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

Rhea-AI Filing 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.

Positive

• U.S. Court of Appeals unanimously upheld FDA approval of LUMRYZ, eliminating a material litigation risk to Avadel’s core product.

Negative

• None.

Insights

Pharmaceutical Litigation Analyst

TL;DR — Unanimous appeals ruling ends legal threat to LUMRYZ

The D.C. Circuit’s affirmation extinguishes Jazz’s final judicial avenue to overturn LUMRYZ approval, materially de-risking Avadel’s flagship asset. The unanimous opinion strengthens the FDA’s original scientific and exclusivity determinations, reducing the probability of future APA challenges. With litigation concluded, management can redeploy resources from legal defense to commercialization, potentially accelerating market penetration. Investors should monitor whether Jazz pursues a Supreme Court petition; however, certiorari odds are historically low for fact-specific APA cases.

Equity Analyst

TL;DR — Legal overhang lifted; valuation upside unlocked

The removal of appellate risk clarifies LUMRYZ’s revenue durability and could narrow AVDL’s discount to specialty-pharma peers. While the filing contains no financial metrics, the binary risk around potential approval revocation is now resolved, supporting higher cash-flow visibility and easing access to capital. Absence of disclosed settlement costs or new contingencies is an incremental positive. Key watch-points: commercialization ramp, payer uptake, and any Jazz competitive tactics outside the courtroom.

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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 8-K

CURRENT REPORT

Pursuant to Section 13 or Section 15(d)

of the Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): June 27, 2025

AVADEL PHARMACEUTICALS PLC

(Exact name of registrant as specified in its charter)

Ireland	001-37977	98-1341933
(State or other jurisdiction	(Commission	(IRS Employer
of incorporation)	File Number)	Identification No.)

10 Earlsfort Terrace Dublin 2, Ireland, D02 T380	Not Applicable
(Address of principal executive offices)	(Zip Code)

Registrant’s telephone number, including area code: +353 1 901 5201

Not Applicable

(Former name or former address, if changed since last report)

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation to the registrant under any of the following provisions:

¨ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

¨ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

¨ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

¨ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b) of the Act:

Title of each class	Trading Symbol(s)	Name of each exchange on which registered
Ordinary Shares, nominal value $0.01 per share	AVDL	The Nasdaq Global Market

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

Emerging growth company ¨

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ¨

Item 8.01 Other Events.

As previously disclosed, on June 22, 2023, Jazz Pharmaceuticals, Inc. (“Jazz”) filed an Administrative Procedure Act (“APA”) suit against the U.S. Food and Drug Administration (the “FDA”), the U.S. Department of Health and Human Services, the Secretary of Health and Human Services and the Commissioner of Food and Drugs in the United States District Court for the District of Columbia (the “D.C. Court”) related to the New Drug Application for LUMRYZ. This suit alleged that the FDA’s approval of LUMRYZ was an unlawful agency action and asked the D.C. Court to set aside FDA’s approval of LUMRYZ.

On October 30, 2024, the D.C. Court granted the FDA and Avadel Pharmaceuticals plc’s Motions for Summary Judgment with respect to the sole count in Jazz’s complaint and denied Jazz’s Motion for Summary Judgment regarding the same. On November 15, 2024, Jazz filed a notice of appeal to the United States Court of Appeals for the District of Columbia Circuit (the “D.C. Court of Appeals”) concerning the D.C. Court’s October 30, 2024 ruling.

On June 27, 2025, the D.C. Court of Appeals, in a unanimous decision, affirmed the D.C. Court’s ruling and upheld the FDA’s approval of LUMRYZ.

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

Date: June 27, 2025	AVADEL PHARMACEUTICALS PLC
	By:	/s/ Jerad G. Seurer
		Name:	Jerad G. Seurer
		Title:	General Counsel & Corporate Secretary

FAQ

What did the appeals court decide about [[**AVDL**]]'s LUMRYZ approval?

On June 27 2025, the D.C. Circuit unanimously affirmed the District Court’s decision, fully upholding the FDA’s approval of LUMRYZ.

Does the ruling mean LUMRYZ can remain on the market for [[**AVDL**]]?

Yes. The decision leaves the FDA approval intact, removing the threat of withdrawal sought by Jazz Pharmaceuticals.

Are further legal appeals expected for [[**AVDL**]] after this decision?

The filing notes no further actions; Jazz could theoretically seek Supreme Court review, but that step is not mentioned.

Did [[**AVDL**]] disclose any financial penalties or settlements related to the case?

No. The 8-K reports the appellate outcome only and does not disclose any penalties, settlements, or cash impacts.

How does this decision affect [[**AVDL**]]’s strategic focus?

With litigation resolved, Avadel can redirect resources toward LUMRYZ commercialization and growth initiatives.