Avadel Pharmaceuticals plc(AVDL)

Search documents
Avadel Pharmaceuticals (AVDL) 2025 Conference Transcript
2025-06-05 15:30
Avadel Pharmaceuticals (AVDL) 2025 Conference June 05, 2025 10:30 AM ET Speaker0 Okay. Alright. We're gonna get started in our next session. I'm Andrew Tsai, senior biotech analyst at Jefferies. Thanks for tuning in. It's my pleasure to have the AVID all team. To my direct right is Greg Divis, CEO. To his right, Tom McHugh, CFO, and to his right, Susan, I believe I'm sorry. I missed your last name. Speaker1 Rodriguez. Speaker0 Rodriguez. Yes. Chief Commercial Officer? Speaker2 Chief Operating Officer. Speak ...
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
Core Viewpoint - Avadel Pharmaceuticals has received Orphan Drug Designation from the FDA for LUMRYZ, aimed at treating Idiopathic Hypersomnia, highlighting its potential clinical superiority due to once-nightly dosing [1][2][3] Company Overview - Avadel Pharmaceuticals plc is a biopharmaceutical company focused on developing innovative therapies for rare sleep disorders [2][21] - The company aims to transform patient care through differentiated therapies, particularly for conditions like Idiopathic Hypersomnia [2][21] Product Information - LUMRYZ is an extended-release sodium oxybate medication, approved as the first and only once-at-bedtime treatment for cataplexy or excessive daytime sleepiness in adults and pediatric patients with narcolepsy [4][6][21] - The FDA granted LUMRYZ Orphan Drug Exclusivity for seven years due to its clinical superiority over existing treatments [6] Clinical Trials - LUMRYZ is currently being evaluated in the REVITALYZ trial, a Phase 3 study designed to assess its efficacy and safety in approximately 150 adults diagnosed with Idiopathic Hypersomnia [2][5] - The trial is expected to be completed by the end of 2025, with enrollment open for participants switching from immediate-release oxybates and those not currently on oxybates [2][5] Regulatory Designation - Orphan Drug Designation is granted to drugs that show promise for treating rare diseases affecting fewer than 200,000 people in the U.S., providing benefits such as market exclusivity and FDA assistance in clinical trial design [3]
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 ...
Wall Street Analysts Think Avadel (AVDL) Could Surge 97.68%: Read This Before Placing a Bet
ZACKS· 2025-05-29 15:00
Avadel (AVDL) closed the last trading session at $9.05, gaining 1.8% over the past four weeks, but there could be plenty of upside left in the stock if short-term price targets set by Wall Street analysts are any guide. The mean price target of $17.89 indicates a 97.7% upside potential.The mean estimate comprises nine short-term price targets with a standard deviation of $3.79. While the lowest estimate of $12 indicates a 32.6% increase from the current price level, the most optimistic analyst expects the s ...
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 ...
All You Need to Know About Avadel (AVDL) Rating Upgrade to Buy
ZACKS· 2025-05-15 17:00
Avadel (AVDL) could be a solid choice for investors given its recent upgrade to a Zacks Rank #2 (Buy). This upgrade is essentially a reflection of an upward trend in earnings estimates -- one of the most powerful forces impacting stock prices.The sole determinant of the Zacks rating is a company's changing earnings picture. The Zacks Consensus Estimate -- the consensus of EPS estimates from the sell-side analysts covering the stock -- for the current and following years is tracked by the system.Individual i ...
Avadel Pharmaceuticals: Moving Nicely Through An 'Inflection Year'
Seeking Alpha· 2025-05-15 15:43
Live Chat on The Biotech Forum has been dominated by discussion of lucrative buy-write or covered call opportunities on selected biotech stocks over the past several months. To see what I and the other season biotech investors are targeting as trading ideas real-time, just join our community at The Biotech Forum by clicking HERE .Today, I am putting Avadel Pharmaceuticals (NASDAQ: AVDL ) back in the spotlight. We last looked at this promising biopharma concern just over three months ago. However, there has ...
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]
Earnings Estimates Moving Higher for Avadel (AVDL): Time to Buy?
ZACKS· 2025-05-12 17:20
Core Viewpoint - Avadel (AVDL) shows a significant improvement in earnings outlook, making it an attractive investment option as analysts continue to raise earnings estimates for the company [1][2]. Earnings Estimate Revisions - The upward trend in earnings estimate revisions indicates growing analyst optimism regarding Avadel's earnings prospects, which is expected to positively impact its stock price [2]. - The current-quarter earnings estimate of $0 per share reflects a +100% change from the previous year, with a 119.88% increase in the Zacks Consensus Estimate over the last 30 days due to three upward revisions [5]. - For the full year, Avadel is projected to earn $0.11 per share, representing a +121.57% change from the prior year, with three estimates moving higher and no negative revisions [6]. Zacks Rank and Performance - Avadel has achieved a Zacks Rank 2 (Buy) due to favorable estimate revisions, which historically correlate with strong stock performance [7]. - Stocks with Zacks Rank 1 (Strong Buy) and 2 (Buy) have shown significant outperformance compared to the S&P 500 [7]. Stock Performance - Avadel's stock has gained 22.3% over the past four weeks, driven by solid estimate revisions and positive earnings growth prospects [8].
Wall Street Analysts Believe Avadel (AVDL) Could Rally 100.21%: Here's is How to Trade
ZACKS· 2025-05-12 15:00
Avadel (AVDL) closed the last trading session at $9.39, gaining 22.3% over the past four weeks, but there could be plenty of upside left in the stock if short-term price targets set by Wall Street analysts are any guide. The mean price target of $18.80 indicates a 100.2% upside potential.The average comprises 10 short-term price targets ranging from a low of $12 to a high of $27, with a standard deviation of $4.59. While the lowest estimate indicates an increase of 27.8% from the current price level, the mo ...