FDA approves molgramostim (MOLBREEVI) for autoimmune pulmonary alveolar proteinosis on or before the disclosed PDUFA goal date of 2026-11-22

The proposition

What was claimed

The FDA takes an approval action on Savara's Biologics License Application for molgramostim inhalation solution (proposed trade name MOLBREEVI) for the treatment of autoimmune pulmonary alveolar proteinosis, with an approval action date on or before 2026-11-22, the PDUFA target action date disclosed in Savara's Form 10-Q filed 2026-08-11.

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

Autoimmune pulmonary alveolar proteinosis

The clock

Dates that constrain the record

resolution window

Today

Evidence cutoff2026-09-26 Registered2026-09-26 Window opens2026-09-27 Deadline2026-11-22

Evidence cutoff

2026-09-26

Registered

2026-09-26

Window opens

2026-09-27

Deadline

2026-11-22

Evidence cutoff

2026-09-26
Nothing after this date informed the estimate.

Registered

2026-09-26
Frozen and hashed.

Resolution window

2026-09-27 → 2026-11-22
When the adjudicator can read the outcome.

Event by

2026-11-22
The final qualifying action date; the frozen resolution rule defines what counts. Add to calendar

ledger 0b638dd5666d29fd6769192cbf9068ceb940dba70bb0e7bfe01b84028d705d81 Copy · operator record jc-1790461082283-30eda9c2

Resolution

The rule that settles the forecast

Resolves YES if the openFDA Drugs@FDA record returned by https://api.fda.gov/drug/drugsfda.json?search=openfda.generic_name:%22molgramostim%22 (or, if that returns nothing, by https://api.fda.gov/drug/drugsfda.json?search=products.active_ingredients.name:%22molgramostim%22) contains an application whose ORIG submission has submission_status AP and a submission_status_date on or before 2026-11-22, and the Drugs@FDA approval letter or label for that application names autoimmune pulmonary alveolar proteinosis in its indication. A proper name that adds a suffix to molgramostim still matches. An approval for a narrower autoimmune pulmonary alveolar proteinosis population than the applicant sought still resolves YES. Resolves NO if no approval action is dated on or before 2026-11-22: 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 2026-11-22 resolves NO as occurred_after_deadline. 2026-11-22 is a Sunday; an approval action dated on or before it counts whatever the weekday. Read no earlier than 2026-12-06. If openFDA has not refreshed by then, the Drugs@FDA web record (https://www.accessdata.fda.gov/scripts/cder/daf/, searched by the name molgramostim) governs; if Drugs@FDA does not show the application either, FDA's Purple Book (https://purplebooksearch.fda.gov/) record of a licensed molgramostim product with Savara or a Savara subsidiary as licensee governs, read with the approval letter for the indication. The application number was not public at the cutoff, so the rule reads by generic name; if the product carries a proprietary name, MOLBREEVI or another, the generic name still identifies it. Savara expected CDER to hold primary jurisdiction (SRC-002); if CBER licenses the product instead, the Purple Book record and the CBER approval letter govern on the same terms. 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:%22molgramostim%22, https://www.accessdata.fda.gov/scripts/cder/daf/, https://purplebooksearch.fda.gov/

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 2026-09-26.

review pathway

Priority Review; Breakthrough Therapy and Fast Track designations (SRC-001, SRC-002); goal date extended three months by a major amendment (SRC-001)

submission type

original BLA, resubmitted after a Refusal to File and filed February 2026 (inhaled GM-CSF with a nebulizer; CDER, as Savara expects, SRC-002)

evidence class

one randomized, double-blind, placebo-controlled phase 3 trial, IMPALA-2 (SRC-002); the earlier phase 2/3 IMPALA trial missed its primary endpoint (SRC-002)

pivotal n

164 patients enrolled in IMPALA-2 (SRC-002)

endpoint type

change from baseline in DLCO (gas exchange) at Week 24; secondary endpoints on SGRQ and exercise capacity (SRC-002)

approved competitors in class

none — no medicine is approved for autoimmune PAP in the U.S.; whole lung lavage is the current procedure (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

BLA filed February 2026 with Priority Review; responses to FDA information requests classed as a major amendment in April 2026 (SRC-001)

odac referral

none announced in the archived sources

sponsor state change

drug substance manufacture moved from GEMA to Fujifilm before resubmission; some vendors not yet FDA-inspected as of the 10-K filed 2026-03-13 (SRC-002)