US Market News
2日前
Savara Announces Chief Financial and Administrative Officer TransitionJune 8, 2026 4:05 PM
Business Wire -- Dave Lowrance to Step Down as Chief Financial and Administrative Officer -- -- Robert Lutz to Assume Combined Role of Chief Operating and Financial Officer -- Savara Inc. (Nasdaq: SVRA) (the Company), a clinical stage biopharmaceutical company focused on rare respiratory diseases, today announced that Dave Lowrance, Chief Financial and Administrative Officer, is stepping down from his role for health-related reasons, effective July 15, 2026. As part of this transition, the financial and administrative responsibilities of the role will be separated going forward. Robert Lutz, M.B.A., the Company's Chief Operating Officer, will assume the additional role of Chief Financial Officer, while the administrative responsibilities will be distributed among members of the senior leadership team. “We are grateful to Dave as his leadership has been a vital part of Savara’s growth for nearly ten years,” said Matt Pauls, J.D., M.B.A., Chair and Chief Executive Officer, Savara. “He has guided the Company through critical milestones ranging from capital raises and Nasdaq listing to advancing our late-stage pipeline. His integrity, expertise, and commitment will leave a lasting mark on this organization. We respect and support his decision to focus on his health at this time and are grateful that his guidance will remain available to us in an advisory capacity.” Pauls continued, “Rob is an experienced leader who has made significant contributions as our Chief Operating Officer since joining Savara in 2023. His background as a two-time Chief Financial and Business Officer, combined with his deep understanding of our operations and strategy, makes him ideally positioned to take on this expanded role. We are confident in his ability to ensure a seamless transition and continued strong financial stewardship.” “It has been a privilege to serve Savara for nearly a decade,” said Dave Lowrance, outgoing Chief Financial and Administrative Officer. “I am proud of what this team has built—from strengthening our balance sheet and supporting the advancement of MOLBREEVI, to helping position the Company for what I believe will be a transformative period. I am grateful to the entire Savara team for their support throughout my tenure and have confidence in Rob and Savara’s path forward.” Mr. Lutz has served as Savara’s Chief Operating Officer since February 2023. He brings more than two decades of operational leadership experience in the pharmaceutical industry, including experience with finance strategy, equity and debt raises, financial planning and analysis, investor relations, business development deal execution, and commercial/operational business analytics. Prior to joining Savara, Mr. Lutz served as Chief Financial and Business Officer of iBio, Inc., and prior to that as Chief Financial and Business Officer of Strongbridge Biopharma plc. Earlier in his career, Mr. Lutz held leadership roles of increasing responsibility at Shire Plc. and Cinergy Corp. and began his career as a Financial Analyst at Goldman Sachs. Mr. Lutz holds a B.A. in Economics and Computer Science from Amherst College and an M.B.A. from the Kellogg School of Management. About Savara Savara is a clinical-stage biopharmaceutical company focused on rare respiratory diseases. Our lead program, MOLBREEVI*, is a recombinant human granulocyte-macrophage colony-stimulating factor (GM-CSF) in Phase 3 development for autoimmune pulmonary alveolar proteinosis (autoimmune PAP). MOLBREEVI is delivered via an investigational eFlow® Nebulizer System (PARI Pharma GmbH) specifically developed for inhalation of MOLBREEVI. Our management team has significant experience in rare respiratory diseases and pulmonary medicine, identifying unmet needs, and effectively advancing product candidates to approval and commercialization. More information can be found at www.savarapharma.com and LinkedIn. *MOLBREEVI is the FDA and EMA conditionally accepted trade name for molgramostim inhalation solution. It is not approved in any indication. MOLBREEVI is a trademark of Savara Inc. Forward-Looking Statements Savara cautions you that statements in this press release that are not a description of historical fact are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements may be identified by the use of words referencing future events or circumstances such as “expect,” “intend,” “plan,” “anticipate,” “believe,” and “will,” among others. Such statements include, but are not limited to, statements related to planned executive changes and the timing and potential impact of those changes. Savara may not actually achieve any of the matters referred to in such forward-looking statements, and you should not place undue reliance on these forward-looking statements. These forward-looking statements are based upon Savara’s current expectations and involve assumptions that may never materialize or may prove to be incorrect. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties, which include, without limitation, the risks associated with our ability to successfully develop, obtain regulatory approval for, and commercialize MOLBREEVI for autoimmune PAP; the ability to project future cash utilization and reserves needed for contingent future liabilities and business operations; the availability of sufficient resources for Savara’s operations and to conduct or continue planned clinical development programs; and the timing and ability of Savara to raise additional capital as needed to fund continued operations. All forward-looking statements are expressly qualified in their entirety by these cautionary statements. For a detailed description of our risks and uncertainties, you are encouraged to review our documents filed with the SEC including our recent filings on Form 8-K, Form 10-K and Form 10-Q. You are cautioned not to place undue reliance on forward-looking statements, which speak only as of the date on which they were made. Savara undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made, except as may be required by law. View source version on businesswire.com: https://www.businesswire.com/news/home/20260608876987/en/ Media and Investor Relations Contact
Savara Inc.
Temre Johnson, Executive Director, Corporate Affairs
ir@savarapharma.com Original: Savara Announces Chief Financial and Administrative Officer Transition
US Market News
3週前
Savara Presented New Biomarker Data from the IMPALA-2 Phase 3 Clinical Trial of Molgramostim Inhalation Solution (Molgramostim) in Autoimmune Pulmonary Alveolar Proteinosis (aPAP) at the American Thoracic Society (ATS) International Conference 2026May 20, 2026 8:15 AM
Business Wire Savara Inc. (Nasdaq: SVRA) (the Company), a clinical stage biopharmaceutical company focused on rare respiratory diseases, presented a poster at the ATS 2026 International Conference that is taking place May 15-20, 2026, in Orlando, Florida. The poster reported new biomarker data from the double-blind period of the IMPALA-2 Phase 3 clinical trial evaluating molgramostim for the treatment of aPAP. Below is a summary of the poster presented. Poster Board 401: “Relationship Between Pulmonary Gas Transfer and Biomarker Levels in Patients with Autoimmune Pulmonary Alveolar Proteinosis (aPAP),” presented by Y. Inoue, M.D.; sponsored by Savara Inc. Presented serum biomarker data from IMPALA-2, a global, randomized, double-blind, placebo-controlled Phase 3 clinical trial in which aPAP patients received nebulized molgramostim 300 µg (n=81) or placebo (n=83) once daily for 48 weeks. Blood samples were collected at baseline and at Weeks 4, 12, 24, and 48, measuring levels of Krebs von den Lungren protein-6 (KL-6), cytokeratin 19 fragments (CYFRA 21-1), carcinoembryonic antigen (CEA), lactate dehydrogenase (LDH), hemoglobin, and hematocrit. At baseline, all biomarker levels were similar between the molgramostim and placebo groups. Molgramostim significantly improved pulmonary gas transfer, as measured by change from baseline in percent predicted diffusing capacity of the lungs for carbon monoxide adjusted for hemoglobin (DLco%) at Week 24 (P=0.0007) and Week 48 (P=0.0008) versus placebo. Post-hoc analyses showed that patients in the molgramostim group also demonstrated significantly greater mean decreases from baseline in LDH (Week 24, P=0.0150; Week 48, P=0.0051), CYFRA 21-1 (Week 24, P=0.0036; Week 48, P=0.0017), and KL-6 (Week 24, P=0.0016; Week 48, P=0.0022) compared with placebo. Mean changes from baseline in hemoglobin, hematocrit, and CEA at Weeks 24 and 48 were similar between the treatment groups. Strong correlations were observed in the overall study population (pooled treatment groups) between improvements in DLco% and decreases in LDH (Week 24, r=-0.5154; Week 48, r=-0.6266), CYFRA 21-1 (Week 24, r=-0.6414; Week 48, r=-0.6908), and KL-6 (Week 24, r=-0.7286; Week 48, r=-0.6864), all P
US Market News
3週前
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)May 19, 2026 2:15 PM
Business Wire -- Data Were Presented at the American Thoracic Society (ATS) International Conference 2026 -- -- All Patients Receive Molgramostim During the OL Treatment Period; 100% of Patients Who Completed the Double-Blind (DB) Period of the Trial Entered into the OL Extension -- -- OL Data Showed Continued Improvement in Patients Who Had Received Molgramostim During DB Period -- -- Efficacy Improved in Patients Who Had Received Placebo During DB Period and Switched to Molgramostim in OL Treatment Period -- Savara Inc. (Nasdaq: SVRA) (the Company), a clinical stage biopharmaceutical company focused on rare respiratory diseases, presented a poster at the ATS 2026 International Conference that is taking place May 15-20, 2026, in Orlando, Florida. The poster reports long-term efficacy and safety data from the first 48 weeks of the ongoing OL treatment period of the IMPALA-2 Phase 3 clinical trial evaluating molgramostim for the treatment of aPAP. IMPALA-2 is the longest and largest clinical trial conducted in aPAP and enrolled 164 patients. Long-term efficacy and safety data from IMPALA-2 were presented. Below is a summary of the poster presentation. Poster Board 403: “Long-Term Efficacy and Safety of Molgramostim in Patients with Autoimmune Pulmonary Alveolar Proteinosis (aPAP): Results from the IMPALA-2 Trial Open-Label Treatment Period,” presented by B.C. Trapnell, M.D.; sponsored by Savara Inc. During the DB period, aPAP patients received nebulized molgramostim 300 µg (n=81) or placebo (n=83) once daily; all patients received molgramostim once daily during the OL period. Results from the first 48 weeks of the 96-week OL period were reported. Efficacy was assessed by change from baseline in percent predicted diffusing capacity of the lungs for carbon monoxide (DLco%) and by St. George’s Respiratory Questionnaire Total (SGRQ-T) and Activity (SGRQ-A) scores assessing respiratory health-related quality of life (HRQoL). Exercise capacity is not evaluated in the OL treatment period. One hundred and sixty-four patients with aPAP enrolled in the DB period, 160 (98%) completed the DB period, and all 160 of those patients opted to continue into the OL period. As of the data cut-off, 9 out of 160 patients discontinued the OL period—a 94% retention rate. Long-term treatment with molgramostim continuously improved pulmonary gas transfer and respiratory HRQoL in patients with aPAP. In addition, placebo crossover patients demonstrated improved pulmonary gas transfer and respiratory HRQoL following initiation of molgramostim treatment. Durability of Effect During First 48 Weeks of OL Treatment Period Data from the first 48 weeks of the OL treatment period showed continuous and sustained improvements in pulmonary gas transfer, as measured by DLco% and respiratory HRQoL, as measured by SGRQ-T and SGRQ-A scores. Pulmonary Gas Transfer Improvements At Week 48 of the DB period, mean (standard error [SE]) changes from baseline in DLco% were 11.6 (1.4) for the molgramostim group and 3.9 (1.5) for the placebo group. During the OL period, patients who received molgramostim in both the DB and OL periods (MOL-MOL) continued to show improvement in DLco% through Week 96, with a mean increase of 2.8 (1.2) during Weeks 48–96 and an overall mean increase from baseline (Weeks 0–96) of 14.7 (1.6). In patients who received placebo during the DB period and crossed over to molgramostim in the OL period (PBO-MOL), DLco% increased through Week 96, with a mean increase of 8.8 (1.6) during Weeks 48–96. Respiratory HRQoL Improvements Both SGRQ-T and SGRQ-A scores range from 0-100, with higher values indicating worse quality of life. Results showed continued improvement in MOL-MOL patients and notable improvements in PBO-MOL crossover patients in SGRQ-T and SGRQ-A scores. At Week 48 of the DB period, mean (standard error [SE]) changes from baseline in SGRQ-T and SGRQ-A scores were -10.8 (2.3) and -12.8 (3.1), respectively, for the molgramostim group and -6.1 (2.1) and -7.8 (2.7), respectively for the placebo group. For SGRQ-T and SGRQ-A scores during the OL period, MOL-MOL patients showed continued improvement during Weeks 48–96 with mean changes of -3.8 (1.6) and -4.2 (2.5) (SGRQ-T and SGRQ-A), respectively, and overall changes from baseline (Weeks 0–96) of -15.0 (2.6) and -18.3 (3.4), respectively. In PBO-MOL patients, corresponding mean changes were -6.5 (1.6) and -7.9 (2.0), respectively, during Weeks 48–96. Safety and Tolerability During First 48-Weeks of OL Treatment Period Data from the OL treatment period indicate that molgramostim was generally well tolerated, with safety and tolerability results consistent with those previously reported for the DB treatment period. There were no study discontinuations due to treatment-related adverse events. “We are pleased to see that after longer-term drug exposure, the MOL-MOL patients showed continuous improvements in efficacy and quality of life, and the PBO-MOL patients showed improvements in the same outcome measures while receiving molgramostim during the OL treatment period—similar to molgramostim patients during the double-blind period,” said Bruce Trapnell, M.D., Professor of Medicine and Pediatrics at the University of Cincinnati College of Medicine and the Lead Clinical Investigator of the IMPALA-2 trial. “Furthermore, we continued to see a very high patient retention rate, attesting to the tolerability of molgramostim over time. These results are similar to results from the open-label period of the IMPALA trial in that they indicate that longer-term treatment with molgramostim results in durability of effect. I believe these data strongly support the potential of molgramostim to be an effective pharmacologic treatment option for aPAP.” The full content of this poster will be available on the Congresses and Publications page of the Savara corporate website. The abstract is published in a supplement of the American Journal of Respiratory and Critical Care Medicine (AJRCCM). For more details about the ATS International Conference, please visit https://conference.thoracic.org/index.php. About aPAP Autoimmune PAP is a rare lung disease characterized by the abnormal build-up of surfactant in the alveoli. Surfactant consists of proteins and lipids and is an important physiological substance that lines the alveoli to prevent them from collapsing. In a healthy lung, excess surfactant is cleared and digested by immune cells called alveolar macrophages. Alveolar macrophages need to be stimulated by granulocyte-macrophage colony-stimulating factor (GM-CSF) to function properly in clearing surfactant, but in aPAP, GM-CSF is neutralized by antibodies against GM-CSF, rendering macrophages unable to adequately clear surfactant. As a result, an excess of surfactant accumulates in the alveoli, causing impaired gas exchange, resulting in clinical symptoms of shortness of breath, often with cough and frequent fatigue. Patients may also experience episodes of fever, chest pain, or coughing up blood, especially if secondary lung infection develops. In the long term, the disease can lead to serious complications, including lung fibrosis and the need for a lung transplant. About Savara Savara is a clinical stage biopharmaceutical company focused on rare respiratory diseases. Our lead program, molgramostim inhalation solution (molgramostim) is a recombinant human granulocyte-macrophage colony-stimulating factor (GM-CSF) in Phase 3 development for autoimmune pulmonary alveolar proteinosis (aPAP). Molgramostim is delivered via a proprietary investigational eFlow® Nebulizer System (PARI Pharma GmbH) specifically developed for inhalation of molgramostim. Our management team has significant experience in rare respiratory diseases and pulmonary medicine, identifying unmet needs, and effectively advancing product candidates to approval and commercialization. More information can be found at www.savarapharma.com and LinkedIn. Forward-Looking Statements Savara cautions you that statements in this press release that are not a description of historical fact are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements may be identified by the use of words referencing future events or circumstances such as “expect,” “intend,” “plan,” “anticipate,” “believe,” and “will,” among others. Savara may not actually achieve any of the matters referred to in such forward-looking statements, and you should not place undue reliance on these forward-looking statements. These forward-looking statements are based upon Savara’s current expectations and involve assumptions that may never materialize or may prove to be incorrect. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties, which include, without limitation, the risks associated with our ability to successfully develop, obtain regulatory approval for, and commercialize molgramostim for aPAP; the actions and decisions of regulatory authorities; the ability to project future cash utilization and reserves needed for contingent future liabilities and business operations; the availability of sufficient resources for Savara’s operations and to conduct or continue planned clinical development programs; and the timing and ability of Savara to raise additional capital as needed to fund continued operations. All forward-looking statements are expressly qualified in their entirety by these cautionary statements. For a detailed description of our risks and uncertainties, you are encouraged to review our documents filed with the SEC including our recent filings on Form 8-K, Form 10-K and Form 10-Q. You are cautioned not to place undue reliance on forward-looking statements, which speak only as of the date on which they were made. Savara undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made, except as may be required by law. View source version on businesswire.com: https://www.businesswire.com/news/home/20260519029544/en/ Media and Investor Relations Contact
Savara Inc.
Temre Johnson, Executive Director, Corporate Affairs
ir@savarapharma.com Original: 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)
US Market News
3週前
Savara Announces New Exercise Capacity Data from the IMPALA-2 Phase 3 Clinical Trial of Molgramostim Inhalation Solution (Molgramostim) in Autoimmune Pulmonary Alveolar Proteinosis (aPAP)May 18, 2026 2:55 PM
Business Wire -- Data Were Presented in an Oral Presentation at the American Thoracic Society (ATS) International Conference 2026 -- Savara Inc. (Nasdaq: SVRA) (the Company), a clinical stage biopharmaceutical company focused on rare respiratory diseases, sponsored an oral presentation at the ATS 2026 International Conference that is taking place May 15-20, 2026, in Orlando, Florida. The presentation reported new exercise capacity data from the double-blind period of the IMPALA-2 Phase 3 clinical trial evaluating molgramostim for the treatment of aPAP. Below is a summary of the data presented. Oral Presentation, Abstract 9296: “Molgramostim Improves Exercise Distance and Duration in Patients with Autoimmune Pulmonary Alveolar Proteinosis (aPAP): Results from the IMPALA-2 Phase 3 Clinical Trial,” presented by B.C. Trapnell, M.D.; sponsored by Savara Inc. Presented exercise capacity data from IMPALA-2, a global, randomized, double-blind, placebo-controlled Phase 3 clinical trial in which adults with aPAP received nebulized molgramostim 300 µg (n=81) or placebo (n=83) once daily for 48 weeks. IMPALA-2 achieved statistical significance on its primary endpoint and other secondary endpoints, including a greater mean improvement in exercise capacity, expressed as peak metabolic equivalents (METs), in the molgramostim group at 48 weeks. This oral presentation reported on the effects of molgramostim on exploratory endpoints of exercise distance and duration, assessed at Weeks 24 and 48 via a conservative, ramp-up, symptom-limited, exercise treadmill test. Greater mean improvement in distance walked was observed in molgramostim-treated patients compared with placebo at Week 48. The least-squares mean (LSM) change in distance walked from baseline to Week 48 was 167.0 m (95% confidence interval [CI], 112.1 to 221.8) in the molgramostim group and 86.4 m (95% CI, 32.4 to 140.4) in the placebo group, yielding an estimated treatment difference of 80.6 m (P=0.0301). Molgramostim patients were also able to exercise for longer periods of time compared with patients who received placebo. At Week 48, the LSM change in duration of exercise from baseline was 2.0 minutes (95% CI, 1.3 to 2.7) in the molgramostim group and 1.0 minute (95% CI, 0.3 to 1.6) in the placebo group, yielding an estimated treatment difference of 1.0 minute (P=0.0262). Consistent with improvements in peak METs, molgramostim improved both distance walked and duration of exercise at Week 48 compared with placebo, supporting the potential clinical benefit of molgramostim treatment in patients with aPAP. "We believe the consistency in improvements observed across both exploratory endpoints—distance walked and exercise duration—and our secondary endpoint of exercise capacity, as measured by peak METs, strengthens the overall efficacy picture," said Yasmine Wasfi, M.D., Ph.D., Chief Medical Officer, Savara. "Taken together, these data suggest that molgramostim may translate into real-world functional benefits for aPAP patients." The full content of this poster will be available on the Congresses and Publications page of the Savara corporate website. The abstract is published in a supplement of the American Journal of Respiratory and Critical Care Medicine (AJRCCM). For more details about the ATS International Conference, please visit https://conference.thoracic.org/index.php. About aPAP Autoimmune PAP is a rare lung disease characterized by the abnormal build-up of surfactant in the alveoli. Surfactant consists of proteins and lipids and is an important physiological substance that lines the alveoli to prevent them from collapsing. In a healthy lung, excess surfactant is cleared and digested by immune cells called alveolar macrophages. Alveolar macrophages need to be stimulated by granulocyte-macrophage colony-stimulating factor (GM-CSF) to function properly in clearing surfactant, but in aPAP, GM-CSF is neutralized by antibodies against GM-CSF, rendering macrophages unable to adequately clear surfactant. As a result, an excess of surfactant accumulates in the alveoli, causing impaired gas exchange, resulting in clinical symptoms of shortness of breath, often with cough and frequent fatigue. Patients may also experience episodes of fever, chest pain, or coughing up blood, especially if secondary lung infection develops. In the long term, the disease can lead to serious complications, including lung fibrosis and the need for a lung transplant. About Savara Savara is a clinical stage biopharmaceutical company focused on rare respiratory diseases. Our lead program, molgramostim inhalation solution (molgramostim) is a recombinant human granulocyte-macrophage colony-stimulating factor (GM-CSF) in Phase 3 development for autoimmune pulmonary alveolar proteinosis (aPAP). Molgramostim is delivered via a proprietary investigational eFlow® Nebulizer System (PARI Pharma GmbH) specifically developed for inhalation of molgramostim. Our management team has significant experience in rare respiratory diseases and pulmonary medicine, identifying unmet needs, and effectively advancing product candidates to approval and commercialization. More information can be found at www.savarapharma.com and LinkedIn. Forward-Looking Statements Savara cautions you that statements in this press release that are not a description of historical fact are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements may be identified by the use of words referencing future events or circumstances such as “expect,” “intend,” “plan,” “anticipate,” “believe,” and “will,” among others. Savara may not actually achieve any of the matters referred to in such forward-looking statements, and you should not place undue reliance on these forward-looking statements. These forward-looking statements are based upon Savara’s current expectations and involve assumptions that may never materialize or may prove to be incorrect. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties, which include, without limitation, the risks associated with our ability to successfully develop, obtain regulatory approval for, and commercialize molgramostim for aPAP; the actions and decisions of regulatory authorities; the ability to project future cash utilization and reserves needed for contingent future liabilities and business operations; the availability of sufficient resources for Savara’s operations and to conduct or continue planned clinical development programs; and the timing and ability of Savara to raise additional capital as needed to fund continued operations. All forward-looking statements are expressly qualified in their entirety by these cautionary statements. For a detailed description of our risks and uncertainties, you are encouraged to review our documents filed with the SEC including our recent filings on Form 8-K, Form 10-K and Form 10-Q. You are cautioned not to place undue reliance on forward-looking statements, which speak only as of the date on which they were made. Savara undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made, except as may be required by law. View source version on businesswire.com: https://www.businesswire.com/news/home/20260518925976/en/ Media and Investor Relations Contact
Savara Inc.
Temre Johnson, Executive Director, Corporate Affairs
ir@savarapharma.com Original: Savara Announces New Exercise Capacity Data from the IMPALA-2 Phase 3 Clinical Trial of Molgramostim Inhalation Solution (Molgramostim) in Autoimmune Pulmonary Alveolar Proteinosis (aPAP)
US Market News
4週前
Savara Reports First Quarter Financial Results and Provides Business UpdateMay 12, 2026 4:05 PM
Business Wire Achieved Regulatory Milestones for the MOLBREEVI* Development Program in Autoimmune Pulmonary Alveolar Proteinosis (Autoimmune PAP): Biologics License Application (BLA) Filed by the U.S. Food & Drug Administration (FDA), Prescription Drug User Fee Act (PDUFA) Target Action Date is November 22, 2026 Marketing Authorization Applications (MAAs) Validated by the European Medicines Agency (EMA) and the U.K. Medicines and Healthcare Products Regulatory Agency (MHRA) with Decisions Expected in Q1 2027 and Q4 2026, respectively Announced New Data from the Phase 3 IMPALA-2 Clinical Trial Will be Presented at the American Thoracic Society (ATS) International Conference in May, Including Data from the Ongoing Open-Label Treatment Period With ~$203M in Cash and Short-Term Investments as of March 31, 2026, and Access to up to an Additional ~$150M of Non-Dilutive Capital upon FDA Approval of MOLBREEVI, the Company Remains Well Capitalized for Launch Savara Inc. (Nasdaq: SVRA) (the Company), a clinical stage biopharmaceutical company focused on rare respiratory diseases, reported financial results for the first quarter ending March 31, 2026 and provided a business update. "With approximately $203 million in cash and, upon MOLBREEVI approval, access to up to an additional $150 million in non-dilutive capital through debt and royalty structures, we remain well capitalized to fund global commercial launch preparations," said Matt Pauls, Chair and CEO, Savara. "With a PDUFA action date of November 22nd, U.S. commercial planning momentum is building. Our newly deployed Rare Disease Specialists are actively driving disease awareness for autoimmune PAP and advancing launch readiness initiatives for MOLBREEVI—a potentially first and only treatment for autoimmune PAP." First Quarter Financial Results Savara's net loss for the first quarter of 2026 was $37.3 million, or $(0.15) per share of which $10.7 million was related to non-cash share based compensation expense, specifically $7.8 million attributed to performance stock units, compared with a net loss of $26.6 million, or $(0.12) per share of which $3.0 million was related to share based compensation expense, for the first quarter of 2025. Research and development expenses increased by $4.2 million, or 22.1%, to $23.4 million for the three months ended March 31, 2026 from $19.2 million for the three months ended March 31, 2025. This increase was primarily due to the performance of tasks related to our MOLBREEVI program, which includes approximately $2.5 million of costs related to our chemistry, manufacturing, and controls activities, primarily driven by activity at our drug substance manufacturer; $3.0 million of higher personnel costs, mainly related to increased share based compensation expense; partially offset by a decrease of $0.7 million of costs related to regulatory affairs consulting and quality assurance consulting and a decrease of $0.6 million of clinical costs. General and administrative expenses increased by $6.3 million, or 68.4%, to $15.6 million for the three months ended March 31, 2026 from $9.2 million for the three months ended March 31, 2025. The increase was primarily attributable to $6.0 million of higher personnel costs, mainly related to increased share based compensation expense; other departmental overhead of $0.6 million, partially offset by a decrease in certain commercial activities of $0.3 million. As of March 31, 2026, the Company had cash, cash equivalents and short-term investments of ~$202.8 million and debt of ~$30.1 million. About Autoimmune Pulmonary Alveolar Proteinosis (Autoimmune PAP) Autoimmune PAP is a rare lung disease characterized by the abnormal build-up of surfactant in the alveoli. Surfactant consists of proteins and lipids and is an important physiological substance that lines the alveoli to prevent them from collapsing. In a healthy lung, excess surfactant is cleared and digested by immune cells called alveolar macrophages. Alveolar macrophages need to be stimulated by granulocyte-macrophage colony-stimulating factor (GM-CSF) to function properly in clearing surfactant, but in autoimmune PAP, GM-CSF is neutralized by autoantibodies against GM-CSF, rendering macrophages unable to adequately clear surfactant. As a result, an excess of surfactant accumulates in the alveoli, causing impaired gas transfer, resulting in clinical symptoms of shortness of breath, often with cough and frequent fatigue. Patients may also experience episodes of fever, chest pain, or coughing up blood, especially if secondary lung infection develops. In the long term, the disease can lead to serious complications, including lung fibrosis and the need for a lung transplant. About Savara Savara is a clinical-stage biopharmaceutical company focused on rare respiratory diseases. Our lead program, MOLBREEVI*, is a recombinant human granulocyte-macrophage colony-stimulating factor (GM-CSF) in Phase 3 development for autoimmune pulmonary alveolar proteinosis (autoimmune PAP). MOLBREEVI is delivered via an investigational eFlow® Nebulizer System (PARI Pharma GmbH) specifically developed for inhalation of a large molecule. Our management team has significant experience in rare respiratory diseases and pulmonary medicine, identifying unmet needs, and effectively advancing product candidates to approval and commercialization. More information can be found at www.savarapharma.com and LinkedIn. *MOLBREEVI is the FDA and EMA conditionally accepted trade name for molgramostim inhalation solution. It is not approved in any indication. MOLBREEVI is a trademark of Savara Inc. Forward-Looking Statements Savara cautions you that statements in this press release that are not a description of historical fact are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements may be identified by the use of words referencing future events or circumstances such as “expect,” “intend,” “plan,” “anticipate,” “believe,” and “will,” among others. Such statements include, but are not limited to, statements related to the PDUFA target action date, the timing of regulatory actions by the EMA and MHRA, upcoming presentations at ATS, that Savara has access to up to ~$150M of non-dilutive capital upon FDA approval of MOLBREEVI, that the Company remains well capitalized for launch, and that MOLBREEVI is a potentially first and only treatment for autoimmune PAP. Savara may not actually achieve any of the matters referred to in such forward-looking statements, and you should not place undue reliance on these forward-looking statements. These forward-looking statements are based upon Savara’s current expectations and involve assumptions that may never materialize or may prove to be incorrect. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties, which include, without limitation, the risks associated with our ability to successfully develop, obtain regulatory approval for, and commercialize MOLBREEVI for autoimmune PAP; changes to applicable laws and regulations; the ability to project future cash utilization and reserves needed for contingent future liabilities and business operations; the availability of sufficient resources for Savara’s operations and to conduct or continue planned clinical development programs; and the timing and ability of Savara to raise additional capital as needed to fund continued operations. All forward-looking statements are expressly qualified in their entirety by these cautionary statements. For a detailed description of our risks and uncertainties, you are encouraged to review our documents filed with the SEC including our recent filings on Form 8-K, Form 10-K and Form 10-Q. You are cautioned not to place undue reliance on forward-looking statements, which speak only as of the date on which they were made. Savara undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made, except as may be required by law. Savara Inc. and Subsidiaries Condensed Consolidated Statements of Operations and Comprehensive Loss (in thousands, except for share and per share amounts) Unaudited Three months ended March 31, 2026 2025 Operating expenses: Research and development $ 23,398 $ 19,159 General and administrative 15,568 9,246 Depreciation and amortization 24 30 Total operating expenses 38,990 28,435 Loss from operations (38,990 ) (28,435 ) Other income (expense), net: 1,706 1,796 Net loss attributable to common stockholders $ (37,284 ) $ (26,639 ) Net loss per share - basic and diluted $ (0.15 ) $ (0.12 ) Weighted average shares - basic and diluted 253,280,551 216,146,934 Other comprehensive (loss) gain (342 ) 118 Total comprehensive loss $ (37,626 ) $ (26,521 ) Savara Inc. and Subsidiaries Condensed Consolidated Balance Sheet Data (in thousands) (Unaudited) March 31, December 31, 2026 2025 Cash, cash equivalents, and short-term investments $ 202,772 $ 235,702 Working capital 193,726 221,220 Total assets 221,645 253,436 Total liabilities 45,606 50,303 Stockholders’ equity: 176,039 203,133 View source version on businesswire.com: https://www.businesswire.com/news/home/20260512677993/en/ Media and Investor Relations Contact
Savara Inc.
Temre Johnson, Executive Director, Corporate Affairs
ir@savarapharma.com Original: Savara Reports First Quarter Financial Results and Provides Business Update
US Market News
2月前
Savara To Present New Data at the American Thoracic Society (ATS) 2026 International ConferenceApril 14, 2026 8:05 AM
Business Wire
-- All Presentations Include New Data from the Phase 3 IMPALA-2 Clinical Trial of Molgramostim Inhalation Solution (Molgramostim) in Autoimmune Pulmonary Alveolar Proteinosis (aPAP), Including Data from the Ongoing Open-Label Treatment Period --
-- Company to Host Industry Theater on aPAP with Renowned Key Opinion Leaders --
Savara Inc. (Nasdaq: SVRA), a clinical stage biopharmaceutical company focused on rare respiratory diseases, announced the acceptance of one oral presentation and two poster presentations at the ATS International Conference in Orlando, Florida, May 17-20, 2026.
Oral Presentation
Title: Molgramostim Improves Exercise Distance and Duration in Patients with Autoimmune Pulmonary Alveolar Proteinosis (aPAP): Results from the IMPALA-2 Phase 3 Clinical Trial
Mini Symposium: B95 – Fibrosis, Cough, and Inflammation: Treatment Strategies in ILD
Abstract Number: 9296
Date/Time: Monday, May 18, 2026, 2:51 - 3:03 PM EDT
Location: W304 E-H Level III, Orange County Convention Center, West Concourse
Presenter: Cormac McCarthy, M.D., Ph.D., FRCPI, Associate Professor of Medicine, University College Dublin (UCD) and Consultant Respiratory Physician, St. Vincent’s University Hospital, Dublin, Ireland
Poster Presentations
Title: Long-term Efficacy and Safety of Molgramostim in Patients with Autoimmune Pulmonary Alveolar Proteinosis (aPAP): Results from the IMPALA-2 Trial Open-Label Treatment Period
Poster Discussion: C104 - Therapeutics, Biomarkers, and Real-World Evidence in ILD
Poster Board: #403
Abstract Number: 9330
Date/Time: Tuesday, May 19, 2026, 2:15 - 4:15 PM EDT
Location: W230 Level II, Orange County Convention Center, West Concourse
Presenter: Bruce Trapnell, M.D., Professor of Medicine and Pediatrics, University of Cincinnati College of Medicine, Cincinnati, OH
Title: Relationship Between Pulmonary Gas Transfer and Biomarker Levels in Patients with Autoimmune Pulmonary Alveolar Proteinosis (aPAP)
Poster Discussion: D23 – Molecular Profiling to Patient-Reported Outcomes – Integrating Phenotypes and Real-World Data in ILD
Poster Board: #401
Abstract Number: 9080
Date/Time: Wednesday, May 20, 2026, 8:15 - 10:15 AM EDT
Location: W230 Level II, Orange County Convention Center, West Concourse
Presenter: Yoshikazu Inoue, M.D., Ph.D., Executive Director of the Clinical Research Center, NHO Kinki Chuo Chest Medical Center and Internal Medicine, Osaka Anti-Tuberculosis Association Osaka Fukujuji Hospital, Osaka, Japan
ATS Industry Theater
Title: Advances in aPAP: From Pathophysiology to Patient Experience
Date/Time: Monday, May 18, 2025, 1:00 - 2:00 PM EDT
Location: Exhibit Hall, Innovation Theater 6
Description: Kevin Davidson, M.D., FCCP, will present an update on aPAP, addressing pathophysiology, clinical presentation, diagnosis, and management, followed by a discussion moderated by Jeff Sippel, M.D., incorporating insights from his clinical experience and the lived experience of Kelsea A., a patient advocate living with aPAP.
About Autoimmune Pulmonary Alveolar Proteinosis (aPAP)
Autoimmune PAP is a rare lung disease characterized by the abnormal build-up of surfactant in the alveoli. Surfactant consists of proteins and lipids and is an important physiological substance that lines the alveoli to prevent them from collapsing. In a healthy lung, excess surfactant is cleared and digested by immune cells called alveolar macrophages. Alveolar macrophages need to be stimulated by granulocyte-macrophage colony-stimulating factor (GM-CSF) to function properly in clearing surfactant, but in aPAP, GM-CSF is neutralized by antibodies against GM-CSF, rendering macrophages unable to adequately clear surfactant. As a result, an excess of surfactant accumulates in the alveoli, causing impaired gas exchange, resulting in clinical symptoms of shortness of breath, often with cough and frequent fatigue. Patients may also experience episodes of fever, chest pain, or coughing up blood, especially if secondary lung infection develops. In the long term, the disease can lead to serious complications, including lung fibrosis and the need for a lung transplant.
About Savara
Savara is a clinical stage biopharmaceutical company focused on rare respiratory diseases. Our lead program, molgramostim inhalation solution (molgramostim) is a recombinant human granulocyte-macrophage colony-stimulating factor (GM-CSF) in Phase 3 development for autoimmune pulmonary alveolar proteinosis (aPAP). Molgramostim is delivered via a proprietary investigational eFlow® Nebulizer System (PARI Pharma GmbH) specifically developed for inhalation of molgramostim. Our management team has significant experience in rare respiratory diseases and pulmonary medicine, identifying unmet needs, and effectively advancing product candidates to approval and commercialization. More information can be found at www.savarapharma.com and LinkedIn.
View source version on businesswire.com: https://www.businesswire.com/news/home/20260414233320/en/
Media and Investor Contact:
Savara Inc.
Temre Johnson, Executive Director, Corporate Affairs
ir@savarapharma.com
Original: Savara To Present New Data at the American Thoracic Society (ATS) 2026 International Conference
US Market News
2月前
Savara Announces the U.K. Medicines and Healthcare Products Regulatory Agency (MHRA) Has Accepted the MOLBREEVI* Marketing Authorisation Application (MAA) for Autoimmune Pulmonary Alveolar Proteinosis (Autoimmune PAP)April 7, 2026 8:05 AM
Business Wire
-- MHRA’s Acceptance Follows Acceptance/Validation of MOLBREEVI Biologics License Application (BLA) and MAA in Autoimmune PAP by the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA), Respectively --
Savara Inc. (Nasdaq: SVRA) (the Company), a clinical stage biopharmaceutical company focused on rare respiratory diseases, today announced that the MHRA has accepted the submission of the MOLBREEVI MAA for the treatment of autoimmune PAP in the U.K. The MAA was accepted under Accelerated Review and qualifies for a 150-day assessment duration. A decision on the application is expected in Q4 2026.
In the U.S., the FDA is reviewing the MOLBREEVI BLA under Priority Review with an August 22, 2026 Prescription Drug User Fee Act (PDUFA) date. In Europe, the MOLBREEVI MAA is being reviewed by the Committee for Medicinal Products for Human Use (CHMP) with a decision expected in Q1 2027.
“Marketing applications for MOLBREEVI in autoimmune PAP are now being reviewed by regulatory agencies across the U.S., EU, and the U.K., all with decisions expected over the next 12 months,” said Matt Pauls, Chair and CEO, Savara. “We look forward to working with these regulators through the review process as we endeavor to address the unmet need in this rare and chronic lung disease by bringing a first-in-class therapy to autoimmune PAP patients living in these geographies.”
In addition to Fast Track and Breakthrough Therapy Designations in the U.S., MOLBREEVI has been granted Orphan Drug Designation for the treatment of autoimmune PAP by the FDA and the EMA, as well as Innovation Passport and Promising Innovative Medicine designations by the MHRA.
About Autoimmune Pulmonary Alveolar Proteinosis (Autoimmune PAP)
Autoimmune PAP is a rare lung disease characterized by the abnormal build-up of surfactant in the alveoli. Surfactant consists of proteins and lipids and is an important physiological substance that lines the alveoli to prevent them from collapsing. In a healthy lung, excess surfactant is cleared and digested by immune cells called alveolar macrophages. Alveolar macrophages need to be stimulated by granulocyte-macrophage colony-stimulating factor (GM-CSF) to function properly in clearing surfactant, but in autoimmune PAP, GM-CSF is neutralized by autoantibodies against GM-CSF, rendering macrophages unable to adequately clear surfactant. As a result, an excess of surfactant accumulates in the alveoli, causing impaired gas transfer, resulting in clinical symptoms of shortness of breath, often with cough and frequent fatigue. Patients may also experience episodes of fever, chest pain, or coughing up blood, especially if secondary lung infection develops. In the long term, the disease can lead to serious complications, including lung fibrosis and the need for a lung transplant.
About Savara
Savara is a clinical-stage biopharmaceutical company focused on rare respiratory diseases. Our lead program, MOLBREEVI*, is a recombinant human granulocyte-macrophage colony-stimulating factor (GM-CSF) in Phase 3 development for autoimmune pulmonary alveolar proteinosis (autoimmune PAP). MOLBREEVI is delivered via a proprietary investigational eFlow® Nebulizer System (PARI Pharma GmbH) specifically developed for inhalation of MOLBREEVI. Our management team has significant experience in rare respiratory diseases and pulmonary medicine, identifying unmet needs, and effectively advancing product candidates to approval and commercialization. More information can be found at www.savarapharma.com and LinkedIn.
*MOLBREEVI is the FDA and EMA conditionally accepted trade name for molgramostim inhalation solution. It is not approved in any indication. MOLBREEVI is a trademark of Savara Inc.
Forward-Looking Statements
Savara cautions you that statements in this press release that are not a description of historical fact are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements may be identified by the use of words referencing future events or circumstances such as “expect,” “intend,” “plan,” “anticipate,” “believe,” and “will,” among others. Such statements include, but are not limited to, statements related to the timing of regulatory actions by the FDA, EMA, and MHRA, and that we endeavor to address the unmet need in this rare and chronic lung disease by bringing a first-in-class therapy to autoimmune PAP patients living in these geographies. Savara may not actually achieve any of the matters referred to in such forward-looking statements, and you should not place undue reliance on these forward-looking statements. These forward-looking statements are based upon Savara’s current expectations and involve assumptions that may never materialize or may prove to be incorrect. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties, which include, without limitation, the risks associated with our ability to successfully develop, obtain regulatory approval for, and commercialize MOLBREEVI for autoimmune PAP; changes to applicable laws and regulations; the ability to project future cash utilization and reserves needed for contingent future liabilities and business operations; the availability of sufficient resources for Savara’s operations and to conduct or continue planned clinical development programs; and the timing and ability of Savara to raise additional capital as needed to fund continued operations. All forward-looking statements are expressly qualified in their entirety by these cautionary statements. For a detailed description of our risks and uncertainties, you are encouraged to review our documents filed with the SEC including our recent filings on Form 8-K, Form 10-K and Form 10-Q. You are cautioned not to place undue reliance on forward-looking statements, which speak only as of the date on which they were made. Savara undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made, except as may be required by law.
View source version on businesswire.com: https://www.businesswire.com/news/home/20260407024140/en/
Media and Investor Relations Contact
Savara Inc.
Temre Johnson, Executive Director, Corporate Affairs
ir@savarapharma.com
Original: Savara Announces the U.K. Medicines and Healthcare Products Regulatory Agency (MHRA) Has Accepted the MOLBREEVI* Marketing Authorisation Application (MAA) for Autoimmune Pulmonary Alveolar Proteinosis (Autoimmune PAP)
US Market News
2月前
Savara Announces European Medicines Agency (EMA) Validation of Marketing Authorization Application (MAA) for MOLBREEVI* in Autoimmune Pulmonary Alveolar Proteinosis (Autoimmune PAP)March 30, 2026 8:05 AM
Business Wire
-- EMA Review of MOLBREEVI MAA Has Now Initiated, Decision Expected in Q1 2027 --
-- MOLBREEVI Biologics License Application (BLA) is Currently Under Priority Review with the U.S. Food and Drug Administration (FDA), with an Action Date of August 22, 2026 --
-- MOLBREEVI MAA Was Submitted to the U.K. Medicines and Healthcare Products Regulatory Agency (MHRA) in March 2026 --
Savara Inc. (Nasdaq: SVRA) (the Company), a clinical stage biopharmaceutical company focused on rare respiratory diseases, today announced that the EMA has validated the submission of the MOLBREEVI MAA in autoimmune PAP; the submission will now be reviewed by the Committee for Medicinal Products for Human Use (CHMP). In the U.S., the FDA is reviewing the MOLBREEVI BLA under Priority Review with an August 22, 2026 Action Date.
“EMA’s validation of the MOLBREEVI MAA confirms the submission is complete and that the review of the application has begun,” said Matt Pauls, Chair and CEO, Savara. “This milestone represents an important advancement in our regulatory strategy, and we appreciate the EMA’s guidance throughout the process to-date. Today’s announcement follows the FDA’s filing of the MOLBREEVI BLA and our recent submission of the marketing application to the MHRA. If approved, MOLBREEVI would be the first drug indicated for the treatment of autoimmune PAP in the U.S. and Europe and has the potential to fundamentally change the way this rare and chronic lung disease is treated.”
In addition to Fast Track and Breakthrough Therapy Designations, MOLBREEVI has been granted Orphan Drug Designation for the treatment of autoimmune PAP by the FDA and the EMA, as well as Innovation Passport and Promising Innovative Medicine designations by the MHRA.
About Autoimmune Pulmonary Alveolar Proteinosis (Autoimmune PAP)
Autoimmune PAP is a rare lung disease characterized by the abnormal build-up of surfactant in the alveoli. Surfactant consists of proteins and lipids and is an important physiological substance that lines the alveoli to prevent them from collapsing. In a healthy lung, excess surfactant is cleared and digested by immune cells called alveolar macrophages. Alveolar macrophages need to be stimulated by granulocyte-macrophage colony-stimulating factor (GM-CSF) to function properly in clearing surfactant, but in autoimmune PAP, GM-CSF is neutralized by autoantibodies against GM-CSF, rendering macrophages unable to adequately clear surfactant. As a result, an excess of surfactant accumulates in the alveoli, causing impaired gas transfer, resulting in clinical symptoms of shortness of breath, often with cough and frequent fatigue. Patients may also experience episodes of fever, chest pain, or coughing up blood, especially if secondary lung infection develops. In the long term, the disease can lead to serious complications, including lung fibrosis and the need for a lung transplant.
About Savara
Savara is a clinical-stage biopharmaceutical company focused on rare respiratory diseases. Our lead program, MOLBREEVI*, is a recombinant human granulocyte-macrophage colony-stimulating factor (GM-CSF) in Phase 3 development for autoimmune pulmonary alveolar proteinosis (autoimmune PAP). MOLBREEVI is delivered via an investigational eFlow® Nebulizer System (PARI Pharma GmbH) specifically developed for inhalation of a large molecule. Our management team has significant experience in rare respiratory diseases and pulmonary medicine, identifying unmet needs, and effectively advancing product candidates to approval and commercialization. More information can be found at www.savarapharma.com and LinkedIn.
*MOLBREEVI is the FDA and EMA conditionally accepted trade name for molgramostim inhalation solution. It is not approved in any indication. MOLBREEVI is a trademark of Savara Inc.
Forward-Looking Statements
Savara cautions you that statements in this press release that are not a description of historical fact are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements may be identified by the use of words referencing future events or circumstances such as “expect,” “intend,” “plan,” “anticipate,” “believe,” and “will,” among others. Such statements include, but are not limited to, statements related to the potential timing of decisions by regulatory authorities in the U.S. and Europe, the next steps in the regulatory review process, and that, if approved, MOLBREEVI would be the first drug indicated for the treatment of autoimmune PAP in the U.S. and Europe and has the potential to fundamentally change the way this rare and chronic lung disease is treated. Savara may not actually achieve any of the matters referred to in such forward-looking statements, and you should not place undue reliance on these forward-looking statements. These forward-looking statements are based upon Savara’s current expectations and involve assumptions that may never materialize or may prove to be incorrect. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties, which include, without limitation, the risks associated with our ability to successfully develop, obtain regulatory approval for, and commercialize MOLBREEVI for autoimmune PAP; changes to applicable laws and regulations; the ability to project future cash utilization and reserves needed for contingent future liabilities and business operations; the availability of sufficient resources for Savara’s operations and to conduct or continue planned clinical development programs; and the timing and ability of Savara to raise additional capital as needed to fund continued operations. All forward-looking statements are expressly qualified in their entirety by these cautionary statements. For a detailed description of our risks and uncertainties, you are encouraged to review our documents filed with the SEC including our recent filings on Form 8-K, Form 10-K and Form 10-Q. You are cautioned not to place undue reliance on forward-looking statements, which speak only as of the date on which they were made. Savara undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made, except as may be required by law.
View source version on businesswire.com: https://www.businesswire.com/news/home/20260330927904/en/
Media and Investor Relations Contact
Savara Inc.
Temre Johnson, Executive Director, Corporate Affairs
ir@savarapharma.com
Original: Savara Announces European Medicines Agency (EMA) Validation of Marketing Authorization Application (MAA) for MOLBREEVI* in Autoimmune Pulmonary Alveolar Proteinosis (Autoimmune PAP)
US Market News
3月前
Savara Reports Fourth Quarter and Year End 2025 Financial Results and Provides Business UpdateMarch 13, 2026 8:05 AM
Business Wire
Achieved Regulatory Milestones for the MOLBREEVI* in Autoimmune Pulmonary Alveolar Proteinosis (Autoimmune PAP) Development Program:
U.S. Food and Drug Administration (FDA) filed the Biologics License Application (BLA)
Priority Review granted, Prescription Drug User Fee Act (PDUFA) date set for August 22, 2026
FDA indicated an Advisory Committee is not planned for the BLA
Submitted Marketing Authorization Applications (MAAs) to the European Medicines Agency (EMA) and the U.K. Medicines and Healthcare Products Regulatory Agency (MHRA)
With ~$236M in Cash and Short-Term Investments as of December 31, 2025, and Access to up to an Additional ~$150M of Non-Dilutive Capital upon FDA Approval of MOLBREEVI, the Company is Well Capitalized for Launch
Savara Inc. (Nasdaq: SVRA) (the Company), a clinical stage biopharmaceutical company focused on rare respiratory diseases, reported financial results for the fourth quarter and full year ending December 31, 2025 and provided a business update.
“Over the last year, we significantly advanced the MOLBREEVI development program,” said Matt Pauls, Chair and Chief Executive Officer, Savara. “With the filing of the BLA, an assigned PDUFA date of August 22nd, and submission of the MAAs we have strong momentum. U.S. commercial planning is underway, most notably with the onboarding of a market development team that will be complete in the second quarter. With approximately $236 million in cash and access to up to an additional $150 million in non-dilutive capital through debt and royalty structures upon MOLBREEVI approval, we can fund global commercial launch activities. Strong financial flexibility combined with meaningful near-term catalysts means we enter 2026 in a position of strength and confidence.”
In addition to Fast Track and Breakthrough Therapy Designations, MOLBREEVI has been granted Orphan Drug Designation for the treatment of autoimmune PAP by the FDA and the EMA, as well as Innovation Passport (IP) and Promising Innovative Medicine (PIM) designations by the UK’s MHRA.
Fourth Quarter Financial Results (Unaudited)
Savara's net loss for the fourth quarter of 2025 was $32.2 million, or $(0.13) per share, compared with a net loss of $29.0 million, or $(0.13) per share, for the fourth quarter of 2024.
Research and development expenses for the fourth quarter of 2025 and 2024 were $20.9 million and $23.3 million, respectively.
General and administrative expenses for the fourth quarter of 2025 and 2024 were $12.5 million and $7.8 million, respectively.
As of December 31, 2025, the Company had cash, cash equivalents and short-term investments of $235.7 million.
Fiscal Year 2025 Financial Results
The Company’s net loss for the year ended December 31, 2025 was $118.8 million, or $(0.53) per share, compared with a net loss of was $95.9 million, or $(0.48) per share for the year ended December 31, 2024.
Research and development expenses increased $3.4 million, or 4.3%, to $81.4 million for the year ended December 31, 2025 from $78.0 million for the year ended December 31, 2024. This increase was primarily due to the performance of tasks related to our MOLBREEVI program, which includes $5.7 million of costs related to regulatory affairs and quality assurance, primarily driven by the BLA submission; $0.5 million of costs related to our chemistry, manufacturing, and controls activities; and $1.0 million other departmental overhead, partially offset by a decrease of $3.8 million in clinical costs.
General and administrative expenses increased $17.0 million, or 68.0%, to $42.1 million for the year ended December 31, 2025 from $25.0 million for the year ended December 31, 2024. The increase was due to higher personnel and related costs, in terms of compensation and an increase in valuation and stock awards, driven by strategic workforce expansion to support and scale operations of $11.2 million; certain additional commercial activities of $3.1 million; and other overhead of $2.7 million primarily driven by expanded patient advocacy and medical affairs activities.
About Autoimmune Pulmonary Alveolar Proteinosis (Autoimmune PAP)
Autoimmune PAP is a rare lung disease characterized by the abnormal build-up of surfactant in the alveoli. Surfactant consists of proteins and lipids and is an important physiological substance that lines the alveoli to prevent them from collapsing. In a healthy lung, excess surfactant is cleared and digested by immune cells called alveolar macrophages. Alveolar macrophages need to be stimulated by granulocyte-macrophage colony-stimulating factor (GM-CSF) to function properly in clearing surfactant, but in autoimmune PAP, GM-CSF is neutralized by autoantibodies against GM-CSF, rendering macrophages unable to adequately clear surfactant. As a result, an excess of surfactant accumulates in the alveoli, causing impaired gas transfer, resulting in clinical symptoms of shortness of breath, often with cough and frequent fatigue. Patients may also experience episodes of fever, chest pain, or coughing up blood, especially if secondary lung infection develops. In the long term, the disease can lead to serious complications, including lung fibrosis and the need for a lung transplant.
About Savara
Savara is a clinical-stage biopharmaceutical company focused on rare respiratory diseases. Our lead program, MOLBREEVI*, is a recombinant human granulocyte-macrophage colony-stimulating factor (GM-CSF) in Phase 3 development for autoimmune pulmonary alveolar proteinosis (autoimmune PAP). MOLBREEVI is delivered via an investigational eFlow® Nebulizer System (PARI Pharma GmbH) specifically developed for inhalation of a large molecule. Our management team has significant experience in rare respiratory diseases and pulmonary medicine, identifying unmet needs, and effectively advancing product candidates to approval and commercialization. More information can be found at www.savarapharma.com and LinkedIn.
*MOLBREEVI is the FDA and EMA conditionally accepted trade name for molgramostim inhalation solution. It is not approved in any indication. MOLBREEVI is a trademark of Savara Inc.
Forward-Looking Statements
Savara cautions you that statements in this press release that are not a description of historical fact are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements may be identified by the use of words referencing future events or circumstances such as “expect,” “intend,” “plan,” “anticipate,” “believe,” and “will,” among others. Such statements include, but are not limited to, statements related to the timing of the PDUFA date and potential FDA approval for MOLBREEVI, that Savara has access to up to ~$150M of non-dilutive capital upon FDA approval of MOLBREEVI, that the Company is well capitalized for launch and can fund global launch activities, and that onboarding of a market development team that will be complete in the second quarter. Savara may not actually achieve any of the matters referred to in such forward-looking statements, and you should not place undue reliance on these forward-looking statements. These forward-looking statements are based upon Savara’s current expectations and involve assumptions that may never materialize or may prove to be incorrect. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties, which include, without limitation, the risks associated with our ability to successfully develop, obtain regulatory approval for, and commercialize MOLBREEVI for autoimmune PAP; changes to applicable laws and regulations; the ability to project future cash utilization and reserves needed for contingent future liabilities and business operations; the availability of sufficient resources for Savara’s operations and to conduct or continue planned clinical development programs; and the timing and ability of Savara to raise additional capital as needed to fund continued operations. All forward-looking statements are expressly qualified in their entirety by these cautionary statements. For a detailed description of our risks and uncertainties, you are encouraged to review our documents filed with the SEC including our recent filings on Form 8-K, Form 10-K and Form 10-Q. You are cautioned not to place undue reliance on forward-looking statements, which speak only as of the date on which they were made. Savara undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made, except as may be required by law.
Financial Information to Follow
Savara Inc. and Subsidiaries
Condensed Consolidated Statements of Operations and Comprehensive Loss
(in thousands, except for share and per share amounts)
(Unaudited)
Three months ended
Twelve months ended
December 31,
December 31,
2025
2024
2025
2024
Operating expenses:
Research and development
$
20,902
$
23,294
$
81,404
$
78,029
General and administrative
12,491
7,848
42,056
25,037
Depreciation and amortization
26
32
87
130
Total operating expenses
33,419
31,174
123,547
103,196
Loss from operations
(33,419
)
(31,174
)
(123,547
)
(103,196
)
Other income, net:
1,183
2,130
4,710
7,315
Net loss attributable to common stockholders
$
(32,236
)
$
(29,044
)
$
(118,837
)
$
(95,881
)
Net loss per share - basic and diluted
$
(0.13
)
$
(0.13
)
$
(0.53
)
$
(0.48
)
Weighted average shares - basic and diluted
240,309,306
215,446,265
222,387,531
198,191,936
Other comprehensive income (loss)
68
(1,049
)
663
(479
)
Total comprehensive loss
$
(32,168
)
$
(30,093
)
$
(118,174
)
$
(96,360
)
Savara Inc. and Subsidiaries
Condensed Consolidated Balance Sheet Data
(in thousands)
December 31,
December 31,
2025
2024
Cash, cash equivalents, and short-term investments
$
235,702
$
196,327
Working capital
221,220
187,411
Total assets
253,436
212,879
Total liabilities
50,303
41,430
Stockholders’ equity
203,133
171,449
View source version on businesswire.com: https://www.businesswire.com/news/home/20260313815938/en/
Media and Investor Relations Contact
Savara Inc.
Temre Johnson, Executive Director, Corporate Affairs
ir@savarapharma.com
Original: Savara Reports Fourth Quarter and Year End 2025 Financial Results and Provides Business Update
US Market News
3月前
Savara Provides Regulatory Update on the MOLBREEVI* Development Program in Autoimmune Pulmonary Alveolar Proteinosis (Autoimmune PAP)March 6, 2026 4:05 PM
Business Wire
-- Day 74 Letter Received from the U.S. Food and Drug Administration (FDA) Indicated the Agency Has No Plans to Convene an Advisory Committee --
-- Company has Submitted the Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) --
-- Submission of the MAA to the U.K. Medicines and Healthcare Products Regulatory Agency (MHRA) Remains on Track by the End of Q1 2026 --
Savara Inc. (the “Company”) (Nasdaq: SVRA), a clinical-stage biopharmaceutical company focused on rare respiratory diseases, today announced that it has received the Day 74 Letter from the FDA which indicated that an Advisory Committee meeting is not planned for the MOLBREEVI Biologics License Application (BLA) and the review is ongoing with a Prescription Drug User Fee Act (PDUFA) target action date of August 22, 2026.
Additionally, the Company recently submitted the MAA to the EMA for MOLBREEVI for the treatment of autoimmune PAP and is on track to submit the MAA to the U.K.’s MHRA by the end of Q1 2026.
“MOLBREEVI has the potential to be a first-in-class treatment for autoimmune PAP, a rare and debilitating lung disease with no approved therapeutics in the U.S. and Europe,” said Matt Pauls, Chair and Chief Executive Officer, Savara. “We are confident in the potential of MOLBREEVI to address the unmet needs of this patient community and look forward to working with the FDA and EMA during the review processes.”
MOLBREEVI was granted Fast Track and Breakthrough Therapy Designations by the FDA, Orphan Drug Designation by the FDA and by the EMA, and Innovation Passport (IP) and Promising Innovative Medicine (PIM) designations by the UK’s MHRA for the treatment of autoimmune PAP.
About Autoimmune Pulmonary Alveolar Proteinosis (Autoimmune PAP)
Autoimmune PAP is a rare lung disease characterized by the abnormal build-up of surfactant in the alveoli. Surfactant consists of proteins and lipids and is an important physiological substance that lines the alveoli to prevent them from collapsing. In a healthy lung, excess surfactant is cleared and digested by immune cells called alveolar macrophages. Alveolar macrophages need to be stimulated by granulocyte-macrophage colony-stimulating factor (GM-CSF) to function properly in clearing surfactant, but in autoimmune PAP, GM-CSF is neutralized by antibodies against GM-CSF, rendering macrophages unable to adequately clear surfactant. As a result, an excess of surfactant accumulates in the alveoli, causing impaired gas exchange, resulting in clinical symptoms of shortness of breath, often with cough and frequent fatigue. Patients may also experience episodes of fever, chest pain, or coughing up blood, especially if secondary lung infection develops. In the long term, the disease can lead to serious complications, including lung fibrosis and the need for a lung transplant.
About Savara
Savara is a clinical stage biopharmaceutical company focused on rare respiratory diseases. Our lead program, MOLBREEVI* is a recombinant human granulocyte-macrophage colony-stimulating factor (GM-CSF) in Phase 3 development for autoimmune pulmonary alveolar proteinosis (autoimmune PAP). MOLBREEVI is delivered via a proprietary investigational eFlow® Nebulizer System (PARI Pharma GmbH) specifically developed for inhalation of MOLBREEVI. Our management team has significant experience in rare respiratory diseases and pulmonary medicine, identifying unmet needs, and effectively advancing product candidates to approval and commercialization. More information can be found at www.savarapharma.com and LinkedIn.
*MOLBREEVI is the FDA and EMA conditionally accepted trade name for molgramostim inhalation solution. It is not approved in any indication. MOLBREEVI is a trademark of Savara Inc.
Forward-Looking Statements
Savara cautions you that statements in this press release that are not a description of historical fact are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements may be identified by the use of words referencing future events or circumstances such as “expect,” “intend,” “plan,” “anticipate,” “believe,” and “will,” among others. Such statements include, but are not limited to, statements related to the FDA’s plans to convene an Advisory Committee for the MOLBREEVI BLA, the timing of the PDUFA target action date and potential FDA approval for MOLBREEVI, the anticipated timing of the MAA submission in the UK, that MOLBREEVI has the potential to be a first-in-class treatment for autoimmune PAP, and that we are confident in the potential of MOLBREEVI to address the unmet needs of this patient community and look forward to working with the FDA and EMA during the review process. Savara may not actually achieve any of the matters referred to in such forward-looking statements, and you should not place undue reliance on these forward-looking statements. These forward-looking statements are based upon Savara’s current expectations and involve assumptions that may never materialize or may prove to be incorrect. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties, which include, without limitation, the risks associated with our ability to successfully develop, obtain regulatory approval for, and commercialize MOLBREEVI for autoimmune PAP; changes to applicable laws and regulations; the ability to project future cash utilization and reserves needed for contingent future liabilities and business operations; the availability of sufficient resources for Savara’s operations and to conduct or continue planned clinical development programs; and the timing and ability of Savara to raise additional capital as needed to fund continued operations. All forward-looking statements are expressly qualified in their entirety by these cautionary statements. For a detailed description of our risks and uncertainties, you are encouraged to review our documents filed with the SEC including our recent filings on Form 8-K, Form 10-K and Form 10-Q. You are cautioned not to place undue reliance on forward-looking statements, which speak only as of the date on which they were made. Savara undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made, except as may be required by law.
View source version on businesswire.com: https://www.businesswire.com/news/home/20260306043046/en/
Media and Investor Relations Contact
Savara Inc.
Temre Johnson, Executive Director, Corporate Affairs
ir@savarapharma.com
Original: Savara Provides Regulatory Update on the MOLBREEVI* Development Program in Autoimmune Pulmonary Alveolar Proteinosis (Autoimmune PAP)
US Market News
4月前
Savara Announces the U.S. Food and Drug Administration (FDA) Filed the MOLBREEVI* Biologics License Application (BLA) in Autoimmune Pulmonary Alveolar Proteinosis (Autoimmune PAP)February 20, 2026 4:15 PM
Business Wire
-- Priority Review Granted, Prescription Drug User Fee Act (PDUFA) Target Action Date Set for August 22, 2026 --
-- Company Plans to Submit the MOLBREEVI Marketing Authorization Applications (MAAs) for Autoimmune PAP to the European Medicines Agency (EMA) and the Medicines and Healthcare Products Regulatory Agency (MHRA) By the End of Q1 2026 --
-- MOLBREEVI Has the Potential to Be the First and Only Approved Therapy for Autoimmune PAP in the U.S. and Europe --
Savara Inc. (Nasdaq: SVRA) (the Company), a clinical-stage biopharmaceutical company focused on rare respiratory diseases, announced the FDA has filed for review the BLA for MOLBREEVI as a therapy to treat patients with autoimmune PAP. The FDA granted Priority Review with a PDUFA action date of August 22, 2026.
“The FDA’s filing of the BLA marks another significant milestone for Savara and the autoimmune PAP community and brings us one step closer to a potential approval in the U.S. in August of this year,” said Matt Pauls, Chair and Chief Executive Officer, Savara. “We believe the considerable body of data in the application demonstrates MOLBREEVI improves pulmonary gas transfer, quality of life, and the clinical symptoms associated with this rare and debilitating lung disease. We are grateful to the FDA for the constructive feedback they have provided throughout development and the review process to date and look forward to continued dialogue with the Agency.”
FDA Priority Review designation directs overall attention and resources to the evaluation of applications for drugs that, if approved, would be significant improvements in the safety or effectiveness of the treatment, diagnosis, or prevention of serious conditions when compared to standard review applications.1
In addition to Fast Track and Breakthrough Therapy Designations, MOLBREEVI has been granted Orphan Drug Designation for the treatment of autoimmune PAP by the FDA and the EMA, as well as Innovation Passport (IP) and Promising Innovative Medicine (PIM) designations by the UK’s MHRA.
About Autoimmune Pulmonary Alveolar Proteinosis (autoimmune PAP)
Autoimmune PAP is a rare lung disease characterized by the abnormal build-up of surfactant in the alveoli. Surfactant consists of proteins and lipids and is an important physiological substance that lines the alveoli to prevent them from collapsing. In a healthy lung, excess surfactant is cleared and digested by immune cells called alveolar macrophages. Alveolar macrophages need to be stimulated by granulocyte-macrophage colony-stimulating factor (GM-CSF) to function properly in clearing surfactant, but in autoimmune PAP, GM-CSF is neutralized by autoantibodies against GM-CSF, rendering macrophages unable to adequately clear surfactant. As a result, an excess of surfactant accumulates in the alveoli, causing impaired gas transfer, resulting in clinical symptoms of shortness of breath, often with cough and frequent fatigue. Patients may also experience episodes of fever, chest pain, or coughing up blood, especially if secondary lung infection develops. In the long term, the disease can lead to serious complications, including lung fibrosis and the need for a lung transplant.
About Savara
Savara is a clinical-stage biopharmaceutical company focused on rare respiratory diseases. Our lead program, MOLBREEVI*, is a recombinant human granulocyte-macrophage colony-stimulating factor (GM-CSF) in Phase 3 development for autoimmune pulmonary alveolar proteinosis (autoimmune PAP). MOLBREEVI is delivered via an investigational eFlow® Nebulizer System (PARI Pharma GmbH) specifically developed for inhalation of a large molecule. Our management team has significant experience in rare respiratory diseases and pulmonary medicine, identifying unmet needs, and effectively advancing product candidates to approval and commercialization. More information can be found at www.savarapharma.com and LinkedIn.
*MOLBREEVI is the FDA and EMA conditionally accepted trade name for molgramostim inhalation solution. It is not approved in any indication. MOLBREEVI is a trademark of Savara Inc.
Forward-Looking Statements
Savara cautions you that statements in this press release that are not a description of historical fact are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements may be identified by the use of words referencing future events or circumstances such as “expect,” “intend,” “plan,” “anticipate,” “believe,” and “will,” among others. Such statements include, but are not limited to, statements related to the timing of the PDUFA action date and potential FDA approval for MOLBREEVI, the anticipated timing of the MAA submissions in Europe and the UK, that MOLBREEVI has the potential to be the first and only approved therapy for autoimmune PAP in the U.S. and Europe, our belief that the considerable body of data in the application demonstrates MOLBREEVI improves pulmonary gas transfer, quality of life, and the clinical symptoms associated with autoimmune PAP, and that we look forward to continued dialogue with the FDA. Savara may not actually achieve any of the matters referred to in such forward-looking statements, and you should not place undue reliance on these forward-looking statements. These forward-looking statements are based upon Savara’s current expectations and involve assumptions that may never materialize or may prove to be incorrect. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties, which include, without limitation, the risks associated with our ability to successfully develop, obtain regulatory approval for, and commercialize MOLBREEVI for autoimmune PAP; changes to applicable laws and regulations; the ability to project future cash utilization and reserves needed for contingent future liabilities and business operations; the availability of sufficient resources for Savara’s operations and to conduct or continue planned clinical development programs; and the timing and ability of Savara to raise additional capital as needed to fund continued operations. All forward-looking statements are expressly qualified in their entirety by these cautionary statements. For a detailed description of our risks and uncertainties, you are encouraged to review our documents filed with the SEC including our recent filings on Form 8-K, Form 10-K and Form 10-Q. You are cautioned not to place undue reliance on forward-looking statements, which speak only as of the date on which they were made. Savara undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made, except as may be required by law.
1U.S. FDA website: https://www.fda.gov/patients/fast-track-breakthrough-therapy-accelerated-approval-priority-review/priority-review
View source version on businesswire.com: https://www.businesswire.com/news/home/20260220017435/en/
Media and Investor Relations Contact
Savara Inc.
Temre Johnson, Executive Director, Corporate Affairs
ir@savarapharma.com
Original: Savara Announces the U.S. Food and Drug Administration (FDA) Filed the MOLBREEVI* Biologics License Application (BLA) in Autoimmune Pulmonary Alveolar Proteinosis (Autoimmune PAP)
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