteer study to evaluate safety, tolerability, dose-ranging, and initial signals of efficacy.
In rare epilepsy, Budur discussed EPX-100, referencing open-label ARGUS data presented at AES showing a “50% median reduction” in CMS-28 from baseline. He emphasized EPX-100 is being developed as adjunctive therapy on top of multiple anti-epileptic drugs and said the program’s differentiation could include tolerability and safety, citing low rates of clinically relevant GI adverse events and no expected need for special routine monitoring such as LFT checks or echocardiograms required with other therapies. Dayno reiterated two phase III trials are advancing in Dravet syndrome and Lennox-Gastaut syndrome, with top-line data anticipated in 2027 and target PDUFA dates in 2028.
Dayno also highlighted business development as a key priority, citing “over $880 million on our balance sheet.” He said Harmony’s focus remains orphan and rare CNS and neuropsychiatric targets, but the company has “opened up the aperture” to consider broader indications adjacent to its sleep-wake and rare epilepsy franchises, including potentially “on market” assets and opportunities ranging from smaller tuck-ins to more transformational deals.
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.
See Also Five stocks we like better than Harmony Biosciences
PLYMOUTH MEETING, Pa.--(BUSINESS WIRE)--Harmony Biosciences Holdings, Inc. (Nasdaq: HRMY) today announced that it will present encore open-label extension data from the company's investigation of EPX-100 (clemizole hydrochloride) in the ongoing Phase 3 ARGUS trial for the treatment of Dravet syndrome at the 2026 American Academy of Neurology Annual Meeting being held April 18 – 22 in Chicago, IL. The ARGUS trial is currently enrolling, and more information about the trial can be found at argust.
PLYMOUTH MEETING, Pa.--(BUSINESS WIRE)--Harmony Biosciences Holdings, Inc. (Nasdaq: HRMY) today announced that it will report first quarter 2026 financial results on Thursday, May 7, 2026, before the open of the U.S. financial markets. Harmony will host a conference call and webcast on May 7, 2026, at 8:30 a.m. ET to discuss the results. To participate in the call, please dial 800-274-8461 (domestic) or 203-518-9814 (international or alternate), and reference passcode HRMYQ126. It is recommende.
Harmony Biosciences Holdings, Inc. (HRMY - Free Report) closed the last trading session at $31.83, gaining 14.7% over the past four weeks, but there could be plenty of upside left in the stock if short-term price targets set by Wall Street analysts are any guide. The mean price target of $42.91 indicates a 34.8% upside potential.
The average comprises 11 short-term price targets ranging from a low of $25.00 to a high of $72.00, with a standard deviation of $13.82. While the lowest estimate indicates a decline of 21.5% from the current price level, the most optimistic estimate points to a 126.2% upside. More than the range, one should note the standard deviation here, as it helps understand the variability of the estimates. The smaller the standard deviation, the greater the agreement among analysts.
While the consensus price target is highly sought after by investors, the ability and unbiasedness of analysts in setting price targets have long been questionable. And investors making investment decisions solely based on this tool would arguably do themselves a disservice.
But, for HRMY, an impressive average price target is not the only indicator of a potential upside. Strong agreement among analysts about the company's ability to report better earnings than they predicted earlier strengthens this view. While a positive trend in earnings estimate revisions doesn't gauge how much a stock could gain, it has proven to be powerful in predicting an upside.
Price, Consensus and EPS Surprise
Here's What You May Not Know About Analysts' Price TargetsAccording to researchers at several universities across the globe, a price target is one of many pieces of information about a stock that misleads investors far more often than it guides. In fact, empirical research shows that price targets set by several analysts, irrespective of the extent of agreement, rarely indicate where the price of a stock could actually be heading.
While Wall Street analysts have deep knowledge of a company's fundamentals and the sensitivity of its business to economic and industry issues, many of them tend to set overly optimistic price targets. Are you wondering why?
They usually do that to drum up interest in shares of companies that their firms either have existing business relationships with or are looking to be associated with. In other words, business incentives of firms covering a stock often result in inflated price targets set by analysts.
However, a tight clustering of price targets, which is represented by a low standard deviation, indicates that analysts have a high degree of agreement about the direction and magnitude of a stock's price movement. While that doesn't necessarily mean the stock will hit the average price target, it could be a good starting point for further research aimed at identifying the potential fundamental driving forces.
That said, while investors should not entirely ignore price targets, making an investment decision solely based on them could lead to disappointing ROI. So, price targets should always be treated with a high degree of skepticism.
Here's Why There Could be Plenty of Upside Left in HRMYAnalysts' growing optimism over the company's earnings prospects, as indicated by strong agreement among them in revising EPS estimates higher, could be a legitimate reason to expect an upside in the stock. That's because empirical research shows a strong correlation between trends in earnings estimate revisions and near-term stock price movements.
For the current year, one estimate has moved higher over the last 30 days compared to no negative revision. As a result, the Zacks Consensus Estimate has increased 0.3%.
Moreover, HRMY currently has a Zacks Rank #2 (Buy), which means it is in the top 20% of more than 4,000 stocks that we rank based on four factors related to earnings estimates. Given an impressive externally-audited track record, this is a more conclusive indication of the stock's potential upside in the near term. You can see the complete list of today's Zacks Rank #1 (Strong Buy) stocks here >>>> .
Therefore, while the consensus price target may not be a reliable indicator of how much HRMY could gain, the direction of price movement it implies does appear to be a good guide.
Investors looking for stocks in the Medical - Biomedical and Genetics sector might want to consider either Harmony Biosciences Holdings, Inc. (HRMY) or argenex SE (ARGX). But which of these two stocks is more attractive to value investors?
Growth stocks are attractive to many investors, as above-average financial growth helps these stocks easily grab the market's attention and produce exceptional returns. But finding a growth stock that can live up to its true potential can be a tough task.
In addition to volatility, these stocks carry above-average risk by their very nature. Also, one could end up losing from a stock whose growth story is actually over or nearing its end.
However, the task of finding cutting-edge growth stocks is made easy with the help of the Zacks Growth Style Score (part of the Zacks Style Scores system), which looks beyond the traditional growth attributes to analyze a company's real growth prospects.
Harmony Biosciences Holdings, Inc. (HRMY - Free Report) is one such stock that our proprietary system currently recommends. The company not only has a favorable Growth Score, but also carries a top Zacks Rank.
Studies have shown that stocks with the best growth features consistently outperform the market. And returns are even better for stocks that possess the combination of a Growth Score of A or B and a Zacks Rank #1 (Strong Buy) or 2 (Buy).
While there are numerous reasons why the stock of this company is a great growth pick right now, we have highlighted three of the most important factors below:
Earnings GrowthEarnings growth is arguably the most important factor, as stocks exhibiting exceptionally surging profit levels tend to attract the attention of most investors. For growth investors, double-digit earnings growth is highly preferable, as it is often perceived as an indication of strong prospects (and stock price gains) for the company under consideration.
While the historical EPS growth rate for Harmony Biosciences is 12.1%, investors should actually focus on the projected growth. The company's EPS is expected to grow 23.4% this year, crushing the industry average, which calls for EPS growth of 14%.
Cash Flow GrowthWhile cash is the lifeblood of any business, higher-than-average cash flow growth is more important and beneficial for growth-oriented companies than for mature companies. That's because, growth in cash flow enables these companies to expand their businesses without depending on expensive outside funds.
Right now, year-over-year cash flow growth for Harmony Biosciences is 9%, which is higher than many of its peers. In fact, the rate compares to the industry average of 2.6%.
While investors should actually consider the current cash flow growth, it's worth taking a look at the historical rate too for putting the current reading into proper perspective. The company's annualized cash flow growth rate has been 32.4% over the past 3-5 years versus the industry average of 4.4%.
Promising Earnings Estimate RevisionsBeyond the metrics outlined above, investors should consider the trend in earnings estimate revisions. A positive trend is a plus here. Empirical research shows that there is a strong correlation between trends in earnings estimate revisions and near-term stock price movements.
The current-year earnings estimates for Harmony Biosciences have been revising upward. The Zacks Consensus Estimate for the current year has surged 0.3% over the past month.
Bottom LineWhile the overall earnings estimate revisions have made Harmony Biosciences a Zacks Rank #2 stock, it has earned itself a Growth Score of B based on a number of factors, including the ones discussed above.
You can see the complete list of today's Zacks #1 Rank (Strong Buy) stocks here.
This combination positions Harmony Biosciences well for outperformance, so growth investors may want to bet on it.
PLYMOUTH MEETING, Pa.--(BUSINESS WIRE)--Harmony Biosciences Holdings, Inc. (Nasdaq: HRMY) today reported Q1 2026 revenue of $215.4 million, delivering 17% year‑over‑year growth for WAKIX®. Performance during the quarter reflected continued strong demand, offset by market access headwinds observed every Q1, which were more pronounced this year. This follows the strongest three consecutive quarters in franchise history, and the Company reinforced 2026 full year revenue guidance. The Company also.
Harmony Biosciences Holdings, Inc. (HRMY - Free Report) came out with quarterly earnings of $0.55 per share, missing the Zacks Consensus Estimate of $0.76 per share. This compares to earnings of $0.78 per share a year ago. These figures are adjusted for non-recurring items.
This quarterly report represents an earnings surprise of -27.94%. A quarter ago, it was expected that this company would post earnings of $0.84 per share when it actually produced earnings of $0.38, delivering a surprise of -54.76%.
Over the last four quarters, the company has not been able to surpass consensus EPS estimates.
Harmony Biosciences, which belongs to the Zacks Medical - Biomedical and Genetics industry, posted revenues of $215.39 million for the quarter ended March 2026, missing the Zacks Consensus Estimate by 3.18%. This compares to year-ago revenues of $184.73 million. The company has topped consensus revenue estimates two 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 12.4% since the beginning of the year versus the S&P 500's gain of 7.6%.
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 mixed. 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 #3 (Hold) for the stock. So, the shares are expected to perform in line with 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 $0.93 on $249.23 million in revenues for the coming quarter and $3.34 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 bottom 40% 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.
Prime Medicine, Inc. (PRME - Free Report) , another stock in the same industry, has yet to report results for the quarter ended March 2026.
This company is expected to post quarterly loss of $0.24 per share in its upcoming report, which represents a year-over-year change of +40%. The consensus EPS estimate for the quarter has been revised 0.6% higher over the last 30 days to the current level.
Prime Medicine, Inc.'s revenues are expected to be $1.56 million, up 7.6% from the year-ago quarter.
PLYMOUTH MEETING, Pa.--(BUSINESS WIRE)--Harmony Biosciences Holdings, Inc. (Nasdaq: HRMY), today announced that Harmony's management team will participate in the following upcoming investor conferences. Goldman Sachs 47th Annual Global Healthcare Conference Fireside Chat: June 9, 2026, at 8:40 a.m. ET Location: Miami, FL Oppenheimer CNS & Neuro-Muscular Summit Fireside Chat: June 10, 2026, at 3:25 p.m. ET Location: Miami, FL A webcast of the fireside chats will be available on the investor.
Harmony Biosciences Holdings, Inc. (Nasdaq: HRMY), today announced that Harmony's management team will participate in the following upcoming investor conferences.
Goldman Sachs 47th Annual Global Healthcare Conference
Fireside Chat: June 9, 2026, at 8:40 a.m. ET Location: Miami, FL Oppenheimer CNS & Neuro-Muscular Summit
Fireside Chat: June 10, 2026, at 3:25 p.m. ET Location: Miami, FL A webcast of the fireside chats will be available on the investor page of the Harmony Biosciences website at https://ir.harmonybiosciences.com/.
About Harmony Biosciences
Harmony Biosciences is a pharmaceutical company dedicated to developing and commercializing innovative therapies for patients with rare neurological diseases who have unmet medical needs. Driven by novel science, visionary thinking, and a commitment to those who feel overlooked, Harmony Biosciences is nurturing a future full of therapeutic possibilities that may enable patients with rare neurological diseases to truly thrive. Established by Paragon Biosciences, LLC, in 2017 and headquartered in Plymouth Meeting, Pa., we believe that when empathy and innovation meet, a better future can begin; a vision evident in the therapeutic innovations we advance, the culture we cultivate, and the community programs we foster. For more information, please visit www.harmonybiosciences.com.
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