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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 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.
Savara (NASDAQ: SVRA) announced the EMA validated its Marketing Authorization Application for MOLBREEVI in autoimmune pulmonary alveolar proteinosis (autoimmune PAP), initiating CHMP review with a decision expected in Q1 2027. The MOLBREEVI BLA is under FDA Priority Review with an August 22, 2026 action date. The company also submitted to the MHRA in March 2026. MOLBREEVI holds Orphan Drug designations from FDA and EMA and MHRA Innovation Passport and Promising Innovative Medicine recognitions.
Savara (Nasdaq: SVRA) reported that the FDA accepted the MOLBREEVI BLA with Priority Review and set a PDUFA date of August 22, 2026. MAAs were submitted to the EMA and MHRA. As of December 31, 2025, cash and short-term investments were $235.7M, with access to up to $150M of non-dilutive capital upon FDA approval.
Financials: Q4 net loss was $32.2M and FY2025 net loss was $118.8M; R&D was $81.4M and G&A increased to $42.1M.
Savara (Nasdaq: SVRA) received a Day 74 letter from the FDA indicating no Advisory Committee is planned for the MOLBREEVI BLA and the review continues toward a PDUFA target action date of August 22, 2026. The company submitted an MAA to the EMA for autoimmune PAP and remains on track to submit to the UK MHRA by end of Q1 2026. MOLBREEVI holds FDA Fast Track, Breakthrough Therapy and Orphan Drug designations, EMA Orphan Drug designation, and MHRA Innovation Passport and PIM designations. The update summarizes regulatory progress and timelines for potential approvals in the U.S., EU and UK.
Savara (Nasdaq: SVRA) said members of management will appear in a fireside chat at the 2026 Citizens Life Sciences Conference on Wednesday, March 11, 2026 at 10:10 AM ET in Miami, FL. The session will be webcast live with a replay archived for 90 days on the company website.