HRMY Harmony Biosciences Holdings Inc.

41.17
+0.42  (+1%)
Previous Close 40.75
Open 41
52 Week Low 25.09
52 Week High 52.74
Market Cap $2,347,323,917
Shares 57,008,474
Float 18,002,884
Enterprise Value $2,429,139,738
Volume 246,242
Av. Daily Volume 584,224
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Upcoming Catalysts

Drug Stage Catalyst Date
WAKIX (pitolisant)
Excessive daytime sleepiness associated with Prader-Willi Syndrome
Phase 2
Phase 2
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WAKIX (pitolisant)
Type 1 myotonic dystrophy (DM1)
Phase 2
Phase 2
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Drug Pipeline

Drug Stage Notes
WAKIX (pitolisant)
Adult cataplexy
Approved
Approved
FDA approval announced October 14, 2020.

Latest News

  1. PLYMOUTH MEETING, Pa., Oct. 21, 2021 /PRNewswire/ -- Harmony Biosciences Holdings, Inc. ("Harmony" or the "Company") (NASDAQ:HRMY), a pharmaceutical company dedicated to developing and commercializing innovative therapies for patients with rare neurological diseases, today announced that it will be added to the S&P SmallCap 600® Index, effective prior to the open of trading on Friday, October 22, 2021.

    "We are very pleased that Harmony will be included in the S&P SmallCap 600® Index and are proud of this recognition," said John C. Jacobs, President and Chief Executive Officer of Harmony. "We believe the inclusion in the index will increase our visibility and raise awareness of the work we are doing to help patients, as we continue to build a leading rare neurological disease company."

    The S&P 600® seeks to measure the small-cap segment of the U.S. equity market. The index is designed to measure the performance of 600 small-cap companies in the U.S. reflecting this market segment's distinctive risk and return characteristics. To be included, companies must have an unadjusted market cap in the range of $850 million to $3.6 billion.

    About Harmony Biosciences

    Harmony Biosciences is a commercial stage pharmaceutical company headquartered in Plymouth Meeting, PA. The Company was established by Paragon Biosciences, LLC, and is focused on providing novel treatment options for people living with rare neurological diseases who have unmet medical needs. For more information on Harmony, please visit the company's website: www.harmonybiosciences.com.

    Harmony Biosciences Investor Contact:

    Patti Bank

    415-513-1284

    ir@harmonybiosciences.com 

    Harmony Biosciences Media Contact:

    Nancy Leone

    215-891-6046

    nleone@harmonybiosciences.com

    Cision View original content to download multimedia:https://www.prnewswire.com/news-releases/harmony-biosciences-to-be-added-to-the-sp-smallcap-600-index-301405226.html

    SOURCE Harmony Biosciences

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  2. NEW YORK, Oct. 18, 2021 /PRNewswire/ -- S&P SmallCap 600 constituent Kite Realty Group Trust (NYSE:KRG) will replace LendingTree Inc. (NASD:TREE) in the S&P MidCap 400, LendingTree will replace Kite Realty Group Trust in the S&P SmallCap 600, and Harmony Biosciences Holdings Inc. (NASD:HRMY) will replace Retail Properties of America Inc. (NYSE:RPAI) in the S&P SmallCap 600 effective prior to the open of trading on Friday, October 22. Kite Realty Group Trust is acquiring Retail Properties of America in a deal expected to close soon pending final closing conditions. LendingTree has a market capitalization that is more representative of the small-cap market space.

    Following is a summary of the changes that will take place prior to the open of trading…

    NEW YORK, Oct. 18, 2021 /PRNewswire/ -- S&P SmallCap 600 constituent Kite Realty Group Trust (NYSE:KRG) will replace LendingTree Inc. (NASD:TREE) in the S&P MidCap 400, LendingTree will replace Kite Realty Group Trust in the S&P SmallCap 600, and Harmony Biosciences Holdings Inc. (NASD:HRMY) will replace Retail Properties of America Inc. (NYSE:RPAI) in the S&P SmallCap 600 effective prior to the open of trading on Friday, October 22. Kite Realty Group Trust is acquiring Retail Properties of America in a deal expected to close soon pending final closing conditions. LendingTree has a market capitalization that is more representative of the small-cap market space.

    Following is a summary of the changes that will take place prior to the open of trading on the effective date:

    Effective Date

    Index Name      

    Action

    Company Name

    Ticker

    GICS Sector

    Oct 22, 2021

    S&P MidCap 400

    Addition

    Kite Realty Group Trust

    KRG

    Real Estate





    Deletion

    LendingTree

    TREE

    Financials



    S&P SmallCap 600

    Addition

    Harmony Biosciences

    HRMY

    Health Care





    Addition

    LendingTree

    TREE

    Financials





    Deletion

    Retail Properties of America

    RPAI

    Real Estate





    Deletion

    Kite Realty Group Trust

    KRG

    Real Estate

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    Cision View original content:https://www.prnewswire.com/news-releases/kite-realty-group-trust-set-to-join-sp-midcap-400-harmony-biosciences-holdings--lendingtree-to-join-sp-smallcap-600-301402782.html

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  3. PLYMOUTH MEETING, Pa., Sept. 22, 2021 /PRNewswire/ -- Harmony Biosciences Holdings, Inc. ("Harmony") (NASDAQ:HRMY), a pharmaceutical company dedicated to developing and commercializing innovative therapies for patients with rare neurological diseases, today announced winners of the Patient at the Heart and Progress at the Heart programs in honor of the third annual World Narcolepsy Day.

    The Patients at the Heart program was created in 2019, and awards funds to not-for-profit organizations working to support and address the challenges of people living with sleep disorders and rare diseases who experience excessive daytime sleepiness (EDS). Initiated in 2021, Progress at the Heart supports innovative programs that address disparities, injustice, and inequities in the rare disease and sleep disorder community.

    "We are so inspired by the diverse and inventive programs submitted for this year's Patients and Progress at the Heart programs," said Cate McCanless, SVP, Corporate Affairs and Public Policy. "Our goal is to improve the lives of people living with sleep disorders and their families, and we hope by supporting these cutting-edge programs, we can make a positive difference for these communities."

    The company chose to announce the winners on World Narcolepsy Day, a day dedicated to raising awareness for this sleep disorder globally. The first Patients at the Heart program awarded $65,000 to four organizations, which was increased to $74,000 in 2020. Now, combined with the Progress at the Heart recipients, total funds awarded in 2021 increased to over $180,000 awarded to eight organizations across the United States.

    The following organizations, by category, were chosen as the 2021 Patients at the Heart recipients:

    Narcolepsy

    • ANGEL Aid:
      • Narcolepsy Caregivers Retreat

        The grant will allow the creation of a six-week virtual Caregivers Wellness Retreat with a focus on mental health, self-care, and connection for up to 25 caregivers of people with narcolepsy.
      • Who Am I? Graphic Novel Workshop

        The funds will aid creation of an art-therapy program designed to foster emotional life skills, self-awareness and a sense of connection for people living with narcolepsy and/or EDS.

    Rare Diseases with EDS

    • Prader-Willi Syndrome Association | USA: Disordered Sleep: A Deep Dive for Parents and Practitioners

      Funds to foster creation of free and accessible tools and resources informed by focus groups and PWS sleep best practices, as well as a PWSA | USA Virtual Sleep Summit.

    The following organizations and programs were chosen as the 2021 Progress at the Heart recipients:

    • Community Health Clinic: Enhancing Sleep Health Awareness Among Chicago's Medically Underserved Population

      This project will provide educational materials about sleep health and various sleep disorders to the target population at Community Health Clinic (CHC), which primarily includes patients from Spanish and Polish-speaking communities, whose annual income is at or below 100% of the Federal Poverty Line. Additionally, this project provides the framework and platform upon which to create and disseminate educational materials that are applicable for similar clinics serving low-income communities across Chicago.
    • Duke Department of Neurology: Duke Health Disparities in Neurology Scorecard

      The grant was awarded for the creation of the Duke Racial Disparities in Neurology Scorecard, inspired by the White Coats for Black Lives Racial Justice Scorecard for medical schools. A calculator will be published electronically that will aid other neurology departments across the country to create their own scorecards.
    • Florida Sickle Cell Center: CRiSIS (Circadian Rhythm & Sleep Impact on Sickle Cell)

      An initiative to investigate the sleep quality of patients living with Sickle Cell Disease (SCD). The objective of this program is to better understand the sleep quality of people living with SCD and how their sleep quality may be contributing to or exacerbating their underlying condition.
    • Project Sleep: Focus Groups to Understand Barriers and Improve Sleep Disorders Awareness, Diagnosis, and Treatment in Black American Communities

      This project aims to uncover important insights by conducting focus groups to better understand the first-hand perspectives of Black Americans, healthcare providers, and trusted community leaders. The findings will help to inform future awareness and education campaigns aiming to reduce delays to diagnosis and treatment of sleep disorders in underserved communities.
    • The Hypersomnia Foundation (HF): Diversity, Equity, and Inclusion (DEI) Initiative

      The DEI Initiative is focused on understanding and identifying the challenges people of diverse backgrounds may face when they need healthcare for EDS and other symptoms of sleep disorders. With a five-step program, led by a DEI Task Force, HF plans to hold listening sessions in the community as first steps.
    • The Sleep Doctor: Bio-Rhythm Program

      A behavioral health intervention designed to promote weight loss through using Fitbit technology to monitor circadian rhythm and coach participants to maintain proper sleep, nutrition, and activity habits. This program will help to educate and monitor participants from underserved Hispanic communities in El Paso, TX to address the high prevalence of sleep disorders contributing to obesity.

    About Harmony Biosciences 

    Harmony Biosciences is a commercial stage pharmaceutical company headquartered in Plymouth Meeting, PA. The Company was established by Paragon Biosciences, LLC, and is focused on providing novel treatment options for people living with rare neurological diseases who have unmet medical needs. For more information on Harmony, please visit the company's website: www.harmonybiosciences.com.

    Harmony Biosciences Media Contact: 

    Nancy Leone 

    215-891-6046 

    nleone@harmonybiosciences.com 

    Harmony Biosciences Investor Contact: 

    Patti Bank

    415-513-1284

    ir@harmonybiosciences.com 

    Cision View original content to download multimedia:https://www.prnewswire.com/news-releases/harmony-biosciences-announces-winners-of-patients-at-the-heart-and-progress-at-the-heart-on-third-annual-world-narcolepsy-day-301382071.html

    SOURCE Harmony Biosciences

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  4. PLYMOUTH MEETING, Pa., Sept. 2, 2021 /PRNewswire/ -- Harmony Biosciences Holdings, Inc. ("Harmony") (NASDAQ:HRMY), a pharmaceutical company dedicated to developing and commercializing innovative therapies for patients with rare neurological diseases, today announced that the American Academy of Sleep Medicine (AASM) has published an updated clinical practice guideline which includes WAKIX® (pitolisant) as a recommended treatment option for adults living with narcolepsy.

    The new clinical practice guideline was published in the Journal of Clinical Sleep Medicine in a special article titled, "Treatment of central disorders of hypersomnolence: an American Academy of Sleep Medicine clinical practice guideline" and was accompanied by another article titled, "Treatment of central disorders of hypersomnolence: an American Academy of Sleep Medicine systematic review, meta-analysis, and GRADE assessment". Together, these papers provide practice recommendations, and the evidence base in support of the recommendations, for the treatment of narcolepsy and other central disorders of hypersomnolence. The new guideline updates and replaces the previous AASM guideline published in 2007, and now includes WAKIX as a strong recommendation for the treatment of narcolepsy in adults based on data that showed clinically significant improvement in excessive daytime sleepiness and cataplexy in patients treated with WAKIX.

    "Harmony is pleased with the inclusion of WAKIX in the updated AASM clinical practice treatment guideline. This evidence-based guideline, which now includes some of the more recent treatment options available, can assist healthcare professionals in therapeutic decision making when managing their patients living with narcolepsy," said Harmony's Chief Medical Officer, Jeffrey Dayno, M.D.

    About WAKIX® (pitolisant) Tablets

    WAKIX, a first-in-class medication, is approved by the U.S. Food and Drug Administration for the treatment of excessive daytime sleepiness or cataplexy in adult patients with narcolepsy and has been commercially available in the U.S. since Q4 2019. It was granted orphan drug designation for the treatment of narcolepsy in 2010, and breakthrough therapy designation for the treatment of cataplexy in 2018. WAKIX is a selective histamine 3 (H3) receptor antagonist/inverse agonist. The mechanism of action of WAKIX is unclear; however, its efficacy could be mediated through its activity at H3 receptors, thereby increasing the synthesis and release of histamine, a wake promoting neurotransmitter. WAKIX was designed and developed by Bioprojet (France). Harmony has an exclusive license from Bioprojet to develop, manufacture and commercialize pitolisant in the United States. 

    Important Safety Information 

    Contradictions 

    WAKIX is contraindicated in patients with known hypersensitivity to pitolisant or any component of the formulation. Anaphylaxis has been reported. WAKIX is also contraindicated in patients with severe hepatic impairment.  

    Warnings and Precautions 

    WAKIX prolongs the QT interval; avoid use of WAKIX in patients with known QT prolongation or in combination with other drugs known to prolong the QT interval. Avoid use in patients with a history of cardiac arrhythmias, as well as other circumstances that may increase the risk of the occurrence of torsade de pointes or sudden death, including symptomatic bradycardia, hypokalemia or hypomagnesemia, and the presence of congenital prolongation of the QT interval. 

    The risk of QT prolongation may be greater in patients with hepatic or renal impairment due to higher concentrations of pitolisant; monitor these patients for increased QTc. Dosage modification is recommended in patients with moderate hepatic impairment and moderate or severe renal impairment (see full prescribing information). WAKIX is not recommended in patients with end-stage renal disease (ESRD). 

    Adverse Reactions 

    In the placebo-controlled clinical trials conducted in patients with narcolepsy with or without cataplexy, the most common adverse reactions (≥5% and twice placebo) for WAKIX were insomnia (6%), nausea (6%), and anxiety (5%). Other adverse reactions that occurred at ≥2% and more frequently than in patients treated with placebo included headache, upper respiratory infection, musculoskeletal pain, heart rate increased, hallucinations, irritability, abdominal pain, sleep disturbance, decreased appetite, cataplexy, dry mouth, and rash. 

    Drug Interactions 

    Concomitant administration of WAKIX with strong CYP2D6 inhibitors increases pitolisant exposure by 2.2-fold. Reduce the dose of WAKIX by half.    

    Concomitant use of WAKIX with strong CYP3A4 inducers decreases exposure of pitolisant by 50%. Dosage adjustments may be required (see full prescribing information).    

    H1 receptor antagonists that cross the blood-brain barrier may reduce the effectiveness of WAKIX. Patients should avoid centrally acting H1 receptor antagonists.    

    WAKIX is a borderline/weak inducer of CYP3A4. Therefore, reduced effectiveness of sensitive CYP3A4 substrates may occur when used concomitantly with WAKIX. The effectiveness of hormonal contraceptives may be reduced when used with WAKIX and effectiveness may be reduced for 21 days after discontinuation of therapy. 

    Use in Specific Populations 

    WAKIX may reduce the effectiveness of hormonal contraceptives. Patients using hormonal contraception should be advised to use an alternative non-hormonal contraceptive method during treatment with WAKIX and for at least 21 days after discontinuing treatment.  

    There is a pregnancy exposure registry that monitors pregnancy outcomes in women who are exposed to WAKIX during pregnancy. Patients should be encouraged to enroll in the WAKIX pregnancy registry if they become pregnant. To enroll or obtain information from the registry, patients can call 1-800-833-7460. The safety and effectiveness of WAKIX have not been established in patients less than 18 years of age.  

    WAKIX is extensively metabolized by the liver. WAKIX is contraindicated in patients with severe hepatic impairment. Dosage adjustment is required in patients with moderate hepatic impairment. 

    WAKIX is not recommended in patients with end-stage renal disease. Dosage adjustment of WAKIX is recommended in patients with moderate or severe renal impairment.  

    Dosage reduction is recommended in patients known to be poor CYP2D6 metabolizers; these patients have higher concentrations of WAKIX than normal CYP2D6 metabolizers. 

    Please see the Full Prescribing Information for WAKIX for more information. 

    To report suspected adverse reactions, contact Harmony Biosciences at 1-800-833-7460 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch

    About Harmony Biosciences 

    Harmony Biosciences is a commercial stage pharmaceutical company headquartered in Plymouth Meeting, PA. The Company was established by Paragon Biosciences, LLC, and is focused on providing novel treatment options for people living with rare neurological diseases who have unmet medical needs. For more information on Harmony, please visit the company's website: www.harmonybiosciences.com.

    Forward Looking Statement

    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 product WAKIX. 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 WAKIX, pitolisant in additional indications, if approved, and any other product candidates we may develop or acquire, if approved; 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 agreement with Bioprojet; the availability of favorable insurance coverage and reimbursement for WAKIX; the impact of the COVID-19 pandemic; 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 needs for additional financing; our ability to identify 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; and 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; significant costs and required management time as a result of operating as a public company. 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 March 25, 2021, 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 Media Contact: 

    Nancy Leone 

    215-891-6046 

    nleone@harmonybiosciences.com 

    Harmony Biosciences Investor Contact: 

    Patti Bank

    415-513-1284

    ir@harmonybiosciences.com 

    Cision View original content to download multimedia:https://www.prnewswire.com/news-releases/harmony-biosciences-announces-inclusion-of-wakix-pitolisant-in-american-academy-of-sleep-medicines-updated-clinical-practice-guideline-301367958.html

    SOURCE Harmony Biosciences

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  5. PLYMOUTH MEETING, Pa., Sept. 2, 2021 /PRNewswire/ -- Harmony Biosciences Holdings, Inc. ("Harmony") (NASDAQ:HRMY), a pharmaceutical company dedicated to developing and commercializing innovative therapies for patients with rare neurological diseases, today announced that Harmony's President and CEO, John C. Jacobs, will participate in fireside chats and host investor meetings at the following upcoming virtual conferences: 

    • Citi's 16th Annual BioPharma Virtual Conference
      • 1x1 Meetings: Wednesday and Thursday, September 8-9, 2021
    • 2021 Virtual Wells Fargo Healthcare Conference
      • Fireside Chat: September 10, 10:40am ET
    • 2021 Cantor Virtual Global Healthcare Conference
      • 1x1 Meetings: Tuesday, September 28, 2021

    The live audio webcast of the fireside chat will be available on the investor page of Harmony's website at https://ir.harmonybiosciences.com/.

    About Harmony Biosciences 

    Harmony Biosciences is a commercial stage pharmaceutical company headquartered in Plymouth Meeting, PA. The Company was established by Paragon Biosciences, LLC, and is focused on providing novel treatment options for people living with rare neurological diseases who have unmet medical needs. For more information on Harmony, please visit the company's website: www.harmonybiosciences.com.

    Harmony Biosciences Investor Contact:

    Patti Bank

    415-513-1284

    ir@harmonybiosciences.com 

    Harmony Biosciences Media Contact: 

    Nancy Leone 

    215-891-6046

    nleone@harmonybiosciences.com  

    Cision View original content to download multimedia:https://www.prnewswire.com/news-releases/harmony-biosciences-to-participate-in-three-investor-conferences-in-september-301367935.html

    SOURCE Harmony Biosciences

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