Registered forecast
65% registered probability event by 2027-02-28 Unresolved
FDA approves Palvella’s QTORIN rapamycin (sirolimus) topical gel NDA for microcystic lymphatic malformations on or before the disclosed PDUFA goal date of 2027-02-28
FF-061 Registered - Registered probability
- 65%
- Decision by
- 2027-02-28
- Reading window
- 2026-11-08 → 2027-02-28
- Decision stage
- 5 Guideline
- 6 Regulatory
- 7 Coverage
- Baselines it has to beat
-
- Authority base rate 80%
- Calendar cycle 70%
- Analyst proxy 65%
nextconsensus.com/forecast/ff-061/ registry snapshot 2026-11-07 Share image
NextConsensus registered this probability on 2026-11-04. It is one of 35 registered FDA goal-date forecasts.
The proposition
What was registered
The FDA takes an approval action on Palvella Therapeutics’ New Drug Application for QTORIN 3.9% rapamycin anhydrous gel (QTORIN rapamycin; rapamycin is also known as sirolimus) for the treatment of microcystic lymphatic malformations, with an approval action date on or before 2027-02-28, the PDUFA target action date disclosed in Exhibit 99.1 to Palvella’s Form 8-K filed 2026-10-28.
- Who decides
- US Food and Drug Administration (FDA), Center for Drug Evaluation and Research (CDER) (US)
- Decision stageThe kind of body that has to act: a guideline panel, a regulator, or a payer. 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.
- Decision typeThe type of decision this forecast is counted with, such as FDA actions by their goal dates
- FDA action by goal date
- Scope
- Microcystic lymphatic malformations
The estimate
The number and the baselines it has to beat
The estimate that the named body takes the action by the deadline, from what was public at the cutoff.
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 applications under Priority Review are approvals. With no evidence input it cannot tell a strong application from a weak one.
An analyst reading the same filings on 2026-11-03 would weigh Breakthrough Therapy designation, Priority Review, a known active ingredient with low systemic exposure, and a disease with no approved therapy, against a single-arm baseline-controlled pivotal study on a clinician-rated scale and a first NDA from a company with no commercial product. 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 method and every record are public, so you can check the work.
The clock
Dates that constrain the record
- Evidence as of
- 2026-11-07
Nothing after this date informed the estimate. - Registered
- 2026-11-04
Frozen and hashed. - Reading window
- 2026-11-08 → 2027-02-28
When the outcome can be read against the rule. - Event by
- 2027-02-28
The final qualifying action date; the frozen resolution rule defines what counts. Add to calendar
dcca2fbb514f824361af6941a485c8ed76b0a7317ef65af59a3ff3d189c87242 · operator record jc-1793799391830-23dd6bab Around this record
- This kind of deadline
- Check it, follow it
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Resolution
The rule that settles the forecast
The application number was not public at the cutoff, and openFDA held no record for the applicant (SRC-005). The adjudicator identifies the qualifying approval by its ingredient, route and indication, never by a name the adjudicator infers: an approval action on an original NDA for a topically applied product (gel, or any topical dosage form) whose active ingredient is sirolimus (rapamycin), under any applicant (Palvella Therapeutics, Inc or a Palvella subsidiary or licensee) and any proprietary name, whose Drugs@FDA approval letter or label names lymphatic malformations (microcystic, or lymphatic malformations including microcystic) in its indication. The sirolimus records that existed at the cutoff do not count: none is a Palvella application and none names lymphatic malformations (SRC-003). Resolves YES if the openFDA Drugs@FDA records returned by https://api.fda.gov/drug/drugsfda.json?search=products.active_ingredients.name:%22SIROLIMUS%22&limit=100 and by https://api.fda.gov/drug/drugsfda.json?search=sponsor_name:%22PALVELLA%22&limit=100, read together, contain such an approval: an application whose ORIG submission has submission_status AP and a submission_status_date on or before 2027-02-28. An approval for a narrower population than the applicant sought (by age, for example) still resolves YES. A tentative approval does not count. Resolves NO if no approval action is dated on or before 2027-02-28: 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 2027-02-28 resolves NO as occurred_after_deadline. 2027-02-28 is a Sunday; an approval action dated on the preceding Friday or earlier counts. Read no earlier than 2027-03-14. If openFDA has not refreshed by then, or both queries return no qualifying record, the Drugs@FDA web record (https://www.accessdata.fda.gov/scripts/cder/daf/, searched by the names sirolimus, rapamycin and QTORIN) 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=products.active_ingredients.name:%22SIROLIMUS%22&limit=100, https://api.fda.gov/drug/drugsfda.json?search=sponsor_name:%22PALVELLA%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
- 65% 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 2026-11-07.
- review pathway
- Priority review, with rolling review granted June 2026; Breakthrough Therapy, Fast Track and Orphan Drug designations (SRC-001, SRC-004). Center CDER is the drafter’s understanding (a small-molecule NDA), unverified.
- submission type
- Original NDA for a new topical formulation of rapamycin (sirolimus); application number not public, and openFDA holds no record for the applicant (SRC-001, SRC-005).
- evidence class
- One single-arm, baseline-controlled phase 3 study, SELVA, in participants aged 3 and older, with phase 2 results and published literature on off-label rapamycin as support (SRC-001, SRC-004).
- pivotal n
- 51 enrolled, 50 treated; 49 aged 6 and older in the intent-to-treat population, 43 completing the efficacy evaluation period (SRC-004)
- endpoint type
- Clinician-rated global assessment: change from baseline on the microcystic LM Investigator Global Assessment (mLM-IGA) at week 24 (primary) (SRC-004).
- approved competitors in class
- none — Palvella states no FDA-approved therapy exists for microcystic LMs (SRC-001); approved sirolimus products are for other indications (SRC-003)
- 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
- Pre-NDA meeting May 2026; rolling review granted and first module submitted June 2026; NDA accepted with Priority Review and a goal date of 2027-02-28, announced 2026-10-28 (SRC-001, SRC-004).
- odac referral
- none announced in the archived sources
- sponsor state change
- none bearing on the application recorded in the archived sources; Palvella says it is preparing a standalone U.S. launch in the first half of 2027 (SRC-001).
Sources
Everything the estimate was built from
Each was retrieved on or before the 2026-11-07 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-001Palvella Therapeutics Form 8-K Exhibit 99.1, filed 2026-10-28: FDA accepted for filing and granted Priority Review to the NDA for QTORIN 3.9% rapamycin anhydrous gel for microcystic lymphatic malformations, with a PDUFA target action date of February 28, 2027. The NDA rests on phase 3 SELVA (all six prespecified efficacy endpoints p<0.001), phase 2 results and published literature on off-label rapamycin; Breakthrough Therapy, Fast Track and Orphan Drug designations; systemic rapamycin below 2 ng/mL at all measured timepoints; no FDA-approved therapy for microcystic LMs. -
SRC-002Ligand Pharmaceuticals Form 8-K Exhibit 99.1, filed 2026-10-29: Q3 2026 results release. Under Qtorin rapamycin, it reports Palvella's 2026-10-28 announcement that FDA accepted and granted Priority Review to the NDA for microcystic LMs, PDUFA target action date February 28, 2027. The same application as SRC-001, disclosed by a partner (calendar row CAL-PDUFA-045). -
SRC-003openFDA drugsfda products.active_ingredients.name:"SIROLIMUS", retrieved 2026-11-03: 16 applications, none from Palvella and none for lymphatic malformations. Topical sirolimus products are HYFTOR gel (NDA213478, Nobelpharma) and SCOMARA cream (NDA218528, AFT Pharmaceuticals); the rest are RAPAMUNE, FYARRO and oral generics. -
SRC-004Palvella Therapeutics Form 10-Q for the quarter ended 2026-06-30, filed 2026-08-04: SELVA design and topline results (51 enrolled, 50 treated, 49 aged 6 and older in the intent-to-treat population; mean mLM-IGA improvement +2.13, p<0.001; 95% (41/43) improved by at least 1 point); pre-NDA meeting completed May 2026; rolling review granted and first NDA module submitted June 2026; microcystic LMs driven by PIK3CA mutations activating the PI3K/mTOR pathway. -
SRC-005openFDA drugsfda sponsor_name:"PALVELLA", retrieved 2026-11-03: 404 No matches found. No application from the applicant.