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Avadel Pharmaceuticals Announces FDA Approval of LUMRYZ™ (sodium oxybate) Extended-Release Oral Suspension (CIII) for the Treatment of Cataplexy or Excessive Daytime Sleepiness in Patients 7 Years of Age and Older with Narcolepsy
GlobeNewswire News Room· 2024-10-17 13:41
-- LUMRYZ is the only FDA-approved once-at-bedtime oxybate treatment for cataplexy or excessive daytime sleepiness (EDS) in patients 7 years of age and older with narcolepsy— -- Granted Orphan Drug Exclusivity in pediatric narcolepsy patients 7 years and older through October 16, 2031 -- DUBLIN, Oct. 17, 2024 (GLOBE NEWSWIRE) -- Avadel Pharmaceuticals plc (Nasdaq: AVDL), a biopharmaceutical company focused on transforming medicines to transform lives, announced today that the U.S. Food and Drug Administrati ...
Avadel Pharmaceuticals Announces Publication of RESTORE Data Highlighting Challenges with Twice-Nightly Oxybates and Strong Patient Preference for Once-Nightly LUMRYZ™ Dosing (sodium oxybate) Extended-Release Oral Suspension (CIII)
GlobeNewswire News Room· 2024-09-03 12:00
– Survey data demonstrate 94% of people with narcolepsy prefer the once-nightly regimen of LUMRYZ over twice-nightly oxybate regimens – – 91% reported being better able to sleep through the night after switching to LUMRYZ – – 93% of those who switched to LUMRYZ would recommend it to family or friends living with narcolepsy – DUBLIN, Sept. 03, 2024 (GLOBE NEWSWIRE) -- Avadel Pharmaceuticals plc (Nasdaq: AVDL), a biopharmaceutical company focused on transforming medicines to transform lives, today announced t ...
Avadel Pharmaceuticals plc(AVDL) - 2024 Q2 - Earnings Call Transcript
2024-08-09 16:27
Avadel Pharmaceuticals plc (NASDAQ:AVDL) Q2 2024 Earnings Conference Call August 8, 2024 8:30 AM ET Company Participants Austin Murtagh - Director, Precision AQ Greg Divis - Chief Executive Officer Richard Kim - Chief Commercial Officer Jennifer Gudeman - Senior Vice President, Medical & Clinical Affairs Tom McHugh - Chief Financial Officer Conference Call Participants Andrew Tsai - Jefferies François Brisebois - Oppenheimer Ami Fadia - Needham & Company David Amsellem - Piper Sandler Marc Goodman - Leerink ...
Avadel Pharmaceuticals plc(AVDL) - 2024 Q2 - Earnings Call Presentation
2024-08-08 20:10
Avadel. Avadel Pharmaceuticals plc (NASDAQ: AVDL) August 2024 ©2024 Avadel. All rights reserved. Safe Harbor Statements 2 This presentation may include forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. These forward-looking statements relate to our future expectations, beliefs, plans, strategies, objectives, results, conditions, financial performance, prospects, or other events. Such forward-looking statements i ...
Avadel Pharmaceuticals plc(AVDL) - 2024 Q2 - Quarterly Report
2024-08-08 13:25
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 ——————— Title of each class Trading Symbol(s) Name of each exchange on which registered Ordinary Shares, nominal value $0.01 per share AVDL The Nasdaq Global Market FORM 10-Q ——————— ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended: June 30, 2024 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period f ...
Avadel Pharmaceuticals plc(AVDL) - 2024 Q2 - Quarterly Results
2024-08-08 11:12
Exhibit 99.1 Avadel Pharmaceuticals Provides Corporate Update and Reports Second Quarter 2024 Financial Results -- Generated $41.5 million in net revenue from sales of LUMRYZ™ -- -- More than 1,900 patients on LUMRYZ as of June 30 -- -- First patient dosed in Phase 3 trial evaluating LUMRYZ in idiopathic hypersomnia -- -- FDA target action date of September 7, 2024 for sNDA for LUMRYZ in pediatric narcolepsy -- -- Management to host a conference call today at 8:30 a.m. ET -- DUBLIN, Ireland, August 8, 2024 ...
Avadel Pharmaceuticals to Join Russell 3000® Index
GlobeNewswire News Room· 2024-06-27 20:05
DUBLIN, June 27, 2024 (GLOBE NEWSWIRE) -- Avadel Pharmaceuticals plc (Nasdaq: AVDL), a biopharmaceutical company focused on transforming medicines to transform lives, announced today that it is set to join the broad-market Russell 3000® Index at the conclusion of the 2024 Russell US Indexes annual reconstitution, effective at the open of US equity markets on Monday, July 1, 2024, according to a preliminary list of additions posted Friday, May 24, 2024. “We are proud to be included in the widely tracked Russ ...
Avadel Pharmaceuticals to Join Russell 3000® Index
Newsfilter· 2024-06-27 20:05
DUBLIN, June 27, 2024 (GLOBE NEWSWIRE) -- Avadel Pharmaceuticals plc (Nasdaq: AVDL), a biopharmaceutical company focused on transforming medicines to transform lives, announced today that it is set to join the broad-market Russell 3000® Index at the conclusion of the 2024 Russell US Indexes annual reconstitution, effective at the open of US equity markets on Monday, July 1, 2024, according to a preliminary list of additions posted Friday, May 24, 2024. “We are proud to be included in the widely tracked Russ ...
Avadel Pharmaceuticals Shares New LUMRYZ™ (sodium oxybate) For Extended-release Oral Suspension (CIII) Data at SLEEP 2024
globenewswire.com· 2024-05-22 12:00
– 11 accepted abstracts, including new data reiterating satisfaction, preference and clinical benefit of LUMRYZ – – Presentations highlight Avadel’s continued commitment to address gaps in narcolepsy care – DUBLIN, May 22, 2024 (GLOBE NEWSWIRE) -- Avadel Pharmaceuticals plc (Nasdaq: AVDL), a company focused on transforming medicines to transform lives, announced today it will present 11 posters, and one oral presentation, supporting the use of LUMRYZ as a narcolepsy treatment option at SLEEP 2024, the 38th ...
Avadel Pharmaceuticals Appoints Naseem Amin, M.D. to its Board of Directors
Newsfilter· 2024-05-21 11:00
DUBLIN, Ireland, May 21, 2024 (GLOBE NEWSWIRE) -- Avadel Pharmaceuticals plc (NASDAQ:AVDL), a biopharmaceutical company focused on transforming medicines to transform lives, announced today the appointment of Naseem Amin, M.D. to its board of directors, effective May 17, 2024. Dr. Amin, a highly successful executive who brings global industry and leadership experience to Avadel, currently serves as Chief Executive Officer of Orphalan SA. "On behalf of the entire Avadel team, we are excited to welcome Dr. Am ...