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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Harmony Biosciences' only product, WAKIX - pitolisant - has generated over $1 billion in net revenue since its launch. The company's Q2 2023 earnings showed a 39.6% growth in net product revenues compared to the same period in 2022. Management believes the drug has ~$2bn peak sales potential. HRMY share price has plummeted over 30% today, however, after the failure of a Phase 3 study for its drug in patients with Idiopathic Hypersomnia.

Harmony Stock Tanks On Study Miss For Narcolepsy Drug: Problems May Be Escalating

Harmony has already gotten approval for the drug to treat adults with excessive daytime sleepiness who have narcolepsy. Harmony's second-quarter revenue was up 25%, year over year.

Why Shares of Harmony Bioscience Are Falling on Friday

Harmony Biosciences Holdings Inc shares sank 38% to $18.66 in late-morning trading on Friday after the pharmaceutical company reported topline results from the INTUNE study of pitolisant, which missed the primary endpoint on the Epworth Sleepiness Scale (ESS).  Pitolisant is marketed as WAKIX in the US for the treatment of excessive daytime sleepiness (EDS) or cataplexy in adult patients with narcolepsy but is not approved for IH and is currently being evaluated as an investigational agent in adult patients with IH, the company said.

Harmony Biosciences stock drops on disappointing study results

PLYMOUTH MEETING, Pa., Oct. 13, 2023 /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 topline results from the INTUNE study in patients with idiopathic hypersomnia (IH).

HARMONY BIOSCIENCES ANNOUNCES TOPLINE DATA FROM PHASE 3 INTUNE STUDY EVALUATING PITOLISANT IN PATIENTS WITH IDIOPATHIC HYPERSOMNIA

Zynerba Pharmaceuticals

New product in development diversifies portfolio to drive  long-term growth  Innovative potential new therapeutic option for rare/orphan neuropsychiatric disorders with high unmet medical needs Zygel™ in pivotal Phase 3 trial for Fragile X syndrome and has completed Phase 2 proof-of-concept study in 22q11.2 deletion syndrome PLYMOUTH MEETING, Pa. , Oct. 11, 2023 /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 it has completed its acquisition of Zynerba Pharmaceuticals, Inc. ("Zynerba") (Nasdaq: ZYNE).

HARMONY BIOSCIENCES COMPLETES ACQUISITION OF ZYNERBA PHARMACEUTICALS AND EXPANDS PIPELINE

PLYMOUTH MEETING, Pa. , Oct. 5, 2023 /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 the presentation of new secondary endpoint data, including improvements in behavioral disturbances, from its Phase 2 signal-detection study evaluating pitolisant for the treatment of excessive daytime sleepiness (EDS) in Prader-Willi syndrome (PWS), at the 2023 Foundation for Prader-Willi Research (FPWR) Symposium and Family Conference.

HARMONY BIOSCIENCES PRESENTS NEW SECONDARY OUTCOME DATA FROM PHASE 2 SIGNAL DETECTION STUDY IN PATIENTS WITH PRADER-WILLI SYNDROME

PLYMOUTH MEETING, Pa. , Sept. 27, 2023 /PRNewswire/ -- In connection with the previously announced merger agreement, Harmony Biosciences Holdings, Inc. ("Harmony") (Nasdaq: HRMY), today announced that Xylophone Acquisition Corp., a wholly owned subsidiary of Harmony, has extended the expiration of its tender offer to acquire all of the outstanding shares of common stock of Zynerba Pharmaceuticals, Inc. ("Zynerba") (Nasdaq: ZYNE) to 5:00 p.m.

HARMONY BIOSCIENCES ANNOUNCES EXTENSION OF TENDER OFFER TO ACQUIRE ZYNERBA PHARMACEUTICALS, INC.

Harmony Biosciences has experienced strong and profitable growth following the approval and commercialization of WAKIX. The company's success has allowed for funding of other programs and acquisitions. Despite the risks associated with dependency on a single drug, the appeal of Harmony Biosciences lures.

Harmony Biosciences: A Balancing Act As Investors Lose Some Sleep

PLYMOUTH MEETING, Pa. , Sept. 20, 2023 /PRNewswire/ -- Jeffrey M.

HARMONY BIOSCIENCES PRESIDENT & CEO JEFFREY M. DAYNO, M.D.

PLYMOUTH MEETING, Pa. , Sept. 13, 2023 /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 Harmony's management team will participate in a fireside chat at the upcoming 2023 Cantor Global Healthcare Conference in New York, NY on Wednesday, September 27, 2023, at 10:20 a.m.

HARMONY BIOSCIENCES TO PARTICIPATE IN 2023 CANTOR GLOBAL HEALTHCARE CONFERENCE

PLYMOUTH MEETING, Pa. , Sept. 7, 2023 /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 U.S. Food and Drug Administration (FDA) has granted Orphan Drug designation to pitolisant for the treatment of idiopathic hypersomnia (IH).

HARMONY BIOSCIENCES ANNOUNCES US FOOD & DRUG ADMINISTRATION ORPHAN DRUG DESIGNATION FOR PITOLISANT FOR TREATMENT OF IDIOPATHIC HYPERSOMNIA

NEW ORLEANS--(BUSINESS WIRE)--Former Attorney General of Louisiana Charles C. Foti, Jr., Esq. and the law firm of Kahn Swick & Foti, LLC (“KSF”) are investigating the proposed sale of Zynerba Pharmaceuticals, Inc. (NasdaqCM: ZYNE) to Harmony Biosciences Holdings, Inc. (NasdaqGM: HRMY). Under the terms of the proposed transaction, shareholders of Zynerba will receive only $1.1059 in cash for each share of Zynerba that they own, plus one non-tradeable contingent value right per share, represe.

ZYNERBA PHARMACEUTICALS INVESTOR ALERT by the Former Attorney General of Louisiana: Kahn Swick & Foti, LLC Investigates Adequacy of Price and Process in Proposed Sale of Zynerba Pharmaceuticals, Inc. - ZYNE

PLYMOUTH MEETING, Pa. , Aug. 28, 2023 /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 commented on the favorable decision by the U.S. Patent and Trademark Office (USPTO) to deny a Petition for Reexamination concerning a patent covering the active ingredient in WAKIX® (pitolisant).

HARMONY BIOSCIENCES REITERATES CONFIDENCE IN WAKIX® (PITOLISANT) PATENTS FOLLOWING FAVORABLE DECISION BY U.S. PATENT AND TRADEMARK OFFICE (USPTO) TO DENY PETITION FOR REEXAMINATION  

Shares of Zynerba Pharmaceuticals Inc. ZYNE, +0.89% jumped 300% premarket on Monday after Harmony Biosciences Holdings Inc. HRMY, -0.47% said it would acquire the cannabinoid therapy company in a deal worth up to $200 million. Harmony, which specializes in therapies for rare neurological diseases, said it would acquire all outstanding shares of Zynerba for $1.1059 per share in cash, or $60 million in the aggregate, with potential additional payments of up to $140 million based on achievement of certain clinical, regulatory and sales milestones.

Harmony Biosciences to buy Zynerba Pharmaceuticals for up to $200 million

HARMONY BIOSCIENCES TO ACQUIRE ZYNERBA PHARMACEUTICALS, INC.

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Harmony Biosciences Holdings, Inc. (HRMY) came out with quarterly earnings of $0.56 per share, missing the Zacks Consensus Estimate of $0.62 per share. This compares to earnings of $0.57 per share a year ago.

Harmony Biosciences Holdings, Inc. (HRMY) Lags Q2 Earnings and Revenue Estimates

WAKIX® (pitolisant) Net Revenue Increased ~25% Year-over-Year to $134.2 Million for Second Quarter 2023 Average Number of Patients on WAKIX Increased by ~350 Sequentially to ~5,450 for Second Quarter 2023 Exited Second Quarter 2023 With ~5,600 Patients on WAKIX Completed Enrollment in Phase 3 Idiopathic Hypersomnia (IH) INTUNE Study; On-track for Topline Data in Fourth Quarter 2023 Plans to Initiate Prader-Willi Syndrome (PWS) Phase 3 Study in  Fourth Quarter 2023 Board of Directors Authorized $125 Million Share Repurchase Program Conference Call and Webcast to be Held Today at 8:30 a.m. ET  PLYMOUTH MEETING, Pa.

Harmony Biosciences Reports Second Quarter 2023 Financial Results and Business Updates

PLYMOUTH MEETING, Pa., Aug. 1, 2023 /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 its Board of Directors authorized the repurchase of up to $125 million of the Company's common stock.

HARMONY BIOSCIENCES ANNOUNCES $125 MILLION SHARE REPURCHASE PROGRAM

Harmony Biosciences is a high-margin, high-growth pharmaceutical business, attracting the attention of short sellers. The company's short position is significant. 38% of float has been borrowed then presold, with an extreme 18-day cover ratio, potentially setting up a short squeeze event. Despite weaker-than-expected operating growth in Q1, Wall Street analysts are forecasting sizable sales and income growth for years.

Harmony Biosciences: Rare Low-Volume Accumulation With Short Squeeze Potential

PLYMOUTH MEETING, Pa. , July 27, 2023 /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 it has entered into a new $185 million senior secured term loan facility with a bank syndicate.

HARMONY BIOSCIENCES ENTERS INTO $185 MILLION TERM LOAN FACILITY

PLYMOUTH MEETING, Pa. , July 25, 2023 /PRNewswire/ -- Harmony Biosciences selected the latest round of nonprofit organizations for its Patients at the Heart and Progress at the Heart awards, which provide funding toward interdisciplinary community initiatives that address complex challenges facing people living with sleep disorders and rare neurological diseases.

Harmony Biosciences Announces Funding for Unique Community Initiatives Through its Patients and Progress at the Heart Awards Programs

PLYMOUTH MEETING, Pa. , July 20, 2023 /PRNewswire/ -- Harmony Biosciences Holdings, Inc. ("Harmony") (Nasdaq: HRMY), a pharmaceutical company dedicated to developing and commercializing innovative therapies for patients with rare neurological diseases, has successfully completed an End-of-Phase 2 meeting with FDA regarding its clinical development plan evaluating pitolisant as a potential treatment for excessive daytime sleepiness (EDS) in patients ages six and older with Prader-Willi syndrome (PWS).

HARMONY BIOSCIENCES ANNOUNCES PLANS TO INITIATE PHASE 3 REGISTRATIONAL STUDY OF PITOLISANT IN PRADER-WILLI SYNDROME FOLLOWING POSITIVE END-OF-PHASE 2 MEETING WITH THE U.S. FOOD AND DRUG ADMINISTRATION

PLYMOUTH MEETING, Pa. , July 18, 2023 /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 report second quarter 2023 financial results on Tuesday, August 1, 2023, before the open of the U.S. financial markets.

HARMONY BIOSCIENCES TO REPORT SECOND QUARTER 2023 FINANCIAL RESULTS ON AUGUST 1, 2023

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