# MOLBREEVI (molgramostim) inhalation solution PDUFA Event: Autoimmune pulmonary alveolar proteinosis Canonical URL: https://biopharmsignal.com/pdufa-calendar/SVRA/molbreevi-molgramostim-autoimmune-pap Ticker: SVRA Company: Savara, Inc. Event date: 2026-11-22 Event type: FDA Decision Stage: PDUFA Result: Pending Application type: BLA FDA decision expected after review extension. FDA extended the PDUFA target action date by three months to November 22, 2026. ## Event Timeline ### November 22, 2026 — FDA decision expected after review extension FDA extended the PDUFA target action date by three months to November 22, 2026. [Savara — PDUFA review extension](https://investors.savarapharma.com/news/news-details/2026/Savara-Announces-the-U-S--Food--Drug-Administration-FDA-Has-Extended-the-Review-Period-for-the-Molgramostim-Inhalation-Solution-Molgramostim-Biologics-License-Application-BLA-in-Autoimmune-Pulmonary-Alveolar-Proteinosis-Autoimmune-PAP/default.aspx) ### May 19, 2026 — Long-term IMPALA-2 extension data were presented Open-label extension results showed continued improvement after longer exposure and improvement among participants who switched from placebo to molgramostim. [Savara — Long-term IMPALA-2 extension results](https://investors.savarapharma.com/news/news-details/2026/Savara-Presented-Long-Term-Efficacy-and-Safety-Data-from-the-Ongoing-IMPALA-2-Phase-3-Clinical-Trial-Open-Label-OL-Extension-of-Molgramostim-Inhalation-Solution-Molgramostim-in-Autoimmune-Pulmonary-Alveolar-Proteinosis-aPAP/default.aspx) ### April 15, 2026 — FDA extended the review after a major amendment FDA determined that Savara's responses to information requests constituted a major amendment; the agency did not cite safety, efficacy or manufacturing concerns in the extension notice. [Savara — PDUFA review extension](https://investors.savarapharma.com/news/news-details/2026/Savara-Announces-the-U-S--Food--Drug-Administration-FDA-Has-Extended-the-Review-Period-for-the-Molgramostim-Inhalation-Solution-Molgramostim-Biologics-License-Application-BLA-in-Autoimmune-Pulmonary-Alveolar-Proteinosis-Autoimmune-PAP/default.aspx) ### February 20, 2026 — FDA filed the BLA with Priority Review FDA accepted the application, assigned the original August 22, 2026 action date and indicated that it did not plan an advisory committee meeting. [Savara — BLA filing and original PDUFA date](https://investors.savarapharma.com/news/news-details/2026/Savara-Announces-the-U-S--Food-and-Drug-Administration-FDA-Filed-the-MOLBREEVI-Biologics-License-Application-BLA-in-Autoimmune-Pulmonary-Alveolar-Proteinosis-Autoimmune-PAP/default.aspx) ### May 19, 2021 — Phase 3 IMPALA-2 study started The pivotal trial began evaluating inhaled molgramostim in adults with autoimmune pulmonary alveolar proteinosis. [ClinicalTrials.gov — IMPALA-2 study record (NCT04544293)](https://clinicaltrials.gov/study/NCT04544293) ## Regulatory Designations - Priority Review FDA: [Savara — BLA filing and Priority Review](https://investors.savarapharma.com/news/news-details/2026/Savara-Announces-the-U-S--Food-and-Drug-Administration-FDA-Filed-the-MOLBREEVI-Biologics-License-Application-BLA-in-Autoimmune-Pulmonary-Alveolar-Proteinosis-Autoimmune-PAP/default.aspx) - Fast Track FDA: [Savara — PDUFA extension and regulatory designations](https://investors.savarapharma.com/news/news-details/2026/Savara-Announces-the-U-S--Food--Drug-Administration-FDA-Has-Extended-the-Review-Period-for-the-Molgramostim-Inhalation-Solution-Molgramostim-Biologics-License-Application-BLA-in-Autoimmune-Pulmonary-Alveolar-Proteinosis-Autoimmune-PAP/default.aspx) - Breakthrough Therapy FDA: [Savara — PDUFA extension and regulatory designations](https://investors.savarapharma.com/news/news-details/2026/Savara-Announces-the-U-S--Food--Drug-Administration-FDA-Has-Extended-the-Review-Period-for-the-Molgramostim-Inhalation-Solution-Molgramostim-Biologics-License-Application-BLA-in-Autoimmune-Pulmonary-Alveolar-Proteinosis-Autoimmune-PAP/default.aspx) - Orphan Drug FDA: [Savara — PDUFA extension and regulatory designations](https://investors.savarapharma.com/news/news-details/2026/Savara-Announces-the-U-S--Food--Drug-Administration-FDA-Has-Extended-the-Review-Period-for-the-Molgramostim-Inhalation-Solution-Molgramostim-Biologics-License-Application-BLA-in-Autoimmune-Pulmonary-Alveolar-Proteinosis-Autoimmune-PAP/default.aspx) - Orphan Drug EMA: [Savara — PDUFA extension and regulatory designations](https://investors.savarapharma.com/news/news-details/2026/Savara-Announces-the-U-S--Food--Drug-Administration-FDA-Has-Extended-the-Review-Period-for-the-Molgramostim-Inhalation-Solution-Molgramostim-Biologics-License-Application-BLA-in-Autoimmune-Pulmonary-Alveolar-Proteinosis-Autoimmune-PAP/default.aspx) ## Related Pages - SVRA PDUFA calendar: https://biopharmsignal.com/pdufa-calendar/SVRA.md - SVRA company profile: https://biopharmsignal.com/company/SVRA.md - PDUFA calendar: https://biopharmsignal.com/pdufa-calendar.md ## Related News - 2019-02-06 — Savara Provides Update on IMPALA and AVAIL Pivotal Clinical Studies: https://biopharmsignal.com/news/SVRA/savara-provides-update-on-impala-and-avail-pivotal-clinical-studies-c9f20311.md - 2018-12-19 — Savara Announces Interim Results for OPTIMA Clinical Study of Molgradex for the Treatment of NTM: https://biopharmsignal.com/news/SVRA/savara-announces-interim-results-for-optima-clinical-study-of-molgradex-for-the--ae8e5931.md - 2018-11-16 — Savara to Present at the Evercore ISI HealthCONx Conference on Tuesday, November 27th: https://biopharmsignal.com/news/SVRA/savara-to-present-at-the-evercore-isi-healthconx-conference-on-tuesday-november--b77faa12.md - 2018-11-07 — Savara Reports Third Quarter 2018 Financial Results and Provides Business Update: https://biopharmsignal.com/news/SVRA/savara-reports-third-quarter-2018-financial-results-and-provides-business-update-d64d7373.md - 2018-10-31 — Savara Completes Enrollment in Molgradex OPTIMA Clinical Study for the Treatment of NTM: https://biopharmsignal.com/news/SVRA/savara-completes-enrollment-in-molgradex-optima-clinical-study-for-the-treatment-f4ebee85.md