Avadel Pharma

Avadel Pharmaceuticals Plc engages in the development and commercialization of pharmaceutical products. Its products include Bloxiverz, Vazculep, Nouress, and Akovaz. It focuses on the approval of FT218, a formulation of sodium oxybate designed to treat excessive daytime sleepiness and cataplexy in adults with narcolepsy. The company was founded in 1990 and is headquartered in Dublin, Ireland.

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Avadel Pharma reports robust Q3 revenue, eyes market expansion

Avadel Pharma's Q3 performance showed solid revenue and positive EBITDA, with strong patient demand for LUMRYZ.
Despite legal challenges and competition, opportunities exist in market expansion and new patient segments.
The company's focus on persistency, market growth, and product efficacy positions it for future success.
Maintaining strong payer coverage and cash flow positivity are key priorities for upcoming quarters.

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Avadel Pharmaceuticals Plc engages in the development and commercialization of pharmaceutical products. Its main product is LUMRYZ is an extended-release formulation of sodium oxybate, which used in the treatment of cataplexy or EDS in adults with narcolepsy. The company was founded on July 21, 1990 and is headquartered in Dublin, Ireland.

The consensus price target hints at a 37.4% upside potential for Avadel (AVDL). While empirical research shows that this sought-after metric is hardly effective, an upward trend in earnings estimate revisions could mean that the stock will witness an upside in the near term.

How Much Upside is Left in Avadel (AVDL)? Wall Street Analysts Think 37.36%

Avadel Pharmaceuticals (AVDL) has seen solid earnings estimate revision activity over the past month, and belongs to a strong industry as well.

Why Avadel Pharmaceuticals (AVDL) Stock Might be a Great Pick

Avadel Pharma's launch of its product LUMRYZ is expected to drive the company's stock performance. LUMRYZ appears to have momentum and is differentiated from current narcolepsy treatments. The potential revenue for Avadel from LUMRYZ could ultimately range from $500 million to $2 billion, depending on market share and expansion into new indications.

Avadel May Continue To Outperform With Positive Launch Momentum

Avadel Pharmaceuticals reported strong Q3 earnings for Lumryz, exceeding consensus estimates and demonstrating successful market launch. Avadel's strategic market positioning and focus on high-volume prescribers contribute to its strong market position. Avadel is actively pursuing opportunities for expansion, including new indications and a low sodium formulation, to drive future growth.

Avadel: Lumryz Lights Up The Oxybate Market, Maintaining Buy Rating

Avadel Pharmaceuticals PLC (NASDAQ:AVDL ) Q3 2023 Earnings Conference Call November 8, 2023 8:30 AM ET Company Participants Austin Murtagh - Stern Investor Relations Gregory Divis - CEO & Director Richard Kim - Chief Commercial Officer Jennifer Gudeman - SVP, Medical & Clinical Affairs Thomas McHugh - SVP & CFO Conference Call Participants Ami Fadia - Needham & Company Rudy Li - Leerink Partners Matthew Kaplan - Ladenburg Thalmann & Co. Francois Brisebois - Oppenheimer Chase Knickerbocker - Craig-Hallum David Amsellem - Piper Sandler & Co. Operator Greetings, and welcome to the Avadel Pharmaceuticals Third Quarter 2023 Earnings Call. [Operator Instructions].

Avadel Pharmaceuticals PLC (AVDL) Q3 2023 Earnings Call Transcript

-- $7.0 million in third quarter LUMRYZ™ net revenue from U.S. commercial launch -- -- Generated robust demand for LUMRYZ with greater than 1,000 patients enrolled in RYZUP TM and more than 400 patients initiating therapy as of September 30 --

Avadel Pharmaceuticals Provides Corporate Update and Reports Third Quarter 2023 Financial Results

– 17 abstracts accepted, including new and encore data emphasizing clinical benefit and patient preference for a once-at-bedtime narcolepsy treatment option –

Avadel Pharmaceuticals Announces Data Supporting Clinical Profile for LUMRYZ™ (sodium oxybate) for extended-release oral suspension (CIII) at World Sleep 2023

DUBLIN, Ireland, Oct. 05, 2023 (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 Biotech CNS/Neuro Summit on Thursday, October 12 at 9:00 a.m. ET.

Avadel Pharmaceuticals to Present at the Jefferies Biotech CNS/Neuro Summit

Avadel's Q2 2023 earnings report shows promising growth and FDA endorsement of Lumryz for narcolepsy treatment. Lumryz has seen positive commercialization with high prescriber enrollments and reimbursement successes. Avadel presents potential growth avenues in exploring new markets and maintains a robust financial position.

Avadel Pharmaceuticals: A Resilient Buy; A Comprehensive Assessment Of Potential Prospects

Avadel Pharmaceuticals plc (NASDAQ:AVDL ) Q2 2023 Earnings Conference Call August 9, 2023 8:30 AM ET Company Participants Austin Murtagh - Stern Investor Relations Gregory Divis - Chief Executive Officer Richard Kim - Chief Commercial Officer Jennifer Gudeman - Senior Vice President, Medical and Clinical Affairs Thomas McHugh - Chief Financial Officer Conference Call Participants Francois Brisebois - Oppenheimer Andrew Tsai - Jefferies Ami Fadia - Needham & Company Marc Goodman - Leerink Matthew Kaplan - Ladenburg Thalmann Chase Knickerbocker - Craig Hallum Myriam Belghiti - LifeSci Capital Operator Greetings, and welcome to Avadel Pharmaceuticals Second Quarter 2023 Earnings Call. At this time, all participants are in a listen-only mode.

Avadel Pharmaceuticals plc (AVDL) Q2 2023 Earnings Call Transcript

-- Successfully commenced U.S. commercial launch of LUMRYZ™ -- -- Received final FDA approval for LUMRYZ with orphan drug exclusivity granted through May 1, 2030 --

Avadel Pharmaceuticals Provides Corporate Update and Reports Second Quarter 2023 Financial Results

DUBLIN, Ireland, Aug. 02, 2023 (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 8:30 a.m. ET on Wednesday, August 9, 2023, to provide a corporate update and discuss the Company's financial results for the second quarter ended June 30, 2023.

Avadel Pharmaceuticals to Provide a Corporate Update and Report Second Quarter Financial Results on August 9

DUBLIN, Ireland, July 20, 2023 (GLOBE NEWSWIRE) -- Avadel Pharmaceuticals plc (Nasdaq: AVDL), a company focused on transforming medicines to transform lives, today announced that the Compensation Committee of Avadel's Board of Directors approved the grant of non-statutory options to three (3) new employees to purchase an aggregate of 20,000 ordinary shares under Avadel's 2021 Inducement Plan. The awards were granted as an inducement material to the employee's acceptance of employment with Avadel in accordance with Nasdaq Listing Rule 5635(c)(4). The options have a ten-year term and vest over four years, with 25% vesting on the one-year anniversary of the grant date and 25% on each anniversary thereafter. The options are subject to the terms and conditions of Avadel's 2021 Inducement Plan approved by the Board of Directors in November 2021 and the terms and conditions of award agreements covering the grants.

Avadel Announces Grant of Inducement Awards Under Nasdaq Listing Rule 5635(c)(4)

Avadel Pharmaceuticals plc finally won approval of Lumryz™ (sodium oxybate), despite cutthroat opposition from Jazz Pharmaceuticals plc. Potential sales estimate is $3bn. Avadel Pharmaceuticals is flying high, as it well should, but I am a buyer on dips.

Avadel Pharmaceuticals: Winning Is Sweet

DUBLIN, Ireland, June 22, 2023 (GLOBE NEWSWIRE) -- Avadel Pharmaceuticals plc (Nasdaq: AVDL), a biopharmaceutical company focused on transforming medicines to transform lives, announced today that it will host a Commercial Day presentation to provide an overview of its commercial strategy for recently launched LUMRYZ on Thursday, June 29, 2023 beginning at 8:00 a.m. ET. LUMRYZ was approved by the U.S. Food & Drug Administration (FDA) in May 2023 for the treatment of cataplexy or excessive daytime sleepiness (EDS) in adults with narcolepsy.

Avadel Pharmaceuticals to Host Commercial Day on June 29 for LUMRYZ™ (sodium oxybate) extended release for oral solution, CIII

DUBLIN, Ireland, June 14, 2023 (GLOBE NEWSWIRE) -- Avadel Pharmaceuticals plc (Nasdaq: AVDL), a company focused on transforming medicines to transform lives, today announced leader sponsorship of the American Academy of Sleep Medicine (AASM) Foundation's 15th Annual Young Investigators Research Forum (YIRF). This will be Avadel's third year as lead sponsor of the YIRF program, which takes place March-June 2023, with virtual events and in-person events.

Avadel Pharmaceuticals Sponsors the Academy of Sleep Medicine Foundation's 2023 Young Investigators Research Forum

Among 100 clinicians, the primary driver of overall oxybate choice, potential to improve patient quality of life, and decrease stress/anxiety was a single bedtime dose over the twice-nightly dosing of first-generation oxybates Among 100 clinicians, the primary driver of overall oxybate choice, potential to improve patient quality of life, and decrease stress/anxiety was a single bedtime dose over the twice-nightly dosing of first-generation oxybates

Avadel Pharmaceuticals Announces Publication of Study Data in Advances in Therapy Highlighting Need for Once-at-Bedtime Oxybate Dosing for Narcolepsy

-LUMRYZ is the first and only once-at-bedtime oxybate for people living with narcolepsy -Once-nightly dosing regimen of LUMRYZ has been found by FDA to provide a major contribution to patient care over all twice-nightly oxybates DUBLIN, Ireland, June 05, 2023 (GLOBE NEWSWIRE) -- Avadel Pharmaceuticals plc (Nasdaq: AVDL), a biopharmaceutical company focused on transforming medicines to transform lives, announced today that LUMRYZ is now commercially available. LUMRYZ is an extended-release formulation of sodium oxybate indicated to be taken once at bedtime for the treatment of cataplexy or excessive daytime sleepiness (EDS) in adults with narcolepsy.

Avadel Pharmaceuticals Announces U.S. Commercial Launch of LUMRYZ™ (sodium oxybate) for the Treatment of Cataplexy or Excessive Daytime Sleepiness in Adults Living with Narcolepsy

DUBLIN, Ireland, June 01, 2023 (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 Healthcare Conference on Thursday, June 8 at 1:00 p.m. ET.

Avadel Pharmaceuticals to Present at the Jefferies Healthcare Conference

– 12 accepted abstracts highlight Company's emerging leadership in narcolepsy – – Data adds to growing body of evidence demonstrating positive clinical benefit and patient preference of once-at-bedtime LUMRYZ – – Company to support symposium on June 6 with leading KOLs discussing unmet needs in the advancement of narcolepsy treatment – DUBLIN, May 31, 2023 (GLOBE NEWSWIRE) -- Avadel Pharmaceuticals plc (Nasdaq: AVDL), a company focused on transforming medicines to transform lives, today announced new data supporting the clinical profile for LUMRYZ™ (sodium oxybate) for extended-release oral suspension (CIII) and patient preference for a once-nightly oxybate in 12 abstracts, including six oral presentations, at SLEEP 2023, the 37th annual joint meeting of the American Academy of Sleep Medicine and the Sleep Research Society, being held from June 3-7, 2023 in Indianapolis. LUMRYZ (previously known as FT218), is an extended-release formulation of sodium oxybate indicated to be taken once at bedtime for the treatment of cataplexy or excessive daytime sleepiness (EDS) in adults with narcolepsy.

Avadel Pharmaceuticals Announces Data Supporting Clinical Profile for LUMRYZ™ at SLEEP 2023

Key update: as we predicted, FDA approval for LUMRYZ, a unique once-at-bedtime narcolepsy treatment. Orphan Drug Exclusivity is granted until May 1, 2030, offering attractive patent protection. Launch expected in June 2023, with a fast sales ramp anticipated considering concentrated (~5,000) prescriber base.

Avadel Pharmaceuticals: Lumryz Approved, Launch Expected June 2023 And We Remain Bullish

Avadel said it plans to launch its lead therapy to treat excessive daytime sleepiness in adults with narcolepsy, in early June. The company had no revenue in the first quarter.

Why Shares of Avadel Soared This Week

Avadel Pharmaceuticals has received full FDA approval for Lumryz, an extended-release formulation of sodium oxybate for the treatment of excessive daytime sleepiness and cataplexy in adults with narcolepsy. The drug's once-nightly dosing regimen gives it a competitive edge over Jazz Pharmaceuticals' twice-nightly dosing product, Xyrem.

Avadel Pharmaceuticals' Strategic Moves To Conquer The Narcolepsy Market (Rating Upgrade)

- Granted Orphan Drug Exclusivity through May 1, 2030 - -Advanced commercial preparations on track; LUMRYZ product availability expected in early June - - Final approval supported by robust efficacy and safety data from pivotal Phase 3 REST-ON clinical trial - - Management to host conference call today, May 1, 2023 at 4:00 p.m. ET - DUBLIN, May 01, 2023 (GLOBE NEWSWIRE) -- Avadel Pharmaceuticals plc (Nasdaq: AVDL), a biopharmaceutical company focused on transforming medicines to transform lives, announced today that the U.S. Food & Drug Administration (FDA) has granted final approval to LUMRYZ, an extended-release formulation of sodium oxybate indicated to be taken once at bedtime for the treatment of cataplexy or excessive daytime sleepiness (EDS) in adults with narcolepsy.

Avadel Pharmaceuticals Announces Final FDA Approval of LUMRYZ™ (sodium oxybate) for Extended-Release Oral Suspension as the First and Only Once-at-Bedtime Oxybate for Cataplexy or Excessive Daytime Sleepiness in Adults with Narcolepsy

Avadel: Sleeping Soundly, Why We're Giving A 'Buy' Rating Ahead Of Lumryz Launch

News for Avadel Pharma Stock (AVDL)