FDA approves relutrigine for SCN2A and SCN8A developmental and epileptic encephalopathies on or before the disclosed PDUFA goal date of 2026-12-27

The proposition

What was claimed

The FDA takes an approval action on Praxis' New Drug Application for relutrigine for the treatment of SCN2A and SCN8A developmental and epileptic encephalopathies, with an approval action date on or before 2026-12-27, the PDUFA target action date, as extended by a major amendment, disclosed in Exhibit 99.1 to Praxis' Form 8-K filed 2026-08-06.

Authority

US Food and Drug Administration (FDA), Center for Drug Evaluation and Research (CDER) (US)

Target rungA step on the 12-rung ladder: rungs 1 to 4 are the evidence moving, rungs 5 to 7 are a guideline body, regulator, or payer acting. The ladder, rung by rung

Rung 6: Regulatory action — Label/indication change, approval action, REMS modification, or withdrawal by FDA, EMA, PMDA, Health Canada, etc.

Forecast classThe group of like forecasts this one is counted and scored with, such as FDA actions by their goal dates

FDA action by goal date

Scope

SCN2A and SCN8A developmental and epileptic encephalopathies

The clock

Dates that constrain the record

resolution window

Today

Evidence cutoff2026-10-15 Registered2026-10-15 Window opens2026-10-16 Deadline2026-12-27

Evidence cutoff

2026-10-15

Registered

2026-10-15

Window opens

2026-10-16

Deadline

2026-12-27

Evidence cutoff

2026-10-15
Nothing after this date informed the estimate.

Registered

2026-10-15
Frozen and hashed.

Resolution window

2026-10-16 → 2026-12-27
When the adjudicator can read the outcome.

Event by

2026-12-27
The final qualifying action date; the frozen resolution rule defines what counts. Add to calendar

ledger 55d89291184e24857575879dca8c42900a4c1e7c2030d141349a63f201dde604 Copy · operator record jc-1792036248979-1ca63aaa

Resolution

The rule that settles the forecast

Resolves YES if the openFDA Drugs@FDA records returned by https://api.fda.gov/drug/drugsfda.json?search=openfda.generic_name:%22relutrigine%22&limit=100 and by https://api.fda.gov/drug/drugsfda.json?search=products.active_ingredients.name:%22RELUTRIGINE%22&limit=100, read together (openFDA does not always fill the generic-name field for a new application), contain an application whose ORIG submission has submission_status AP and a submission_status_date on or before 2026-12-27, and the Drugs@FDA approval letter or label for that application names SCN2A or SCN8A developmental and epileptic encephalopathy in its indication. An approval for one of the two genotypes, or a narrower population than the applicant sought, still resolves YES. Resolves NO if no approval action is dated on or before 2026-12-27: a complete response letter, a further goal-date extension, withdrawal or no action. The goal date is frozen as disclosed at the cutoff; a later extension does not move it, and an approval dated after 2026-12-27 resolves NO as occurred_after_deadline. 2026-12-27 is a Sunday; an approval action dated that day still counts. Read no earlier than 2027-01-10. If openFDA has not refreshed by then, the Drugs@FDA web record (https://www.accessdata.fda.gov/scripts/cder/daf/, searched by the name relutrigine) governs. The application number was not public at the cutoff, so the rule reads by name; a suffix on the nonproprietary name or a proprietary name does not change the identification. Resolves unresolvable only if none of these sources can be read after the read floor. Resolves VOID, with the reason recorded, only if FDA withdraws every public record of approval actions named above without an equivalent public successor, so that no approval date for this product can be read; while any of them publishes it, the rule stands.

Source the rule names: https://api.fda.gov/drug/drugsfda.json?search=openfda.generic_name:%22relutrigine%22&limit=100, https://api.fda.gov/drug/drugsfda.json?search=products.active_ingredients.name:%22RELUTRIGINE%22&limit=100, https://www.accessdata.fda.gov/scripts/cder/daf/

Readers: Resolver A, clinical methodology; Resolver B, payer evidence. The same two reader roles are assigned to every forecast registered so far.

What this record will show once it resolves

Frozen covariatesThe facts about the evidence and the authority's process that were frozen with the forecast at its cutoff

The state of the record at the cutoff

Recorded as they stood on 2026-10-15.

review pathway

Priority review (SRC-003), extended three months by major amendment (SRC-002). Center CDER is the drafter's understanding, unverified.

submission type

Original NDA (SRC-003, SRC-005).

evidence class

Registrational cohort of the randomized, double-blind, placebo-controlled Phase 2 EMBOLD study, stopped early for efficacy on Data Monitoring Committee recommendation (SRC-005).

pivotal n

EMBOLD registrational cohort: relutrigine-treated patients n=51 (SRC-005); placebo n not stated in the archived sources.

endpoint type

Motor seizure frequency (clinical): 53% placebo-adjusted seizure reduction over 16 weeks (SRC-005).

approved competitors in class

Not named in the archived sources; Praxis states relutrigine, if approved, "will be the first therapy for SCN2A and SCN8A DEEs" (SRC-001).

months since last guideline revision

not applicable — no guideline is the subject of this proposition

panel cycle position

not applicable — the act is an FDA approval action

sponsor request status

NDA submitted (stated as submitted in the 10-K filed 2026-02-19, SRC-005); accepted for priority review (announced by 2026-05-07, SRC-004); extension notified June 2026 (SRC-002).

odac referral

Stated not planned: "The agency confirmed that no advisory committee meeting is planned." (SRC-001, SRC-003).

sponsor state change

None reported (Praxis reported ~$1.4 billion cash and investments as of March 31, 2026, SRC-004).