Savara Pharmaceuticals

What Savara Pharmaceuticals does

Savara Inc. (NASDAQ: SVRA) is a clinical-stage biopharmaceutical company focused exclusively on rare respiratory diseases, with its lead and only product candidate MOLBREEVI (molgramostim inhalation solution) under regulatory review in the U.S., EU, and UK as the first potential approved pharmaceutical treatment for autoimmune pulmonary alveolar proteinosis (autoimmune PAP). The therapy is a non-glycosylated recombinant human granulocyte-macrophage colony-stimulating factor (GM-CSF) delivered via PARI's proprietary eFlow nebulizer system, designed to restore surfactant-clearing activity of alveolar macrophages in patients whose lungs accumulate surfactant due to anti-GM-CSF autoantibodies. The company went public via reverse merger with Mast Therapeutics in April 2017, is headquartered in Langhorne, Pennsylvania, and employs 51-100 staff across the U.S. and Europe.

MOLBREEVI's clinical package is anchored by two positive trials — IMPALA (Phase 2/3, 138 patients in 18 countries, results published in NEJM September 2020) and IMPALA-2 (Phase 3, 164 patients in 16 countries, results published in NEJM August 2025) — and the FDA has granted Orphan Drug, Fast Track, Breakthrough Therapy, and Priority Review designations. Following an initial BLA rejection in May 2025 (which triggered a securities class action lawsuit), Savara resubmitted the BLA in December 2025, with a PDUFA target action date of November 22, 2026. The company has also filed marketing authorization applications validated by the EMA (March 2026) and accepted by the UK MHRA (April 2026), and was granted a European patent covering the MOLBREEVI-eFlow drug-device combination extending to March 2043.

Savara is pre-revenue, reporting a FY2025 net loss of $118.8M on operating expenses of $123.5M. Its forward commercial model targets approximately 1,700 accounts and 4,500 healthcare professionals in the U.S. with analyst-projected pricing of $400,000-$500,000 per patient per year and peak U.S. sales of $500M-$1B if approved. The capital structure has been reinforced through a $100M offering (June 2024), a $149.5M raise (October 2025), a $75M RTW royalty financing (October 2025), and a $75M Hercules Capital debt facility (January 2026), providing a reported $236M in cash plus access to up to $150M in additional non-dilutive capital contingent on FDA approval. Distribution will run through specialty pharmacy and specialty distributor networks, supported by the WEP Clinical Early Access Program and the aPAP ClearPath diagnostic testing service.

Name

Savara Pharmaceuticals

Legal name

Savara Inc.

Website

https://savarapharma.com

Company type

Public

Founded year

2007

Operating status

Operating

Headcount range

101–250 employees

Short description

Savara Pharmaceuticals is a clinical-stage biopharmaceutical company developing MOLBREEVI, an inhaled recombinant GM-CSF therapy, as the first potential approved pharmaceutical treatment for autoimmune pulmonary alveolar proteinosis (aPAP), with regulatory reviews active in the U.S., EU, and UK.

Ownership category

akta.pro rank

Product category

Rare Disease Biopharmaceuticals

NAICS

Biological Product (except Diagnostic) Manufacturing (325414)

SIC

Pharmaceutical Preparations (2834)

akta.pro primary industry

Monoclonal Antibody Therapeutics (mAbs) (HLAAAAAA)

akta.pro secondary industry

Regulatory Strategy & IND/NDA/BLA Submissions Support (HLAIALAH)

Keywords

• Rare respiratory disease therapeutics
• Inhaled biopharmaceutical products
• Autoimmune pulmonary alveolar proteinosis
• Recombinant GM-CSF therapy
• Specialty orphan drug development

Headquarters

HQ city

Austin

HQ country

United States

HQ region

North America

Offices1 record

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

Technology or R&D, Personnel, Marketing or Sales, Operations

Revenue model

1. Pharmaceutical Product Sales: Savara is a clinical-stage biopharmaceutical company preparing for commercial launch of MOLBREEVI. Upon FDA approval, the company will generate revenue through product sales directly to healthcare providers and specialty pharmacies for autoimmune PAP treatment.
2. Royalty Financing: $75 million royalty funding agreement with RTW Investments, contingent on FDA approval. This is a non-dilutive capital arrangement tied to MOLBREEVI sales performance in the US.
3. Credit Facility: $26.5 million credit facility with Silicon Valley Bank secured in April 2022 for debt refinancing.

Pricing tiers

Go-to-market motion1 record

Distribution channels3 records

Marketing channels5 records

Core offering

Savara is a clinical-stage biopharmaceutical company developing MOLBREEVI (molgramostim inhalation solution), an inhaled non-glycosylated recombinant human GM-CSF therapy intended to be the first approved pharmaceutical treatment for autoimmune pulmonary alveolar proteinosis (autoimmune PAP). The company also operates the aPAP ClearPath Testing Program, a no-charge blood diagnostic service for autoimmune PAP, and a global Expanded Access Program for patients outside clinical trials.

Product overview

Savara is a clinical-stage biopharmaceutical company developing MOLBREEVI (molgramostim inhalation solution), an inhaled recombinant human GM-CSF therapy for autoimmune pulmonary alveolar proteinosis (autoimmune PAP). The company operates a complementary diagnostic service (aPAP ClearPath Testing Program) and an early access program to support patients. MOLBREEVI is the lead product candidate in Phase 3 development, with regulatory applications filed in the U.S. (FDA), Europe (EMA), and UK (MHRA). The company has two completed clinical trial programs (IMPALA and IMPALA-2) supporting the MOLBREEVI BLA.

Differentiator

Problem solved

Functional benefit

Products and services

• MOLBREEVI (molgramostim inhalation solution) An inhaled non-glycosylated recombinant human granulocyte-macrophage colony-stimulating factor (GM-CSF) therapy for autoimmune pulmonary alveolar proteinosis (autoimmune PAP). Inhaled delivery activates macrophages in lung alveoli to restore surfactant-clearing activity and improve oxygenation. To be administered to autoimmune PAP patients via PARI's eFlow nebulizer system.
• aPAP ClearPath Testing Program A diagnostic testing service providing a no-charge blood test using GM-CSF autoantibody detection to confirm or rule out autoimmune PAP. Designed to reduce the average 18-month delay in diagnosis and to identify eligible patients for therapy. Targeted at pulmonologists, respiratory specialists, and autoimmune PAP patients.
• Savara Early Access Program (Expanded Access) A global expanded access service operated in partnership with WEP Clinical, providing eligible patients with autoimmune PAP access to molgramostim outside of clinical trials. Designed to support patients pre-approval while MOLBREEVI remains under regulatory review in the US, EU, and UK.

Named customers1 record

Segments3 records

Ideal customer profiles2 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature3 records

Partnerships

Two partnerships are on record, tiered core.

• PARI Pharma GmbHcoreTechnology or Integration · 2 December 2025Savara and PARI were jointly granted a European patent covering the drug-device combination of MOLBREEVI delivered via PARI's proprietary eFlow nebulizer system. The patent provides intellectual property protection until March 2043 for the combination therapy.
• WEP ClinicalcoreStrategic or Co-development PartnerSavara partnered with WEP Clinical, a specialist early access service provider, to operate the global Savara Early Access Program (also called Expanded Access Program) for molgramostim in eligible patients with autoimmune PAP outside of clinical trials.

Scale indicators8 records

Recent moves6 records

Expansion highlights6 records

Direct peers

• PTC Therapeutics: PTC Therapeutics commercializes several rare disease therapies including Translarna for Duchenne muscular dystrophy and Emflaza. Comparable mid-cap rare disease commercial-stage biotech with specialty sales force, orphan drug pricing, and pipeline concentration risk. Savara's CCO Braden Parker previously led US commercial at PTC.
• Insmed Incorporated: Insmed is a rare disease biopharma commercializing Arikayce (inhaled amikacin) for nontuberculous mycobacterial lung disease. Most direct peer - both develop inhaled therapeutics for rare lung conditions using orphan drug economics and specialty distribution, and Savara's CEO Matt Pauls was previously CCO at Insmed.
• United Therapeutics Corporation: United Therapeutics develops and commercializes rare pulmonary therapies including Tyvaso (inhaled treprostinil) for PAH and PH-ILD. Highly comparable model of inhaled specialty biologic for rare lung disease with orphan drug pricing and focused field sales targeting specialty prescribers.
• Vertex Pharmaceuticals: Vertex commercializes Trikafta/Kaftrio for cystic fibrosis, a rare pulmonary disease. Comparable as a profitable rare-disease respiratory franchise built on disease-modifying therapy, with a similar specialty distribution and high-priced orphan model targeting pulmonologists.
• Chiesi Farmaceutici S.p.A. Chiesi is a privately-held specialty pharma with a significant rare respiratory franchise including inhaled therapies for cystic fibrosis and other pulmonary conditions. Comparable as a focused rare respiratory commercial player with inhaled drug expertise and global distribution capabilities.
• Amicus Therapeutics: Amicus commercializes Galafold for Fabry disease and is developing rare disease therapies including inhaled treatments. Comparable mid-cap rare disease biotech with specialty distribution model and biologics expertise. Savara's CMO Yasmine Wasfi previously held leadership roles at Amicus.
• Mallinckrodt plc: Mallinckrodt commercializes Acthar Gel and other specialty therapies including inhaled respiratory products. Comparable rare disease specialty commercial organization with established specialty distribution and orphan drug commercialization experience.

Emerging players

• Arcturus Therapeutics Holdings: Arcturus is a clinical-stage mRNA and inhaled therapeutics company developing therapies for rare respiratory diseases including cystic fibrosis. Comparable emerging player with inhaled delivery technology focus and similar clinical-stage rare lung disease pipeline.

Broad incumbents

• Roche Holding AG / Genentech: Roche is a global biopharma with significant respiratory franchise and rare disease biologics capabilities (e.g., Pulmozyme for cystic fibrosis). Comparable as a broad incumbent with overlapping respiratory expertise and biologic manufacturing scale, though Savara operates in a more focused niche. Savara board member Joe McCracken is a former Roche Pharma executive.
• Shire Pharmaceuticals (now part of Takeda): Takeda (via Shire acquisition) commercializes rare respiratory and specialty therapies globally. Savara's CEO Matt Pauls and several other leaders held prior executive roles at Shire, reflecting comparable rare disease specialty commercialization expertise and infrastructure.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat4 records

Key risks4 records

Key highlights7 records

Customer concentration

• Xx.com/savarapharma
• LinkedInlinkedin.com/company/savara-pharmaceuticals

Revenue estimate

Valuation estimate

Number of profiles

Profiles12 records

Funding overview

Funding rounds20 records

Investors22 records

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A2 records

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about Savara Pharmaceuticals