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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), 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.
Savara (Nasdaq: SVRA), a clinical-stage biopharmaceutical company focused on rare respiratory diseases, will participate in a fireside chat at the H.C. Wainwright & Co. 4th Annual BioConnect Investor Conference.
The event is on Tuesday, May 19 at 10:00 a.m. ET at NASDAQ headquarters, with a live webcast and 90-day replay on the company’s website.
Savara (NASDAQ: SVRA) announced inducement equity grants to new hires on April 14, 2026. The Compensation Committee granted awards to 24 new employees under the 2021 Inducement Equity Incentive Plan pursuant to NASDAQ Rule 5635(c)(4).
The inducement package totals 18,500 stock options (exercise price $6.07, 10-year term), 141,000 RSUs (vest in full at two years) and 85,000 PSUs (vest on achieving a specified quarterly revenue target), each subject to continued employment and plan terms.
Savara (Nasdaq: SVRA) said the FDA extended the PDUFA target action date for its molgramostim BLA in autoimmune pulmonary alveolar proteinosis by three months to November 22, 2026.
The FDA classes the review as Priority Review, found the company's responses a major amendment, and did not cite safety, efficacy, or manufacturing concerns. Molgramostim retains Fast Track, Breakthrough Therapy, and Orphan Drug designations from the FDA, EMA orphan designation, and MHRA Innovation Passport and Promising Innovative Medicine status.
Savara (Nasdaq: SVRA) will present new clinical data at the American Thoracic Society (ATS) International Conference in Orlando, May 17-20, 2026. Presentations feature Phase 3 IMPALA-2 results for molgramostim inhalation solution in autoimmune pulmonary alveolar proteinosis (aPAP), including open-label data.
The company has one oral presentation (May 18, 2026), two poster presentations (May 19–20, 2026), and will host an ATS industry theater on aPAP that includes expert and patient perspectives.
Savara (Nasdaq: SVRA) announced the U.K. Medicines and Healthcare Products Regulatory Agency has accepted the MOLBREEVI Marketing Authorisation Application for autoimmune pulmonary alveolar proteinosis under Accelerated Review.
The MHRA acceptance qualifies for a 150-day assessment and targets a decision in Q4 2026; the FDA BLA has a PDUFA date of August 22, 2026 and the EMA CHMP decision is expected in Q1 2027. MOLBREEVI holds multiple expedited and orphan designations.