Narcolepsy

Pharma Two B to Present Additional Phase 3 Positive Results of P2B001, a once-daily, fixed-dose combination of low-dose pramipexole and low-dose rasagiline, at 2023 International Congress of Parkinson’s Disease and Movement Disorders®

Retrieved on: 
Monday, August 28, 2023
PD, Narcolepsy, EDS, Movement disorder, Inova Health System, Dopamine, ESS, Parkinson's disease, Patient, Data analysis, Epworth Sleepiness Scale, Somnolence, Health, Palladium, Pharmaceutical industry

In all subgroups, the results demonstrate greater symptomatic benefit of P2B001 versus its components, and comparable efficacy with currently marketed, optimally titrated, extended-release pramipexole, yet with reduced EDS.

Key Points: 
  • In all subgroups, the results demonstrate greater symptomatic benefit of P2B001 versus its components, and comparable efficacy with currently marketed, optimally titrated, extended-release pramipexole, yet with reduced EDS.
  • Across all subgroups, P2B001 provided comparable symptomatic efficacy versus currently marketed, optimally titrated, extended-release pramipexole.
  • Dan Teleman, CEO of Pharma Two B, adds, “We are encouraged by the consistency of the Phase 3 trial's sub-group analyses.
  • They reinforce our commitment to advancing P2B001 and improving the lives of people with Parkinson's disease.”

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

Retrieved on: 
Monday, August 28, 2023
Harmony, Patent, Narcolepsy, Patient, Idiopathic hypersomnia, DSM-IV codes, Pharmaceutical industry

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).

Key Points: 
  • 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).
  • The Company issued the following statement:
    We are pleased that the U.S. Patent and Trademark Office (USPTO) rejected a challenge to the validity of claims within the patent covering the active ingredient in WAKIX® (pitolisant), in line with our expectations.
  • This decision not only underscores our confidence in the strength of the WAKIX patent portfolio but also reinforces our belief in the potential of the WAKIX franchise.
  • We are proud of the work we do every day to address the unmet medical needs of patients living with rare neurological diseases.

Centessa Pharmaceuticals to Present Preclinical Data for Novel Orexin Receptor 2 (OX2R) Agonist at World Sleep Congress

Retrieved on: 
Wednesday, August 23, 2023
Congress, CNTA, Narcolepsy, Sleep, MD, Patient, Doctor of Philosophy, OX2R, Pharmaceutical industry

ORX750 is an orally administered, selective orexin receptor 2 (OX2R) agonist in preclinical development for the treatment of narcolepsy and other sleep disorders.

Key Points: 
  • ORX750 is an orally administered, selective orexin receptor 2 (OX2R) agonist in preclinical development for the treatment of narcolepsy and other sleep disorders.
  • In addition, Sarah Wurts Black, PhD, Head of Biology for Centessa’s orexin program, will co-chair a symposium at the Congress focused on the development of orexin receptor agonists.
  • Details of the presentation are as follows:
    Additional information about the World Sleep Congress is available at https://worldsleepcongress.com/program .
  • Centessa plans to make its presentation available on the Centessa website at https://investors.centessa.com/events-presentations after the presentations conclude.

Zevra Therapeutics Reports Corporate Updates and Second Quarter 2023 Financial Results

Retrieved on: 
Monday, August 14, 2023
Exercise, Drug development, Priority review, Conference call, Food, New Drug Application, NDA, Business, Narcolepsy, G&A, Research, Sale, Zebra, Acquisition, Investment, Niemann–Pick disease, Patient, Data, Corporation, Webcast, SDX, NPC, R, FDA, Therapy, Sleep, Regulation of tobacco by the U.S. Food and Drug Administration, IND, Idiopathic hypersomnia, Conference, Disease, Real estate, Broadcasting, Pharmaceutical industry, Cryptocurrency, IH

CELEBRATION, Fla., Aug. 14, 2023 (GLOBE NEWSWIRE) --  Zevra Therapeutics, Inc. (NasdaqGS: ZVRA) (Zevra, or the Company), a rare disease therapeutics company, today provided corporate updates and reported its financial results for the quarter ended June 30, 2023. 

Key Points: 
  • ET
    CELEBRATION, Fla., Aug. 14, 2023 (GLOBE NEWSWIRE) --  Zevra Therapeutics, Inc. (NasdaqGS: ZVRA) (Zevra, or the Company), a rare disease therapeutics company, today provided corporate updates and reported its financial results for the quarter ended June 30, 2023.
  • AZSTARYS milestone revenues, ongoing royalties from AZSTARYS, and the French early access program for arimoclomol primarily drove Q2 2023 net revenue.
  • General and administrative (G&A) expenses were $7.0 million for Q2 2023, compared to $3.6 million in Q2 2022.
  • ET, to discuss its corporate and financial results for Q2 2023.

Centessa Pharmaceuticals Reports Financial Results and Business Highlights for the Second Quarter of 2023

Retrieved on: 
Monday, August 14, 2023
Narcolepsy, Investment, CD3, Neoplasm, CNTA, Haemophilia, Fast Track, Toxicity, Part, Person, Trial of the century, Congress, Development, ATM, Patient, Administration, OX2R, APC, FDA, Sleep, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, IND, Food, Palladium, Pharmaceutical industry, Vaccine, Cryptocurrency

Research & Development Expenses: $33.7 million for the second quarter ended June 30, 2023, compared to $53.7 million for the second quarter ended June 30, 2022.

Key Points: 
  • Research & Development Expenses: $33.7 million for the second quarter ended June 30, 2023, compared to $53.7 million for the second quarter ended June 30, 2022.
  • General & Administrative Expenses: $13.3 million for the second quarter ended June 30, 2023, compared to $14.8 million the second quarter ended June 30, 2022.
  • Net Loss Attributable to Ordinary Shareholders: $24.9 million for the second quarter ended June 30, 2023, compared to $64.7 million for the second quarter ended June 30, 2022.
  • The net loss for the second quarter of 2023 included a tax benefit of $24.1 million, which primarily relates to a release of a valuation allowance on certain U.S. deferred tax assets in the quarter.

Avadel Pharmaceuticals Provides Corporate Update and Reports Second Quarter 2023 Financial Results

Retrieved on: 
Wednesday, August 9, 2023
Sodium oxybate, Cataplexy, NT2, Pharmacy, EDS, Narcolepsy, Marketing, Anxiety, Sleep, Sleep Research Society, American depositary receipt, NDA, Prescription, American Academy, U.S. FDA, Avadel Pharmaceuticals, American Academy of Sleep Medicine, Patient, NT1, ESI, Somnolence, Growth, FDA, Health, Pharmaceutical industry, Nursing, Fine chemical

DUBLIN, Ireland, Aug. 09, 2023 (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 second quarter ended June 30, 2023.

Key Points: 
  • ET --
    DUBLIN, Ireland, Aug. 09, 2023 (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 second quarter ended June 30, 2023.
  • Recognized $1.5 million in net product revenues for the second quarter 2023.
  • R&D expenses were $4.2 million in the quarter ended June 30, 2023, compared to $4.5 million for the same period in 2022.
  • SG&A expenses were $46.8 million in the quarter ended June 30, 2023, compared to $21.8 million for the same period in 2022.

Axsome Therapeutics Reports Second Quarter 2023 Financial Results and Provides Business Update

Retrieved on: 
Monday, August 7, 2023
Shift, Total, Migraine, Central nervous system, Narcolepsy, SG, SWD, Eating disorder, Binge eating disorder, FOCUS, New Drug Application, Food and Drug Administration, DCC, NDA, Prescription, NMDA, SYMPHONY, CNS, Government, ES, Medicare, Breakthrough therapy, MD, Physician, Patient, Esreboxetine, Reboxetine, BED, Fibromyalgia, Somnolence, Webcast, R, Research, AD, FDA, Therapy, Smoking, Dextromethorphan/bupropion, Agitation, Food, Safety, Pharmaceutical industry, Video game, Bank, Security (finance), Dietary supplement, Medicaid, Solriamfetol, ADHD

Auvelity® net product sales were $27.6 million for the second quarter of 2023, representing a 76% sequential increase versus the first quarter of 2023.

Key Points: 
  • Auvelity® net product sales were $27.6 million for the second quarter of 2023, representing a 76% sequential increase versus the first quarter of 2023.
  • Approximately 53,000 prescriptions were reported for Auvelity in the second quarter of 2023, representing a 72% sequential increase versus the first quarter of 2023.
  • Second quarter 2023 U.S. Sunosi total prescriptions increased by 15% versus the second quarter of 2022, and sequentially by 8% versus the first quarter of 2023.
  • Axsome will host a conference call and webcast today at 8:00 AM Eastern to discuss first quarter 2023 financial results as well as to provide a corporate update.

Sosei Heptares Operational Highlights and Consolidated Results for the Second Quarter and First Half of 2023

Retrieved on: 
Friday, August 4, 2023
Tokyo Stock Exchange, Obesity, Senior, Diabetes, Nordic Growth Market, Schizophrenia, Lean, EVP, Annual, Calendar, Deficit spending, Narcolepsy, Cerebral vasospasm, G&A, Bristol Myers Squibb, Cash, NAM, Movement, Strategic management, Glutamate (neurotransmitter), Insomnia, Acquisition, GPCR, JPY, Patient, Mizuho Bank, OX2R, GPR52, FDA, Sleep, IND, Pfizer, Management, Fine chemical, Pharmaceutical industry, Cryptocurrency, Idorsia

Tokyo, Japan and Cambridge, UK, 4 August 2023 – Sosei Group Corporation (“the Company”; TSE: 4565) provides an update on operational activities and reports its consolidated results for the second quarter and first half ended 30 June 2023.

Key Points: 
  • Tokyo, Japan and Cambridge, UK, 4 August 2023 – Sosei Group Corporation (“the Company”; TSE: 4565) provides an update on operational activities and reports its consolidated results for the second quarter and first half ended 30 June 2023.
  • Sosei Heptares will explore next steps with Pfizer for the future development of lotiglipron.
  • Revenue totalled JPY 2,146 million (US$15.9 million*), a decrease of JPY 311 million (US$4.1 million) vs. the prior corresponding period.
  • Core operating loss** totalled JPY 2,720 million (US$20.2 million) vs. a core operating loss of JPY 2,378 million (US$19.4 million) in the prior corresponding period.

Harmony Biosciences Reports Second Quarter 2023 Financial Results and Business Updates

Retrieved on: 
Tuesday, August 1, 2023
Total, Share repurchase, Bank statement, IH, Narcolepsy, GAAP, History, DSM-IV codes, Marketing, Myotonic dystrophy, Harmony, Research and development, Development, Shanda, Patient, Administration, Growth, Research, PWS, FDA, Benchmarking, Hand, Regulation of tobacco by the U.S. Food and Drug Administration, Conference, Food, Silviculture, Pharmaceutical industry, Bank, Arms industry, Video game, Webcast

ET

Key Points: 
  • ET
    PLYMOUTH MEETING, Pa., Aug. 01, 2023 (GLOBE NEWSWIRE) -- 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 reported financial results and business updates for the quarter ended June 30, 2023.
  • The average number of patients on WAKIX increased by approximately 350 sequentially to approximately 5,450 patients for the quarter ended June 30, 2023.
  • Reconciliations of applicable GAAP financial measures to Non-GAAP financial measures are included at the end of this press release.
  • ET
    We are hosting our second quarter 2023 financial results conference call and webcast today at 8:30 a.m. Eastern Time.

The New England Journal of Medicine Publishes Data from Phase 2 Study of First Oral Orexin Receptor 2 Agonist TAK-994 in Patients with Narcolepsy Type 1

Retrieved on: 
Wednesday, July 26, 2023
Health, Other Health, Clinical Trials, General Health, Pharmaceutical, Biotechnology, Hepatotoxicity, Cataplexy, The New England Journal of Medicine, TAK, Narcolepsy, Wakefulness, Patient, OX2R, Somnolence, Disease, Pharmaceutical industry, Takeda, NT1

Takeda ( TSE:4502/NYSE:TAK ) today announced that data from the Phase 2 study of orexin receptor 2 (OX2R) agonist TAK-994 in patients with narcolepsy type 1 (NT1) was published in The New England Journal of Medicine.

Key Points: 
  • Takeda ( TSE:4502/NYSE:TAK ) today announced that data from the Phase 2 study of orexin receptor 2 (OX2R) agonist TAK-994 in patients with narcolepsy type 1 (NT1) was published in The New England Journal of Medicine.
  • These data represent the first-ever clinical data to be published of an oral orexin agonist in NT1.
  • The article appears in the July 27 issue of the journal and is titled, “Oral Orexin Receptor 2 Agonist in Narcolepsy Type 1.”
    “There is significant unmet need for patients with narcolepsy, a chronic neurologic disease caused by severe loss or absence of the neuropeptide orexin, also known as hypocretin.
  • Today, most patients with NT1 require multiple therapies that only manage excessive daytime sleepiness and cataplexy.