Avadel Pharmaceuticals plc Ordinary Share - AVDL STOCK NEWS

Avadel Pharmaceuticals reported strong Q3 2024 results with $50.0 million in net revenue from LUMRYZ sales. The company reached 2,300 patients on LUMRYZ by September 30th, adding 700 new patients in Q3. Key developments include FDA approval for LUMRYZ in patients 7 years and older with narcolepsy, granted Orphan Drug Exclusivity through October 2031. The company reported a minimal operating loss of $0.3 million and a net loss of $2.6 million ($0.03 per share). Cash position stood at $65.8 million as of September 30, 2024.

Avadel Pharmaceuticals (Nasdaq: AVDL) announced it will host a conference call and live webcast on November 12, 2024, at 8:30 a.m. ET to discuss its third quarter 2024 financial results and provide a corporate update. The conference call can be accessed by dialing (800) 579-2543 with conference ID AVADEL. A live webcast will be available on the company's investor relations website, and a replay will be archived for 90 days.

Avadel Pharmaceuticals (Nasdaq: AVDL) announced a favorable U.S. District Court ruling upholding the FDA's approval of LUMRYZ, the first once-at-bedtime oxybate treatment for narcolepsy. The Court ruled against Jazz Pharmaceuticals' challenge under the Administrative Procedure Act, confirming LUMRYZ's clinical superiority to Jazz's twice-nightly oxybate products. The decision maintains LUMRYZ's Orphan Drug Exclusivity granted in May 2023 and validates its unique dosing schedule as a significant advancement in patient care.

Avadel Pharmaceuticals (AVDL) and nference published real-world data in Sleep Advances analyzing demographic characteristics and comorbidities in narcolepsy patients. The study, based on electronic health data from over 2,000 narcolepsy patients and 2,000 matched controls through Mayo Clinic Platform, revealed that people with narcolepsy were more likely to have psychiatric, sleep, and pain disorders. Unlike previous claims-based studies, cardiovascular disease was not among the top 20 comorbidities. This marks the first real-world study in narcolepsy using aggregate electronic health record data.

Avadel Pharmaceuticals (Nasdaq: AVDL) announced FDA approval of LUMRYZ (sodium oxybate) Extended-Release Oral Suspension for treating cataplexy or excessive daytime sleepiness in narcolepsy patients aged 7 and older. LUMRYZ is the only FDA-approved once-at-bedtime oxybate treatment for this condition, granted Orphan Drug Exclusivity for pediatric narcolepsy patients through October 16, 2031.

This approval expands LUMRYZ's use to the pediatric population, offering a single bedtime dose option. Narcolepsy affects about 1 in 2,000 people in the US, with 5% under 18. LUMRYZ was first approved for adult narcolepsy patients on May 1, 2023. The drug carries a boxed warning as a CNS depressant with potential for abuse and is available only through a restricted REMS program.

Avadel Pharmaceuticals (Nasdaq: AVDL) announced the publication of a post-hoc analysis from their Phase 3 REST-ON clinical trial for LUMRYZ (sodium oxybate) in treating narcolepsy. The study, published in Sleep Medicine, showed that LUMRYZ significantly improved wakefulness, overall condition, weekly cataplexy episodes, and excessive daytime sleepiness compared to placebo, regardless of concomitant use of alerting agents.

The analysis involved 119 participants (63%) taking alerting agents and 71 (37%) not taking them. Significant improvements were observed with LUMRYZ at all doses versus placebo for Maintenance of Wakefulness Test (MWT), Clinical Global Impression-Improvement (CGI-I) rating, and weekly cataplexy episodes (p<0.05). The Epworth Sleepiness Scale (ESS) also showed significant improvements in both groups.

These findings highlight that alerting agents alone may be insufficient for treating excessive daytime sleepiness in narcolepsy patients, and LUMRYZ could be an effective treatment option, either as monotherapy or in combination with alerting agents.

Avadel Pharmaceuticals (Nasdaq: AVDL) announced the publication of final data from the RESTORE study, highlighting the advantages of LUMRYZ, their once-nightly oxybate treatment for narcolepsy, over twice-nightly alternatives. Key findings include:

- 94% of participants preferred LUMRYZ's once-nightly regimen
- 91% reported better sleep through the night with LUMRYZ
- 93% would recommend LUMRYZ to others with narcolepsy
- 79% were very satisfied with LUMRYZ compared to previous treatments

The study also revealed challenges with twice-nightly oxybates, including missed doses, grogginess, and the need for assistance in taking the second dose. LUMRYZ, approved by the FDA in 2023, addresses these issues as the first and only once-nightly oxybate treatment for narcolepsy.

Avadel Pharmaceuticals (Nasdaq: AVDL), a biopharmaceutical company, has announced its participation in three upcoming investor conferences in September 2024:

• 2024 Wells Fargo Healthcare Conference: Fireside chat on September 4 at 3:45 p.m. ET
• Morgan Stanley 22nd Annual Global Healthcare Conference: Fireside chat on September 6 at 10:00 a.m. ET
• H.C. Wainwright 25th Annual Global Investment Conference: Fireside chat on September 11 at 11:30 a.m. ET

Live webcasts and archived recordings of these events will be available on Avadel's Investor Relations website for 90 days following each conference.

Avadel Pharmaceuticals (AVDL) has published results from a post-hoc analysis of their Phase 3 REST-ON clinical trial for LUMRYZ, a once-nightly sodium oxybate treatment for narcolepsy. The study, published in Clinical Therapeutics, showed that LUMRYZ use was associated with weight loss in narcolepsy patients.

Key findings include:

• LUMRYZ-treated participants lost a mean of 1.3 kg over 13 weeks, while placebo group gained 0.2 kg
• 17.8% of LUMRYZ group experienced ≥5% weight loss vs 3.8% in placebo group
• Significant BMI reduction observed in LUMRYZ group compared to placebo
• Weight loss group showed improvements in narcolepsy symptoms

These results suggest LUMRYZ may offer a tailored treatment approach for narcolepsy patients who are overweight or obese, addressing both core symptoms and weight management.