Savara Inc Stock Price, News & Analysis

Savara (NASDAQ:SVRA) presented new analyses from its Phase 3 IMPALA-2 clinical trial of molgramostim for autoimmune Pulmonary Alveolar Proteinosis (aPAP) at the ERS Congress 2025. The data showed that molgramostim demonstrated significant improvements in pulmonary gas transfer (DLco%), quality of life, and patient functionality regardless of disease severity.

Key findings revealed that changes in DLco% (the primary endpoint) significantly correlated with improvements in respiratory health-related quality of life, patient functionality, and reduced surfactant burden. Additionally, Savara's partner TrilliumBiO presented data on a new dried blood spot test showing high precision and sensitivity for detecting GM-CSF autoantibodies, potentially advancing aPAP diagnosis.

[ "Molgramostim showed efficacy across all disease severity levels", "Significant improvements in multiple clinical measures including pulmonary gas transfer and quality of life", "Development of new diagnostic tool with high precision for aPAP detection", "Strong correlation between primary endpoint (DLco%) and clinical outcomes" ]

Savara (Nasdaq: SVRA) has announced a significant update in the estimated U.S. patient population for autoimmune Pulmonary Alveolar Proteinosis (PAP). A new health claims data analysis reveals approximately 5,500 autoimmune PAP patients in the U.S., representing a 50% increase from the previous estimate of ~3,600 patients in 2023.

The company is preparing to resubmit its Biologics License Application (BLA) for MOLBREEVI in December 2025, with plans to request priority review. The drug candidate has received multiple regulatory designations, including Fast Track and Breakthrough Therapy from the FDA. Recently, the New England Journal of Medicine published results from Savara's pivotal Phase 3 IMPALA-2 clinical trial of MOLBREEVI in autoimmune PAP.

Savara (Nasdaq: SVRA), a clinical stage biopharmaceutical company specializing in rare respiratory diseases, has announced its participation in two major healthcare investor conferences. The management team will conduct one-on-one meetings and deliver presentations at the Wells Fargo Securities Healthcare Conference on September 3, 2025, at 4:30 PM ET and the H.C. Wainwright Global Healthcare Conference on September 9, 2025, at 1:00 PM ET.

Both presentations will be accessible via live webcast on Savara's corporate website under the "Events & Presentations" section, with recordings available for 90 days following the events.

Savara (Nasdaq: SVRA) announced that the New England Journal of Medicine (NEJM) will publish results from their pivotal Phase 3 IMPALA-2 clinical trial studying molgramostim inhalation solution for autoimmune pulmonary alveolar proteinosis (PAP).

The trial demonstrated statistically significant improvements in key metrics: DLco% increased by 9.8% vs 3.8% for placebo at Week 24 (p<0.001), and 11.6% vs 4.7% at Week 48. Quality of life measures showed significant improvement with SGRQ Total score reduction of -11.5 points vs -4.9 points for placebo at Week 24. Exercise capacity improved with peak-METs showing a 1.1 vs 0.6 difference at Week 48.

The treatment was well-tolerated with 98% of molgramostim patients completing the 48-week trial, and most adverse events were mild to moderate. The study represents the largest and longest Phase 3 trial conducted in autoimmune PAP patients.

Savara Inc. (Nasdaq: SVRA) announced the acceptance of three abstracts for poster presentation at the European Respiratory Society (ERS) Congress 2025, taking place September 27 – October 1 in Amsterdam. The presentations will focus on new data from the Phase 3 IMPALA-2 trial of Molgramostim, an inhaled treatment for autoimmune Pulmonary Alveolar Proteinosis (aPAP).

The company will present posters on the relationship between pulmonary gas transfer and quality of life, the efficacy of inhaled Molgramostim based on aPAP severity, and their partner TrilliumBiO will present on a new dried blood spot test for aPAP diagnosis. Additionally, Savara will host an Industry Evening Mini Symposium titled "Advances in Autoimmune Pulmonary Alveolar Proteinosis" featuring expert speakers discussing disease management and pathophysiology.

Savara (Nasdaq: SVRA) reported Q2 2025 financial results and provided updates on MOLBREEVI, its treatment for Autoimmune Pulmonary Alveolar Proteinosis (PAP). The company has aligned with the FDA on requirements for BLA resubmission with FUJIFILM Biotechnologies as the drug substance manufacturer, planned for December 2025. Marketing authorization applications to EMA and MHRA are anticipated in Q1 2026.

Financial highlights include a net loss of $30.4 million ($0.14 per share) in Q2 2025, compared to $22.2 million in Q2 2024. R&D expenses increased 17.8% to $20.8 million, while G&A expenses rose 92.3% to $10.7 million. The company reported $146.4 million in cash and short-term investments, believed sufficient to fund operations into Q1 2027.

Savara (Nasdaq: SVRA), a clinical stage biopharmaceutical company specializing in rare respiratory diseases, has granted inducement awards to two new employees. The awards, approved by the Compensation Committee on July 15, 2025, include options to purchase 20,000 shares of common stock at $2.29 per share and restricted stock units (RSUs) covering 20,000 shares.

The equity awards were granted under Savara's 2021 Inducement Equity Incentive Plan, complying with NASDAQ Rule 5635(c)(4). The options have a 10-year term with quarterly vesting over four years, while RSUs fully vest after two years, both subject to continued employment.

Savara (SVRA) received a Refusal to File (RTF) letter from the FDA regarding their Biologics License Application (BLA) for MOLBREEVI, a treatment for autoimmune Pulmonary Alveolar Proteinosis (PAP). The FDA determined the March 2025 BLA submission was incomplete, requesting additional Chemistry, Manufacturing, and Controls (CMC) data. Importantly, the RTF was not due to safety concerns, and no additional efficacy studies were requested. Savara plans to request a Type A meeting with the FDA within 30 days and expects to resubmit the BLA in Q4 2025. The company is progressing with establishing a redundant supply chain and has completed three upstream process performance qualification batches. MOLBREEVI maintains its Fast Track, Breakthrough Therapy, Orphan Drug, Innovation Passport, and Promising Innovative Medicine designations.

Savara (SVRA) has granted inducement awards to five new employees as part of their employment compensation package. The awards include: • Stock options to purchase 85,000 shares with an exercise price of $2.91 per share • Restricted stock units (RSUs) covering 75,000 shares The options have a 10-year term and vest quarterly (1/16th each quarter), while the RSUs vest fully after two years. These equity awards were granted under Savara's 2021 Inducement Equity Incentive Plan, complying with NASDAQ Rule 5635(c)(4).