Avadel Pharmaceu Stock Price, News & Analysis

Avadel Pharmaceuticals (Nasdaq: AVDL) announced positive post hoc analyses from the Phase 3 REST-ON clinical trial of FT218, a once-nightly sodium oxybate formulation for narcolepsy. Data show significant improvements in excessive daytime sleepiness across narcolepsy subtypes, with substantial weight loss benefits for patients. FT218 demonstrated statistically significant efficacy at all doses evaluated, with a PDUFA date at the FDA set for October 15, 2021. The findings were presented at the SLEEP 2021 conference, highlighting FT218's potential as a transformative treatment for narcolepsy.

Avadel Pharmaceuticals (Nasdaq: AVDL) announced it will present pivotal Phase 3 REST-ON clinical trial data for FT218 at the virtual SLEEP 2021 meeting from June 10-13, 2021. FT218, a once-nightly formulation of sodium oxybate, targets excessive daytime sleepiness and cataplexy in narcolepsy patients. The presentation includes six abstracts focusing on various efficacy and safety aspects. The FDA has accepted the NDA for FT218, aiming for a decision by October 15, 2021, and granted it Orphan Drug Designation, indicating potential clinical superiority over existing treatments.

Avadel Pharmaceuticals announces key leadership appointments to bolster its team ahead of the anticipated U.S. regulatory approval and commercialization of FT218, an investigational treatment for narcolepsy. Jeff Cruikshank joins as Vice President of Sales, Denise Strauss as Vice President of Marketing and New Product Strategy, and Angela Woods as Vice President of People and Culture. These roles are designed to enhance the company’s capabilities to support FT218’s market launch, which is expected to bring a significant impact to patients dealing with narcolepsy.

DUBLIN, Ireland, May 25, 2021 – Avadel Pharmaceuticals (Nasdaq: AVDL) announced that CEO Greg Divis will participate in a fireside chat on June 1 at 9:00 a.m. ET. This event will focus on FT218, an investigational once-nightly formulation of sodium oxybate aimed at treating excessive daytime sleepiness and cataplexy in adults with narcolepsy. A live webcast and an archived recording will be accessible on Avadel’s Investor Relations website for 90 days following the conference.

Avadel Pharmaceuticals announced that the FDA accepted the NDA for once-nightly FT218, targeting a PDUFA date of October 15, 2021. Positive secondary endpoint data from the REST-ON trial was presented at the AAN 2021 Annual Meeting, indicating FT218's efficacy in improving sleep quality for narcolepsy patients. The company reported no revenue for Q1 2021, down from $12.2 million in Q1 2020, with a net loss of $13.4 million, or ($0.23) per share. However, cash reserves stand at $205 million, positioning the company well for upcoming developments.

Avadel Pharmaceuticals plc (Nasdaq: AVDL) has announced a conference call on May 10, 2021, at 8:30 a.m. ET to discuss its financial results for Q1 2021, ending March 31, 2021. The call will provide updates on the company’s progress, particularly focusing on FT218, a sodium oxybate formulation intended for treating narcolepsy symptoms. Investors can join via dial-in or listen to a live webcast from the investor relations section of Avadel's website, with a replay available for 90 days.

Avadel Pharmaceuticals (Nasdaq: AVDL) presented positive secondary endpoint data for FT218 at the 2021 AAN Meeting. The investigational once-nightly formulation of sodium oxybate showed significant improvements at doses of 6 g, 7.5 g, and 9 g in treating excessive daytime sleepiness and cataplexy in adults with narcolepsy. Results demonstrated clinically meaningful enhancements in sleep quality, arousals, and nocturnal sleep disturbances, with a PDUFA target action date set for October 15, 2021, for FDA review.

Avadel Pharmaceuticals (Nasdaq: AVDL) is set to present new secondary endpoint data from its pivotal REST-ON Phase 3 trial of FT218, a once-nightly sodium oxybate formulation, at the 2021 American Academy of Neurology Annual Meeting from April 17-22. Key poster presentations include polysomnographic measures of sleep continuity and the impact of daytime sleepiness, sleep quality, hallucinations, and sleep paralysis in narcolepsy patients. FT218, aimed at treating excessive daytime sleepiness and cataplexy, received FDA's Orphan Drug Designation and has a PDUFA target date of October 15, 2021.

Avadel Pharmaceuticals plc (Nasdaq: AVDL) will participate in a fireside chat at Stifel's Third Annual CNS Day on March 31 at 3 p.m. ET. The discussion will focus on FT218, an investigational formulation of sodium oxybate aimed at treating excessive daytime sleepiness and cataplexy in adults with narcolepsy. A live webcast will be available for attendees, along with a recording accessible for 90 days on the company’s website.