sNDA submission for LUMRYZ in idiopathic hypersomnia by year-end 2026
sNDA submission for LUMRYZ in idiopathic hypersomnia by year-end 2026, expected in Q4 2026 (Oct–Dec) (no exact date yet). A company milestone for Alkermes (LUMRYZ (sodium oxybate ER) for idiopathic hypersomnia): a step in the program rather than a decision or a data readout.
Plain-English summary generated from this entry’s own fields (drug, condition, stage, date). Glossary
- Company
- Alkermes plc ALKS
- Drug
- LUMRYZ (sodium oxybate ER)
- For
- idiopathic hypersomnia
- Stage
- sNDA
- When
- Q4 2026 · the company gave a window, not a day; the calendar never invents one
- Source note
- REVITALYZ Phase 3 topline PR (May 12, 2026), reiterated on Q2 2026 call. Note: contractual restriction bars marketing LUMRYZ for IH before March 1, 2028, regardless of approval timing.
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- Source: stocktitan.net ↗ — where this entry was taken from
- SEC filings (8-K) ↗ — press releases are attached to 8-K filings
- ClinicalTrials.gov ↗ — trials of this drug
- ALKS headlines on this site
Alkermes expects to report results from its Phase 3 study of Alixorexton (ALKS 2680) for Idiopathic hypersomnia in Q4 2026 (Oct–Dec) (no exact date yet). Phase 3 is the last stage before a drug can be approved, so this result usually decides the program’s future.
More details
- Entry
- Vibrance-3 Phase 2 completion in idiopathic hypersomnia · Clinical trial results (readout / topline data)
- Drug
- Alixorexton (ALKS 2680)
- For
- Idiopathic hypersomnia
- Stage
- Phase 3 · the last stage before a drug can be approved
- When
- Q4 2026 · the company gave a window, not a day
- Source note
- Q2 2026 earnings call: Vibrance-3 study completion expected in Q4 2026, with topline data to follow; split-dose arm still enrolling.
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- Checked by a person when it was added
- Verify it
- Source: finance.yahoo.com ↗ — where this entry was taken from
- SEC filings (8-K) ↗ — press releases are attached to 8-K filings
- ClinicalTrials.gov ↗ — trials of this drug
- ALKS headlines on this site
Plain-English summary generated from this entry’s own fields (drug, condition, stage, date). Glossary · Open this catalyst’s page
Alkermes expects to report results from its Phase 3 study of Alixorexton (ALKS 2680) for Narcolepsy type 1 and type 2 during 2027 (no exact date yet). Phase 3 is the last stage before a drug can be approved, so this result usually decides the program’s future.
More details
- Entry
- Brilliance Phase 3 studies completion in narcolepsy (NT1/NT2) · Clinical trial results (readout / topline data)
- Drug
- Alixorexton (ALKS 2680)
- For
- Narcolepsy type 1 and type 2
- Stage
- Phase 3 · the last stage before a drug can be approved
- When
- 2027 · the company gave a window, not a day
- Source note
- Q2 2026 earnings call: Phase 3 Brilliance studies (initiated April 2026) completion expected in 2027 (year-level precision only); alixorexton holds FDA Breakthrough Therapy designation in NT1.
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- Checked by a person when it was added
- Verify it
- Source: finance.yahoo.com ↗ — where this entry was taken from
- SEC filings (8-K) ↗ — press releases are attached to 8-K filings
- ClinicalTrials.gov ↗ — trials of this drug
- ALKS headlines on this site
Plain-English summary generated from this entry’s own fields (drug, condition, stage, date). Glossary · Open this catalyst’s page