secwatch.observer — SEC 8-K summary
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Issuer:     Alkermes plc. (ALKS)
CIK:        0001520262
Form:       8-K
Filed at:   2026-09-21T11:10:39+00:00
Accession:  0001193125-26-396065
Event type: other_material
Sentiment:  positive
Materiality: 0.85
Item codes: 7.01, 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

Alkermes ALKS 7290 shows positive Phase 1b ADHD data; AISRS cuts 14–19 pts
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- ALKS 7290 (OX2R agonist) improved ADHD symptoms: median AISRS reductions of 14.0 (20 mg) and 19.0 (50 mg) at day 14.
- CGI-S median reductions of 1.0 (20 mg) and 2.0 (50 mg) at day 14; shift from markedly/moderately ill to mildly ill.
- Generally well tolerated; no serious TEAEs; most common mild events: insomnia, pollakiuria, dizziness, change in sustained attention.
- Phase 2 study (NCT07755410) enrolling ~312 adults with ADHD; first dose Sept 2026; data expected 2027.
- First orexin 2 receptor agonist to show clinically meaningful ADHD improvements; supports broader orexin portfolio.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1520262/000119312526396065/0001193125-26-396065-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1520262/000119312526396065/alks-20260921.htm
  HTML page:      https://secwatch.observer/filing/0001193125-26-396065

License: Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer