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.

DUBLIN, Ireland, Nov. 08, 2021 (GLOBE NEWSWIRE) -- Avadel Pharmaceuticals plc (Nasdaq: AVDL), a company focused on transforming medicines to transform lives, today provided a corporate update and announced its financial results for the third quarter ended September 30, 2021.

Avadel Pharmaceuticals Provides Corporate Update and Reports Third Quarter 2021 Financial Results

DUBLIN, Ireland, Nov. 01, 2021 (GLOBE NEWSWIRE) -- Avadel Pharmaceuticals plc (Nasdaq: AVDL), a 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 Monday, November 8, 2021, to provide a corporate update and discuss the Company's financial results for the third quarter ended September 30, 2021.

Avadel Pharmaceuticals to Provide a Corporate Update and Report Third Quarter 2021 Financial Results on November 8th

FT218 PDUFA was delayed by the FDA, reasons unknown, suspected staffing issues at the agency. FT218 has a clear advantage over Xyrem.

Avadel Pharmaceuticals: I Am Holding

- Post-hoc responder analyses demonstrated a significantly greater proportion of patients receiving FT218 experienced reductions in weekly cataplexy attacks and improvement in mean sleep latency compared to placebo -

Avadel Presents New Data Supporting Clinical Benefit with Once-at-Bedtime FT218 and Preference for Once-Nightly Dosing in Patients with Narcolepsy at CHEST 2021

A key regulatory decision is overdue, leaving shareholders to wonder when it might arrive.

Why Shares of Avadel Are Sinking Today

The FDA has notified Avadel Pharmaceuticals plc (NASDAQ: AVDL) that the review of its marketing application for FT218 is still ongoing, and action will likely not be taken in October.  Related:   Needham Initiates Coverage With Buy For This Narcolepsy Player.

Avadel Shares Fall As FDA Pushes Approval For Its Narcolepsy Treatment Candidate

DUBLIN, Ireland, Oct. 15, 2021 (GLOBE NEWSWIRE) -- Avadel Pharmaceuticals plc (Nasdaq: AVDL), a company focused on transforming medicines to transform lives, announced today that the U.S. Food and Drug Administration (FDA) notified the company that the review of the New Drug Application (NDA) for FT218 is still ongoing, and action will likely not be taken in October. The FDA informed the company that there are no information requests at this time and a new target action date will be provided as soon as possible.

Avadel Pharmaceuticals Announces Ongoing FDA Review of NDA for FT218 for Patients with Narcolepsy

Investors need to pay close attention to Avadel (AVDL) stock based on the movements in the options market lately.

Implied Volatility Surging for Avadel (AVDL) Stock Options

DUBLIN, Ireland, Aug. 16, 2021 (GLOBE NEWSWIRE) -- Avadel Pharmaceuticals plc (Nasdaq: AVDL), a company focused on developing FT218, an investigational, once-nightly formulation of sodium oxybate for treating excessive daytime sleepiness (EDS) and cataplexy in adults with narcolepsy, announced today the publication of data from its pivotal Phase 3 REST-ON trial of FT218 in SLEEP, the journal of the Sleep Research Society. The paper, titled “Once-Nightly Sodium Oxybate (FT218) Demonstrated Improvement of Symptoms in a Phase 3 Randomized Clinical Trial in Patients With Narcolepsy,” can be accessed at https://academic.oup.com/sleep/advance-article/doi/10.1093/sleep/zsab200/6343406?searchresult=1.

Avadel Pharmaceuticals Announces Publication of Data from Pivotal Phase 3 REST-ON Trial of FT218 in Adults with Narcolepsy in SLEEP

Avadel Pharmaceuticals plc (AVDL) CEO Gregory Divis on Q2 2021 Results - Earnings Call Transcript

DUBLIN, Ireland, Aug. 09, 2021 (GLOBE NEWSWIRE) -- Avadel Pharmaceuticals plc (Nasdaq: AVDL), a company focused on developing FT218, an investigational, once-nightly formulation of sodium oxybate for treating excessive daytime sleepiness (EDS) and cataplexy in adults with narcolepsy, today provided a corporate update and announced its financial results for the second quarter ended June 30, 2021.

Avadel Pharmaceuticals Provides Corporate Update and Reports Second Quarter 2021 Financial Results

Avadel's once-nightly FT218 improves considerably over Xyrem's twice-nightly dosing.

Avadel Pharmaceuticals, The Jazz-Killer

DUBLIN, Ireland, Aug. 02, 2021 (GLOBE NEWSWIRE) -- Avadel Pharmaceuticals plc (Nasdaq: AVDL), a company primarily focused on developing FT218, an investigational, once-nightly formulation of sodium oxybate designed to treat excessive daytime sleepiness (EDS) and cataplexy in adults with narcolepsy, announced today that it will host a conference call and live webcast at 8:30 a.m. ET on Monday, August 9, 2021, to provide a corporate update and discuss the Company's financial results for the second quarter ended June 30, 2021.

Avadel Pharmaceuticals to Provide a Corporate Update and Report Second Quarter 2021 Financial Results on August 9th

DUBLIN, Ireland, July 07, 2021 (GLOBE NEWSWIRE) -- Avadel Pharmaceuticals plc (Nasdaq: AVDL), a company focused on developing FT218, an investigational, once-nightly formulation of sodium oxybate for treating excessive daytime sleepiness and cataplexy in adults with narcolepsy, announced today that Greg Divis, Chief Executive Officer of Avadel, will participate in a fireside chat on Wednesday, July 14 at 11:00 a.m. ET.

Avadel Pharmaceuticals to Present at the Ladenburg Thalmann Annual Healthcare Conference 2021

DUBLIN, Ireland, June 09, 2021 (GLOBE NEWSWIRE) -- Avadel Pharmaceuticals plc (Nasdaq: AVDL), a company focused on developing FT218, an investigational, once-nightly formulation of sodium oxybate for treating excessive daytime sleepiness and cataplexy in adults with narcolepsy, today announced new post hoc analyses of data from the completed pivotal Phase 3 REST-ON clinical trial of FT218. The data were presented in three separate posters at SLEEP 2021, the 35th Annual Meeting of the Associated Professional Sleep Societies (APSS), a joint meeting of the American Academy of Sleep Medicine and the Sleep Research Society.

Avadel Presents New Clinical Data from Pivotal Phase 3 REST-ON Trial Supporting Clinical Benefit of FT218 in Patients with Narcolepsy at SLEEP 2021

DUBLIN, Ireland, June 03, 2021 (GLOBE NEWSWIRE) -- Avadel Pharmaceuticals plc (Nasdaq: AVDL), a company focused on developing FT218, an investigational, once-nightly formulation of sodium oxybate for treating excessive daytime sleepiness and cataplexy in adults with narcolepsy, today announced it will present primary and secondary endpoint data, including new post hoc analyses, from the pivotal Phase 3 REST-ON clinical trial at SLEEP 2021, at the 35th Annual Meeting of the Associated Professional Sleep Societies (APSS). This joint meeting of the American Academy of Sleep Medicine and the Sleep Research Society is being held virtually from June 10-13, 2021.

Avadel to Present New Efficacy and Safety Data from Pivotal Phase 3 REST-ON Trial of FT218 at SLEEP 2021

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Bolsters team with addition of established biopharma industry leaders in advance of anticipated regulatory approval and commercialization of once-nightly FT218 for narcolepsy Bolsters team with addition of established biopharma industry leaders in advance of anticipated regulatory approval and commercialization of once-nightly FT218 for narcolepsy

Avadel Pharmaceuticals Expands Leadership Team with Three Strategic Hires

DUBLIN, Ireland, May 25, 2021 (GLOBE NEWSWIRE) -- Avadel Pharmaceuticals plc (Nasdaq: AVDL), a company focused on developing FT218, an investigational, once-nightly formulation of sodium oxybate for treating excessive daytime sleepiness and cataplexy in adults with narcolepsy, announced today that Greg Divis, Chief Executive Officer of Avadel, will participate in a fireside chat on Tuesday, June 1 at 9:00 a.m. ET.

Avadel Pharmaceuticals to Present at the Jefferies Virtual Healthcare Conference

AVDL's once-nightly controlled release formulation of sodium oxybate (FT218) for narcolepsy addresses a key liability in the leading drug, Xyrem, which requires a second dose during the night. The FDA accepted the NDA for FT218 in March 2021 and set a PDUFA date of Oct 15.

Avadel Pharmaceuticals - A Compelling Buy

Avadel Pharmaceuticals plc (AVDL) CEO Greg Divis on Q1 2021 Results - Earnings Call Transcript

DUBLIN, Ireland, May 10, 2021 (GLOBE NEWSWIRE) -- Avadel Pharmaceuticals plc (Nasdaq: AVDL), a company focused on developing FT218, an investigational, once-nightly formulation of sodium oxybate designed to treat excessive daytime sleepiness and cataplexy in adults with narcolepsy, today provided a corporate update and announced its financial results for the first quarter ended March 31, 2021.

Avadel Pharmaceuticals Provides Corporate Update and Reports First Quarter 2021 Financial Results

DUBLIN, Ireland, April 29, 2021 (GLOBE NEWSWIRE) -- Avadel Pharmaceuticals plc (Nasdaq: AVDL), a company focused on developing FT218, an investigational, once-nightly formulation of sodium oxybate designed to treat excessive daytime sleepiness and cataplexy in patients with narcolepsy, announced today that it will host a conference call and live webcast at 8:30 a.m. ET on Monday, May 10, 2021, to provide a corporate update and discuss the Company's financial results for the first quarter ended March 31, 2021.

Avadel Pharmaceuticals to Provide a Corporate Update and Report First Quarter 2021 Financial Results on May 10th

DUBLIN, Ireland, April 17, 2021 (GLOBE NEWSWIRE) -- Avadel Pharmaceuticals plc (Nasdaq: AVDL), a company focused on developing FT218, an investigational, once-nightly formulation of sodium oxybate (ON-SXB) for the treatment of excessive daytime sleepiness and cataplexy in adults with narcolepsy, today announced the presentation of positive secondary endpoint data at the 2021 American Academy of Neurology Annual (AAN) Meeting being held virtually from April 17-22, 2021. FT218 is currently under review at the U.S. Food and Drug Administration with a Prescription Drug User Fee Act (PDUFA) target date of October 15, 2021.

Avadel Presents New Data from its Pivotal REST-ON Phase 3 Trial of FT218, once-nightly sodium oxybate, at the 2021 American Academy of Neurology Annual Meeting

Avadel Pharmaceuticals plc (AVDL) CEO Greg Divis on Q4 2020 Results - Earnings Call Transcript

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