Avadel Pharmaceu SEC Filings

AVDL NASDAQ

Welcome to our dedicated page for Avadel Pharmaceu SEC filings (Ticker: AVDL), a comprehensive resource for investors and traders seeking official regulatory documents including 10-K annual reports, 10-Q quarterly earnings, 8-K material events, and insider trading forms.

Clinical trial tables, FDA letters, and royalty footnotes buried in Avadel Pharmaceuticals’ SEC forms can overwhelm even seasoned analysts. When the once-at-bedtime LUMRYZ story spans hundreds of pages, pinpointing safety data or patent-expiry timelines becomes a serious time drain.

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Whether you’re evaluating patent duration, tracking narcolepsy market expansion, or simply looking for Avadel Pharmaceuticals SEC filings explained simply, this hub delivers. Every filing type—10-K, 10-Q, 8-K, S-3, plus Avadel Pharmaceuticals executive stock transactions Form 4—is indexed, searchable, and paired with expert commentary. That means Avadel Pharmaceuticals annual report 10-K simplified or Avadel Pharmaceuticals 8-K material events explained are always one click away.

06/27/2025 04:02 PM

Filing

[8-K] Avadel Pharmaceuticals plc Ordinary Share Reports Material Event

Rhea-AI Summary

Avadel Pharmaceuticals (Nasdaq: AVDL) filed an 8-K disclosing a decisive legal outcome.

On June 27 2025, the U.S. Court of Appeals for the D.C. Circuit issued a unanimous ruling affirming the District Court’s October 30 2024 judgment that upheld the FDA’s approval of LUMRYZ. The appeal was brought by Jazz Pharmaceuticals, which had alleged the approval violated the Administrative Procedure Act. With the appeal dismissed, LUMRYZ’s approval stands, eliminating a significant regulatory and litigation overhang.

No further conditions, penalties, or operational changes were reported.

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FAQ

What is the current stock price of Avadel Pharmaceu (AVDL)?

The current stock price of Avadel Pharmaceu (AVDL) is $9.2 as of June 28, 2025.

What is the market cap of Avadel Pharmaceu (AVDL)?

The market cap of Avadel Pharmaceu (AVDL) is approximately 889.5M.

What is Avadel Pharmaceuticals' core focus?

Avadel Pharmaceuticals is dedicated to developing and commercializing innovative drug products that transform patient care. The company focuses on addressing treatment challenges in areas such as sleep medicine, urology, and hospital markets.

How does Avadel differentiate its product offerings?

Avadel differentiates itself through its proprietary polymer-based technology that enables the development of once-at-bedtime dosing regimens. This innovative approach improves patient adherence by eliminating the need for disruptive middle-of-the-night dosing.

Which therapeutic areas are central to Avadel's operations?

The company primarily operates in sleep medicine, particularly in treating narcolepsy, while also addressing needs in urology and hospital markets. This multi-therapeutic focus helps Avadel address a range of unmet medical needs.

What benefits does the once-at-bedtime dosing regimen offer?

The once-at-bedtime dosing regimen simplifies treatment by reducing the need for nocturnal awakenings, thus enhancing overall patient adherence and quality of life. This regimen has been well validated in clinical trials, showcasing its effectiveness compared to traditional twice-nightly regimens.

What role does clinical research play in Avadel's strategy?

Clinical research is central to Avadel’s strategy, providing rigorous validation of its product efficacy and safety. The company’s extensive trials, including studies like REST-ON, underpin its regulatory approvals and scientific credibility.

How does Avadel ensure the quality and safety of its pharmaceutical products?

Avadel ensures product quality and safety through continuous clinical evaluation, strict adherence to regulatory standards, and robust manufacturing protocols across its global operations. FDA approvals and orphan drug designations further validate the company’s commitment to high safety and efficacy standards.

Avadel Pharmaceu

NASDAQ:AVDL

AVDL Rankings

#2641 Ranked by Market Cap

N/A Ranked by Dividends

AVDL Stock Data

Market Cap 889.55M

Float 92.22M

Insiders Ownership 4.92%

Institutions Ownership 85.01%

Short Percent 10.03%

Industry Drug Manufacturers - Specialty & Generic

Sector Pharmaceutical Preparations

Website Link

Country Ireland

City DUBLIN