Harmony Biosciences(HRMY)

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HARMONY BIOSCIENCES ACKNOWLEDGES U.S. FOOD & DRUG ADMINISTRATION (FDA) ACTION DENYING THE CITIZEN PETITION FOR WAKIX® (PITOLSIANT)
Prnewswire· 2024-06-25 12:05
Use in Specific Populations WAKIX is extensively metabolized by the liver. WAKIX is contraindicated in patients with severe hepatic impairment. Dosage adjustment is recommended in patients with moderate hepatic impairment. To report suspected adverse reactions, contact Harmony Biosciences at 1-800-833-7460 or the FDA at 1-800- FDA-1088 or www.fda.gov/medwatch. This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements con ...
HARMONY BIOSCIENCES PRESENTS POSITIVE DATA FOR PITOLISANT IN THE TREATMENT OF EXCESSIVE DAYTIME SLEEPINESS AND FATIGUE IN MYOTONIC DYSTROPHY TYPE 1
Prnewswire· 2024-06-05 12:05
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). "More than 80 percent of DM1 patients experience EDS and fatigue, which patient-reported outcomes research has shown to be nearly as debilitating as the primary symptoms of DM1, namely myotonia and muscle weakness,"1 said Kumar Budur, M.D., M. ...
HARMONY BIOSCIENCES TO PARTICIPATE IN GOLDMAN SACHS 45th ANNUAL GLOBAL HEALTHCARE CONFERENCE
prnewswire.com· 2024-05-28 12:05
Luis Sanay, CFA 445-235-8386 [email protected] Harmony Biosciences Media Contact: 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. ET. A webcast of the fireside chat will be available on the investor page of Harmony's website at https://ir.harmon ...
Looking for a Growth Stock? 3 Reasons Why Harmony Biosciences (HRMY) is a Solid Choice
Zacks Investment Research· 2024-05-01 17:46
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.That's because, these stocks usually carry above-average risk and volatility. In fact, betting on a stock for which the growth story is actually over or nearing its end could lead to significant loss.However, the Zacks Growth Style Score (part of the Zacks ...
HRMY or TECH: Which Is the Better Value Stock Right Now?
Zacks Investment Research· 2024-05-01 16:41
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? We'll need to take a closer look.We have found that the best way to discover great value opportunities is to pair a strong Zacks Rank with a great grade in the Value category of our Style Scores system. The proven Zacks Rank emphasizes companies with positive estimat ...
Harmony Biosciences(HRMY) - 2024 Q1 - Earnings Call Transcript
2024-04-30 17:49
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 Sa ...
Harmony Biosciences(HRMY) - 2024 Q1 - Earnings Call Presentation
2024-04-30 16:03
Q1 2024 This presentation includes information related to market opportunity as well as cost and other estimates obtained from internal analyses and external sources. The internal analyses are based upon management's understanding of market and industry conditions and have not been verified by independent sources. Similarly, the externally sourced information has been obtained from sources the Company believes to be reliable, but the accuracy and completeness of such information cannot be assured. Neither t ...
Harmony Biosciences(HRMY) - 2024 Q1 - Quarterly Report
2024-04-30 12:00
Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the Quarterly Period Ended March 31, 2024 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number: 001-39450 HARMONY BIOSCIENCES HOLDINGS, INC. (Exact name of registrant as specified in its charter) (State or oth ...
Harmony Biosciences(HRMY) - 2024 Q1 - Quarterly Results
2024-04-30 11:45
Exhibit 99.1 PLYMOUTH MEETING, Pa., April 30, 2024 — Harmony Biosciences Holdings, Inc. (Nasdaq: HRMY), today reported year-over-year net revenue growth of 30 percent for 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 Establishe ...
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
Newsfilter· 2024-04-30 11:05
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 Pharma ...