Registered forecast
70% registered probability event by 2027-02-12 Unresolved
FDA approves oral tinlarebant for Stargardt disease type 1 on or before the disclosed PDUFA goal date of 2027-02-12
FF-053 Registered - Registered probability
- 70%
- Event by
- 2027-02-12
- Resolution window
- 2026-10-22 → 2027-02-12
- Target rung
- 5 Guideline
- 6 Regulatory
- 7 Coverage
- Baselines it has to beat
-
- Authority base rate 80%
- Calendar cycle 80%
- Analyst proxy 70%
nextconsensus.com/forecast/ff-053/ registry snapshot 2026-10-21 Share image
NextConsensus registered this probability on 2026-10-21. It is one of 27 registered FDA goal-date forecasts.
The proposition
What was claimed
The FDA takes an approval action on Belite Bio's New Drug Application for oral tinlarebant for the treatment of Stargardt disease type 1 (STGD1), with an approval action date on or before 2027-02-12, the PDUFA target action date disclosed in Exhibit 99.1 to Belite Bio's Form 6-K 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
- Stargardt disease type 1
The estimate
The number and the baselines it has to beat
The alternatives it was registered against, each with the reasoning that produced it. They were set at registration: how often this kind of decision happens on time, what the calendar alone suggests, and a reading of the same public record without this method. Each one's reasoning shows whether it is a count of past decisions or an estimate.
ESTIMATE FROM THE SHAPE OF THE CLASS, NOT AN ENUMERATED COUNT. Original NDAs under Priority Review with a positive phase 3 trial are approved at their first goal date in a large majority of cases; first NDAs from small sponsors carry more complete-response risk on manufacturing and inspection. The calendar's own met-goal-date share for disclosed PDUFA dates does not exist yet (docs/foundations/short-horizon-reference-classes.md §4.1).
A clock-only model: the goal date is inside the window, FDA meets most goal dates, and most first-cycle actions on original NDAs are approvals. With no evidence input it cannot tell a strong application from a weak one.
An analyst reading the same filings on 2026-10-20 would weigh a phase 3 trial that met its primary endpoint, Priority Review and Breakthrough Therapy designation, and a disease with no approved treatment, against one modest-sized trial on a structural endpoint with no visual-acuity result reported, drug-related ocular adverse events reported as mild (SRC-006), and a first NDA from a small sponsor. 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
- 2026-10-21
Nothing after this date informed the estimate. - Registered
- 2026-10-21
Frozen and hashed. - Resolution window
- 2026-10-22 → 2027-02-12
When the outcome can be read against the rule. - Event by
- 2027-02-12
The final qualifying action date; the frozen resolution rule defines what counts. Add to calendar
46b8f22573354dbaf2a5b1906a9032fa8d1670a760ef413cc6f6671b0b62f077 · operator record jc-1792548712659-9d77113a
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
The application number was not public at the cutoff, and openFDA held no record for the ingredient (SRC-004, SRC-005). The adjudicator identifies the qualifying approval by its indication plus its ingredient, never by a name the adjudicator infers: an approval action whose Drugs@FDA approval letter or label names Stargardt disease (STGD1, or Stargardt disease caused by ABCA4 mutations) in its indication, for a product whose active ingredient is tinlarebant (LBS-008) or a salt of it, under any applicant (Belite Bio, Inc or a Belite Bio subsidiary) and any proprietary name. Resolves YES if the openFDA Drugs@FDA records returned by https://api.fda.gov/drug/drugsfda.json?search=products.active_ingredients.name:%22TINLAREBANT%22&limit=100 and by https://api.fda.gov/drug/drugsfda.json?search=openfda.generic_name:%22tinlarebant%22&limit=100, read together (openFDA does not always fill the generic-name field for a new application), contain such an approval: an application whose ORIG submission has submission_status AP and a submission_status_date on or before 2027-02-12. An approval for a narrower STGD1 population than the applicant sought (by age, for example) still resolves YES, as does accelerated rather than traditional approval. Resolves NO if no approval action is dated on or before 2027-02-12: 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 2027-02-12 resolves NO as occurred_after_deadline. 2027-02-12 is a Friday. Read no earlier than 2027-02-26. If openFDA has not refreshed by then, or both queries return nothing, the Drugs@FDA web record (https://www.accessdata.fda.gov/scripts/cder/daf/, searched by the name tinlarebant) governs, under the same identification test. 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:%22tinlarebant%22&limit=100, https://api.fda.gov/drug/drugsfda.json?search=products.active_ingredients.name:%22TINLAREBANT%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
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
- 70% 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 2026-10-21.
- review pathway
- Priority Review (SRC-001, SRC-002). Breakthrough Therapy, Fast Track, Rare Pediatric Disease and Orphan Drug designations in the U.S. (SRC-001). Center CDER is the drafter's understanding (a small-molecule NDA), unverified.
- submission type
- Original NDA for oral tinlarebant in STGD1 (SRC-001); application number not public, and openFDA holds no record for the ingredient (SRC-004, SRC-005).
- evidence class
- One completed placebo-controlled phase 3 trial, DRAGON: 24 months, 104 subjects aged 12 to 20, randomized 2:1, double-masked, which met its primary endpoint (SRC-001, SRC-003). A phase 2/3 trial (DRAGON II) is ongoing (SRC-001).
- pivotal n
- 104 (SRC-001)
- endpoint type
- Structural imaging endpoint: growth rate of atrophic retinal lesions, reduced 35.7% against placebo (SRC-006; SRC-002 describes it as slowing lesion growth); quantitative autofluorescence reported as a secondary endpoint (SRC-001). The archived sources report no visual-acuity result.
- approved competitors in class
- None: Belite Bio states tinlarebant would be the first approved treatment for STGD1 (SRC-001, SRC-002).
- 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 accepted with Priority Review, announced by 2026-08-12 (SRC-001); Japanese NDA under Sakigake submitted 2026-09-08 (SRC-002).
- odac referral
- none announced in the archived sources
- sponsor state change
- Uplisted to the Nasdaq Global Select Market 2026-10-19 (SRC-003); no change to the application recorded in the archived sources.
Sources
Everything the estimate was built from
Each was retrieved on or before the 2026-10-21 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-001Belite Bio Form 6-K Exhibit 99.1, filed 2026-08-13: Q2 2026 results press release dated 2026-08-12. FDA accepted the NDA for tinlarebant in Stargardt disease type 1 with Priority Review and a PDUFA target action date of February 12, 2027; phase 3 DRAGON (24 months, 104 subjects aged 12 to 20, randomized 2:1) met its primary endpoint; Breakthrough Therapy, Fast Track, Rare Pediatric Disease and Orphan Drug designations; 279.9 million dollars cash and 500.1 million dollars in treasuries at 2026-06-30. -
SRC-002Belite Bio Form 6-K Exhibit 99.1, filed 2026-09-08: NDA for tinlarebant in STGD1 submitted to Japan's MHLW under the Sakigake designation; restates the U.S. Priority Review and the PDUFA target action date of February 12, 2027, and describes the data as slowing the growth rate of retinal lesions against placebo. -
SRC-003Belite Bio Form 6-K Exhibit 99.1, filed 2026-10-19: uplisting to the Nasdaq Global Select Market; restates that DRAGON met its primary endpoint and that DRAGON II and PHOENIX are ongoing. No change to the U.S. application. -
SRC-004openFDA drugsfda products.active_ingredients.name:"TINLAREBANT", retrieved 2026-10-20: 404 No matches found. No application for the ingredient. -
SRC-005openFDA drugsfda openfda.generic_name:"tinlarebant", retrieved 2026-10-20: 404 No matches found. -
SRC-006Healio, 2026-01-02, reporting Belite Bio's DRAGON topline release: lesion growth rate reduced 35.7% against placebo (primary endpoint met); four treatment-related drug discontinuations; the most common drug-related ocular adverse event was xanthopsia, with delayed dark adaptation and night vision impairment, mild and mostly resolved during the trial. It reports no visual-acuity result.