# EDGAR Filing Document

**Accession Number:** 0001520262
**File Stem:** 0001193125-26-003453
**Filing Date:** 2026-1
**Character Count:** 12960
**Document Hash:** 09ed56a9be2260b6c4466d60229c2188
**Contains OCR:** False
**Source Format:** 

## Filing Content

## Filing Summary
**0001193125-26-003453.hdr.sgml**: 20260106

**ACCESSION NUMBER**: 0001193125-26-003453

**CONFORMED SUBMISSION TYPE**: 8-K

**PUBLIC DOCUMENT COUNT**: 11

**CONFORMED PERIOD OF REPORT**: 20260106

**ITEM INFORMATION**: Regulation FD Disclosure

**ITEM INFORMATION**: Other Events

**ITEM INFORMATION**: Financial Statements and Exhibits

**FILED AS OF DATE**: 20260106

**DATE AS OF CHANGE**: 20260106

**FILER**: 

**COMPANY DATA:**
- **COMPANY CONFORMED NAME:** Alkermes plc.
- **CENTRAL INDEX KEY:** 0001520262
- **STANDARD INDUSTRIAL CLASSIFICATION:** PHARMACEUTICAL PREPARATIONS [2834]
- **ORGANIZATION NAME:** 03 Life Sciences
- **EIN:** 981007018
- **FISCAL YEAR END:** 1231

**FILING VALUES:**
- **FORM TYPE:** 8-K
- **SEC ACT:** 1934 Act
- **SEC FILE NUMBER:** 001-35299
- **FILM NUMBER:** 26509388

**BUSINESS ADDRESS:**
- **STREET 1:** CONNAUGHT HOUSE
- **STREET 2:** 1 BURLINGTON ROAD
- **CITY:** DUBLIN 4
- **STATE:** L2
- **ZIP:** 00000
- **BUSINESS PHONE:** 00-353-1-772-8000

**MAIL ADDRESS:**
- **STREET 1:** CONNAUGHT HOUSE
- **STREET 2:** 1 BURLINGTON ROAD
- **CITY:** DUBLIN 4
- **STATE:** L2
- **ZIP:** 00000

**FORMER COMPANY:**
- **FORMER CONFORMED NAME:** ANTLER SCIENCE TWO PLC
- **DATE OF NAME CHANGE:** 20110804

**FORMER COMPANY:**
- **FORMER CONFORMED NAME:** Antler Science Two Ltd
- **DATE OF NAME CHANGE:** 20110509

?xml version='1.0' encoding='ASCII'? 8-K

**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):** January 6, 2026

ALKERMES PUBLIC LIMITED COMPANY

(Exact name of registrant as specified in its charter)

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

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| | | |
|:---|:---|:---|
| &nbsp;&nbsp;**Title of each class** | &nbsp;&nbsp;**Trading Symbol(s)** | &nbsp;&nbsp;**Name of each exchange on which registered** |
| &nbsp;&nbsp;Ordinary shares, $0.01 par value | &nbsp;&nbsp;ALKS | &nbsp;&nbsp;Nasdaq Global Select Market |

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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. ☐

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**Item 7.01 Regulation FD Disclosure.**

On January 6, 2026, Alkermes plc (the "Company") issued a press release announcing the grant of Breakthrough Therapy designation to alixorexton, as described in Item 8.01 of this Current Report on Form 8-K. A copy of the related press release 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 January 6, 2026, the Company announced that the U.S. Food and Drug Administration has granted Breakthrough Therapy designation to alixorexton for the treatment of narcolepsy type 1.

**Item 9.01 Financial Statements and Exhibits.** 

(d) Exhibits

**EXHIBIT INDEX**

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| | |
|:---|:---|
| **Exhibit No.** | **Description** |
| 99.1 | [<u>Press release issued by Alkermes plc dated January 6, 2026.</u>](alks-ex99_1.htm) |
| 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.

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| | | |
|:---|:---|:---|
|  | **ALKERMES PLC** | **ALKERMES PLC** |
| Date: January 6, 2026 | By: | /s/ David J. Gaffin |
|  |  | David J. Gaffin |
|  |  | Secretary |

---

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## Exhibit 99.1

**Exhibit 99.1**

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| | |
|:---|:---|
| &nbsp;&nbsp;<u>Alkermes Contacts:</u> |  |
| &nbsp;&nbsp;For Investors: | &nbsp;&nbsp;Sandy Coombs, +1 781 609 6377 |
| &nbsp;&nbsp;For Media:  | &nbsp;&nbsp;Gretchen Murphy,+1 781 609 6419 |

---

**Alixorexton Granted Breakthrough Therapy Designation by U.S. FDA for the Treatment of Narcolepsy Type 1**

**DUBLIN, Jan. 6, 2026** -- <u>Alkermes plc</u> (Nasdaq: ALKS) today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to alixorexton for the treatment of narcolepsy type 1 (NT1), based on phase 1 and phase 2 clinical data, including positive results from Vibrance-1, a large (n=92) phase 2 study evaluating alixorexton in patients with NT1. Alixorexton is the company's novel, investigational, oral, selective orexin 2 receptor (OX2R) agonist in development for the treatment of NT1, narcolepsy type 2 (NT2) and idiopathic hypersomnia (IH).

The FDA's Breakthrough Therapy designation process is designed to expedite the development and review of drugs that are intended to treat a serious condition, and where preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over available therapy on one or more clinically significant endpoints.<sup>1</sup>

"Alixorexton may offer substantial improvements over available therapy for people living with narcolepsy type 1, a community that has continued to face profound unmet medical needs despite available treatments. This Breakthrough Therapy designation underscores the strength of alixorexton's initial clinical data and supports our conviction that targeting the orexin pathway has the potential to fundamentally shift treatment expectations for central disorders of hypersomnolence. If approved, alixorexton's differentiated profile and compelling efficacy may

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represent a new standard of care in narcolepsy type 1. We look forward to working closely with the FDA as we plan to advance alixorexton into phase 3 development later this quarter," said Craig Hopkinson, M.D., Chief Medical Officer and Executive Vice President of Research & Development at Alkermes.

In the Vibrance-1 phase 2 study, alixorexton met the primary endpoint across all doses tested, demonstrating statistically significant, clinically meaningful and dose-dependent improvements from baseline compared to placebo in wakefulness on the Maintenance of Wakefulness Test (MWT) in patients with NT1. Alixorexton was generally well tolerated at all doses tested.

Alkermes plans to initiate the alixorexton narcolepsy global phase 3 program in the first quarter of 2026.

**<u>About Alixorexton</u>**

Alixorexton (formerly referred to as ALKS 2680) is a novel, investigational, oral, selective orexin 2 receptor (OX2R) agonist in development for the treatment of narcolepsy type 1 (NT1), narcolepsy type 2 (NT2) and idiopathic hypersomnia (IH). Orexin, a neuropeptide produced in the lateral hypothalamus, is considered to be the master regulator of wakefulness due to its activation of multiple, downstream wake-promoting pathways that project widely throughout the brain.<sup>2</sup> Targeting the orexin system may address excessive daytime sleepiness across hypersomnolence disorders, whether or not deficient orexin signaling is the underlying cause of disease.<sup>3</sup> Once-daily oral administration of alixorexton was previously evaluated in a phase 1 study in healthy volunteers and patients with NT1, NT2 and IH, and in Vibrance-1 and

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Vibrance-2, phase 2 studies in patients with NT1 and NT2, respectively. It is currently being evaluated in the phase 2 Vibrance-3 study in patients with IH.

**<u>About Alkermes plc</u>**<br> Alkermes plc, a mid-cap growth and value equity, is a global biopharmaceutical company that seeks to develop innovative medicines in the field of neuroscience. The company has a portfolio of proprietary commercial products for the treatment of alcohol dependence, opioid dependence, schizophrenia and bipolar I disorder, and a pipeline of clinical and preclinical candidates in development for neurological disorders, including narcolepsy and idiopathic hypersomnia. Headquartered in Ireland, Alkermes also has a corporate office and research and development center in Massachusetts and a manufacturing facility in Ohio. For more information, please visit Alkermes' website at <u>www.alkermes.com</u>.

**<u>Note Regarding Forward-Looking Statements</u>**

Certain statements set forth in this press release constitute "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including, but not limited to, statements concerning: the potential therapeutic and commercial value of alixorexton (formerly referred to as ALKS 2680) and the company's expectations, including timelines, related to the alixorexton development program. The company cautions that forward-looking statements are inherently uncertain. Although the company believes that such statements are based on reasonable assumptions within the bounds of its knowledge of its business and operations, the forward-looking statements are neither promises nor guarantees and they are necessarily subject to a high degree of uncertainty and risk. Actual performance and results may

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differ materially from those expressed or implied in the forward-looking statements due to various risks and uncertainties. These risks and uncertainties include, among others: whether initial clinical results for alixorexton will be predictive of results of future stages of ongoing clinical studies, future clinical studies or real-world results; whether ongoing or future clinical studies for alixorexton will be initiated or completed on expected timelines or at all; whether alixorexton could be shown to be ineffective or unsafe; potential changes in the cost, scope and duration of the alixorexton development program; and those risks and uncertainties described under the heading "Risk Factors" in the company's Annual Report on Form 10-K for the year ended Dec. 31, 2024 and in subsequent filings made by the company with the U.S. Securities and Exchange Commission (SEC), which are available on the SEC's website at <u>www.sec.gov</u>. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. Except as required by law, the company disclaims any intention or responsibility for updating or revising any forward-looking statements contained in this press release.

<sup>1</sup> U.S. Food and Drug Administration. *Breakthrough Therapy*, available at: https://www.fda.gov/patients/fast-track-breakthrough-therapy-accelerated-approval-priority-review/breakthrough-therapy.

<sup>2</sup> Buysse, D. Diagnosis and assessment of sleep and circadian rhythm disorders. *Journal of Psychiatric Practice*. 2005; 11(2):102-115<br> <sup>3</sup> Ten-Blanco M, Flores A, Cristino L, Pereda-Perez I. Targeting the orexin/hypocretin system for the treatment of neuropsychiatric and neurodegenerative diseases: From animal to clinical studies. Frontiers in Neuroendocrinology. 2023;69(101066). https://www.sciencedirect.com/science/article/pii/S0091302223000146

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