Harmony Biosciences Holdings

Harmony Biosciences Holdings, Inc. is a commercial-stage pharmaceutical company, which engages in the development and commercialization of therapies for the treatment of neurological disorders. Its product, WAKIX, is a molecule with a novel mechanism of action designed to increase histamine signaling in the brain by binding to H3 receptors. The company was founded by Jeffrey S. Aronin on July 25, 2017 and is headquartered in Plymouth Meeting, PA.

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Harmony Biosciences excels in Q4, eyes growth in new markets

Harmony Biosciences delivered strong financial results, emphasizing growth strategies and confidence in WAKIX's revenue potential. The company is well-positioned with a focus on new prescribers, lifecycle management, and potential business development opportunities.

Harmony Biosciences excels in Q1, eyes expansion and shareholder value

Harmony Biosciences' Q1 2023 showcased strong financial performance, significant patient growth on WAKIX, and strategic plans for portfolio expansion.
The company's commercial model evolution and confidence in WAKIX's growth potential position it well for future opportunities.
Addressing challenges like patient attrition rates and regulatory concerns while exploring new business development avenues highlight Harmony's proactive approach.
With a focus on maximizing shareholder value and sustaining growth post-WAKIX, Harmony Biosciences remains poised for continued success.

Harmony Biosciences excels in Q2, eyes growth amid challenges

Harmony Biosciences delivered a strong Q2 performance, showcasing growth in net sales and patient numbers for WAKIX. The company's financial strength, strategic capital deployment, and focus on clinical development programs position it well for future growth. While facing challenges like patent disputes and market dynamics, Harmony Biosciences remains confident in its business fundamentals and growth potential.

Harmony Biosciences Achieves Record Revenue in Q3 2023

Harmony Biosciences delivered a stellar performance in Q3 2023, marked by record revenue, strong profitability, and strategic acquisitions, positioning the company for future growth.
While facing challenges in patent litigation and regulatory approvals, the company's focus on innovation, commercial excellence, and financial strength underpin its resilience.
With a clear market opportunity in narcolepsy, ongoing pipeline advancements, and a commitment to shareholder value, Harmony Biosciences remains well-positioned for long-term success.

Harmony Biosciences reports robust earnings, eyes strategic growth in 2024

Harmony Biosciences' strong financial performance, strategic acquisitions, and clinical advancements position the company for continued growth and market success.
Balancing revenue growth, pricing strategies, and clinical developments will be key focus areas for the company in navigating market challenges and opportunities.
With a focus on innovation, regulatory relationships, and financial prudence, Harmony Biosciences aims to drive sustainable growth and shareholder value in 2024.
The company's proactive approach to business development, share repurchases, and revenue guidance reflects a strategic and forward-thinking mindset for future success.

Harmony Biosciences excels in Q1, poised for long-term growth

Harmony Biosciences delivered strong financial performance in Q1, driven by WAKIX's growth and strategic acquisitions, positioning the company for continued success.
Despite operational challenges and market competition, the company's focus on innovation, rare disease treatments, and CNS franchises presents significant growth opportunities.
With a robust financial position, disciplined capital deployment, and a promising pipeline, Harmony Biosciences is poised for long-term value creation and revenue growth.
FDA recognition of unmet medical needs, positive clinical developments, and strong IP protection underscore the company's potential for market leadership and patient impact.

Harmony Biosciences reports robust Q2 performance and growth opportunities

Harmony Biosciences delivered a strong Q2 performance with revenue growth, FDA approvals, and pipeline advancements. The company's financial strength, upheld patents, and strategic growth focus position it well for future success despite some challenges.

Harmony Biosciences excels in Q3, eyes growth amid legal challenges

Harmony Biosciences demonstrated strong financial performance and pipeline progress in Q3 2024, positioning itself for continued growth.
While facing IP litigation and challenges in rare orphan categories, the company's focus on innovation and market positioning presents opportunities for future success.
Maintaining financial strength, pursuing pipeline advancements, and navigating legal hurdles will be key for Harmony Biosciences' sustained growth and market leadership.

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WAKIX® (pitolisant) Net Revenue of $172.8 Million for Second Quarter 2024; ~29% Growth Year-over-Year Next Generation Pitolisant High-Dose (HD) Program Advances Based on Pilot Pharmacokinetic (PK) Data with PDUFA Date Expected in 2028 to Extend Pitolisant Franchise Beyond 2040 WAKIX Patent Upheld Again - U.S. Patent and Trademark Office (USPTO) Issues Final Denial After Two Attempts to Challenge the WAKIX Patent Received U.S. Food and Drug Administration (FDA) Approval and Launched WAKIX for the Treatment of EDS in Pediatric Patients with Narcolepsy Providing the First and Only Non-Scheduled Treatment Option On Track to Submit Supplemental New Drug Application for Pitolisant in Idiopathic Hypersomnia (IH) in Fourth Quarter 2024 Reiterates 2024 Net Product Revenue Guidance of $700 - $720 Million Company to Host Investor Day in New York City on October 1st Conference Call and Webcast to be Held Today at 8:30 a.m. ET  PLYMOUTH MEETING, Pa.

Harmony Biosciences Reports Strong Second Quarter 2024 Financial Results and Advances Pitolisant High-Dose Program Toward Expected PDUFA Date in 2028

PLYMOUTH MEETING, Pa. , July 23, 2024 /PRNewswire/ -- Harmony Biosciences Holdings, Inc. (Nasdaq: HRMY) today announced that it will report second quarter 2024 financial results on Tuesday, August 6, 2024, before the open of the U.S. financial markets.

HARMONY BIOSCIENCES TO REPORT SECOND QUARTER 2024 FINANCIAL RESULTS ON AUGUST 6, 2024

The average of price targets set by Wall Street analysts indicates a potential upside of 32.8% in Harmony Biosciences (HRMY). While the effectiveness of this highly sought-after metric is questionable, the positive trend in earnings estimate revisions might translate into an upside in the stock.

Wall Street Analysts See a 32.82% Upside in Harmony Biosciences (HRMY): Can the Stock Really Move This High?

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FDA confirms the favorable benefit-risk profile of WAKIX Harmony Biosciences focused on continuing to advance its pipeline assets across three rare CNS franchises; anticipates at least one new product or indication launch annually over the next five years PLYMOUTH MEETING, Pa. , June 25, 2024 /PRNewswire/ -- Harmony Biosciences Holdings, Inc. (Nasdaq: HRMY), today announced that the U.S. Food and Drug Administration denied the Citizen Petition filed by a short seller claiming that WAKIX is not safe and effective for the treatment of excessive daytime sleepiness (EDS) and cataplexy in adults with narcolepsy.

HARMONY BIOSCIENCES ACKNOWLEDGES U.S. FOOD & DRUG ADMINISTRATION (FDA) ACTION DENYING THE CITIZEN PETITION FOR WAKIX® (PITOLSIANT)

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PLYMOUTH MEETING, Pa. , June 24, 2024 /PRNewswire/ -- Harmony Biosciences (Nasdaq: HRMY) today announced that the U.S. Food and Drug Administration (FDA) has approved its supplemental New Drug Application (sNDA) for WAKIX® (pitolisant) tablets for the treatment of excessive daytime sleepiness (EDS) in pediatric patients 6 years of age and older with narcolepsy.

HARMONY BIOSCIENCES RECEIVES U.S. FOOD AND DRUG ADMINISTRATION APPROVAL FOR WAKIX® (PITOLISANT) IN PEDIATRIC PATIENTS WITH NARCOLEPSY

PLYMOUTH MEETING, Pa. , June 5, 2024 /PRNewswire/ -- Harmony Biosciences (Nasdaq: HRMY) presented data from its Phase 2 signal detection study showing that pitolisant reduced excessive daytime sleepiness (EDS) and fatigue in adults with Myotonic dystrophy Type 1 (DM1).

HARMONY BIOSCIENCES PRESENTS POSITIVE DATA FOR PITOLISANT IN THE TREATMENT OF EXCESSIVE DAYTIME SLEEPINESS AND FATIGUE IN MYOTONIC DYSTROPHY TYPE 1

PLYMOUTH MEETING, Pa. , May 28, 2024 /PRNewswire/ -- Harmony Biosciences Holdings, Inc. (Nasdaq: HRMY), today announced that Harmony's management team will participate in a fireside chat at the upcoming Goldman Sachs 45th Annual Global Healthcare Conference in Miami Beach, FL on Monday, June 10, 2024, at 9:20 a.m.

HARMONY BIOSCIENCES TO PARTICIPATE IN GOLDMAN SACHS 45th ANNUAL GLOBAL HEALTHCARE CONFERENCE

Harmony Biosciences (HRMY) could produce exceptional returns because of its solid growth attributes.

Looking for a Growth Stock? 3 Reasons Why Harmony Biosciences (HRMY) is a Solid Choice

Investors interested in Medical - Biomedical and Genetics stocks are likely familiar with Harmony Biosciences Holdings, Inc. (HRMY) and Techne (TECH). But which of these two stocks offers value investors a better bang for their buck right now?

HRMY or TECH: Which Is the Better Value Stock Right Now?

Harmony Biosciences Holdings, Inc (NASDAQ:HRMY ) Q1 2024 Earnings Conference Call April 30, 2024 8:30 AM ET Company Participants Luis Sanay - Head of Investor Relations Jeffrey Dayno - President & Chief Executive Officer Jeffrey Dierks - Chief Commercial Officer Kumar Budur - Chief Medical Officer Sandip Kapadia - Chief Financial Officer & Chief Administrative Officer Conference Call Participants Charles Duncan - Cantor Fitzgerald Francois Brisebois - Oppenheimer Ami Fadia - Needham David Amsellem - Piper Sandler Graig Suvannavejh - Mizuho Corinne Jenkins - Goldman Sachs Jason Gerberry - Bank of America Danielle Brill - Raymond James Operator Good morning. My name is Madison, and I will be your conference operator today.

Harmony Biosciences Holdings, Inc (HRMY) Q1 2024 Earnings Call Transcript

WAKIX® (pitolisant) Net Revenue of $154.6 Million for First Quarter 2024; ~30% Growth Year-over-Year Supplemental New Drug Application for Pitolisant in Idiopathic Hypersomnia Planned for Second Half 2024 On Track Toward Pediatric Exclusivity to Extend WAKIX Exclusivity to September 2030: Pediatric Narcolepsy sNDA PDUFA Date of June 21, 2024; PWS Phase 3 TEMPO Study Initiated in March 2024 Pitolisant Franchise Revenue Potential Extended Beyond 2040 With Next-Generation Formulations; Reports Positive Pharmacokinetic Data on Next-Generation Formulation 1 (NG1); PDUFA Expected in 2026 Strengthens Leadership Position in Sleep/Wake with Licensing of TPM-1116, a Highly Potent and Selective Oral Orexin-2 Receptor Agonist Establishes Potential Billion Dollar Plus Rare Epilepsy Franchise Through Acquisition of Epygenix Therapeutics, Inc. Reiterates 2024 Net Product Revenue Guidance of $700 - $720 Million Conference Call and Webcast to be Held Today at 8:30 a.m. ET  PLYMOUTH MEETING, Pa.

Harmony Biosciences Reports Strong First Quarter Financial Results and Acceleration of Its Growth Strategy; Advances Pitolisant Franchise to Extend Revenue Potential Beyond 2040; Strenghtens Sleep/Wake Leadership and Diversifies Into Rare Epilepsy

Lead Candidate, EPX-100, Holds Orphan Drug and Rare Pediatric Disease Designations EPX-100 in Pivotal Registrational Trial for Dravet Syndrome; Topline Data Expected in 2026 Plan to Initiate Phase 3 Trial for Lennox-Gastaut Syndrome in Second Half of 2024 Potential Billion Dollar Plus Market Opportunity in Rare Epilepsy PLYMOUTH MEETING, Pa. , April 30, 2024 /PRNewswire/ -- Harmony Biosciences (Nasdaq: HRMY), today announced the acquisition of Epygenix Therapeutics, Inc., accelerating its growth strategy by adding a rare epilepsy franchise to its expanding late-stage pipeline of innovative CNS assets.

Harmony Biosciences Acquires Epygenix Therapeutics, Inc., Adding Late-Stage Epilepsy Franchise to Growing Pipeline of Innovative CNS Assets

PLYMOUTH MEETING, Pa. , April 16, 2024 /PRNewswire/ -- Harmony Biosciences Holdings, Inc. (Nasdaq: HRMY) today announced that it will report first quarter 2024 financial results on Tuesday, April 30, 2024, before the open of the U.S. financial markets.

HARMONY BIOSCIENCES TO REPORT FIRST QUARTER 2024 FINANCIAL RESULTS ON APRIL 30, 2024

PLYMOUTH MEETING, Pa. , April 11, 2024 /PRNewswire/ -- Harmony Biosciences Holdings, Inc. (Nasdaq: HRMY) today announced an exclusive licensing agreement with Bioprojet to develop, manufacture and commercialize TPM-1116, a highly potent and selective oral orexin-2 receptor (OX2R) agonist that will be evaluated for the treatment of narcolepsy and other sleep/wake disorders.

HARMONY BIOSCIENCES ANNOUNCES EXCLUSIVE AGREEMENT TO DEVELOP AND COMMERCIALIZE TPM-1116, A HIGHLY POTENT AND SELECTIVE ORAL OREXIN-2 RECEPTOR AGONIST

PLYMOUTH MEETING, Pa. , April 3, 2024 /PRNewswire/ -- Harmony Biosciences Holdings, Inc. ("Harmony") (Nasdaq: HRMY) has initiated its global Phase 3 registrational trial, the TEMPO study, to evaluate the safety and efficacy of pitolisant as a treatment for excessive daytime sleepiness (EDS) and behavioral symptoms in patients aged six years and older with Prader-Willi syndrome (PWS).

HARMONY BIOSCIENCES INITIATES GLOBAL PHASE 3 REGISTRATIONAL TRIAL (TEMPO STUDY) OF PITOLISANT IN PATIENTS WITH PRADER-WILLI SYNDROME

PLYMOUTH MEETING, Pa. , March 26, 2024 /PRNewswire/ -- Harmony Biosciences Holdings, Inc. (Nasdaq: HRMY), today announced that Harmony's management team will participate in a fireside chat at the upcoming 23rd Annual Needham Virtual Healthcare Conference on Monday, April 8, 2024, at 9:30 a.m.

HARMONY BIOSCIENCES TO PARTICIPATE IN 23RD ANNUAL NEEDHAM VIRTUAL HEALTHCARE CONFERENCE

Investors interested in stocks from the Medical - Biomedical and Genetics sector have probably already heard of Harmony Biosciences Holdings, Inc. (HRMY) and Techne (TECH). But which of these two stocks is more attractive to value investors?

HRMY vs. TECH: Which Stock Is the Better Value Option?

Harmony Biosciences Holdings, Inc. (HRMY) came out with quarterly earnings of $0.45 per share, missing the Zacks Consensus Estimate of $0.74 per share. This compares to earnings of $1.01 per share a year ago.

Harmony Biosciences Holdings, Inc. (HRMY) Misses Q4 Earnings and Revenue Estimates

WAKIX® (pitolisant) Net Revenue of $168.4 Million for Fourth Quarter and $582.0 Million for Full Year 2023; Representing Growth of ~31% and ~33%, Respectively

Harmony Biosciences Reports Fourth Quarter and Full Year 2023 Financial Results and Business Updates

Prescription Drug User Fee Act date is June 21, 2024 PLYMOUTH MEETING, Pa., Feb. 21, 2024 /PRNewswire/ -- Harmony Biosciences Holdings, Inc. (Nasdaq: HRMY) announced that the U.S. Food and Drug Administration (FDA) granted priority review for its supplemental New Drug Application (sNDA) for WAKIX® (pitolisant) tablets for the treatment of excessive daytime sleepiness (EDS) or cataplexy in pediatric patients 6 years of age and older with narcolepsy.

U.S. FOOD AND DRUG ADMINISTRATION GRANTS PRIORITY REVIEW TO HARMONY BIOSCIENCES' APPLICATION FOR WAKIX® (PITOLISANT) IN PEDIATRIC NARCOLEPSY

PLYMOUTH MEETING, Pa. , Feb. 20, 2024 /PRNewswire/ -- Harmony Biosciences Holdings, Inc. (Nasdaq: HRMY), announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug designation to pitolisant for the treatment of Prader-Willi syndrome (PWS).

News for Harmony Biosciences Holdings Stock (HRMY)