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
MOLBREEVI and Molgramostim. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
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:
- 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
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:
- 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
- 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- Drug:
- Molgramostim (IMPALA-2)
- Announced Date:
- June 26, 2024
- Estimated Event Date Range:
- January 1, 2025 - June 30, 2025
- Target Action Date:
- 2025-H1
- 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
