Avadel Pharma (Flamel Technologies S.A. Acquired Avadel)

224 articles with Avadel Pharma (Flamel Technologies S.A. Acquired Avadel)

• Avadel Pharmaceuticals to Participate in a Fireside Chat at Stifel’s Third Annual CNS Day on March 31st

  3/18/2021

  Avadel Pharmaceuticals plc (Nasdaq: AVDL), a company focused on developing FT218, an investigational, once-nightly formulation of sodium oxybate for treating excessive daytime sleepiness and cataplexy in adults with narcolepsy, announced today that members of the Avadel management team will participate in a fireside chat at Stifel's Third Annual CNS Day, which is being held on March 31 st .

• Avadel Pharmaceuticals Provides Corporate Update and Reports Fourth Quarter and Full Year 2020 Financial Results

  3/9/2021

  New Drug Application (NDA) for once-nightly FT218 to treat excessive daytime sleepiness and cataplexy in adults with narcolepsy accepted for filing by the FDA; assigned a Prescription Drug User Fee Act (PDUFA) target date of October 15, 2021 Completed key appointments for Commercial, Clinical and Medical Affairs functions to lead launch planning and readiness to capitalize on significant market opportunity

• Avadel Pharmaceuticals and the American Academy of Sleep Medicine Foundation Announce an Exclusive Collaboration on the 2021 Young Investigators Research Forum

  3/4/2021

  Avadel to support AASM Foundation scholarships and training for early career sleep researchers

• Avadel Pharmaceuticals Announces Publication of Once-Nightly FT218 Pharmacokinetic Studies

  3/2/2021

  Avadel Pharmaceuticals plc (Nasdaq: AVDL), a company focused on developing FT218, an investigational, once-nightly formulation of sodium oxybate designed to treat excessive daytime sleepiness and cataplexy in adults with narcolepsy, today announced the online publication in Clinical Therapeutics of four Phase 1 studies from the FT218 pharmacokinetic program. Clinical Therapeutics is a leading, peer-reviewed journal publishing recent devel

• Avadel Pharmaceuticals Appoints Richard Kim as Chief Commercial Officer to Lead the Commercial Launch of Once-Nightly FT218

  2/17/2021

  Avadel Pharmaceuticals plc (Nasdaq: AVDL), a company focused on developing FT218, an investigational, once-nightly formulation of sodium oxybate designed to treat excessive daytime sleepiness and cataplexy in adults with narcolepsy, today announced the appointment of Richard Kim to the newly formed role of Chief Commercial Officer. In this role his responsibilities will include leading all aspects of the U.S. commercial launch of the company’s lead program

• Avadel Pharmaceuticals Added to NASDAQ Biotechnology Index

  12/15/2020

  Avadel Pharmaceuticals plc (Nasdaq: AVDL), a company focused on developing FT218, an investigational, once-nightly formulation of sodium oxybate designed to treat excessive daytime sleepiness and cataplexy in patients with narcolepsy, today announced that it has been selected for addition to the NASDAQ Biotechnology Index (Nasdaq: NBI), effective prior to market open on Monday, December 21, 2020. The NASDAQ Biotechnology Index is designed to

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  BioSpace Movers & Shakers, Dec. 11

  12/11/2020

  Biopharma and life science companies and organizations strengthen their leadership teams and boards with these Movers & Shakers.

• Avadel Pharmaceuticals to Present at Upcoming December 2020 Investor Conferences

  11/23/2020

  Avadel Pharmaceuticals plc (Nasdaq: AVDL), a company focused on developing FT218, an investigational, once-nightly formulation of sodium oxybate for treating excessive daytime sleepiness and cataplexy in patients with narcolepsy, announced today that members of the Avadel management team will present at both the 32nd Annual Piper Sandler Virtual Healthcare Conference and the 3rd Annual Evercore ISI HealthCONx Conference that are being held in

• Avadel Pharmaceuticals Reports Third Quarter 2020 Financial Results and Provides Update on FT218 Development Program

  11/9/2020

  New market assessment dataidentifies a significant potential market expansion opportunity for once-nightly FT218beyondexisting twice-nightly sodium oxybate patients

• Avadel Pharmaceuticals to Report Third Quarter 2020 Financial Results on November 9th

  10/26/2020

  Avadel Pharmaceuticals plc (Nasdaq: AVDL), a company focused on developing FT218, an investigational, once-nightly formulation of sodium oxybate designed to treat excessive daytime sleepiness and cataplexy in patients with narcolepsy, announced today that it will host a conference call and live webcast at 8:30 a.m. ET on Monday, November 9, 2020, to provide a corporate update and discuss the Company's financial results for the third quarter en

• Avadel Pharmaceuticals Reports Second Quarter 2020 Financial Results and Recent Business Update

  8/10/2020

  Presented positive topline data from the pivotal Phase 3 REST-ON study Announced today that results of the data analyses for the secondary endpoints of the REST-ON study were consistent with the primary analyses and further demonstrated the overall statistical significance of FT218 compared to placebo Completed the pre-NDA meeting for FT218 with the Food and Drug Administration First patient dosed in the open-label extension/switch study of investigational once-nightly FT218

• Avadel Pharmaceuticals to Report Second Quarter 2020 Financial Results on August 10th

  7/27/2020

  Avadel Pharmaceuticals plc (Nasdaq: AVDL) announced today that it will host a conference call and live webcast at 8:30 a.m. ET on Monday, August 10, 2020, to provide a corporate update and discuss the Company's financial results for the second quarter ended June 30, 2020. To access the conference call, investors are invited to dial 877-407-9716 (U.S. and Canada) or 201-493-6779 (international). The conference ID number is 13707645. A live au

• Avadel Pharmaceuticals Announces First Patient Dosed in Open-Label Extension/Switch Study of Investigational Once-Nightly FT218 as a Potential Treatment for Excessive Daytime Sleepiness and Cataplexy in Patients with Narcolepsy

  7/13/2020

  Clinical study to enroll 250 patients from sites that participated in the REST-ON study Study to examine the long-term safety and maintenance of efficacy in patients, and evaluate dosing and preference for patients switching from twice-nightly sodium oxybate to once-nightly FT218

• Avadel Announces Sale of Hospital Sterile Injectable Drug Portfolio for $42.0 Million

  7/1/2020

  Avadel Pharmaceuticals plc (Nasdaq: AVDL), a company focused on developing FT218, an investigational, once-nightly formulation of sodium oxybate for treating excessive daytime sleepiness and cataplexy in patients with narcolepsy, today announced the sale of its portfolio of sterile injectable drugs used in the hospital setting, including three commercial products, Bloxiverz ® , Vazculep ® , and Akovaz ® , as well as Nouress™, which is approved

• Avadel Pharmaceuticals to Present at BIO Digital

  6/8/2020

  Avadel Pharmaceuticals plc (Nasdaq: AVDL) a company focused on developing FT218, an investigational, once-nightly formulation of sodium oxybate for treating excessive daytime sleepiness and cataplexy in patients with narcolepsy, today announced that Greg Divis, Chief Executive Officer of Avadel, and Jordan Dubow, M.D., Chief Medical Officer of Avadel, will present a corporate overview at BIO Digital from June 8-12, 2020. The presentation wil

• Avadel Pharmaceuticals to Present at Jefferies Virtual Healthcare Conference

  6/1/2020

  Avadel Pharmaceuticals plc (Nasdaq: AVDL) a company focused on developing FT218, an investigational, once-nightly formulation of sodium oxybate for treating excessive daytime sleepiness and cataplexy in patients with narcolepsy, today announced that members of the Avadel management team will participate in a virtual fireside chat at the Jefferies Healthcare Conference at 10:00 a.m. ET on Thursday, June 4, 2020. A live webcast of the event wi

• Avadel Pharmaceuticals Reports First Quarter 2020 Financial Results

  5/11/2020

  Strengthened balance sheet with $190 million in gross proceeds from a private placement in February 2020 and public equity offering in May 2020

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  Clinical Catch-Up: April 27-May 1

  5/4/2020

  There’s plenty of news related to clinical trials related to COVID-19, but it does seem to be drowning out non-COVID-19-related clinical trials. Here’s a look.

• Avadel Pharmaceuticals to Report First Quarter 2020 Financial Results on May 11th

  5/4/2020

  Avadel Pharmaceuticals plc announced that it will host a conference call and live webcast at 8:30 a.m. ET on Monday, May 11, 2020, to provide a corporate update and discuss the Company's financial results for the first quarter ended March 31, 2020.

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  Avadel's Once-Nightly Narcolepsy Drug Hits Three Co-Primary Endpoints in Late-Stage Trial

  4/27/2020

  Avadel Pharma announced positive topline data from its pivotal Phase III REST-ON clinical trial of FT218 for excessive daytime sleepiness and cataplexy in patients with narcolepsy.