Alkermes posts positive Phase 2 Vibrance‑2 topline in narcolepsy

Alkermes plc reported positive topline results from Vibrance‑2, a randomized, double‑blind phase 2 study of alixorexton (formerly ALKS 2680) versus placebo in patients with narcolepsy type 2.

Rhea-AI Filing Summary

Alkermes plc reported positive topline results from Vibrance‑2, a randomized, double‑blind phase 2 study of alixorexton (formerly ALKS 2680) versus placebo in patients with narcolepsy type 2.

The company hosted an investor webcast and conference call to present the topline data, and furnished a press release as Exhibit 99.1 and an investor presentation as Exhibit 99.2. Information in Item 7.01 and Exhibit 99.1 is furnished and not deemed filed under the Exchange Act.

Insights

Biotech clinical development analyst

Positive phase 2 topline in NT2; early but encouraging signal.

Alkermes announced positive topline results from Vibrance‑2, a randomized, double‑blind phase 2 study of alixorexton in narcolepsy type 2. Topline results indicate favorable outcomes versus placebo, which can support continued development.

Because only topline findings are described here, specifics on efficacy magnitude, safety profile, or next study design are not included in this excerpt. Actual impact will depend on detailed data shown in the furnished press release and investor presentation.

The company presented the results via webcast on November 12, 2025. Subsequent disclosures may clarify endpoints, safety signals, and regulatory plans.

8-K Event Classification

3 items: 7.01, 8.01, 9.01

3 items

Item 7.01 Regulation FD Disclosure Disclosure

Material non-public information disclosed under Regulation Fair Disclosure, often investor presentations or guidance.

Item 8.01 Other Events Other

Voluntary disclosure of events the company deems important to shareholders but not covered by other items.

Item 9.01 Financial Statements and Exhibits Exhibits

Financial statements, pro forma financial information, or exhibit attachments filed with this report.

FAQ

AI-generated questions and answers. How Rhea-AI works. Not financial advice.

What did Alkermes (ALKS) announce in this 8-K?

Alkermes reported positive topline results from Vibrance‑2, a randomized, double‑blind phase 2 study of alixorexton in narcolepsy type 2.

What is alixorexton (ALKS 2680) in the Alkermes (ALKS) filing?

Alixorexton is the company’s investigational therapy, formerly referred to as ALKS 2680, evaluated in narcolepsy type 2.

Which exhibits accompany Alkermes’ (ALKS) announcement?

A press release is furnished as Exhibit 99.1 and an investor presentation is furnished as Exhibit 99.2.

How is the information treated under the Exchange Act?

The information in Item 7.01 and Exhibit 99.1 is furnished and not deemed filed for purposes of Section 18.

When were the Vibrance‑2 topline results announced by Alkermes (ALKS)?

The results were announced on November 12, 2025.

What patient population was studied in Vibrance‑2?

Patients with narcolepsy type 2 were evaluated in the randomized, double‑blind treatment period.

Where is Alkermes (ALKS) listed?

Alkermes’ ordinary shares trade on the Nasdaq Global Select Market under the symbol ALKS.

AI-generated analysis. How Rhea-AI works. Not financial advice.

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Accepted by SEC EDGAR 11/12/2025 - 08:45 AM Learn about SEC filing dates

False0001520262Alkermes plc.00015202622025-11-122025-11-12

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 8-K

CURRENT REPORT
PURSUANT TO SECTION 13 OR 15(d) OF THE

SECURITIES EXCHANGE ACT OF 1934

Date of Report (Date of earliest event reported): November 12, 2025

ALKERMES PUBLIC LIMITED COMPANY

(Exact name of registrant as specified in its charter)

Ireland		001-35299				98-1007018
(State or other jurisdiction		(Commission				(IRS Employer
of incorporation)		File Number)				Identification No.)
Connaught House, 1 Burlington Road
Dublin 4, Ireland D04 C5Y6
(Address of principal executive offices)

Registrant's telephone number, including area code: + 353-1-772-8000

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):

☐		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, $0.01 par value		ALKS		Nasdaq Global Select 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 7.01 Regulation FD Disclosure.

On November 12, 2025, Alkermes plc (the “Company”) issued a press release regarding the positive topline results described in Item 8.01 of this Current Report on Form 8-K. A copy of the press release containing a summary of the topline results is furnished herewith as Exhibit 99.1 and is incorporated herein by reference.

The information in this Item 7.01, and in Exhibit 99.1 furnished herewith, shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, or incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as shall be expressly set forth by specific reference in such a filing.

Item 8.01 Other Events.

On November 12, 2025, the Company announced positive topline results from the randomized, double-blind treatment period of Vibrance-2, a phase 2 study evaluating the safety and efficacy of alixorexton (formerly referred to as ALKS 2680) compared to placebo in patients with narcolepsy type 2. Alkermes hosted an investor webcast and conference call to present the topline results. A copy of the presentation displayed during the webcast and conference call detailing the topline results is attached hereto as Exhibit 99.2 and is incorporated herein by reference.

Item 9.01 Financial Statements and Exhibits.

(d) Exhibits

EXHIBIT INDEX

Exhibit No.		Description
99.1		Press release issued by Alkermes plc dated November 12, 2025.
99.2		Investor presentation of Alkermes plc displayed on November 12, 2025.
104		Cover page interactive data file (embedded within the Inline XBRL document).

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SIGNATURE

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

	ALKERMES PLC
Date: November 12, 2025	By:		/s/ David J. Gaffin
			David J. Gaffin
			Secretary

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