secwatch.observer — SEC 8-K summary
======================================

Issuer:     Alkermes plc. (ALKS)
CIK:        0001520262
Form:       8-K
Filed at:   2026-05-12T11:07:58+00:00
Accession:  0001193125-26-218150
Event type: other_material
Sentiment:  positive
Materiality: 0.75
Item codes: 7.01, 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

LUMRYZ meets all primary, key secondary endpoints in Phase 3 idiopathic hypersomnia study
--------------------------------------------------------------------------------

- Primary endpoint ESS showed statistically significant improvement vs placebo (p<0.0001).
- Key secondary endpoints PGI-C and IHSS also met with p<0.0001.
- Safety profile consistent with known LUMRYZ safety; common AEs included nausea, headache.
- Alkermes plans to file sNDA with FDA by end of 2026 for IH indication.
- Settlement agreement restricts marketing of LUMRYZ for IH until March 1, 2028.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1520262/000119312526218150/0001193125-26-218150-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1520262/000119312526218150/alks-20260512.htm
  HTML page:      https://secwatch.observer/filing/0001193125-26-218150

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