Selected 2027 goal dates
This is a small forward-looking subset, not a full 2027 regulatory pipeline. The same source and review rules apply across the year boundary.
Seven selected U.S. application/indication goal dates, reported by sponsors. Not a complete FDA calendar; dates and status can change. Manual review date is separate from source publication date.
2026-11-14
| 2027-01-29 | Ulixacaltamide HCl | Praxis Precision Medicines | Essential tremor | NDA | FDA review ongoing in sponsor 10-Q | 2026-11-09 | Primary source |
| 2027-02-01 | Mitapivat | Agios Pharmaceuticals | Sickle cell disease | sNDA | Updated goal date in sponsor Q3 release | 2026-11-05 | Primary source |
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Separate a supplemental application from an existing label
The mitapivat row concerns a supplemental application for sickle cell disease. The existence of other indications does not decide this application. Praxis’s ulixacaltamide row is separate from its relutrigine application, even though both appear in the same sponsor filing.
Planning with a future target
Save a source-linked watchlist entry, then recheck it when the sponsor publishes a new quarterly report or regulatory update. As a target approaches, use the sponsor’s current news archive and FDA sources to verify any announced action.
A stale future row should be labeled for review after its goal date, not automatically converted to “approved” or “rejected.”
Source notes
- Praxis Precision Medicines — Ulixacaltamide HCl ↗
Sponsor-reported goal date and indication; source dated 2026-11-09
- Agios Pharmaceuticals — Mitapivat ↗
Sponsor-reported goal date and indication; source dated 2026-11-05
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