Savara (SVRA) has upcoming FDA regulatory milestones for MOLBREEVI and Molgramostim (IMPALA-2). The table below outlines estimated target dates and event types for these pending regulatory actions.
This section highlights FDA-related milestones and regulatory updates for drugs developed by Savara (SVRA).
Over the past two years, Savara has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
Molgramostim and MOLBREEVI. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
Select a button below to view the list of FDA events for that drug.
Molgramostim (IMPALA-2) FDA Regulatory Timeline and Events
Molgramostim (IMPALA-2) is a drug developed by Savara for the following indication: Autoimmune Pulmonary Alveolar Proteinosis (aPAP).
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- Molgramostim (IMPALA-2)
- Announced Date:
- April 15, 2026
- Target Action Date:
- November 22, 2026
- Indication:
- Autoimmune Pulmonary Alveolar Proteinosis (aPAP)
Announcement
Savara Inc. announced Prescription Drug User Fee Act (PDUFA) Target Action Date Extended by Three Months to November 22, 2026
AI Summary
Savara Inc. announced that the U.S. Food and Drug Administration has extended the Prescription Drug User Fee Act (PDUFA) target action date for its regulatory submission by three months. The new target date for the agency’s decision is November 22, 2026. The company’s original review timeline will be shifted to this later date, which delays when a final FDA determination can be expected.
This extension means the FDA will have additional time to complete its review; it does not by itself indicate whether the application will be approved or denied. Savara and investors should expect updates as the new date approaches and if the company provides further information or receives requests from the agency during the extended review period.
Read Announcement- Drug:
- Molgramostim (IMPALA-2)
- Announced Date:
- April 15, 2026
- Indication:
- Autoimmune Pulmonary Alveolar Proteinosis (aPAP)
Announcement
Savara Inc. announced that the FDA has extended the review period for the molgramostim BLA in autoimmune PAP by three months.
AI Summary
Savara Inc. announced that the U.S. Food and Drug Administration has extended the review period for its biologics license application (BLA) for molgramostim, a treatment candidate for autoimmune pulmonary alveolar proteinosis (PAP). The agency added three months to the review clock, moving the PDUFA target action date to November 22, 2026.
The extension delays the FDA’s final decision on the molgramostim BLA by three months. Savara’s public notice did not provide detailed reasons for the extension. The company and regulators will continue the review process during the extended period, and stakeholders will await further updates about the application and any next steps leading to a regulatory decision.
Read Announcement- Drug:
- Molgramostim (IMPALA-2)
- Announced Date:
- April 14, 2026
- Indication:
- Autoimmune Pulmonary Alveolar Proteinosis (aPAP)
Announcement
Savara Inc announced the acceptance of one oral presentation and two poster presentations at the ATS International Conference in Orlando, Florida, May 17-20, 2026.
AI Summary
Savara Inc. announced that the ATS International Conference in Orlando (May 17–20, 2026) accepted one oral presentation and two poster presentations from the company. All three presentations will include new data from the Phase 3 IMPALA‑2 clinical trial of molgramostim inhalation solution in autoimmune pulmonary alveolar proteinosis (aPAP), including data from the ongoing open‑label treatment period. These materials are intended to share updated clinical findings and longer‑term observations from IMPALA‑2 with the pulmonary research community.
In addition, Savara will host an Industry Theater at the conference featuring renowned key opinion leaders to discuss aPAP and the IMPALA‑2 findings. The company plans to use the meeting to engage physicians and researchers about its inhaled molgramostim program and potential next steps.
Read Announcement- Drug:
- Molgramostim (IMPALA-2)
- Announced Date:
- October 2, 2025
- Indication:
- Autoimmune Pulmonary Alveolar Proteinosis (aPAP)
Announcement
Savara Inc. announced the acceptance of two abstracts for poster presentation and one abstract as an oral presentation at CHEST 2025 in Chicago, Illinois, October 19-22.
AI Summary
Savara Inc (NASDAQ: SVRA) announced that two of its research abstracts were accepted for poster presentation and one for an oral presentation at CHEST 2025 in Chicago from October 19–22, 2025.
The oral presentation, titled “Efficacy of Inhaled Molgramostim According to Severity of Autoimmune Pulmonary Alveolar Proteinosis,” will be delivered by Dr. Cormac McCarthy on October 21 in Exhibit Hall Rapid Fire 3A at McCormick Place.
One Savara poster on lung function and quality of life in aPAP (Poster #4260) will be presented by Dr. Bruce Trapnell on October 22. TrilliumBiO will present a poster on a dried serum assay for detecting GM-CSF antibodies (Poster #4257) the same day.
Savara will also host a Learning Theatre session, “Advances in Autoimmune Pulmonary Alveolar Proteinosis,” on October 21, presented by Dr. Kevin Davidson. All conference attendees can attend, and materials will be posted on Savara’s website.
Read Announcement- Drug:
- Molgramostim (IMPALA-2)
- Announced Date:
- September 29, 2025
- Indication:
- Autoimmune Pulmonary Alveolar Proteinosis (aPAP)
Announcement
Savara Inc. announced additional analyses from its pivotal Phase 3 IMPALA-2 clinical trial of molgramostim in aPAP were presented as poster presentations at the ERS Congress 2025 in Amsterdam, The Netherlands.
AI Summary
Savara Inc. announced that new analyses from its pivotal Phase 3 IMPALA-2 clinical trial of inhaled molgramostim in autoimmune pulmonary alveolar proteinosis (aPAP) were shared as posters at the ERS Congress 2025 in Amsterdam. These presentations highlight how the treatment works across different levels of lung function impairment.
One poster showed that molgramostim improved the primary endpoint, diffusing capacity of the lungs for carbon monoxide (DLco%), equally in patients with both mild and more severe aPAP. Beyond DLco%, treated patients also reported better respiratory quality of life on the St. George’s Respiratory Questionnaire and increased exercise capacity, measured by peak metabolic equivalents (METs), compared with placebo.
A second poster examined post-hoc correlations and found that increases in DLco% were linked with better quality of life scores, higher exercise capacity, and lower surfactant burden in the lungs. These results reinforce DLco% as a meaningful measure of clinical benefit in aPAP.
Additionally, Savara’s partner TrilliumBiO presented a dried blood spot assay for GM-CSF autoantibodies, offering a practical tool to aid early diagnosis of aPAP.
Read Announcement- Drug:
- Molgramostim (IMPALA-2)
- Announced Date:
- August 20, 2025
- Indication:
- Autoimmune Pulmonary Alveolar Proteinosis (aPAP)
Announcement
Savara Inc. announced that the results from the Phase 3 IMPALA-2 clinical trial will be published online in NEJM.
AI Summary
Savara Inc. announced that the results from the Phase 3 IMPALA-2 clinical trial of molgramostim inhalation solution will be published online in the New England Journal of Medicine on August 21, 2025. Titled “A Phase 3 Trial of Inhaled Molgramostim Therapy in Autoimmune Pulmonary Alveolar Proteinosis,” the manuscript will be available at www.nejm.org and later on the company’s website.
IMPALA-2 was the largest and longest randomized, double-blind, placebo-controlled study in autoimmune PAP. After 48 weeks of once-daily treatment, molgramostim significantly reduced lung surfactant buildup and improved gas transfer (DLco% up by 9.8% vs. 3.8% at Week 24 and 11.6% vs. 4.7% at Week 48), respiratory quality of life, and exercise capacity. Patients reported better scores on the St. George’s Respiratory Questionnaire, and the therapy was well tolerated with no major safety issues.
Following the NEJM online release, the full paper will be posted on Savara’s Congresses & Publications page.
Read Announcement- Drug:
- Molgramostim (IMPALA-2)
- Announced Date:
- August 18, 2025
- Indication:
- Autoimmune Pulmonary Alveolar Proteinosis (aPAP)
Announcement
Savara Inc announced the acceptance of three abstracts for poster presentation at the European Respiratory Society (ERS) Congress 2025, September 27 – October 1, Amsterdam, The Netherlands.
AI Summary
Savara Inc. announced that three abstracts were accepted for poster presentation at the European Respiratory Society (ERS) Congress 2025 in Amsterdam, September 27 – October 1. Two are from Savara on pulmonary gas transfer and the efficacy of inhaled molgramostim in autoimmune pulmonary alveolar proteinosis (aPAP). The third, by partner TrilliumBiO, describes a dried serum assay to detect GM-CSF antibodies and aid aPAP diagnosis.
All three posters will appear in session PS-37 on Monday, September 29 from 8:00 to 9:30 CEST at RAI Amsterdam. Francesco Bonella, M.D., Ph.D., and Cormac McCarthy, M.D., Ph.D., will present Savara’s studies, while Eagappanath Thiruppathi, Ph.D., will present TrilliumBiO’s assay research.
Savara will also host an Industry Evening Mini Symposium titled “Advances in Autoimmune Pulmonary Alveolar Proteinosis” on Monday, September 29 from 17:30 to 19:00 CEST at RAI Amsterdam. Experts will discuss the disease’s biology, symptoms, and treatment.
Read Announcement- Drug:
- Molgramostim (IMPALA-2)
- Announced Date:
- May 18, 2025
- Indication:
- Autoimmune Pulmonary Alveolar Proteinosis (aPAP)
Announcement
Savara Inc announced new data in two poster presentations at the ATS International Conference 2025. Data presented were from the Phase 3 IMPALA-2 clinical trial of molgramostim in aPAP and demonstrated that molgramostim reduces surfactant burden and improves health-related quality of life outcomes in patients with aPAP.
AI Summary
Savara Inc recently shared new data at the ATS International Conference 2025 from the Phase 3 IMPALA-2 clinical trial of molgramostim in patients with autoimmune pulmonary alveolar proteinosis (aPAP). The trial showed that molgramostim significantly reduced surfactant burden, as seen by a greater decrease in ground-glass opacification scores compared to placebo. This reduction helps lessen the need for rescue whole lung lavage procedures, a key treatment for aPAP.
In addition to lowering surfactant burden, the treatment improved health-related quality of life outcomes. Patients reported better respiratory health on standard questionnaires such as the St. George’s Respiratory Questionnaire and EQ-5D-5L, showing improvements in breathing, mobility, and physical activity. These findings support the potential of molgramostim to provide a beneficial treatment effect for aPAP patients.
Read Announcement- Drug:
- Molgramostim (IMPALA-2)
- Announced Date:
- March 17, 2025
- Indication:
- Autoimmune Pulmonary Alveolar Proteinosis (aPAP)
Announcement
Savara Inc announced the acceptance of two abstracts for poster presentation at the American Thoracic Society (ATS) International Conference taking place May 16-21, 2025, in San Francisco, CA.
AI Summary
Savara Inc. announced that two abstracts have been accepted for poster presentations at the American Thoracic Society (ATS) International Conference, which will take place from May 16-21, 2025, in San Francisco, CA. One poster, presented by Dr. Tisha S. Wang of UCLA, highlights results from the IMPALA-2 Phase 3 Clinical Trial, showing that molgramostim treatment reduced surfactant build-up and decreased the number of whole lung lavage procedures in patients with autoimmune pulmonary alveolar proteinosis (aPAP). The second poster, presented by Dr. Ali Ataya of the University of Florida, examines how molgramostim improves respiratory health-related quality of life and patient-reported outcomes in aPAP cases. In addition, Savara will host an Industry Theater session titled “Advances in Autoimmune Pulmonary Alveolar Proteinosis,” featuring experts Bruce Trapnell and Cormac McCarthy, who will provide updates on the latest clinical insights and management strategies for this rare lung disease.
Read Announcement- Drug:
- Molgramostim (IMPALA-2)
- Announced Date:
- November 22, 2024
- Indication:
- Autoimmune Pulmonary Alveolar Proteinosis (aPAP)
Announcement
Savara Inc. announced that an encore presentation of results from the pivotal, Phase 3 IMPALA-2 trial will be presented at the British Thoracic Society (BTS) Winter Meeting, taking place November 27-29, 2024, in London, England.
AI Summary
Savara Inc., a clinical stage biopharmaceutical company focused on rare respiratory diseases, announced that an encore presentation from its pivotal Phase 3 IMPALA-2 trial will be featured at the British Thoracic Society (BTS) Winter Meeting in London, England, from November 27-29, 2024.
The presentation, titled "Inhaled Molgramostim Improves Pulmonary Gas Exchange and Respiratory Health-Related Quality of Life in Patients with Autoimmune Pulmonary Alveolar Proteinosis (aPAP): Results from IMPALA-2," will be delivered on November 29, 2024, from 8:30 to 9:50 am GMT. The session is part of the BTS "The Famous Five" series on emerging clinical trial data and will take place at the QEII Centre in London. Speaker Dr. Cormac McCarthy, Associate Professor of Medicine at the University College Dublin and Consultant Respiratory Physician at St. Vincent’s University Hospital, will lead the discussion. After the session, presentation slides will be available on Savara’s corporate website for further review.
Read Announcement- Drug:
- Molgramostim (IMPALA-2)
- Announced Date:
- September 8, 2024
- Indication:
- Autoimmune Pulmonary Alveolar Proteinosis (aPAP)
Announcement
Savara Inc. announced that new data from the Phase 3 IMPALA-2 clinical trial of molgramostim in patients with autoimmune Pulmonary Alveolar Proteinosis (aPAP) were presented at the European Respiratory Society (ERS) Congress 2024 in Vienna, Austria.
AI Summary
Savara Inc. recently presented new data at the European Respiratory Society (ERS) Congress 2024 in Vienna, Austria, from its Phase 3 IMPALA-2 clinical trial examining molgramostim in patients with autoimmune Pulmonary Alveolar Proteinosis (aPAP). The study showed that treatment with molgramostim led to significant improvements in disease severity scores at both 24 and 48 weeks compared to placebo. Key efficacy outcomes included enhanced gas exchange as measured by DLCO% responder analyses and improved quality of life according to the St. George’s Respiratory Questionnaire (SGRQ) scores.
Additional trial findings highlighted a meaningful reduction in surfactant burden, evaluated by changes in the Ground Glass Opacification (GGO) score, supporting the drug’s potential to correct the underlying lung pathology in aPAP. The data also indicated durable improvements and a favorable benefit/risk profile, as nearly all patients completed the treatment period while showing enhanced lung function and overall patient outcomes.
Read Announcement- Drug:
- Molgramostim (IMPALA-2)
- Announced Date:
- August 15, 2024
- Indication:
- Autoimmune Pulmonary Alveolar Proteinosis (aPAP)
Announcement
Savara Inc announced the acceptance of an abstract for poster presentation at the European Respiratory Society (ERS) Congress 2024, taking place September 7-11, 2024, in Vienna, Austria.
AI Summary
Savara Inc., a clinical stage biopharmaceutical company focused on rare respiratory diseases, has received acceptance for an abstract at the European Respiratory Society (ERS) Congress 2024 in Vienna, Austria, from September 7-11, 2024. The abstract titled “Inhaled Molgramostim Improves Pulmonary Gas Exchange and Respiratory Health-Related Quality of Life (HRQoL) in Patients with Autoimmune Pulmonary Alveolar Proteinosis (aPAP): Results from IMPALA-2” will be presented during Poster Session PS-29 on September 8, 2024, from 12:30 to 14:00 CET.
Additionally, Savara is hosting an Industry Symposium entitled “Pulmonary Alveolar Proteinosis: Pathophysiology, Diagnosis, and Management.” This session is scheduled for the same day from 17:30 to 19:00 CET at the ERS Congress Industry Theater. These events underline the company’s commitment to advancing research and treatment options for rare respiratory conditions.
Read Announcement- Drug:
- Molgramostim (IMPALA-2)
- Announced Date:
- June 26, 2024
- Target Action Date:
- H1 2025
- Estimated Target Date Range:
- January 1, 2025 - June 30, 2025
- Indication:
- Autoimmune Pulmonary Alveolar Proteinosis (aPAP)
Announcement
Savara Inc announced that Company Plans to Complete BLA Submission in 1H 2025
AI Summary
Savara Inc, a biopharmaceutical company focused on rare respiratory diseases, announced positive findings from its Phase 3 IMPALA-2 trial evaluating molgramostim in patients with autoimmune pulmonary alveolar proteinosis (aPAP). The trial showed significant improvements in lung function and quality-of-life measures, with patients experiencing better gas exchange and overall health. Building on these strong results, Savara revealed that it plans to complete its Biologics License Application (BLA) submission in the first half of 2025. This important milestone moves the company closer to delivering the first approved therapeutic option for aPAP in the U.S. and Europe. With high patient retention and a favorable safety profile in the trial, Savara is optimistic about addressing the unmet medical needs of those living with this rare lung disease. The upcoming BLA submission represents a key step forward in this effort.
Read Announcement- Drug:
- Molgramostim (IMPALA-2)
- Announced Date:
- June 26, 2024
- Indication:
- Autoimmune Pulmonary Alveolar Proteinosis (aPAP)
Announcement
Savara Inc. announced positive results from the pivotal, Phase 3 IMPALA-2 clinical trial. IMPALA-2 is a 48-week, randomized, double-blind, placebo-controlled trial assessing the efficacy and safety of molgramostim 300 mcg administered once daily by inhalation with matching placebo in adult patients with aPAP (NCT04544293).
AI Summary
Savara Inc. announced positive results from its pivotal Phase 3 IMPALA-2 trial, a 48‐week, randomized, double‐blind, placebo-controlled study testing molgramostim 300 mcg administered once daily by inhalation in adult patients with autoimmune pulmonary alveolar proteinosis (aPAP). The trial met its primary endpoint by showing a statistically significant improvement in the hemoglobin-adjusted percent predicted DLCO at Week 24, with benefits sustained at Week 48. These results indicate that molgramostim not only enhances lung function but also provides durable effects. Additionally, improvements in patients’ quality of life were noted through better scores on the St. George’s Respiratory Questionnaire. The study had a high completion rate and confirmed that the treatment was well tolerated by the participants. This positive outcome supports the potential of molgramostim to become the first approved targeted therapy for aPAP, addressing an important unmet need in this patient population.
Read Announcement
MOLBREEVI FDA Regulatory Timeline and Events
MOLBREEVI is a drug developed by Savara for the following indication: Treatment for aPAP.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- MOLBREEVI
- Announced Date:
- April 7, 2026
- Indication:
- Treatment for aPAP.
Announcement
Savara Inc. announced that the MHRA has accepted the submission of the MOLBREEVI MAA for the treatment of autoimmune PAP in the U.K.
AI Summary
Savara announced that the U.K. Medicines and Healthcare products Regulatory Agency (MHRA) has accepted the marketing-authorisation application (MAA) for MOLBREEVI to treat autoimmune pulmonary alveolar proteinosis (PAP) in the U.K. MHRA acceptance starts the formal review of the company’s clinical and manufacturing data and is an important regulatory milestone in the drug’s path toward possible approval and availability in the U.K.
The MHRA has also granted MOLBREEVI Innovation Passport and Promising Innovative Medicine designations, which can provide regulatory support and help prioritize development and review. MOLBREEVI is not approved for any indication; acceptance of the MAA does not mean it is approved, only that the review process has begun.
MOLBREEVI is the trade name for molgramostim inhalation solution, being developed to treat autoimmune PAP, a rare lung disease in which surfactant accumulates and impairs breathing. Savara will await the MHRA’s review outcome.
Read Announcement- Drug:
- MOLBREEVI
- Announced Date:
- February 20, 2026
- Target Action Date:
- August 22, 2026
- Indication:
- Treatment for aPAP.
Announcement
Savara Inc announced that The FDA granted Priority Review with a PDUFA action date of August 22, 2026.
AI Summary
Savara Inc. announced that the U.S. Food and Drug Administration has granted Priority Review for MOLBREEVI (molgramostim inhalation solution) and set a PDUFA target action date of August 22, 2026. Priority Review means the FDA will direct extra attention and resources to evaluating the application because the therapy could be a meaningful improvement for a serious condition if approved.
Savara plans to submit marketing authorization applications to the European Medicines Agency and the UK’s MHRA by the end of Q1 2026. MOLBREEVI has the potential to be the first and only approved treatment for autoimmune pulmonary alveolar proteinosis (autoimmune PAP) in the U.S. and Europe. Autoimmune PAP is a rare lung disease that causes surfactant to build up in the air sacs, leading to breathing problems. The trade name MOLBREEVI is conditionally accepted by regulators and the product is not yet approved for any use.
Read Announcement- Drug:
- MOLBREEVI
- Announced Date:
- February 20, 2026
- Indication:
- Treatment for aPAP.
Announcement
Savara Inc announced the FDA has filed for review the BLA for MOLBREEVI as a therapy to treat patients with autoimmune PAP.
AI Summary
Savara Inc. announced that the U.S. Food and Drug Administration has filed for review the biologics license application (BLA) for MOLBREEVI, a molgramostim inhalation solution being developed to treat patients with autoimmune pulmonary alveolar proteinosis (autoimmune PAP). MOLBREEVI is an investigational therapy and is not yet approved. The BLA filing starts the formal regulatory review process that will determine whether the drug can be licensed for use in the United States.
Savara says MOLBREEVI has the potential to become the first and only approved treatment for autoimmune PAP in the U.S. and Europe. The company also plans to submit marketing authorization applications to European regulators by the end of the first quarter of 2026 to seek approval in those regions.
Read Announcement- Drug:
- MOLBREEVI
- Announced Date:
- December 22, 2025
- Indication:
- Treatment for aPAP.
Announcement
Savara Inc announced that it has resubmitted the MOLBREEVI BLA to the FDA, with Fujifilm as the drug substance manufacturer.
Read Announcement- Drug:
- MOLBREEVI
- Announced Date:
- May 27, 2025
- Indication:
- Treatment for aPAP.
Announcement
Savara Inc. announced that the Company received an RTF letter from the FDA for the BLA of MOLBREEVI as a therapy to treat patients with autoimmune PAP.
AI Summary
Savara Inc. announced that it received a Response for Further Information (RTF) letter from the FDA regarding its Biologics License Application (BLA) for MOLBREEVI, a therapy targeting autoimmune pulmonary alveolar proteinosis (PAP). The FDA’s review found that the BLA, submitted in March 2025, lacked sufficient information in the area of Chemistry, Manufacturing, and Controls (CMC) to support a complete review. Importantly, the agency did not flag any safety concerns or ask for further studies on how well the drug works. In response, Savara plans to request a Type A meeting with the FDA within the next 30 days to discuss the additional data needed. The company is currently working to generate the required CMC data and is confident in addressing the FDA’s questions. Savara expects to resubmit the BLA in the fourth quarter of 2025 and remains committed to advancing its therapy for treating autoimmune PAP.
Read Announcement- Drug:
- MOLBREEVI
- Announced Date:
- March 26, 2025
- Indication:
- Treatment for aPAP.
Announcement
Savara Inc. nnounced that it has completed submission of the BLA to the FDA for MOLBREEVI as a treatment for aPAP.
AI Summary
Savara Inc. announced it has completed the submission of its Biologics License Application (BLA) to the FDA for MOLBREEVI as a treatment for autoimmune pulmonary alveolar proteinosis (aPAP). This submission is an important milestone for both Savara and the aPAP patient community. The company highlighted that the extensive data provided in the application shows MOLBREEVI improves pulmonary gas exchange while alleviating key clinical symptoms associated with the rare lung disease. As part of the submission, Savara has requested Priority Review from the FDA, which, if granted, could reduce the review period to six months instead of the standard ten. Savara’s commercial launch plans are progressing, and preparations are underway for a potential early 2026 launch. This step represents a significant advance in the fight against aPAP and may pave the way for the first approved therapy for this condition in the U.S. and Europe.
Read Announcement
