Savara (SVRA) Company Report

Savara Inc. has amended its loan agreement with Hercules Capital, providing access to an additional $75 million in debt funding upon U.S. Food and Drug Administration (FDA) approval of MOLBREEVI.
This additional debt, combined with a $75 million royalty financing from RTW announced in October 2025, will provide Savara with approximately $150 million of non-dilutive capital to support the launch of MOLBREEVI.
The company resubmitted the MOLBREEVI Biologics License Application (BLA) to the FDA in December 2025, with potential approval in 3Q 2026 if Priority Review is granted.

4 days ago

Press Release

Savara Provides Update on Mobrevi BLA Submission and Commercialization Plans

SVRA

Product Launch

New Projects/Investments

Guidance Update

Savara, a single-asset company, has submitted its Biologics License Application (BLA) for Mobrevi (molgramostim inhalation solution) in the U.S. for autoimmune pulmonary alveolar proteinosis (PAP), a severe, rare lung disease with no approved therapeutic options.
The company anticipates FDA acceptance and filing by the end of February, with a potential PDUFA date in the August timeframe, and expects priority review.
Mobrevi has received Breakthrough Designation in the U.S. and Orphan Drug Designation in Europe, offering significant regulatory exclusivity.
Savara estimates a U.S. market of approximately 5,500 autoimmune PAP patients and projects a pricing corridor of $400,000-$500,000 per patient per year for Mobrevi.
The company is well-capitalized with approximately $264 million in cash pro forma and is actively preparing for the potential market launch, including offering a free diagnostic blood test for autoimmune PAP.

Jan 15, 2026, 1:15 AM

Transcript

Savara Submits BLA for Mobrevi and Outlines Commercialization Plans

SVRA

Product Launch

New Projects/Investments

Guidance Update

Savara (SVRA) has submitted its Biologics License Application (BLA) for Mobrevi in the U.S. for autoimmune PAP in December, with anticipated FDA acceptance and filing by the end of February and a potential PDUFA date in August 2026, assuming priority review.
The company plans to file the Marketing Authorization Application (MAA) in Europe and the U.K. by the end of the first quarter.
Mobrevi, a novel inhaled biologic, demonstrated positive results in the global Phase 3 IMPALA-2 trial, meeting its primary and key secondary endpoints, with data published in the New England Journal of Medicine.
Savara estimates a U.S. market of approximately 5,500 autoimmune PAP patients and has guided a pricing corridor of $400,000-$500,000 per patient per year for Mobrevi.
The company is well-capitalized with approximately $264 million in cash (pro forma) and expects 12 years of regulatory exclusivity in the U.S. and 10 years in Europe upon approval.

Jan 15, 2026, 1:15 AM

Transcript

Savara Discusses MOLBREEVI's BLA Submission, Market Opportunity, and Financial Position

SVRA

Product Launch

New Projects/Investments

Savara has submitted its Biologics License Application (BLA) for MOLBREEVI, a novel inhaled biologic for autoimmune pulmonary alveolar proteinosis (PAP), in the U.S. in December, with anticipated FDA acceptance and filing by the end of February 2026 and a PDUFA date in the August timeframe under priority review.
MOLBREEVI targets an estimated 5,500 autoimmune PAP patients in the U.S., a severe, rare lung disease with no approved therapeutic options, and has received breakthrough designation in the U.S., offering 12 years of regulatory exclusivity upon approval.
The company projects a pricing corridor of $400,000-$500,000 per patient per year for MOLBREEVI, which it believes has blockbuster potential due to the significant unmet need and market opportunity.
Savara is well capitalized with approximately $264 million in cash (pro forma) and is actively preparing the market for MOLBREEVI's potential launch, including scaling up a free diagnostic blood test for autoimmune PAP.

Jan 15, 2026, 1:15 AM

Transcript

Savara Resubmits MOLBREEVI BLA to FDA

SVRA

Product Launch

New Projects/Investments

Savara Inc. (SVRA) has resubmitted its Biologics License Application (BLA) for MOLBREEVI to the U.S. Food and Drug Administration (FDA), naming FUJIFILM Biotechnologies as the drug-substance manufacturer and requesting Priority Review.
MOLBREEVI is an inhaled granulocyte-macrophage colony-stimulating factor (GM-CSF) product designed to treat autoimmune pulmonary alveolar proteinosis (autoimmune PAP), a rare, chronic lung disease.
The program has previously received multiple regulatory designations, including FDA Fast Track, Breakthrough Therapy, and Orphan Drug status.
Savara is a clinical-stage biopharmaceutical company with no commercial revenue and negative earnings (EPS of -0.53), focused on rare respiratory diseases.

Dec 22, 2025, 1:37 PM

Morningstar

Sequana Medical Secures Additional US Patent for DSR Program

SVRA

New Projects/Investments

Sequana Medical announced the granting of a key additional US patent (number 12,496,384 B2) for its DSR (Direct Sodium Removal) program, which covers the DSR infusate and its method of operation for treating cardiorenal syndrome and diuretic-resistant heart failure.
This patent strengthens DSR patent protection based on extensive clinical and pre-clinical experience, building upon existing granted DSR patents in the US, Europe, Japan, and China.
The US MOJAVE clinical study of DSR is planned to enter its randomized controlled phase following dedicated DSR financing.
Data published in the European Journal of Heart Failure supports DSR as a potential breakthrough in the treatment of cardiorenal syndrome and diuretic-resistant heart failure.

Dec 18, 2025, 6:00 AM

Press Release

Savara Announces European Patent for MOLBREEVI Liquid Formulation

SVRA

New Projects/Investments

Product Launch

The European Patent Office (EPO) intends to grant Savara a patent for the liquid formulation of MOLBREEVI, which will provide protection in Europe until March 2041.
This new patent, along with a recently granted European patent for the MOLBREEVI drug-device combination (protected until March 2043), strengthens the company's intellectual property for its potentially first-in-class therapy to treat autoimmune PAP.
Savara anticipates 10 years of Orphan Drug regulatory exclusivity for MOLBREEVI in the EU upon approval.
The company expects to resubmit the MOLBREEVI BLA to the FDA in December 2025 and submit MAA applications in the EU and U.K. by the end of Q1 2026.

Dec 11, 2025, 1:05 PM

Press Release

Savara Provides Update on Molbrivi for Autoimmune PAP and Regulatory Timelines

SVRA

Product Launch

New Projects/Investments

Savara (SVRA) is an orphan rare disease company with positive Phase III data for its inhaled biologic, Molbrivi, targeting autoimmune pulmonary alveolar proteinosis (autoimmune PAP).
A Biologics License Application (BLA) for Molbrivi is scheduled for submission in December 2025, with Marketing Authorization Applications (MAAs) in Europe and the UK expected by the end of Q1 2026.
The estimated U.S. prevalence for autoimmune PAP is approximately 5,500 patients, or 16 per million.
Preliminary pricing research for Molbrivi suggests a range of $400,000-$500,000 per patient per year.
The Phase III IMPALA-2 trial demonstrated a clinically significant 9.8% difference change from baseline in the DLCO endpoint at 24 weeks, with 100% of patients completing the double-blind portion opting to enter the open-label extension.

Dec 4, 2025, 3:00 PM

Transcript

Savara Provides Update on Molbreevi's Regulatory Submission and Market Opportunity for Autoimmune PAP

SVRA

Product Launch

New Projects/Investments

Revenue Acceleration/Inflection

Savara (SVRA) is a single-asset orphan rare disease company developing Molbreevi, an inhaled biologic for autoimmune pulmonary alveoli proteinosis (aPAP).
A Biologics License Application (BLA) for Molbreevi is being submitted this month (December 2025), with Marketing Authorization Applications (MAA) for Europe and the U.K. planned by the end of Q1 2026. The company is resubmitting its BLA with Fujifilm as its primary drug substance partner.
The target indication, autoimmune PAP, affects approximately 5,500 patients in the U.S., representing about 16 per million.
Molbreevi's Phase III trial (IMPALA-2) showed a 9.8 difference change from baseline in DLCO at 24 weeks, which is considered clinically significant. All 159 patients who completed the 48-week trial opted for open-label extension, indicating positive patient experience.
Preliminary pricing research suggests a potential range of $400,000-$500,000 per patient per year for Molbreevi.

Dec 4, 2025, 3:00 PM

Transcript

Savara Provides Update on MOLBREEVI BLA Resubmission, Commercialization Plans, and Financial Runway

SVRA

Product Launch

Guidance Update

New Projects/Investments

Savara Inc. is on track for MOLBREEVI's BLA resubmission in December, anticipating a 60-day review, filing, and priority review, which would place the PDUFA date in August.
The company plans to submit MAAs in Europe and the UK by the end of Q1, intending to "go it alone" in these markets, which have a patient population similar to the US.
Savara has identified 5,500 diagnosed APAP patients in the US and aims for 1,000 patients at line of sight by launch. The commercial team will comprise approximately 30 customer-facing individuals.
Payers have indicated a pricing range of $300,000-$500,000 per patient per year, with Savara narrowing its target to $400,000-$500,000 due to perceived pricing power. Pro forma cash of over $260 million plus a $75 million royalty financing extends the financial runway beyond previous guidance of into 2027.