Registered forecast
35% registered probability event by 2026-11-14 Unresolved
FDA approves the IGALMI at-home use supplement to NDA 215390 on or before the disclosed PDUFA goal date of 2026-11-14
FF-009 Registered - Registered probability
- 35%
- Event by
- 2026-11-14
- Resolution window
- 2026-09-27 → 2026-11-14
- Target rung
- 5 Guideline
- 6 Regulatory
- 7 Coverage
- Baselines it has to beat
-
- Authority base rate 85%
- Calendar cycle 80%
- Analyst proxy 40%
nextconsensus.com/forecast/ff-009/ registry snapshot 2026-10-06 Share image
NextConsensus registered this probability on 2026-09-26. It is one of 14 registered FDA goal-date forecasts.
The proposition
What was claimed
The FDA takes an approval action on a supplement to NDA 215390 (dexmedetomidine sublingual film, IGALMI; applicant at the cutoff BioXcel Therapeutics) whose approved labeling permits IGALMI to be taken at home, without the supervision of a healthcare provider, for the acute treatment of agitation associated with schizophrenia or bipolar disorder, with an approval action date on or before 2026-11-14, the PDUFA target action date disclosed in BioXcel's Form 10-Q filed 2026-08-13.
- 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
- Agitation associated with bipolar disorder or schizophrenia (at-home use)
The estimate
The number and the baselines it has to beat
The alternatives it was registered against, each with the reasoning that produced it.
ESTIMATE FROM THE SHAPE OF THE CLASS, NOT AN ENUMERATED COUNT. Efficacy supplements to approved drugs are approved at their first goal date more often than original applications. The calendar's own count does not exist yet.
A clock-only model: the goal date is inside the window, FDA meets most goal dates, and most first-cycle supplement actions are approvals. With no input beyond the clock it cannot see the package request, the supplier facility or the sponsor's bankruptcy.
An analyst reading the same public record on 2026-09-24 would weigh a completed phase 3 safety trial and positive pre-sNDA feedback against an FDA request to redesign the package during the review, an OAI classification at the sole active-ingredient supplier, and an applicant in Chapter 11 selling itself with milestones tied to the timing of this action. Such an analyst would call approval by the date less likely than not. Estimated by reconstructing that read, not by surveying analysts.
Regulatory action (FDA): offered on judgment, with no calibration figure until 15 in the class have resolved.
The clock
Dates that constrain the record
- Evidence cutoff
- 2026-09-26
Nothing after this date informed the estimate. - Registered
- 2026-09-26
Frozen and hashed. - Resolution window
- 2026-09-27 → 2026-11-14
When the adjudicator can read the outcome. - Event by
- 2026-11-14
The final qualifying action date; the frozen resolution rule defines what counts. Add to calendar
132037f290c965911776fecf29f898a2e433a4794ebee5b18eb54c6e3c04a89d · operator record jc-1790461082269-0a69cc40
Around this record
- This kind of deadline
- Check it, follow it
Single-claim evaluation
Waiting on the FDA for an asset of your own?
Name the claim, who decides it, and the date your team commits to: a P&T meeting, an HTA submission, a label negotiation, a deal closing. Yours is registered under the same rules as the forecast on this page.
Resolution
The rule that settles the forecast
Resolves YES if the openFDA Drugs@FDA record for application NDA215390 (https://api.fda.gov/drug/drugsfda.json?search=application_number:%22NDA215390%22) contains a submission with submission_type SUPPL, submission_status AP and a submission_status_date on or before 2026-11-14, and either the Drugs@FDA approval letter for that supplement states that it provides for use at home, in the outpatient setting or without the supervision of a healthcare provider, or the label approved with it permits any dose to be taken without the supervision of a healthcare provider. The supplement is identified by that content, not by its number or class code. At the cutoff the approved label required administration under the supervision of a healthcare provider (SRC-001), and the latest approved supplement was SUPPL 2, approved 2025-11-19, which openFDA classes EFFICACY and Drugs@FDA lists as Efficacy-New Indication but which updated the prescribing information with a repeat-dosing study and is not this supplement (SRC-002, SRC-003, SRC-005). A label that keeps the first dose under supervision and permits later doses at home still resolves YES, as does an at-home approval narrower than the applicant sought (one of the two disorders, or one strength). An approval under a new holder of NDA 215390 counts. Resolves NO if no such supplement is approved on or before 2026-11-14: 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 2026-11-14 resolves NO as occurred_after_deadline. 2026-11-14 is a Saturday; an approval action dated that day still counts. Read no earlier than 2026-11-28; if openFDA has not refreshed, the Drugs@FDA web record for NDA 215390 (https://www.accessdata.fda.gov/scripts/cder/daf/) governs. Resolves unresolvable only if neither source 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=application_number:%22NDA215390%22, 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
Beside every result, the count for its class (FDA action by goal date): registered, resolved, unresolved, and expired. One forecast is one instance, not a rate.
- The finding
- As the rule above reads it: occurred on time, did not occur, or left unscored.
- The readers and their sources
- Two reader roles read the source named above: Resolver A, clinical methodology; Resolver B, payer evidence. Who adjudicated it is named here, with the sources they read when the adjudication lists them. Being named as a reader means applying the frozen rule to the public record; it is not support for the estimate, the method, or NextConsensus.
- The number against its baselines
- 35% beside three baselines, each scored by the same rule (squared error), so a reader can see how the record did against each of them.
Reasoning
What the number rests on
The facts it was built from are below, as they stood at the cutoff, with every source archived; each baseline above carries the reasoning that produced it. The written mechanism and the conditions that would make the proposition ill-posed were frozen with the record and are held in the ledger, which the hash on this page covers.
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 2026-09-26.
- review pathway
- not stated in the archived sources; ten months from submission to goal date is consistent with standard review (drafter's understanding, unverified)
- submission type
- efficacy supplement to NDA 215390, a 505(b)(2) application for a new dosage form (SRC-002, SRC-003); seeks a new setting of use, not a new disorder (SRC-001)
- evidence class
- randomized, placebo-controlled 12-week phase 3 trial, SERENITY At-Home, with safety as the primary objective and exploratory efficacy (SRC-001)
- pivotal n
- 246 randomized; 208 patients treated 2,437 agitation episodes (SRC-001)
- endpoint type
- primary objective safety and tolerability of the 120 mcg dose at home; exploratory efficacy on a modified CGI-S scale scored by patients or caregivers (SRC-001)
- approved competitors in class
- none for at-home use, as BioXcel states: no FDA-approved options for the at-home population (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
- sNDA submitted 2026-01-14 and accepted with a PDUFA target action date; FDA requested a change to the child-resistant package feature during review, and a new design was planned (SRC-001)
- odac referral
- none announced in the archived sources
- sponsor state change
- Chapter 11 petition 2026-08-27; stalking-horse sale of substantially all assets to Teva pending court approval (SRC-004); latest approved supplement SUPPL 2, 2025-11-19, a prescribing-information update that is not the at-home supplement (SRC-002, SRC-003)
Sources
Everything the estimate was built from
Each was retrieved on or before the 2026-09-26 cutoff and archived at the digest shown. If a publisher edits a page after the fact, the digest stops matching and the substitution is visible.
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SRC-001BioXcel Therapeutics 10-Q for the quarter ended 2026-06-30, filed 2026-08-13. States that IGALMI is approved for self-administration under the supervision of a health care provider; that an sNDA for IGALMI for at-home use in the acute treatment of agitation associated with bipolar disorders or schizophrenia, based on the SERENITY At-Home phase 3 safety trial and designed to remove the healthcare supervision requirement, was submitted on January 14, 2026 and accepted with a PDUFA target action date of November 14, 2026. Also states that during the review FDA requested a change to the child-resistant feature of the primary package, which BioXcel planned to answer with a new package design, and that a facility of the sole active-ingredient supplier is under an FDA official action indicated (OAI) classification that BioXcel says could delay the action. -
SRC-002openFDA Drugs@FDA record for NDA215390 (IGALMI, dexmedetomidine sublingual film) retrieved at the cutoff. The starting state: ORIG 1 approved 2022-04-05, SUPPL 1 (LABELING) approved 2022-10-24, SUPPL 2 (EFFICACY) approved 2025-11-19. No supplement is pending in the record; SUPPL 2 predates the at-home sNDA's 2026-01-14 submission (SRC-001). -
SRC-003FDA approval letter for NDA 215390/S-002, signed 2025-11-19. S-002 is a prior-approval supplement updating Sections 5.4, 5.5 and 9 of the prescribing information with the results of Study BXCL501-404, a repeat-dosing study intended to fulfil a postmarketing requirement. It is not the at-home supplement, although openFDA classes it EFFICACY and Drugs@FDA lists it as Efficacy-New Indication. -
SRC-004BioXcel Therapeutics 8-K filed 2026-08-28. States that BioXcel and two subsidiaries filed voluntary Chapter 11 petitions on 2026-08-27 and continue to operate as debtors-in-possession, and that they signed a stalking-horse asset purchase agreement with Teva for substantially all assets: 57.5 million dollars upfront plus up to 67.5 million dollars in development milestones tied to the outcome and timing of the pending IGALMI at-home sNDA, subject to higher bids and court approval, with a termination right if the sale is not consummated by 2026-10-30. -
SRC-005Drugs@FDA web record for NDA 215390 retrieved at the cutoff. Lists ORIG-1 (2022-04-05), SUPPL-1 (2022-10-24, Labeling-Container/Carton Labels) and SUPPL-2 (2025-11-19, Efficacy-New Indication) with their letters and labels. The category Drugs@FDA gives SUPPL-2 is why the resolution rule identifies the at-home supplement by the content of its letter or label, not by its category or class code.