Cataplexy

Jazz Pharmaceuticals and Sumitomo Pharma Announce Exclusive License Agreement to Develop and Commercialize DSP-0187, a Potent, Highly Selective Oral Orexin-2 Receptor Agonist

Retrieved on: 
Wednesday, May 4, 2022
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DUBLIN and OSAKA, Japan, May 4, 2022 /PRNewswire/ -- Jazz Pharmaceuticals plc (Nasdaq: JAZZ) and Sumitomo Pharma Co., Ltd. (Head Office: Osaka, Japan; Representative Director, President, and CEO: Hiroshi Nomura; Securities Code: 4506, Prime Market of TSE) today announced that the companies have entered into an exclusive licensing agreement under which Jazz has acquired development and commercialization rights in the United States, Europe and other territories for Sumitomo Pharma's investigational DSP-0187, a potent, highly selective oral orexin-2 receptor agonist with potential application for the treatment of narcolepsy, idiopathic hypersomnia and other sleep disorders. Jazz has designated this molecule JZP441.

Key Points: 
  • Sumitomo Pharma initiated a Phase 1 trial in Japan of DSP-0187 in November 2021 to evaluate safety, tolerability and pharmacokinetics in healthy volunteers.
  • "Orexin agonism is an exciting area of sleep disorder research and an approach that may be complementary to oxybate therapy.
  • "DSP-0187 is a potent, highly selective oral orexin-2 receptor agonist, which is a novel small molecule compound originally created by Sumitomo Pharma by utilizing our advanced expertise in drug discovery for central nervous system disorders.
  • DSP-0187 is a potent, highly selective orexin-2 receptor agonist designed to activate orexin signaling.

Avadel Pharmaceuticals to Provide a Corporate Update and Report First Quarter Financial Results on May 9

Retrieved on: 
Monday, May 2, 2022
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ET on Monday, May 9, 2022, to provide a corporate update and discuss the Company's financial results for the first quarter ended March 31, 2022.

Key Points: 
  • ET on Monday, May 9, 2022, to provide a corporate update and discuss the Company's financial results for the first quarter ended March 31, 2022.
  • 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.

Avadel Pharmaceuticals Provides Comment on Recent Trading Activity

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Tuesday, April 26, 2022
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DUBLIN, Ireland, April 26, 2022 (GLOBE NEWSWIRE) -- Avadel Pharmaceuticals plc (Nasdaq: AVDL), a biopharmaceutical company focused on transforming medicines to transform lives, today provided a statement in response to the trading volatility and subsequent brief trading halt of its shares that occurred yesterday.

Key Points: 
  • DUBLIN, Ireland, April 26, 2022 (GLOBE NEWSWIRE) -- Avadel Pharmaceuticals plc (Nasdaq: AVDL), a biopharmaceutical company focused on transforming medicines to transform lives, today provided a statement in response to the trading volatility and subsequent brief trading halt of its shares that occurred yesterday.
  • The company is not aware of any new information, including regarding the ongoing review of the FT218 NDA, that caused yesterdays share price movement and brief trading halt, said Greg Divis, Chief Executive Officer of Avadel Pharmaceuticals.
  • 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.
  • Avadel Pharmaceuticals plc (Nasdaq: AVDL) is a biopharmaceutical company focused on transforming medicines to transform lives.

Avadel Pharmaceuticals Announces Interim Data from the Open-Label RESTORE Study at the 2022 American Academy of Neurology Annual Meeting

Retrieved on: 
Monday, April 25, 2022
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DUBLIN, Ireland, April 25, 2022 (GLOBE NEWSWIRE) -- Avadel Pharmaceuticals plc (Nasdaq: AVDL), a biopharmaceutical company focused on transforming medicines to transform lives, today announced the presentation of interim data from the ongoing RESTORE open-label extension/switch study of FT218 at the 2022 American Academy of Neurology Annual (AAN) Meeting being held virtually from April 24-26, 2022.

Key Points: 
  • DUBLIN, Ireland, April 25, 2022 (GLOBE NEWSWIRE) -- Avadel Pharmaceuticals plc (Nasdaq: AVDL), a biopharmaceutical company focused on transforming medicines to transform lives, today announced the presentation of interim data from the ongoing RESTORE open-label extension/switch study of FT218 at the 2022 American Academy of Neurology Annual (AAN) Meeting being held virtually from April 24-26, 2022.
  • Results from the questionnaire follow:
    Out of 60 participants, 38 (63%) unintentionally missed their second twice-nightly oxybate dose within the preceding three months.
  • Avadel is currently evaluating the long-term safety and tolerability of FT218 in the open-label RESTORE clinical study.
  • We do not undertake any obligation to publicly update or revise our forward-looking statements, except as required by law.

Avadel Pharmaceuticals Announces Publication of Positive Secondary Endpoint Data from Pivotal Phase 3 REST-ON Trial

Retrieved on: 
Wednesday, April 6, 2022
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In addition, patient-reported assessments of sleep quality and refreshing nature of sleep, as measured on a visual analog scale, were analyzed.

Key Points: 
  • In addition, patient-reported assessments of sleep quality and refreshing nature of sleep, as measured on a visual analog scale, were analyzed.
  • Additional post-hoc data further supported improvements in sleep architecture with increases in N3, or slow wave sleep and increased REM latency.
  • Additional secondary and post-hoc data were presented at SLEEP (the annual Meeting of the Associated Professional Sleep Societies) and World Sleep .
  • In March 2020, Avadel completed the REST-ON trial, a randomized, double-blind, placebo-controlled, pivotal Phase 3 trial, to assess the efficacy and safety of FT218 in adults with narcolepsy.

Avadel Pharmaceuticals to Present at Upcoming Investor Conferences

Retrieved on: 
Tuesday, March 22, 2022
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DUBLIN, Ireland, March 22, 2022 (GLOBE NEWSWIRE) -- Avadel Pharmaceuticals plc (Nasdaq: AVDL), a company focused on transforming medicines to transform lives, announced today that Greg Divis, Chief Executive Officer of Avadel, will participate in the following upcoming investor conferences:

Key Points: 
  • DUBLIN, Ireland, March 22, 2022 (GLOBE NEWSWIRE) -- Avadel Pharmaceuticals plc (Nasdaq: AVDL), a company focused on transforming medicines to transform lives, announced today that Greg Divis, Chief Executive Officer of Avadel, will participate in the following upcoming investor conferences:
    Stifel 2022 Virtual CNS Day: Fireside chat on Tuesday, March 29 at 12:00 p.m. E.T.
  • 21st Annual Needham Virtual Healthcare Conference: Fireside chat on Monday, April 11 at 2:15 p.m. E.T.
  • Live webcast of these events, as well as archived recordings, will be available on Avadels Investor Relations website, investors.avadel.com , for 90 days following each conference.
  • Avadel Pharmaceuticals plc (Nasdaq: AVDL) is a biopharmaceutical company focused on transforming medicines to transform lives.

Avadel Pharmaceuticals Announces Appointment of Brandi Robinson as Senior Vice President, Corporate Affairs

Retrieved on: 
Monday, March 14, 2022
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DUBLIN, Ireland, March 14, 2022 (GLOBE NEWSWIRE) -- Avadel Pharmaceuticals plc (Nasdaq: AVDL), a company focused on transforming medicines to transform lives, today announced the appointment of Brandi Robinson to the newly created position of Senior Vice President, Corporate Affairs.

Key Points: 
  • DUBLIN, Ireland, March 14, 2022 (GLOBE NEWSWIRE) -- Avadel Pharmaceuticals plc (Nasdaq: AVDL), a company focused on transforming medicines to transform lives, today announced the appointment of Brandi Robinson to the newly created position of Senior Vice President, Corporate Affairs.
  • Brandi brings a wealth of corporate affairs experience in the biopharmaceutical industry, which will support the company as we expand.
  • Its an exciting time to join Avadel, as the Company continues to build operational capabilities for the potential launch of FT218, said Brandi Robinson.
  • At Rafael Holdings, Brandi led the communications, corporate affairs and patient advocacy functions, and served as a member of the Executive Committee.

Avadel Pharmaceuticals to Provide a Corporate Update and Report Fourth Quarter and Full Year 2021 Financial Results on March 17th

Retrieved on: 
Monday, March 14, 2022
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ET on Thursday, March 17, 2022, to provide a corporate update and discuss the Company's financial results for the fourth quarter and full year ended December 31, 2021.

Key Points: 
  • ET on Thursday, March 17, 2022, to provide a corporate update and discuss the Company's financial results for the fourth quarter and full year ended December 31, 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.

Avadel Announces New Positive Data for Once-at-Bedtime FT218 for Narcolepsy and Once-Nightly Dosing Preference Among Patients and Clinicians at World Sleep 2022

Retrieved on: 
Friday, March 11, 2022
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New post-hoc data from the completed pivotal Phase 3 REST-ON clinical trial of FT218 and interim data from the ongoing RESTORE open-label extension/switch study of FT218 will also be presented.

Key Points: 
  • New post-hoc data from the completed pivotal Phase 3 REST-ON clinical trial of FT218 and interim data from the ongoing RESTORE open-label extension/switch study of FT218 will also be presented.
  • We know that untreated narcolepsy can have a devastating effect on patients quality of life and ability to function and that additional treatment options would benefit patients and clinicians.
  • All accepted abstracts are available on the World Sleep Congress website and will be published in an upcoming Sleep Medicine journal supplement.
  • At Avadel, we believe in listening to patients to develop solutions that will have a meaningful impact on their symptoms.

Avadel Pharmaceuticals to Present at the Oppenheimer 32nd Annual Healthcare Conference

Retrieved on: 
Thursday, March 10, 2022
Cataplexy, Nasdaq, Somnolence, Narcolepsy, GLOBE, Conference, Patient, Sodium oxybate, Pharmaceutical industry, Avadel Pharmaceuticals

DUBLIN, Ireland, March 10, 2022 (GLOBE NEWSWIRE) -- Avadel Pharmaceuticals plc (Nasdaq: AVDL), a company focused on transforming medicines to transform lives, announced today that Greg Divis, Chief Executive Officer of Avadel, will participate in participate in a virtual fireside chat at the Oppenheimer 32nd Annual Healthcare Conference on Thursday, March 17 at 10:40 a.m.

Key Points: 
  • DUBLIN, Ireland, March 10, 2022 (GLOBE NEWSWIRE) -- Avadel Pharmaceuticals plc (Nasdaq: AVDL), a company focused on transforming medicines to transform lives, announced today that Greg Divis, Chief Executive Officer of Avadel, will participate in participate in a virtual fireside chat at the Oppenheimer 32nd Annual Healthcare Conference on Thursday, March 17 at 10:40 a.m.
  • A live webcast of the fireside chat, as well as an archived recording, will be available on Avadels Investor Relations website, investors.avadel.com , for 90 days following the conference.
  • Avadel Pharmaceuticals plc (Nasdaq: AVDL) is a biopharmaceutical company focused on transforming medicines to transform lives.
  • Our approach includes applying innovative solutions to the development of medications that address the challenges patients face with current treatment options.