secwatch.observer — SEC 8-K summary
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Issuer:     Alkermes plc. (ALKS)
CIK:        0001520262
Form:       8-K
Filed at:   2025-11-12T23:59:59+00:00
Accession:  0001193125-25-276161
Event type: other_material
Sentiment:  positive
Materiality: 0.80
Item codes: 7.01, 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

Alkermes' alixorexton meets dual primary endpoints in Phase 2 narcolepsy type 2 study
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- Alixorexton (10, 14, 18 mg) showed statistically significant improvements vs placebo on MWT and ESS at week 8.
- 14 mg and 18 mg doses achieved statistical significance on MWT (p<0.05); 18 mg dose on ESS (p<0.05).
- Drug was generally well tolerated; most common TEAEs were pollakiuria, insomnia, urinary urgency, dizziness, headache.
- No serious TEAEs, no safety signals in hepatic, renal, vitals, ECGs, or ophthalmic exams.
- Phase 3 program for narcolepsy type 1 and type 2 expected to initiate in Q1 2026.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1520262/000119312525276161/0001193125-25-276161-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1520262/000119312525276161/alks-20251112.htm
  HTML page:      https://secwatch.observer/filing/0001193125-25-276161

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