Name in SEC filings: Praxis Precision Medicines, Inc.
| Program | Event | Stage | Stated timing | Filing |
|---|---|---|---|---|
| relutrigine | target date (company stated) | PDUFA | December 27, 2026 | SEC filing · |
| ulixacaltamide | PDUFA target date (company stated) | PDUFA | January 29, 2027 | SEC filing · |
| elsunersen | /data readout | Phase 3 | 2027 | 10-Q · |
| relutrigine | submission | — | 2027 | 8-K · |
Source: ORION, orionbiotechai.com/company/PRAX, data as of Oct 13, 2026
https://www.orionbiotechai.com/company/PRAX
relutrigine · PDUFA target date (company stated) · December 27, 2026
SEC sources last checked .
○ Quote matched to filing (not yet reviewed by founder) · ✓ Checked by founder.
SCN2A and SCN8A developmental and epileptic encephalopathies
PDUFA target date (company stated)December 27, 2026
Stage: PDUFASEC filing · “PDUFA target action date”
Public float: $883,200,000 · as of · SEC filing
PDUFA target action date of December 27, 2026
SEC filing · Filed · Last checked
Alert me · Calendar: same stage and window-end month (2026-12)
essential tremor
PDUFA target date (company stated)January 29, 2027
Stage: PDUFASEC filing · “target action date under the Prescription Drug User Fee Act, or PDUFA”
Public float: $883,200,000 · as of · SEC filing
target action date under the Prescription Drug User Fee Act, or PDUFA, of January 29, 2027
SEC filing · Filed · Last checked
Alert me · Calendar: same stage and window-end month (2027-01)
Topline/data readout2027
Stage: Phase 3SEC filing · “Phase 3”
Public float: $883,200,000 · as of · SEC filing
EMBRAVE3, a Phase 3 registrational study for early-seizure-onset SCN2A DEE, and expect to announce topline results in 2027
10-Q · Filed · Last checked
Alert me · Calendar: same stage and window-end month (2027-12)
NDA/BLA submission2027
Stage: —
Public float: $883,200,000 · as of · SEC filing
assuming successful initial NDA approval of relutrigine, the EMERALD study, if positive, would serve as the basis for a supplemental NDA submission in 2027.
8-K · Filed · Last checked
Alert me · Calendar: same stage and window-end month (2027-12)
Company periods and sentences are quoted as written. A matching disclosure uses the SEC filing date for the same program and event type. As of .
| Program / event | Stated period and SEC wording | Disclosure in stated period |
|---|---|---|
| elsunersenClinical results | 2027“EMBRAVE3, a Phase 3 registrational study for early-seizure-onset SCN2A DEE, and expect to announce topline results in 2027” Filed · 10-Q | Period not started The stated period has not started yet, so there is nothing to compare. |
| relutrigineFDA decision | December 27, 2026“PDUFA target action date of December 27, 2026” Filed · SEC original | Period not started The stated period has not started yet, so there is nothing to compare. |
| relutrigineFDA decision | September 27, 2026“PDUFA action date of September 27, 2026” Filed · SEC original | Not compared ORION has no confirmed start and end dates for this wording, so it is not compared with filings. |
| relutrigineFDA decision | December 27, 2026“PDUFA action date of December 27, 2026” Filed · SEC original | Period not started The stated period has not started yet, so there is nothing to compare. |
| relutrigineFDA decision | December 27, 2026“PDUFA date of December 27, 2026” Filed · SEC original | Period not started The stated period has not started yet, so there is nothing to compare. |
| relutrigineSubmission | 2027“assuming successful initial NDA approval of relutrigine, the EMERALD study, if positive, would serve as the basis for a supplemental NDA submission in 2027.” Filed · EX-99.1 | Period not started The stated period has not started yet, so there is nothing to compare. |
| ulixacaltamideFDA decision | January 29, 2027“target action date under the Prescription Drug User Fee Act, or PDUFA, of January 29, 2027” Filed · SEC original | Period not started The stated period has not started yet, so there is nothing to compare. |
| ulixacaltamideFDA decision | January 29, 2027“PDUFA date of January 29, 2027” Filed · SEC original | Period not started The stated period has not started yet, so there is nothing to compare. |
| relutrigineFDA decision | September 27, 2026“PDUFA target action date from September 27, 2026” Filed · SEC original | Not compared ORION has no confirmed start and end dates for this wording, so it is not compared with filings. |
| elsunersenClinical results | 2027“EMBRAVE3 registrational trial, with topline results expected in 2027” Filed · EX-99.1 | Period not started The stated period has not started yet, so there is nothing to compare. |
| elsunersenClinical results | 2027“topline results in 2027” Filed · 10-Q | Period not started The stated period has not started yet, so there is nothing to compare. |
| relutrigineFDA decision | September 27, 2026“PDUFA target action date of September 27, 2026” Filed · SEC original | Not compared ORION has no confirmed start and end dates for this wording, so it is not compared with filings. |
| relutrigineFDA decision | September 27, 2026“PDUFA action date of September 27, 2026” Filed · SEC original | Not compared ORION has no confirmed start and end dates for this wording, so it is not compared with filings. |
| relutrigineSubmission | 2027“Assuming successful initial NDA approval of relutrigine, the EMERALD study, if positive, would serve as the basis for a supplemental NDA submission in 2027.” Filed · EX-99.1 | Period not started The stated period has not started yet, so there is nothing to compare. |
| relutrigineSubmission | 2027“Assuming approval of the NDA for relutrigine, we believe the EMERALD study, if positive, could serve as the basis for a supplemental NDA, or sNDA, submission in 2027.” Filed · 10-Q | Period not started The stated period has not started yet, so there is nothing to compare. |
| ulixacaltamideFDA decision | January 29, 2027“target action date under the Prescription Drug User Fee Act (PDUFA) of January 29, 2027” Filed · SEC original | Period not started The stated period has not started yet, so there is nothing to compare. |
| ulixacaltamideFDA decision | January 29, 2027“PDUFA target action date of January 29, 2027” Filed · SEC original | Period not started The stated period has not started yet, so there is nothing to compare. |
| ulixacaltamideFDA decision | January 29, 2027“target action date under the Prescription Drug User Fee Act, or PDUFA, of January 29, 2027” Filed · SEC original | Period not started The stated period has not started yet, so there is nothing to compare. |
| ulixacaltamideFDA decision | January 29, 2027“target action date under the Prescription Drug User Fee Act of January 29, 2027” Filed · SEC original | Period not started The stated period has not started yet, so there is nothing to compare. |
| relutrigineFDA decision | September 27, 2026“target action date under the Prescription Drug User Fee Act of September 27, 2026” Filed · SEC original | Not compared ORION has no confirmed start and end dates for this wording, so it is not compared with filings. |
| elsunersenClinical results | 2027“topline results in 2027” Filed · 10-K | Period not started The stated period has not started yet, so there is nothing to compare. |
| relutrigineSubmission | 2027“Assuming successful initial NDA approval of relutrigine, the EMERALD study, if positive, would serve as the basis for a supplemental NDA submission in 2027.” Filed · EX-99.1 | Period not started The stated period has not started yet, so there is nothing to compare. |
“Not compared” means ORION has not matched this wording against a complete set of SEC filings for its period. It says nothing either way about whether a matching filing exists. Wording without exact dates is not given calendar dates.
Historical summaries and source dates are retained separately from the SEC timing quotes above. Earlier publications were collected retrospectively.
Historical catalog checked .
No historical announcement trail is retained for this company in this catalog.
Original ClinicalTrials.gov record · Open the selected study
These are selected linked records and dated source metadata, not a live registry recheck or the company’s full pipeline. Company announcements and the selected registry study are separate evidence sets. No stage or event timing is borrowed between them.
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