FDA approves ulixacaltamide for essential tremor on or before the disclosed PDUFA goal date of 2027-01-29

The proposition

What was claimed

The FDA takes an approval action on Praxis' New Drug Application for ulixacaltamide hydrochloride for the treatment of essential tremor in adults, with an approval action date on or before 2027-01-29, the PDUFA date 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

Essential tremor in adults

The clock

Dates that constrain the record

resolution window

Today

Evidence cutoff2026-10-15 Registered2026-10-15 Window opens2026-10-16 Deadline2027-01-29

Evidence cutoff

2026-10-15

Registered

2026-10-15

Window opens

2026-10-16

Deadline

2027-01-29

Evidence cutoff

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

Registered

2026-10-15
Frozen and hashed.

Resolution window

2026-10-16 → 2027-01-29
When the adjudicator can read the outcome.

Event by

2027-01-29
The final qualifying action date; the frozen resolution rule defines what counts. Add to calendar

ledger 6cd7820ace1c35bc8346892f8b767d059fcb0e7d819a5fdef261a11e9b8aa51b Copy · operator record jc-1792036249340-0a27ee0a

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:%22ulixacaltamide%22&limit=100 and by https://api.fda.gov/drug/drugsfda.json?search=products.active_ingredients.name:%22ULIXACALTAMIDE%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 2027-01-29, and the Drugs@FDA approval letter or label for that application names essential tremor in its indication. An approval for a narrower essential tremor population than the applicant sought still resolves YES. Resolves NO if no approval action is dated on or before 2027-01-29: a complete response letter, a 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 2027-01-29 resolves NO as occurred_after_deadline. Read no earlier than 2027-02-12. If openFDA has not refreshed by then, the Drugs@FDA web record (https://www.accessdata.fda.gov/scripts/cder/daf/, searched by the name ulixacaltamide) 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:%22ulixacaltamide%22&limit=100, https://api.fda.gov/drug/drugsfda.json?search=products.active_ingredients.name:%22ULIXACALTAMIDE%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, including the one field whose value was unknown then. It is left unknown rather than filled in.

review pathway

unknown — not stated in the archived sources (no priority review stated for this NDA, unlike relutrigine). Center CDER is the drafter's understanding, unverified.

submission type

Original NDA (SRC-002, SRC-003).

evidence class

Two Phase 3 pivotal studies in the Essential3 program: Study 1 (double-blind, placebo-controlled parallel-group) and Study 2 (randomized-withdrawal) (SRC-004).

pivotal n

Study 1: 473 patients randomized 1:1; Study 2: 238 patients enrolled (SRC-004).

endpoint type

Clinical/functional: change from baseline in modified Activities of Daily Living 11 (mADL11) at Week 8 (Study 1); proportion maintaining response (Study 2) (SRC-004).

approved competitors in class

Approved ET therapies such as propranolol; off-label primidone (SRC-004). Praxis states ulixacaltamide is the first investigational therapy with a positive Phase 3 program in ET (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-004); FDA acceptance announced April 14, 2026 (SRC-003).

odac referral

Stated not planned: FDA "is not planning to hold an advisory committee meeting" (SRC-003); "The agency confirmed that no advisory committee meeting is planned" (SRC-002).

sponsor state change

None reported.