Idiopathic hypersomnia

Zevra Therapeutics Reports First Quarter 2024 Financial Results and Corporate Updates

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水曜日, 5月 8, 2024
Corporation, FDA, Society, EAP, Sale, Celiprolol, Acer, Investment, Priority review, NDA, Conference call, Research, Sleep, License, Conference, Discover, Idiopathic hypersomnia, Disease, Exercise, IH, PDUFA, Patient, Acquisition, Physician, NPC, UCD, Caregiver, Therapy, Pharmaceutical industry

CELEBRATION, Fla., May 08, 2024 (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 first quarter ended March 31, 2024. 

Key Points: 
  • ET
    CELEBRATION, Fla., May 08, 2024 (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 first quarter ended March 31, 2024.
  • Zevra has seen a meaningful increase in reimbursement coverage, reaching nearly 75% of covered lives as of May 1, 2024.
  • Overview of Q1 2024 Financial Results:
    Net revenue for Q1 2024 was $3.4 million, compared to net revenue of $3.2 million in Q1 2023.
  • ET, to discuss its corporate and financial results for Q1 2024.

Avadel Pharmaceuticals Provides Corporate Update and Reports First Quarter 2024 Financial Results

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水曜日, 5月 8, 2024
FDA, Shanda, International, EDS, Food, Idiopathic hypersomnia, Webcast, Avadel Pharmaceuticals, Patient, Caregiver, Narcolepsy, Cataplexy, Marketing, Food and Drug Administration, Nursing

DUBLIN, Ireland, May 08, 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 quarter ended March 31, 2024.

Key Points: 
  • ET --
    DUBLIN, Ireland, May 08, 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 quarter ended March 31, 2024.
  • Recognized $27.2 million in net product revenue and gross profit of $25.7 million for the quarter ended March 31, 2024.
  • R&D expenses were $3.1 million in the quarter ended March 31, 2024, compared to $3.8 million for the same period in 2023.
  • SG&A expenses were $48.6 million in the quarter ended March 31, 2024, compared to $24.5 million for the same period in 2023.

Axsome Therapeutics Reports First Quarter 2024 Financial Results and Provides Business Update

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月曜日, 5月 6, 2024
Shift, Migraine, FDA, Agitation, Research, EMERGE, Webcast, CNS, Prescription, Reboxetine, Privacy, Medicine, BED, Obstructive sleep apnea, Fibromyalgia, Shift work, Deficit spending, Food, Sleep, System, ADHD, SWD, SYMPHONY, NT1, Therapy, Quality of life, Food and Drug Administration, MDD, Narcolepsy Network, Shirin David, Patient, Somnolence, FOCUS, Safety, Depression, CGRP, Binge eating disorder, Medicare, Cataplexy, Central nervous system, Government, DSM-IV codes, Clinical trial, EDS, NDA, NMDA, GPO, Psychiatry, MD, Idiopathic hypersomnia, Smoking, CMAI, Pivotal, Breakthrough therapy, Growth, Pharmaceutical industry

Auvelity net product sales were $53.4 million for the first quarter of 2024, representing 240% year-over-year growth.

Key Points: 
  • Auvelity net product sales were $53.4 million for the first quarter of 2024, representing 240% year-over-year growth.
  • Total cost of revenue was $6.3 million for the first quarter of 2024.
  • Research and development (R&D) expenses were $36.8 million for the first quarter of 2024, compared to $17.8 million for the comparable period in 2023, respectively.
  • Approximately 95,000 prescriptions were written for Auvelity in the first quarter of 2024, representing a 12% sequential increase versus the fourth quarter of 2023.

Centessa Pharmaceuticals Announces Open IND for ORX750; Proof-of-Concept Data in Sleep-Deprived Healthy Volunteers Planned for 2H 2024

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月曜日, 4月 22, 2024
Volunteering, FDA, Safety, Pharmacokinetics, Sleep, Food, CNTA, MWT, NT2, Idiopathic hypersomnia, IND, IH, SAD, POC, Patient, Narcolepsy, NT1, OX2R, Clinical trial, PD, Investigational New Drug, KSS, Pharmaceutical industry

The Phase 1 study will evaluate the safety, tolerability and pharmacokinetics of single-ascending doses (SAD) and multiple-ascending doses (MAD) of ORX750 in healthy adult subjects.

Key Points: 
  • The Phase 1 study will evaluate the safety, tolerability and pharmacokinetics of single-ascending doses (SAD) and multiple-ascending doses (MAD) of ORX750 in healthy adult subjects.
  • The Company expects to commence dosing of the Phase 1 study in healthy volunteers imminently, and proof-of-concept data are anticipated in the second half of 2024.
  • “We are excited to begin executing what we believe is an elegant, adaptive Phase 1 study aimed at generating early proof-of-concept data for ORX750 in acutely sleep-deprived healthy volunteers in the second half of this year.
  • We expect this study to enable dose selection for planned studies evaluating ORX750 in patients with NT1 and in patient populations with normal orexin levels, including NT2 and IH.”

Zevra Therapeutics Reports Fourth Quarter and Full Year 2023 Financial Results and Corporate Updates

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木曜日, 3月 28, 2024
Narcolepsy, Exercise, Somnolence, New Drug Application, Patient, Visual analogue scale, Sale, NDA, G&A, Arimoclomol, Nature, IND, Bank statement, Microsoft Access, Investment, Therapy, Priority review, Corporation, Audit committee, Research, Niemann–Pick disease, Medical science liaison, Sleep disorder, Brain, Trial of the century, Safety, Interim, Food, Sleep, QuickStart, Disease, FY, Acquisition, Emetine, UCD, COL3A1, Celiprolol, Syndrome, FDA, Marketing, Conference call, Conference, EAP, SDX, NPC, Epworth Sleepiness Scale, Idiopathic hypersomnia, Physician, PDUFA, Pharmaceutical industry

CELEBRATION, Fla., March 28, 2024 (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 fourth quarter and year ended December 31, 2023. 

Key Points: 
  • ET
    CELEBRATION, Fla., March 28, 2024 (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 fourth quarter and year ended December 31, 2023.
  • “We made solid progress on our key priorities in 2023,” said Neil F. McFarlane, President and Chief Executive Officer of Zevra.
  • Overview of Q4 2023 and FY 2023 Financial Results:
    Net revenue for Q4 2023 was $13.2 million, compared to prior year Q4 net revenue of $2.2 million.
  • ET, to discuss its corporate and financial results for Q4 and FY 2023.

Zevra Therapeutics Announces Top-Line Data from the Phase 2 Clinical Trial of KP1077 for Idiopathic Hypersomnia

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火曜日, 3月 26, 2024
Brain, Disease, Somnolence, Appetite, Partnership, Headache, Visual analogue scale, Patient, Insomnia, EDS, Anxiety, SDX, Doctor of Philosophy, Epworth Sleepiness Scale, Nausea, Clinical trial, Therapy, Safety, Narcolepsy, ESS, IHSS, Idiopathic hypersomnia, Clouding of consciousness, BFS, Food, Pharmaceutical industry

CELEBRATION, Fla., March 26, 2024 (GLOBE NEWSWIRE) -- Zevra Therapeutics, Inc. (NasdaqGS: ZVRA) (Zevra, or the Company) a rare disease therapeutics company, today announced top-line data from its placebo-controlled, double-blind Phase 2 clinical trial (NCT05668754) evaluating the safety and tolerability of KP1077 (serdexmethylphenidate, or SDX) in patients with idiopathic hypersomnia (IH). This proof-of-concept study was not powered to demonstrate statistical significance.   The data gathered for several secondary and exploratory endpoints, including the Epworth Sleepiness Scale (ESS), Idiopathic Hypersomnia Severity Scale (IHSS) and Sleep Inertia Visual Analog Scale (SIVAS) will inform the Phase 3 study design.

Key Points: 
  • CELEBRATION, Fla., March 26, 2024 (GLOBE NEWSWIRE) -- Zevra Therapeutics, Inc. (NasdaqGS: ZVRA) (Zevra, or the Company) a rare disease therapeutics company, today announced top-line data from its placebo-controlled, double-blind Phase 2 clinical trial ( NCT05668754 ) evaluating the safety and tolerability of KP1077 (serdexmethylphenidate, or SDX) in patients with idiopathic hypersomnia (IH).
  • The data gathered for several secondary and exploratory endpoints, including the Epworth Sleepiness Scale (ESS), Idiopathic Hypersomnia Severity Scale (IHSS) and Sleep Inertia Visual Analog Scale (SIVAS) will inform the Phase 3 study design.
  • The results from the completed Phase 2 trial provide key information for the design of a potentially pivotal Phase 3 trial of KP1077 in patients with IH.
  • The Company plans to request an end-of-Phase 2 (EOP2) meeting with the U.S. Food and Drug Administration to seek guidance on the Phase 3 clinical trial design.

Axsome Therapeutics Announces Results of CRESCENDO Narcolepsy Patient Survey Demonstrating Unmet Needs in Treated Narcolepsy Type 1 Patients

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月曜日, 3月 25, 2024
Diagnosis, Neurology, Sleep, Depression, Somnolence, Deficit spending, Thomas Jefferson University, Partnership, Central nervous system, NT1, Cataplexy, Patient, CNS, Sleep disorder, Cognitive deficit, Ageing, EDS, Columbia, Anxiety, Hallucination, Narcolepsy Network, Epworth Sleepiness Scale, Life, Therapy, Sleep paralysis, ESS, Medical director, Idiopathic hypersomnia, FDA, Human, Nursing

NEW YORK, March 25, 2024 (GLOBE NEWSWIRE) -- Axsome Therapeutics, Inc. (NASDAQ: AXSM), a biopharmaceutical company developing and delivering novel therapies for the management of central nervous system (CNS) disorders, today announced topline results from the CRESCENDO (Characterizing Patient Perspectives on Unmet Needs in Narcolepsy) survey of patients with narcolepsy type 1 (NT1, i.e., narcolepsy with cataplexy) receiving treatment, demonstrating high rates of persistent symptoms and significant patient burden, despite being on current treatments. CRESCENDO was conducted in partnership with Narcolepsy Network, a national non-profit patient support organization for people with narcolepsy, idiopathic hypersomnia, and related sleep disorders.

Key Points: 
  • CRESCENDO was conducted in partnership with Narcolepsy Network, a national non-profit patient support organization for people with narcolepsy, idiopathic hypersomnia, and related sleep disorders.
  • All patients taking part in the survey were currently undergoing treatment for NT1.
  • The most common treatments were wake promoting agents (about 53% of surveyed patients), oxybates (47%), and stimulants (42%).
  • Axsome plans to present the detailed results of the CRESCENDO survey at upcoming scientific meetings.

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

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月曜日, 3月 4, 2024
Idiopathic hypersomnia, Caregiver, Narcolepsy, Marketing, FDA, Food, System, Shanda, Cataplexy, UnitedHealth Group, Food and Drug Administration, Webcast, EDS, Patient, PBM, Avadel Pharmaceuticals, Trial of the century, Nursing

-- 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.

Illuminate Hypersomnia Initiative Shines Light on What It's Like to Live with Idiopathic Hypersomnia

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木曜日, 12月 7, 2023
Organization, Food, Human voice, Therapy, IH, Patient, Jazz Pharmaceuticals, Fatigue, Partner, Idiopathic hypersomnia, Hatred, Diagnosis, PALM, Doctor of Philosophy, News, Pharmaceutical industry, Nursing, Takeda

WEST PALM BEACH, Fla., Dec. 7, 2023 /PRNewswire/ -- The Sleep Consortium, in collaboration with sleep-related patient advocacy organizations worldwide, announces the Illuminate Hypersomnia initiative, a groundbreaking effort to highlight the lived experience of idiopathic hypersomnia (IH). This initiative aims to fully describe the impact of IH on the lives of those affected, their current management strategies, and the treatment benefits that matter most to them as new therapies are developed.

Key Points: 
  • The meeting will be streamed live, bringing members of the global IH community together to share their experiences and perspectives.
  • The Illuminate Hypersomnia initiative also aims to expand collaboration and support within the IH community to help individuals learn from and empower one another.
  • "Our mission with the Illuminate Hypersomnia initiative is clear: bring to light the hidden struggles of idiopathic hypersomnia and unite in the quest for better treatments," remarked CEO of Sleep Consortium Lindsay Jesteadt, PhD.
  • Organizations generously supporting the Illuminate Hypersomnia initiative with unrestricted educational grants include Alkermes, Avadel Pharmaceuticals, Harmony Biosciences, Jazz Pharmaceuticals, Takeda, and Zevra Therapeutics.

Project Sleep Launches the Sleep Helpline™ to Provide Free and Personalized Support for People Facing Sleep Issues and Sleep Disorders

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水曜日, 12月 6, 2023
Sleep, JD, Kleine–Levin syndrome, DSM-IV codes, REM, Narcolepsy, Sleep disorder, Patient, LOS, Obstructive sleep apnea, Idiopathic hypersomnia, Uncertainty, Sleep-related breathing disorder, Central sleep apnea, Eastern Time Zone, Caregiver, University, Upper airway resistance syndrome, Parasomnia, Diagnosis, Social, Doctor of Philosophy, Sleepwalking, Restless legs syndrome, Non-24-hour sleep–wake disorder, Pharmaceutical industry, Nursing

LOS ANGELES, Dec. 6, 2023 /PRNewswire/ -- Project Sleep, a nonprofit dedicated to raising awareness of sleep health, sleep equity, and sleep disorders, is thrilled to announce the official launch of the Sleep Helpline™, a new, professionally-staffed national helpline providing timely and trusted resources to help individuals navigate sleep issues and sleep disorders at every step of the journey.

Key Points: 
  • "An estimated 50-70 million Americans live with a chronic sleep disorder, yet the majority are undiagnosed," said Julie Flygare , JD, President & CEO of Project Sleep.
  • "We know that the path to finding accurate sleep disorder diagnosis, treatment, and support is often long, lonely, and inefficient.
  • This is why the new Sleep Helpline will meet people where they are in moments of uncertainty, to provide free and personalized one-to-one support and resources."
  • Special thanks to Jazz Pharmaceuticals and Harmony Biosciences for generously providing sponsorship funding to support the development of Project Sleep's new Sleep Helpline to support millions of people facing sleep issues and sleep disorders.