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Savara Inc. develops therapies for rare respiratory diseases, with a lead program in molgramostim inhalation solution, conditionally named MOLBREEVI, for autoimmune pulmonary alveolar proteinosis. Molgramostim is a recombinant human GM-CSF delivered through an investigational eFlow Nebulizer System developed for inhalation of the large-molecule therapy.
Recurring company developments include clinical data from the IMPALA-2 program, regulatory submissions and agency-review updates in the U.S., Europe and the U.K., financial results, financing arrangements, equity inducement grants and investor conference participation. Savara's updates also note that MOLBREEVI is not approved in any indication.
Savara (Nasdaq: SVRA) reported that on August 17, 2026, its Board’s Compensation Committee granted employment inducement equity awards to eight new employees under the 2021 Inducement Equity Incentive Plan, pursuant to NASDAQ Rule 5635(c)(4).
The awards comprise stock options for 74,500 shares and RSUs for 64,500 shares of common stock. Options have a $5.37 exercise price, a 10-year term, and vest quarterly over four years. RSUs vest fully on the two-year anniversary of each employee’s start date, in each case subject to continued employment.
Savara (Nasdaq: SVRA) reported unaudited second quarter 2026 results and a business update focused on its lead program MOLBREEVI* (molgramostim inhalation solution) for autoimmune PAP. The MOLBREEVI BLA now has a U.S. FDA PDUFA target action date of November 22, 2026, while Marketing Authorization Applications are under review by the EMA and U.K. MHRA, with decisions expected in Q1 2027 and Q4 2026, respectively.
According to Savara, data presented at ATS showed continuous long-term improvements in lung function and respiratory health-related quality of life with molgramostim. The European and Australian patent offices granted patents on the MOLBREEVI liquid formulation, providing protection until March 2041. As of June 30, 2026, Savara reported ~$173.0M in cash, cash equivalents and short-term investments, debt of ~$30.1M, and noted access to up to ~$150M of non-dilutive capital upon potential FDA approval of MOLBREEVI. Q2 2026 net loss was $40.2M (or $(0.16) per share) versus $30.4M (or $(0.14) per share) in Q2 2025, driven by higher R&D and commercial build-out costs.
Savara (Nasdaq: SVRA) announced that the European Patent Office has granted European patent No. 4121000 covering the liquid formulation of MOLBREEVI*, providing protection in Europe through March 2041. The Australian Patent Office has granted a corresponding patent, No. 62/990,810, securing protection in Australia to the same date.
Separately, Savara and PARI were granted a joint European patent in December 2025 for the investigational MOLBREEVI drug-device combination delivered via PARI’s proprietary eFlow® nebulizer system, providing protection through March 2043. MOLBREEVI for autoimmune PAP has multiple FDA, EMA and MHRA regulatory designations.
Savara (Nasdaq: SVRA) granted equity inducement awards to four new employees on June 11, 2026.
The awards include options for 36,500 shares at a $5.27 exercise price, 42,500 RSUs, and 8,000 PSUs under the 2021 Inducement Equity Incentive Plan, following Nasdaq Rule 5635(c)(4).
Savara (Nasdaq: SVRA) announced a leadership transition effective July 15, 2026. Chief Financial and Administrative Officer Dave Lowrance will step down for health-related reasons and remain as an advisor. Chief Operating Officer Robert Lutz will also become Chief Financial Officer, while administrative duties move to the senior leadership team.
Savara (Nasdaq: SVRA), a clinical-stage biopharma focused on rare respiratory diseases, will participate in the 2026 Jefferies Global Healthcare Conference.
Management will host one-on-one meetings and a fireside chat on June 3, 2026, at 11:05 a.m. ET, with a webcast and 90-day replay on its website.
Savara (Nasdaq: SVRA) presented new biomarker data from the double-blind period of the IMPALA-2 Phase 3 trial of molgramostim inhalation solution in autoimmune pulmonary alveolar proteinosis (aPAP) at ATS 2026.
Molgramostim 300 µg once daily for 48 weeks showed statistically significant improvements in DLco% at Weeks 24 and 48 versus placebo and greater decreases in LDH, CYFRA 21-1, and KL-6, with strong correlations between biomarker reductions and DLco% improvements.
Savara (Nasdaq: SVRA) presented 48-week open-label data from the ongoing IMPALA-2 Phase 3 trial of molgramostim inhalation in autoimmune pulmonary alveolar proteinosis (aPAP) at ATS 2026. All 160 patients completing the double-blind period entered the open-label extension, with a 94% retention rate at data cut-off.
Patients receiving molgramostim throughout showed continued gains in DLco% and further reductions in SGRQ-T and SGRQ-A scores through Week 96. Placebo crossover patients improved after starting molgramostim. According to Savara, molgramostim was generally well tolerated with no discontinuations due to treatment-related adverse events.
Savara (Nasdaq: SVRA) reported new exercise capacity data from the double-blind period of the Phase 3 IMPALA-2 trial of molgramostim in autoimmune pulmonary alveolar proteinosis (aPAP).
Molgramostim showed statistically significant improvements over placebo in distance walked and exercise duration at Week 48, complementing earlier peak METs results.
Savara (Nasdaq: SVRA) reported Q1 2026 results and key milestones for the MOLBREEVI autoimmune PAP program.
A BLA has been filed with the FDA with a PDUFA target date of November 22, 2026, and MAAs were validated by EMA and MHRA with decisions expected in Q1 2027 and Q4 2026.
Q1 2026 net loss was $37.3M versus $26.6M a year earlier. R&D rose 22.1% to $23.4M and G&A rose 68.4% to $15.6M, driven largely by higher share-based compensation. Cash and short-term investments were about $202.8M with debt of ~$30.1M and potential access to ~$150M in non-dilutive capital upon FDA approval.