Narcolepsy

Avadel Pharmaceuticals Issues Statement On Patent Litigation

Retrieved on: 
Monday, March 4, 2024

DUBLIN, Ireland, March 04, 2024 (GLOBE NEWSWIRE) -- Avadel Pharmaceuticals plc (Nasdaq: AVDL), today issued a statement in response to a jury ruling from the United States District Court for the District of Delaware (“Court”) in a patent suit brought by Jazz Pharmaceuticals Inc. regarding LUMRYZ™.

Key Points: 
  • DUBLIN, Ireland, March 04, 2024 (GLOBE NEWSWIRE) -- Avadel Pharmaceuticals plc (Nasdaq: AVDL), today issued a statement in response to a jury ruling from the United States District Court for the District of Delaware (“Court”) in a patent suit brought by Jazz Pharmaceuticals Inc. regarding LUMRYZ™.
  • Avadel is pleased with the jury’s decision ruling in favor of Avadel with respect to one of the contested patents.
  • As it relates to the jury’s decision against Avadel regarding the additional contested patent, the company is disappointed in the outcome.
  • Avadel does not expect the jury’s decision to impact the ongoing commercial launch or potential for LUMRYZ™ to transform the lives of people living with narcolepsy.

Avadel Pharmaceuticals Provides Corporate Update and Reports Fourth Quarter and Full Year 2023 Financial Results

Retrieved on: 
Monday, March 4, 2024

-- Management to host a conference call today at 7:30 a.m. ET --

Key Points: 
  • ET --
    DUBLIN, Ireland, March 04, 2024 (GLOBE NEWSWIRE) -- Avadel Pharmaceuticals plc (Nasdaq: AVDL), a biopharmaceutical company focused on transforming medicines to transform lives, today provided a corporate update and announced its financial results for the fourth quarter ended December 31, 2023.
  • “We are carrying significant momentum into 2024 following the successful launch of LUMRYZ and are pleased with the strong early launch results we have seen.
  • Recognized $19.5 million and $28.0 million in net product revenue for the quarter and year ended December 31, 2023, respectively.
  • Net product revenue consists of LUMRYZ product sales, which was launched in the U.S. on June 5, 2023.

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

Retrieved on: 
Thursday, February 22, 2024

Net product revenue for the quarter ended December 31, 2023 was $168.4 million, compared to $128.3 million for the same period in 2022.

Key Points: 
  • Net product revenue for the quarter ended December 31, 2023 was $168.4 million, compared to $128.3 million for the same period in 2022.
  • The average number of patients on WAKIX increased by approximately 350 sequentially to approximately 6,150 for the quarter ended December 31, 2023.
  • Total Operating Expenses in the fourth quarter of 2023 included one-time Zynerba transaction related costs of $9.8 million.
  • ET
    We are hosting our fourth quarter and full year 2023 financial results conference call and webcast today at 8:30 a.m. Eastern Time.

Axsome Therapeutics Reports Fourth Quarter and Full Year 2023 Financial Results and Provides Business Update

Retrieved on: 
Tuesday, February 20, 2024

Auvelity® net product sales were $49.0 million and $130.1 million for the fourth quarter and full year of 2023, the first full year of launch.

Key Points: 
  • Auvelity® net product sales were $49.0 million and $130.1 million for the fourth quarter and full year of 2023, the first full year of launch.
  • Total costs of revenue were $7.4 million and $26.1 million for the fourth quarter and full year of 2023, respectively.
  • Approximately 84,000 prescriptions were written for Auvelity in the fourth quarter of 2023, representing a 23% sequential increase versus the third quarter of 2023.
  • Axsome will host a conference call and webcast today at 8:00 AM Eastern to discuss fourth quarter and full year 2023 financial results as well as to provide a corporate update.

HARMONY BIOSCIENCES RECEIVES U.S. FOOD AND DRUG ADMINISTRATION ORPHAN DRUG DESIGNATION FOR PITOLISANT IN PRADER-WILLI SYNDROME

Retrieved on: 
Tuesday, February 20, 2024

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).

Key Points: 
  • 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).
  • "The decision to grant Orphan Drug designation to pitolisant indicates that it could be a promising treatment option for people living with Prader-Willi syndrome," said Kumar Budur, M.D., M.S., Chief Medical Officer at Harmony Biosciences.
  • FDA Orphan Drug designation incentivizes the advancement of promising therapies for rare diseases by providing tax credits for clinical development, waivers for user fees, and seven years of market exclusivity following drug approval.
  • In the upcoming Phase 3 registrational TEMPO study, Harmony will assess the safety and efficacy of pitolisant in treating EDS and behavioral disturbances in PWS.

Takeda Intends to Rapidly Initiate the First Global Phase 3 Trials of TAK-861, an Oral Orexin Agonist, in Narcolepsy Type 1 in First Half of Fiscal Year 2024

Retrieved on: 
Thursday, February 8, 2024

It is currently classified into two different types: narcolepsy type 1 (NT1) caused by significant loss of orexin neurons with resulting lack of orexin, and narcolepsy type 2 (NT2) where orexin levels are generally normal.

Key Points: 
  • It is currently classified into two different types: narcolepsy type 1 (NT1) caused by significant loss of orexin neurons with resulting lack of orexin, and narcolepsy type 2 (NT2) where orexin levels are generally normal.
  • Stimulating the orexin receptor 2 in NT1 patients targets the underlying pathophysiology of the disease to restore orexin signaling.
  • Based on these results, and in consultation with global health authorities, Takeda plans to initiate global Phase 3 trials of TAK-861 in NT1 rapidly in the first half of its fiscal year 2024.
  • Results from the Phase 2b trials have no impact on the full year consolidated reported forecast for the fiscal year ending March 31, 2024 (Fiscal Year 2023).

Global Narcolepsy Drugs Market Research Report 2024: Pipeline Analysis, Key Company Profiles and Recent Developments 2023-2030 - ResearchAndMarkets.com

Retrieved on: 
Tuesday, January 30, 2024

The "Global Narcolepsy Drugs Market (By Therapeutic Type, Disease Type, End User, Regional Analysis), Pipeline Analysis, Key Company Profiles and Recent Developments - Forecast to 2030" report has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "Global Narcolepsy Drugs Market (By Therapeutic Type, Disease Type, End User, Regional Analysis), Pipeline Analysis, Key Company Profiles and Recent Developments - Forecast to 2030" report has been added to ResearchAndMarkets.com's offering.
  • The global narcolepsy drugs market has witnessed significant growth in recent years owing to the rising prevalence of narcolepsy and increased awareness about the condition.
  • Latin America and Middle East & Africa are competing closely to grab the maximum share of the global narcolepsy drugs market.
  • Global Narcolepsy Drugs Market - Key Company Profiles, Recent Developments, Financial Insights

Los Angeles Center for Ear, Nose, Throat and Allergy Welcomes Sleep Medicine Specialist, Dr. Cyrus Haghighian, M.D. to Practice

Retrieved on: 
Thursday, February 1, 2024

LOS ANGELES, Feb. 1, 2024 /PRNewswire/ -- The Los Angeles Center for Ear, Nose, Throat, and Allergy (LA CENTA) has announced the addition of Dr. Cyrus Haghighian to their practice. Dr. Haghighian is board certified with a robust educational background and extensive training in sleep conditions.

Key Points: 
  • LOS ANGELES, Feb. 1, 2024 /PRNewswire/ -- The Los Angeles Center for Ear, Nose, Throat, and Allergy (LA CENTA) has announced the addition of Dr. Cyrus Haghighian to their practice.
  • With a specialty in Sleep Medicine, Dr. Haghighian strives to help patients achieve better sleep and overall well-being.
  • Plus, his specialty in sleep medicine is a sought-after expertise that we are lucky to be able to offer."
  • To further advance his expertise he went on to pursue a fellowship in Sleep Medicine at the University of Southern California.

Kleine-Levin Syndrome Foundation Relaunches Medical Advisory Board

Retrieved on: 
Tuesday, January 30, 2024

SAN JOSE, Calif., Jan. 30, 2024 /PRNewswire/ -- The Kleine-Levin Syndrome Foundation today relaunched its Medical Advisory Board to help accelerate scientific understanding about KLS. The volunteer members of the Medical Advisory Board encourage scientific research to advance the search for a cause and a cure for KLS, provide objective medical knowledge to build awareness about KLS, and offer guidance for KLS patients and their caregivers.

Key Points: 
  • Members help encourage scientific inquiry; provide patients evidence-based information and guidance
    SAN JOSE, Calif., Jan. 30, 2024 /PRNewswire/ -- The Kleine-Levin Syndrome Foundation today relaunched its Medical Advisory Board to help accelerate scientific understanding about KLS.
  • "The KLS Foundation Board of Directors is grateful for the extensive knowledge and expertise of these respected researchers and clinicians," said Kleine-Levin Syndrome Foundation President Steve Maier, who experienced 18 KLS episodes from age 13-27.
  • "The Medical Advisory Board will provide the evidence-based guidance sought by so many KLS patients and their caregivers."
  • The relaunched Medical Advisory Board is composed of experts who volunteer their time and knowledge in many medical disciplines relating to KLS, including sleep disorders, neurology, and psychiatry.

Orphan designation: N-{(2S,3R)-4,4-Difluoro-1-(2-hydroxy-2-methylpropanoyl)-2-[(2,3',5'-trifluoro[1,1'-biphenyl]-3-yl)methyl]pyrrolidin-3-yl}ethanesulfonamide Treatment of narcolepsy, 08/11/2023 Positive

Retrieved on: 
Sunday, February 4, 2024

Key facts

Key Points: 
  • Key facts
    - Active substance
    - N-{(2S,3R)-4,4-Difluoro-1-(2-hydroxy-2-methylpropanoyl)-2-[(2,3',5'-trifluoro[1,1'-biphenyl]-3-yl)methyl]pyrrolidin-3-yl}ethanesulfonamide
    - Intended use
    - Treatment of narcolepsy
    - Orphan designation status
    - Positive
    - EU designation number
    - EU/3/23/2851
    - Date of designation
    - Sponsor
    Takeda Pharma A/S
    Patients' organisations
    For contact details of patients’ organisations whose activities are targeted at rare diseases, see:
    European Organisation for Rare Diseases (EURORDIS), a non-governmental alliance of patient organisations and individuals active in the field of rare diseases.
  • EU register of orphan medicines
    The list of medicines that have received an orphan designation in the EU is available on the European Commission's website:
    EMA list of opinions on orphan medicinal product designation
    EMA publishes information on orphan medicinal product designation adopted by the Committee for Orphan Medicinal Products (COMP) on the IRIS online platform: