Narcolepsy

Avadel Pharmaceuticals Provides Corporate Update and Reports Third Quarter 2021 Financial Results

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Monday, November 8, 2021
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ET

Key Points: 
  • ET
    DUBLIN, Ireland, Nov. 08, 2021 (GLOBE NEWSWIRE) -- Avadel Pharmaceuticals plc (Nasdaq: AVDL), a company focused on transforming medicines to transform lives, today provided a corporate update and announced its financial results for the third quarter ended September 30, 2021.
  • SG&A expenses were $21.3 million in the quarter ended September 30, 2021, compared to $8.4 million for the same period in 2020.
  • These forward-looking statements relate to our future expectations, beliefs, plans, strategies, objectives, results, conditions, financial performance, prospects, or other events.
  • The Company does not undertake any obligation to publicly update or revise our forward-looking statements, except as required by law.

Axsome Therapeutics Reports Third Quarter 2021 Financial Results and Provides Business Update

Retrieved on: 
Monday, November 8, 2021
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NEW YORK, Nov. 08, 2021 (GLOBE NEWSWIRE) -- Axsome Therapeutics, Inc. (NASDAQ: AXSM), a biopharmaceutical company developing novel therapies for the management of central nervous system (CNS) disorders, today reported financial results for the third quarter ended September 30, 2021.

Key Points: 
  • NEW YORK, Nov. 08, 2021 (GLOBE NEWSWIRE) -- Axsome Therapeutics, Inc. (NASDAQ: AXSM), a biopharmaceutical company developing novel therapies for the management of central nervous system (CNS) disorders, today reported financial results for the third quarter ended September 30, 2021.
  • Cash: At September 30, 2021, Axsome had $114.6 million of cash compared to $183.9 million at December 31, 2020.
  • Axsome will host a conference call and webcast today at 8:00 AM Eastern to discuss third quarter 2021 financial results as well as to provide a corporate update.
  • Axsome Therapeutics, Inc. is a biopharmaceutical company developing novel therapies for central nervous system (CNS) conditions that have limited treatment options.

SHAREHOLDER ALERT: Pomerantz Law Firm Investigates Claims On Behalf of Investors of Avadel Pharmaceuticals plc - AVDL

Retrieved on: 
Monday, November 1, 2021
New Drug Application, Narcolepsy, NASDAQ, FDA, Food, Review, Time, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Company, NDA, News, GLOBE, Avadel Pharmaceuticals, Private investigator

NEW YORK, Nov. 01, 2021 (GLOBE NEWSWIRE) -- Pomerantz LLP is investigating claims on behalf of investors of Avadel Pharmaceuticals plc (Avadel or the Company) (NASDAQ:AVDL).

Key Points: 
  • NEW YORK, Nov. 01, 2021 (GLOBE NEWSWIRE) -- Pomerantz LLP is investigating claims on behalf of investors of Avadel Pharmaceuticals plc (Avadel or the Company) (NASDAQ:AVDL).
  • Such investors are advised to contact Robert S. Willoughby at [email protected] or 888-476-6529, ext.
  • The investigation concerns whether Avadel and certain of its officers and/or directors have engaged in securities fraud or other unlawful business practices.
  • Founded by the late Abraham L. Pomerantz, known as the dean of the class action bar, the Pomerantz Firm pioneered the field of securities class actions.

Avadel Pharmaceuticals to Provide a Corporate Update and Report Third Quarter 2021 Financial Results on November 8th

Retrieved on: 
Monday, November 1, 2021
ID, Nasdaq, International, Patient, Sodium oxybate, Cataplexy, Company, GLOBE, Webcast, Narcolepsy, Somnolence, Pharmaceutical industry

ET on Monday, November 8, 2021, to provide a corporate update and discuss the Company's financial results for the third quarter ended September 30, 2021.

Key Points: 
  • ET on Monday, November 8, 2021, to provide a corporate update and discuss the Company's financial results for the third quarter ended September 30, 2021.
  • To access the conference call, investors are invited to dial (844) 388-0559 (U.S. and Canada) or (216) 562-0393 (International).
  • A live audio webcast can be accessed by visiting the investor relations section of the Companys website, www.avadel.com.
  • Avadel Pharmaceuticals plc (Nasdaq: AVDL) is a biopharmaceutical company focused on transforming medicines to transform lives.

SHAREHOLDER ALERT: Pomerantz Law Firm Investigates Claims On Behalf of Investors of Avadel Pharmaceuticals plc - AVDL

Retrieved on: 
Thursday, October 21, 2021
New Drug Application, Narcolepsy, NASDAQ, FDA, Food, Review, Time, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Company, NDA, News, GLOBE, Avadel Pharmaceuticals, Private investigator

NEW YORK, Oct. 20, 2021 (GLOBE NEWSWIRE) -- Pomerantz LLP is investigating claims on behalf of investors of Avadel Pharmaceuticals plc (Avadel or the Company) (NASDAQ:AVDL).

Key Points: 
  • NEW YORK, Oct. 20, 2021 (GLOBE NEWSWIRE) -- Pomerantz LLP is investigating claims on behalf of investors of Avadel Pharmaceuticals plc (Avadel or the Company) (NASDAQ:AVDL).
  • Such investors are advised to contact Robert S. Willoughby at [email protected] or 888-476-6529, ext.
  • The investigation concerns whether Avadel and certain of its officers and/or directors have engaged in securities fraud or other unlawful business practices.
  • Founded by the late Abraham L. Pomerantz, known as the dean of the class action bar, the Pomerantz Firm pioneered the field of securities class actions.

Avadel Presents New Data Supporting Clinical Benefit with Once-at-Bedtime FT218 and Preference for Once-Nightly Dosing in Patients with Narcolepsy at CHEST 2021

Retrieved on: 
Tuesday, October 19, 2021
Psychiatry, EDS, American College of Chest Physicians, Hospital, Clinical trial, Sodium oxybate, Harvard Medical School, Narcolepsy, Department, Nasdaq, Massachusetts General Hospital, Excessive daytime sleepiness, Quality of life, DCE, GLOBE, Patient, Maintenance, Review, Randomized controlled trial, Population, Cataplexy, Food, American College, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Physician, Massachusetts, Pharmaceutical industry, Lithium

DUBLIN, Oct. 19, 2021 (GLOBE NEWSWIRE) -- Avadel Pharmaceuticals plc (Nasdaq: AVDL), a company focused on transforming medicines to transform lives, today announced new data from the completed pivotal Phase 3 REST-ON clinical trial of FT218, also known as ON-SXB. The post-hoc data are being presented in as two separate posters at the American College of Chest Physicians (CHEST) annual meeting, taking place virtually October 17 – 20, 2021, along with the results of a discrete choice experiment (DCE) to understand patient preference. FT218 is the Company’s lead drug candidate, an investigational formulation of sodium oxybate designed to be taken once at bedtime for the treatment of excessive daytime sleepiness (EDS) or cataplexy in adults with narcolepsy. FT218 is currently under review at the U.S. Food and Drug Administration.

Key Points: 
  • The new post-hoc responder analyses demonstrating that ON-SXB improved EDS provide further confidence in ON-SXB for people with narcolepsy.
  • These ON-SXB data represent a compelling way to set expectations for patients receiving therapy.
  • FT218 has demonstrated meaningful improvement in cataplexy attacks and measurements of EDS with a dosing regimen preferred by patients.
  • We do not undertake any obligation to publicly update or revise our forward-looking statements, except as required by law.

Centessa Pharmaceuticals Subsidiary, Orexia Therapeutics, and Schrödinger Announce Collaboration to Discover Novel Orexin Receptor Agonists

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Monday, October 18, 2021
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NEW YORK, BOSTON and LONDON, Oct. 18, 2021 (GLOBE NEWSWIRE) -- Schrödinger (Nasdaq: SDGR) and Centessa Pharmaceuticals plc (“Centessa”) (Nasdaq: CNTA), together with subsidiary Orexia Therapeutics (“Orexia”), today announced an exclusive collaboration focused on the discovery of novel therapeutics targeting the orexin-2 receptor (OX2R), which is known to play a role in a broad spectrum of sleep disorders including narcolepsy. The collaboration provides Orexia with substantial access to Schrödinger’s entire computational platform as well as Schrödinger’s extensive expertise in ultra-large-scale deployment of its technology.

Key Points: 
  • The collaboration provides Orexia with substantial access to Schrdingers entire computational platform as well as Schrdingers extensive expertise in ultra-large-scale deployment of its technology.
  • The collaboration represents the first time Schrdingers technology will be applied in an orexin agonist setting at scale.
  • Orexias utilization of OX2R stabilized receptors (StaR technology) provides the foundation for R&D which could significantly benefit patients with NT1.
  • We look forward to partnering with Schrdinger to complement the discovery and development work we are conducting at Orexia, said Saurabh Saha, MD, PhD, Chief Executive Officer of Centessa.

Centessa Pharmaceuticals Subsidiary, Orexia Therapeutics, and Schrödinger Announce Collaboration to Discover Novel Orexin Receptor Agonists

Retrieved on: 
Monday, October 18, 2021
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Schrdinger (Nasdaq:SDGR) and Centessa Pharmaceuticals plc (Centessa) (Nasdaq:CNTA), together with subsidiary Orexia Therapeutics (Orexia), today announced an exclusive collaboration focused on the discovery of novel therapeutics targeting the orexin-2 receptor (OX2R), which is known to play a role in a broad spectrum of sleep disorders, including narcolepsy.

Key Points: 
  • Schrdinger (Nasdaq:SDGR) and Centessa Pharmaceuticals plc (Centessa) (Nasdaq:CNTA), together with subsidiary Orexia Therapeutics (Orexia), today announced an exclusive collaboration focused on the discovery of novel therapeutics targeting the orexin-2 receptor (OX2R), which is known to play a role in a broad spectrum of sleep disorders, including narcolepsy.
  • The collaboration provides Orexia with substantial access to Schrdingers entire computational platform as well as Schrdingers extensive expertise in ultra-large-scale deployment of its technology.
  • The collaboration represents the first time Schrdingers technology will be applied in an orexin agonist setting at scale.
  • We look forward to partnering with Schrdinger to complement the discovery and development work we are conducting at Orexia, said Saurabh Saha, M.D., Ph.D., chief executive officer of Centessa.

Avadel Pharmaceuticals Announces Ongoing FDA Review of NDA for FT218 for Patients with Narcolepsy

Retrieved on: 
Friday, October 15, 2021
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We have not been informed of any deficiencies in our application and remain fully committed to work closely with the FDA for the duration of its review of our NDA for FT218, said Greg Divis, Chief Executive Officer of Avadel.

Key Points: 
  • We have not been informed of any deficiencies in our application and remain fully committed to work closely with the FDA for the duration of its review of our NDA for FT218, said Greg Divis, Chief Executive Officer of Avadel.
  • In February 2021, the FDA accepted Avadels NDA for FT218 and assigned a target action date of October 15, 2021.
  • In March 2020, Avadel completed the REST-ON study, a randomized, double-blind, placebo-controlled, pivotal Phase 3 trial, to assess the efficacy and safety of FT218 in patients with narcolepsy.
  • Such forward-looking statements include, but are not limited to, expectations regarding the timing of the FDAs review of the NDA for FT218 and the sufficiency of data supporting the NDA for FT218.

Vallon Pharmaceuticals Provides Update on Recent Pipeline and Corporate Advancements

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PHILADELPHIA, PA, Oct. 12, 2021 (GLOBE NEWSWIRE) -- Vallon Pharmaceuticals, Inc. (NASDAQ: VLON), (“Vallon” or the “Company”), a clinical-stage biopharmaceutical company primarily focused on the development of novel drugs that are designed to deter abuse in the treatment of central nervous system (CNS) disorders, today provided an update on the progress of its development programs, ADAIR and ADMIR, which leverage the Company’s proprietary technology that is designed to resist manipulation for snorting and provide barriers to injection.

Key Points: 
  • Additionally, we have made important advancements in our second development program, ADMIR, by finalizing the selection of a very promising abuse-deterrent formulation of methylphenidate (Ritalin).
  • In addition, weve strengthened our corporate expertise and leadership with the formation of a scientific advisory board.
  • We believe their knowledge and expertise will be a significant asset and validates our approach to the advancement our CNS-focused, novel abuse-deterrent platform.
  • Vallon Pharmaceuticals, Inc. is a clinical-stage biopharmaceutical company, headquartered in Philadelphia, PA.