LUMRYZ

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Avadel Pharmaceuticals Announces Unanimous Appeals Court Decision Upholding FDA Approval of LUMRYZ in Narcolepsy in Administrative Procedure Act Litigation
Globenewswire· 2025-06-30 11:00
DUBLIN, June 30, 2025 (GLOBE NEWSWIRE) -- Avadel Pharmaceuticals plc (Nasdaq: AVDL), a biopharmaceutical company focused on transforming medicines to transform lives, announced that, on Friday, June 27, 2025, the U.S. Court of Appeals for the District of Columbia Circuit (the "Appeals Court") affirmed a prior decision of the U.S. District Court for the District of Columbia (the "District Court") in favor of the U.S. Food and Drug Administration ("FDA") in a suit brought by Jazz Pharmaceuticals Inc. ("Jazz") ...
Avadel Pharmaceuticals Receives Orphan Drug Designation from FDA for LUMRYZ™ (sodium oxybate) for Extended-Release Oral Suspension for the Treatment of Idiopathic Hypersomnia
GlobeNewswire News Room· 2025-06-05 11:30
DUBLIN, June 05, 2025 (GLOBE NEWSWIRE) -- Avadel Pharmaceuticals plc (Nasdaq: AVDL), a biopharmaceutical company focused on transforming medicines to transform lives, announced today that LUMRYZTM has been granted Orphan Drug Designation (ODD) from the U.S. Food & Drug Administration (FDA) for the treatment of Idiopathic Hypersomnia (IH). Specifically, ODD was granted based on the plausible hypothesis that LUMRYZ may be clinically superior to the same drug(s) already approved for the same indication, becaus ...
Avadel Pharmaceuticals to Present New Data on LUMRYZ™ (sodium oxybate) For Extended-Release Oral Suspension at SLEEP 2025
Globenewswire· 2025-05-29 20:05
– 14 abstracts accepted, including four oral presentations – – Interim analysis of real-world REFRESH study demonstrated clinically significant efficacy and improvement of EDS for patients who switched from twice-nightly oxybate to once-at-bedtime LUMRYZ – – Data reflecting the therapeutic results of LUMRYZ treatment in people with narcolepsy across clinical as well as real-world settings will be presented – DUBLIN, Ireland, May 29, 2025 (GLOBE NEWSWIRE) -- Avadel Pharmaceuticals plc (Nasdaq: AVDL), a biop ...
Avadel Pharmaceuticals to Present at the Jefferies Global Healthcare Conference
Globenewswire· 2025-05-29 12:00
DUBLIN, Ireland, May 29, 2025 (GLOBE NEWSWIRE) -- Avadel Pharmaceuticals plc (Nasdaq: AVDL), a biopharmaceutical company focused on transforming medicines to transform lives, announced today that members of management will participate in a fireside chat at the Jefferies Global Healthcare Conference on Thursday, June 5 at 10:30 a.m. ET. A live webcast of the fireside chat, as well as an archived recording, will be available on Avadel’s Investor Relations website, investors.avadel.com, for 90 days following t ...
Avadel Pharmaceuticals Expands Leadership Team with Appointment of Susan Rodriguez as Chief Operating Officer
Globenewswire· 2025-05-13 20:15
Core Insights - Avadel Pharmaceuticals has appointed Susan Rodriguez as Chief Operating Officer to lead the company's commercial strategy and operations, particularly in relation to the launch of LUMRYZ [1][2][17] - Rodriguez brings over 30 years of experience in the life sciences industry, having held leadership roles in various biopharmaceutical companies, which positions her well to support Avadel's growth and market expansion [2][17] Company Developments - LUMRYZ, an extended-release sodium oxybate medication, was approved by the FDA on May 1, 2023, as the first and only once-at-bedtime treatment for cataplexy or excessive daytime sleepiness in adults with narcolepsy [3][5][17] - The FDA also approved LUMRYZ for pediatric patients aged 7 years and older on October 16, 2024, further expanding its market potential [3][5] Clinical and Regulatory Highlights - The approval of LUMRYZ was supported by the REST-ON™ Phase 3 trial, which demonstrated significant improvements in excessive daytime sleepiness, overall patient functioning, and cataplexy attacks compared to placebo [4][5] - LUMRYZ has been granted 7 years of Orphan Drug Exclusivity due to its clinical superiority over existing treatments, providing a once-nightly dosing regimen that enhances patient care [5][6] Market Position and Strategy - The company aims to scale operations to meet increasing patient demand for LUMRYZ, particularly in the narcolepsy community, and is exploring potential label expansion to include idiopathic hypersomnia [2][17] - Rodriguez's expertise in launching innovative therapies in rare diseases is expected to be instrumental in accelerating the growth of LUMRYZ and maximizing its market impact [2][17]
Avadel Pharmaceuticals plc(AVDL) - 2025 Q1 - Earnings Call Presentation
2025-05-07 12:03
AVADEL Pharmaceuticals plc (NASDAQ: AVDL) First Quarter 2025 Earnings Slides TRANSFORMING MEDICINES TO TRANSFORM LIVES A BIOPHARMACEUTICAL COMPANY FOCUSED ON 2 Safe Harbor Statements 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, ...
Avadel Pharmaceuticals Reports First Quarter 2025 Financial Results and Raises Guidance
Globenewswire· 2025-05-07 11:00
-- Generated $52.5 million in net revenue from sales of LUMRYZ™, a 93% increase over the first quarter of 2024 -- -- 2,800 patients on LUMRYZ as of March 31, 2025, a net increase of 300 patients since December 31, 2024 and a 100% year over year increase over the first quarter of 2024 -- -- Raises 2025 guidance; expects to generate $255 - $265 million in net product revenue and cash flow of $30 - $40 million, driven by 3,400 - 3,600 patients on LUMRYZ by year end -- -- Federal Circuit ruled in Avadel's favor ...
Avadel Pharmaceuticals Announces Favorable Ruling in Appeal of Delaware Court Injunction
Globenewswire· 2025-05-06 16:30
- With this ruling, Avadel can seek and be granted FDA approval for LUMRYZ in Idiopathic Hypersomnia - - Federal Circuit decision permits new clinical trials and further development of LUMRYZ™ for the treatment of indications beyond narcolepsy - DUBLIN, Ireland, May 06, 2025 (GLOBE NEWSWIRE) -- Avadel Pharmaceuticals plc (Nasdaq: AVDL), a biopharmaceutical company focused on transforming medicines to transform lives, today announced that the United States Court of Appeals for the Federal Circuit (the “Fede ...
Avadel Pharmaceuticals plc(AVDL) - 2024 Q4 - Earnings Call Transcript
2025-03-04 04:53
Avadel Pharmaceuticals plc (NASDAQ:AVDL) Q4 2024 Earnings Conference Call March 3, 2025 8:30 AM ET Company Participants Austin Murtagh - Precision AQ Gregory Divis - Chief Executive Officer Thomas McHugh - Chief Financial Officer Conference Call Participants François Brisebois - Oppenheimer Poorna Kannan - Needham & Company Oren Livnat - H.C. Wainwright & Co. David Amsellem - Piper Sandler & Co. Madhumita Yennawar - Leerink Partners Myriam Belghiti - LifeSci Capital David Hoang - Deutsche Bank AG Brandon Fo ...