Alkermes Public Limited Company filed a Current Report on Form 8-K on September 21, 2026, announcing positive topline results from a phase 1 proof-of-concept study of its investigational compound ALKS 7290 in development for the treatment of ADHD.

Key Highlights

  • Positive topline results: Alkermes announced positive topline results from a phase 1 proof-of-concept study of ALKS 7290.
  • Compound description: ALKS 7290 is described in the filing as a "novel, investigational orexin 2 receptor (OX2R) agonist."
  • Target indication: ALKS 7290 is in development for the treatment of attention-deficit hyperactivity disorder (ADHD).
  • Press release furnished: A press release dated September 21, 2026, was furnished as Exhibit 99.1 and incorporated by reference.
  • Exchange listing: Alkermes ordinary shares trade on the Nasdaq Global Select Market under the symbol NASDAQ:ALKS.

Alkermes Discloses Phase 1 ALKS 7290 Study Outcomes Under Regulation FD

According to the filing, Alkermes plc disclosed on September 21, 2026, that it had completed a phase 1 proof-of-concept study for ALKS 7290, which the company describes as its "novel, investigational orexin 2 receptor (OX2R) agonist in development for the treatment of attention-deficit hyperactivity disorder (ADHD)." The company reported the results as positive at the topline level, without providing additional clinical data within the body of the 8-K itself.

The disclosure was filed under two items. Item 7.01 covers a Regulation FD disclosure, through which the company furnished a press release as Exhibit 99.1. Item 8.01, classified as Other Events, contains the substantive announcement of the study results. The filing notes that the information in Item 7.01 and Exhibit 99.1 "shall not be deemed 'filed' for purposes of Section 18 of the Securities Exchange Act of 1934," as stated in the filing's standard regulatory language.

The filing was signed by David J. Gaffin, identified as Secretary of Alkermes plc, on September 21, 2026. Alkermes is incorporated in Ireland and lists its principal executive offices at Connaught House, 1 Burlington Road, Dublin 4, Ireland. The company is not designated as an emerging growth company, according to the filing.

What Was Disclosed

Alkermes plc filed an 8-K on September 21, 2026, reporting positive topline results from a phase 1 proof-of-concept study of ALKS 7290, a novel investigational OX2R agonist being studied for ADHD treatment. A supporting press release was furnished as Exhibit 99.1.