Alkermes (NASDAQ: ALKS) details phase 2 alixorexton data for narcolepsy

Rhea-AI Filing Summary

Alkermes plc furnished an update related to its narcolepsy program. The company issued a press release detailing safety and efficacy results from Vibrance-1, its phase 2 study of alixorexton (formerly ALKS 2680) versus placebo in patients with narcolepsy type 1. The update coincides with Alkermes’ participation at the World Sleep Congress held September 5–10, 2025.

The press release, an investor presentation and scientific presentations are included as exhibits and are incorporated by reference, but the information is being furnished under Regulation FD rather than filed for liability purposes. This 8-K does not itself include numerical trial results, but directs investors to the accompanying materials for detailed clinical data.

8-K Event Classification

2 items: 7.01, 9.01

2 items

Item 7.01 Regulation FD Disclosure Disclosure

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

Item 9.01 Financial Statements and Exhibits Exhibits

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

Understanding 8-K Material Events →

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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): September 8, 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 September 8, 2025, in connection with its participation at the World Sleep Congress taking place September 5-10, 2025, Alkermes plc (the “Company”) issued a press release announcing detailed safety and efficacy results from Vibrance-1, the Company’s phase 2 study evaluating the safety and efficacy of alixorexton (formerly referred to as ALKS 2680) compared to placebo in patients with narcolepsy type 1. Copies of the Company’s press release and related investor presentation and scientific presentations are furnished herewith as Exhibit 99.1, Exhibit 99.2 and Exhibit 99.3, respectively, and are incorporated herein by reference.

The information in this Item 7.01, and in Exhibit 99.1, Exhibit 99.2 and Exhibit 99.3 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, nor 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 9.01 Financial Statements and Exhibits.

(d) Exhibits

EXHIBIT INDEX

Exhibit No.		Description
99.1		Press release issued by Alkermes plc dated September 8, 2025.
99.2		Investor presentation of Alkermes plc displayed on September 8, 2025.
99.3		Scientific presentations of Alkermes plc displayed on September 8, 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: September 8, 2025	By:		/s/ David J. Gaffin
			David J. Gaffin
			Secretary

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FAQ

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

Alkermes plc reported that it released detailed safety and efficacy results from Vibrance-1, its phase 2 study of alixorexton versus placebo in patients with narcolepsy type 1, and furnished a press release and related presentations as exhibits.

What is Vibrance-1 in Alkermes (ALKS) research pipeline?

Vibrance-1 is a phase 2 clinical study conducted by Alkermes to evaluate the safety and efficacy of alixorexton (formerly ALKS 2680) compared to placebo in patients diagnosed with narcolepsy type 1.

Which drug candidate did Alkermes (ALKS) highlight in this update?

The update highlights alixorexton, Alkermes’ investigational therapy for narcolepsy type 1, which was previously referred to as ALKS 2680 in company materials.

How were Alkermes’ Vibrance-1 results shared with investors?

Alkermes shared the Vibrance-1 results through a press release, an investor presentation, and scientific presentations, which are furnished as Exhibits 99.1, 99.2 and 99.3 to this 8-K.

Are the Vibrance-1 results considered filed financial information?

No. The company states that the information in Item 7.01 and Exhibits 99.1, 99.2 and 99.3 is furnished, not filed, under the Exchange Act and is not subject to Section 18 liabilities unless later specifically incorporated by reference.

What event coincided with Alkermes’ Vibrance-1 disclosure?

The disclosure of the detailed Vibrance-1 safety and efficacy results coincided with Alkermes’ participation at the World Sleep Congress, which took place from September 5–10, 2025.