Avadel Pharmaceuticals Receives Orphan Drug Designation from FDA for LUMRYZ™ (sodium oxybate) for Extended-Release Oral Suspension for the Treatment of Idiopathic Hypersomnia
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, because LUMRYZ may provide a major contribution to patient care due to its once-nightly dosing for patients with IH, a chronic sleep disorder that requires potentially lifelong treatment.
Avadel Pharmaceuticals to Present New Data on LUMRYZ™ (sodium oxybate) For Extended-Release Oral Suspension at SLEEP 2025
– 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 biopharmaceutical company focused on transforming medicines to transform lives, today announced that new data supporting the use of LUMRYZ as a narcolepsy treatment and additional data to better understand the real-life experience of people living with narcolepsy will be presented in four oral presentations and 14 posters at SLEEP 2025, the 39th Annual Meeting of the Associated Professional Sleep Societies (APSS), taking place June 8-11, 2025 in Seattle. “Post-hoc analysis of the pivotal Phase 3 REST-ON clinical trial, restricted to those study participants with the most severe sleepiness at baseline as measured both objectively and subjectively, showed LUMRYZ participants with a median Epworth Sleepiness Scale (ESS) score at Week 13 that was improved to the range at or below that considered normal.
Wall Street Analysts Think Avadel (AVDL) Could Surge 97.68%: Read This Before Placing a Bet
The average of price targets set by Wall Street analysts indicates a potential upside of 97.7% in Avadel (AVDL). While the effectiveness of this highly sought-after metric is questionable, the positive trend in earnings estimate revisions might translate into an upside in the stock.
All You Need to Know About Avadel (AVDL) Rating Upgrade to Buy
Avadel (AVDL) might move higher on growing optimism about its earnings prospects, which is reflected by its upgrade to a Zacks Rank #2 (Buy).
Avadel Pharmaceuticals: Moving Nicely Through An 'Inflection Year'
Avadel Pharmaceuticals is gaining momentum with strong Q1 results, a key legal win, and moving swiftly to profitability. LUMRYZ, Avadel's once-daily sodium oxybate, is growing rapidly and could enter the idiopathic hypersomnia market after a favorable court ruling. Analysts remain bullish, reiterating Buy ratings and projecting significant revenue and profit growth through FY2026 as LUMRYZ adoption accelerates.
Earnings Estimates Moving Higher for Avadel (AVDL): Time to Buy?
Avadel (AVDL) shares have started gaining and might continue moving higher in the near term, as indicated by solid earnings estimate revisions.
Wall Street Analysts Believe Avadel (AVDL) Could Rally 100.21%: Here's is How to Trade
The mean of analysts' price targets for Avadel (AVDL) points to a 100.2% upside in the stock. While this highly sought-after metric has not proven reasonably effective, strong agreement among analysts in raising earnings estimates does indicate an upside in the stock.
Avadel Pharmaceuticals plc (AVDL) Q1 2025 Earnings Call Transcript
Avadel Pharmaceuticals plc (NASDAQ:AVDL ) Q1 2025 Earnings Conference Call May 7, 2025 9:00 AM ET Company Participants Austin Murtagh - IR Greg Divis - CEO Tom McHugh - CFO Conference Call Participants Andrew Tsai - Jefferies David Amsellem - Piper Sandler Mark Goodman - Leerink David Huang - Deutsche Bank Myriam Belghiti - LSC Ami Fadia - Needham Chase Knickerbocker - Craig Hallum Operator Greetings, and welcome to Avadel Pharmaceuticals First Quarter 2025 Earnings Call. At this time, all participants are in a listen only mode.
Avadel Pharmaceuticals Reports First Quarter 2025 Financial Results and Raises Guidance
-- 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 --
Avadel Pharmaceuticals Announces Favorable Ruling in Appeal of Delaware Court Injunction
- 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 “Federal Circuit”) has ruled in favor of Avadel, overturning important parts of the injunction imposed by the U.S. District Court for the District of Delaware (the “Delaware Court”) regarding LUMRYZ™ as a potential treatment of indications beyond narcolepsy. The Federal Circuit vacated the portion of the injunction that prohibited Avadel from applying for FDA approval of LUMRYZ for any indication beyond narcolepsy, calling the district court's analysis “simply too speculative and tenuous.
Avadel Pharmaceuticals to Provide a Corporate Update and Report First Quarter 2025 Financial Results on May 7
DUBLIN, Ireland, April 30, 2025 (GLOBE NEWSWIRE) -- Avadel Pharmaceuticals plc (Nasdaq: AVDL), a biopharmaceutical company focused on transforming medicines to transform lives, announced today that it will host a conference call and live webcast at 8:00 a.m. ET on Wednesday, May 7, 2025, to provide a corporate update and discuss the Company's financial results for the first quarter ended March 31, 2025.
Avadel and nference Announce Publication of Real-World Data on Sodium Oxybate Treatment Patterns in the Journal of Clinical Neuroscience
-- Retrospective analysis reveals no significant differences in comorbidities in narcolepsy patients treated vs. not treated with sodium oxybate -- -- One third of patients taking immediate-release, twice-nightly sodium oxybate discontinued treatment, most often due to lack of efficacy; inability to wake up was most common reason for missing second nightly dose -- DUBLIN, April 17, 2025 (GLOBE NEWSWIRE) -- Avadel Pharmaceuticals plc (Nasdaq: AVDL), a biopharmaceutical company focused on transforming medicines to transform lives, and nference , a health tech company dedicated to making biomedical data computable, today announced the publication of real-world data on comorbidities and treatment patterns of people with narcolepsy treated versus not treated with immediate-release sodium oxybate.
