SVRA

Savara Inc. (NASDAQ:SVRA) is one of the 10 Best Penny Stocks to Buy for Long Term. On May 12, 2026, Savara Inc. (NASDAQ:SVRA) reported Q1 EPS of (15c), versus the consensus estimate of (14c). Chair and CEO Matt Pauls said the company ended the quarter with approximately $203M in cash and expects to have access to as much as $150M in additional non-dilutive funding through debt and royalty financing structures if MOLBREEVI receives approval. Management said this positions the company to support global commercial launch activities. Pauls added that preparations ahead of the November 22 PDUFA date are accelerating, with the company’s Rare Disease Specialist team already focused on increasing awareness of autoimmune PAP and advancing launch readiness for MOLBREEVI, which could become the first approved treatment for the disease. Copyright: djoronimo / 123RF Stock Photo Last month, Oppenheimer analyst Mazahir Alimohamed assumed coverage of Savara Inc. (NASDAQ:SVRA) with an Outperform rating and raised the firm’s price target to $11 from $9. The firm said the company’s investment story is increasingly centered on regulatory execution and commercialization following the FDA’s Priority Review for the BLA submission of molgramostim, an inhaled GM-CSF therapy. Oppenheimer added that data from the Phase 3 IMPALA-2 study in autoimmune PAP support a high-probability approval outlook, noting that prior FDA feedback was primarily related to chemistry, manufacturing, and controls. Savara Inc. (NASDAQ:SVRA) is a clinical-stage biopharmaceutical company focused on therapies for rare respiratory diseases. While we acknowledge the potential of SVRA as an investment, we believe certain AI stocks offer greater upside potential and carry less downside risk. If you're looking for an extremely undervalued AI stock that also stands to benefit significantly from Trump-era tariffs and the onshoring trend, see our free report on the best short-term AI stock. READ NEXT: 33 Stocks That Should Double in 3 Years and Cathie Wood 2026 Portfolio: 10 Best Stocks to Buy. Disclosure: None. Follow Insider Monkey on Google News.

Achieved Regulatory Milestones for the MOLBREEVI* Development Program in Autoimmune Pulmonary Alveolar Proteinosis (Autoimmune PAP): Biologics License Application (BLA) Filed by the U.S. Food & Drug Administration (FDA), Prescription Drug User Fee Act (PDUFA) Target Action Date is November 22, 2026 Marketing Authorization Applications (MAAs) Validated by the European Medicines Agency (EMA) and the U.K. Medicines and Healthcare Products Regulatory Agency (MHRA) with Decisions Expected in Q1 2027 and Q4 2026, respectively Announced New Data from the Phase 3 IMPALA-2 Clinical Trial Will be Presented at the American Thoracic Society (ATS) International Conference in May, Including Data from the Ongoing Open-Label Treatment Period With ~$203M in Cash and Short-Term Investments as of March 31, 2026, and Access to up to an Additional ~$150M of Non-Dilutive Capital upon FDA Approval of MOLBREEVI, the Company Remains Well Capitalized for Launch LANGHORNE, Pa., May 12, 2026--(BUSINESS WIRE)--Savara Inc. (Nasdaq: SVRA) (the Company), a clinical stage biopharmaceutical company focused on rare respiratory diseases, reported financial results for the first quarter ending March 31, 2026 and provided a business update. "With approximately $203 million in cash and, upon MOLBREEVI approval, access to up to an additional $150 million in non-dilutive capital through debt and royalty structures, we remain well capitalized to fund global commercial launch preparations," said Matt Pauls, Chair and CEO, Savara. "With a PDUFA action date of November 22nd, U.S. commercial planning momentum is building. Our newly deployed Rare Disease Specialists are actively driving disease awareness for autoimmune PAP and advancing launch readiness initiatives for MOLBREEVI—a potentially first and only treatment for autoimmune PAP." First Quarter Financial Results Savara's net loss for the first quarter of 2026 was $37.3 million, or $(0.15) per share of which $10.7 million was related to non-cash share based compensation expense, specifically $7.8 million attributed to performance stock units, compared with a net loss of $26.6 million, or $(0.12) per share of which $3.0 million was related to share based compensation expense, for the first quarter of 2025. Research and development expenses increased by $4.2 million, or 22.1%, to $23.4 million for the three months ended March 31, 2026 from $19.2 mill...

Achieved Regulatory Milestones for the MOLBREEVI* in Autoimmune Pulmonary Alveolar Proteinosis (Autoimmune PAP) Development Program: U.S. Food and Drug Administration (FDA) filed the Biologics License Application (BLA) Priority Review granted, Prescription Drug User Fee Act (PDUFA) date set for August 22, 2026 FDA indicated an Advisory Committee is not planned for the BLA Submitted Marketing Authorization Applications (MAAs) to the European Medicines Agency (EMA) and the U.K. Medicines and Healthcare Products Regulatory Agency (MHRA) With ~$236M in Cash and Short-Term Investments as of December 31, 2025, and Access to up to an Additional ~$150M of Non-Dilutive Capital upon FDA Approval of MOLBREEVI, the Company is Well Capitalized for Launch LANGHORNE, Pa., March 13, 2026--(BUSINESS WIRE)--Savara Inc. (Nasdaq: SVRA) (the Company), a clinical stage biopharmaceutical company focused on rare respiratory diseases, reported financial results for the fourth quarter and full year ending December 31, 2025 and provided a business update. "Over the last year, we significantly advanced the MOLBREEVI development program," said Matt Pauls, Chair and Chief Executive Officer, Savara. "With the filing of the BLA, an assigned PDUFA date of August 22nd, and submission of the MAAs we have strong momentum. U.S. commercial planning is underway, most notably with the onboarding of a market development team that will be complete in the second quarter. With approximately $236 million in cash and access to up to an additional $150 million in non-dilutive capital through debt and royalty structures upon MOLBREEVI approval, we can fund global commercial launch activities. Strong financial flexibility combined with meaningful near-term catalysts means we enter 2026 in a position of strength and confidence." In addition to Fast Track and Breakthrough Therapy Designations, MOLBREEVI has been granted Orphan Drug Designation for the treatment of autoimmune PAP by the FDA and the EMA, as well as Innovation Passport (IP) and Promising Innovative Medicine (PIM) designations by the UK’s MHRA. Fourth Quarter Financial Results (Unaudited) Savara's net loss for the fourth quarter of 2025 was $32.2 million, or $(0.13) per share, compared with a net loss of $29.0 million, or $(0.13) per share, for the fourth quarter of 2024. Research and development expenses for the fourth quarter of 2025 and 2024...

-- On Track to Resubmit the Biologics License Application (BLA) for MOLBREEVI* in Autoimmune Pulmonary Alveolar Proteinosis (Autoimmune PAP) in December and Will Request Priority Review -- -- Expect to Submit the MOLBREEVI Marketing Authorization Applications (MAA) for Autoimmune PAP to the European Medicines Agency (EMA) and the UK Medicines and Healthcare Products Regulatory Agency (MHRA) in 1Q 2026 -- -- Recently Strengthened Balance Sheet with ~$149.5M Equity Financing, Which Added ~$140M to the ~$124M in Cash, Cash Equivalents, and Short-Term Investments Reported as of September 30, 2025, and Announced $75M Royalty Funding Agreement to Support Potential MOLBREEVI Launch -- LANGHORNE, Pa., November 12, 2025--(BUSINESS WIRE)--Savara Inc. (Nasdaq: SVRA) (the Company), a clinical stage biopharmaceutical company focused on rare respiratory diseases, reported financial results for the third quarter ending September 30, 2025. "Our recent strategic financings further strengthen our balance sheet, significantly increase our cash runway, and allow us to accelerate our investment in preparing for the potential commercialization of MOLBREEVI," said Matt Pauls, J.D., M.B.A., Chair and Chief Executive Officer, Savara. "We remain on track to resubmit the MOLBREEVI BLA in December as well as submit the MAAs for MOLBREEVI in Europe and the UK in the first quarter of 2026." Pauls continued, "At this year’s European Respiratory Society meeting we presented new data analyses from the pivotal IMPALA-2 trial that further support the efficacy of MOLBREEVI for the treatment of autoimmune PAP. Given that there are no approved therapies for autoimmune PAP in the U.S. or Europe, we are steadfast in our goal to bring the first and only pharmacologic treatment for autoimmune PAP to market and are confident that MOLBREEVI could fundamentally change the way this rare and chronic lung disease is treated." Third Quarter Financial Results (Unaudited) Savara's net loss for the third quarter of 2025 was $29.6 million, or $(0.14) per share, compared with a net loss of $24.2 million, or $(0.11) per share, for the third quarter of 2024. Research and development expenses increased by $0.3 million, or 1.4%, to $20.6 million for the three months ended September 30, 2025 from $20.3 million for the three months ended September 30, 2024. This increase was primarily due to the performance of tasks...

-- Savara’s Partner, TrilliumBiO, to Present Encore Data on the Development of a Dried Blood Spot Test to Aid in the Diagnosis of aPAP -- LANGHORNE, Pa., October 02, 2025--(BUSINESS WIRE)--Savara Inc. (Nasdaq: SVRA) (the Company), a clinical-stage biopharmaceutical company focused on rare respiratory diseases, today announced the acceptance of two abstracts for poster presentation and one abstract as an oral presentation at CHEST 2025 in Chicago, Illinois, October 19-22. The Company will also host a Learning Theatre titled "Advances in Autoimmune Pulmonary Alveolar Proteinosis" at the meeting which is open to all registered conference attendees. CHEST 2025 Posters, Oral Session and Learning Theater Savara Presentations Oral Presentation Title: Efficacy of Inhaled Molgramostim According to Severity of Autoimmune Pulmonary Alveolar Proteinosis (aPAP) Session Title: Innovations in Assessment and Treatment of Fibrosing Lung Disease Session ID: 4053 Date/Time of Presentation Session: October 21, 2025, 10:56-11:00 AM CDT Location: Exhibit Hall Rapid Fire 3A, McCormick Place, Chicago Presenter: Cormac McCarthy, M.D., Ph.D., FRCPI, Associate Professor of Medicine at the University College Dublin (UCD) and Consultant Respiratory Physician at St. Vincent’s University Hospital, Dublin, Ireland Poster Title: Relationship Between Pulmonary Gas Transfer, Respiratory Health-Related Quality of Life (HRQoL), Exercise Capacity, and Surfactant Burden in Autoimmune Pulmonary Alveolar Proteinosis (aPAP) Session Title: Diffuse Lung Disease Scientific Abstract Posters (D) Date/Time of Poster Discussion Session: October 22, 2025, 10:20-11:05 AM CDT Poster Number: 4260 Location: Poster Hall Exhibit, McCormick Place, Chicago Presenter: Bruce Trapnell, M.D., Professor of Medicine and Pediatrics at the University of Cincinnati College of Medicine TrilliumBiO Presentation Poster Title: Development of a Dried Serum Assay for the Detection of GM-CSF Antibodies to Aid in the Diagnosis of Autoimmune Pulmonary Alveolar Proteinosis (aPAP) Session Title: Diffuse Lung Disease Scientific Abstract Posters (D) Poster Number: 4257 Date/Time of Poster Presentation Session: October 22, 2025, 10:20-11:05 AM CDT Location: Poster Hall Exhibit, McCormick Place, Chicago Presenter: Eagappanath Thiruppathi, Ph.D., Director, Test and Method Development, TrilliumBiO Savara Learning Theater Title: Advances in...

-- In the Largest Clinical Trial Conducted in Autoimmune PAP, Molgramostim Inhalation Solution (Molgramostim) Reduced Surfactant Burden and Improved Pulmonary Gas Transfer, Respiratory Health-Related Quality of Life, and Patient Functionality -- LANGHORNE, Pa., August 20, 2025--(BUSINESS WIRE)--Savara Inc. (Nasdaq: SVRA) (the Company), a clinical stage biopharmaceutical company focused on rare respiratory diseases, announced that the results from the Phase 3 IMPALA-2 clinical trial will be published online in NEJM. The manuscript, titled "A Phase 3 Trial of Inhaled Molgramostim Therapy in Autoimmune Pulmonary Alveolar Proteinosis" will appear in the August 21, 2025, online version of the publication and can be found at www.nejm.org. Following the online publication in NEJM, the manuscript will be available on the Congresses & Publications page of the Company’s corporate website. "IMPALA-2, the largest and longest Phase 3 clinical trial conducted in patients with autoimmune PAP, demonstrated that 48 weeks of once daily administration of inhaled molgramostim addresses the underlying pathophysiology of this chronic rare lung disease," said Bruce Trapnell, M.D., Professor of Medicine and Pediatrics, University of Cincinnati College of Medicine and Lead Clinical Investigator of the IMPALA-2 trial. "Treatment with molgramostim improved the cardinal manifestations of autoimmune PAP, namely it reduced pulmonary surfactant burden and improved pulmonary gas transfer, respiratory health-related quality of life, and patient functionality. Additionally, molgramostim was well tolerated with no notable safety concerns." IMPALA-2 achieved statistical significance on its primary endpoint, change from baseline in the hemoglobin-adjusted percent predicted diffusing capacity of the lungs for carbon monoxide (DLco%) at Week 24. Molgramostim significantly improved pulmonary gas transfer as measured by DLco% at Week 24 compared with placebo (9.8% vs. 3.8%; estimated treatment difference, 6.0%; P<0.001 by comparison of least-squares means [LSMs]). The beneficial effect of molgramostim on pulmonary gas transfer was maintained to Week 48 as shown by the difference in LSM change from baseline in DLco% at Week 48 between molgramostim and placebo groups (11.6% vs. 4.7%; estimated treatment difference, 6.9%; P<0.001). The mean improvements in DLco% from baseline for molgramostim (9.8% at...

-- Reached Alignment with the U.S. Food and Drug Administration (FDA) on Information Needed for Resubmission of the Biologics License Application (BLA) for MOLBREEVI* as a Treatment for Autoimmune Pulmonary Alveolar Proteinosis (Autoimmune PAP) -- -- Plan to Resubmit the BLA in December with FUJIFILM Biotechnologies (Fujifilm) as the Drug Substance Manufacturer and Will Request Priority Review -- -- Anticipate Submitting the MOLBREEVI Marketing Authorization Applications for Autoimmune PAP to the European Medicines Agency (EMA) and the UK Medicines and Healthcare Products Regulatory Agency (MHRA) in 1Q 2026 -- -- Reported ~$146M in Cash and Short-Term Investments as of June 30, 2025, Company Believes It Is Sufficiently Capitalized into 1Q 2027 -- LANGHORNE, Pa., August 13, 2025--(BUSINESS WIRE)--Savara Inc. (Nasdaq: SVRA) (the Company), a clinical stage biopharmaceutical company focused on rare respiratory diseases, reported financial results for the second quarter ending June 30, 2025 and provided a business update. "Following a recent Type A meeting with the FDA, and receipt of the meeting minutes, we believe we have aligned on a path forward for the information needed to resubmit the BLA with Fujifilm as our drug substance manufacturer," said Matt Pauls, Chair and CEO, Savara. "With the Process Performance Qualification campaigns now complete at Fujifilm, and finalization of the analytical data package expected early in the fourth quarter, we plan to resubmit the BLA in December. We are grateful for the constructive and timely dialogue with the FDA and are pleased to be working with Fujifilm, a top 10 biologics manufacturer with more than 20 approved drug substances globally and a successful inspection history with numerous regulatory authorities." Pauls continued, "With no approved therapies in the United States or Europe for autoimmune PAP, there is a high unmet medical need to treat this rare and debilitating lung disease. We are committed to our goal of providing these patients with the first and only pharmacologic treatment option. We continue our work, with urgency, to pursue approval for MOLBREEVI." Second Quarter Financial Results (Unaudited) Savara's net loss for the second quarter of 2025 was $30.4 million, or $(0.14) per share, compared with a net loss of $22.2 million, or $(0.12) per share, for the second quarter of 2024. Research and developm...

-- Completed Submission of the Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for MOLBREEVI* as a Treatment for Autoimmune Pulmonary Alveolar Proteinosis (Autoimmune PAP) and Requested Priority Review -- -- Company Remains on Track to Submit the MOLBREEVI Marketing Authorization Application (MAA) for Autoimmune PAP to the European Medicines Agency (EMA) and the Medicines and Healthcare Products Regulatory Agency (MHRA) by End of the Year -- -- Entered into a Non-Dilutive Debt Financing in March for up to $200M Which Included $30M at Close to Refinance Existing Debt Facility -- -- Reported ~$172.5M in Cash and Short-Term Investments as of March 31, 2025, Company Believes it is Sufficiently Capitalized into 2H 2027 -- LANGHORNE, Pa., May 13, 2025--(BUSINESS WIRE)--Savara Inc. (Nasdaq: SVRA) (the Company), a clinical stage biopharmaceutical company focused on rare respiratory diseases, reported financial results for the first quarter ending March 31, 2025 and provided a business update. "At the end of 1Q 2025, we announced the on-time submission of the MOLBREEVI BLA to the FDA for the treatment of autoimmune PAP and requested priority review," said Matt Pauls, Chair and Chief Executive Officer, Savara. "If Priority Review is granted, we anticipate a PDUFA date by the end of the year and are preparing for a U.S. commercial launch in early 2026. We are also on track to submit the MAA in both Europe and the U.K. by the end of the year. Lastly, with approximately $172.5 million in cash, and the optionality to further finance the company through access to low-cost capital from our recent debt financing, we are in a strong financial position and believe our current cash runway extends into 2H 2027, well beyond a U.S. launch." Upcoming Presentations at American Thoracic Society (ATS) Conference New data from the Phase 3 IMPALA-2 trial of MOLBREEVI in patients with autoimmune PAP will be presented at the ATS International Conference 2025 in San Francisco, May 16-21, 2025. The Company is also hosting an Industry Symposium with leading key opinion leaders in autoimmune PAP. For more information see our recent press release. First Quarter Financial Results (Unaudited) Savara's net loss for the first quarter of 2025 was $26.6 million, or $(0.12) per share, compared with a net loss of $20.3 million, or $(0.11) per share, for the first qua...

-- Completed Submission of the Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for MOLBREEVI* as a Treatment for Autoimmune Pulmonary Alveolar Proteinosis (aPAP) -- -- Priority Review Was Requested, Commercial Launch Preparations Underway -- -- With ~$196M in Cash and Short-Term Investments as of December 31, 2024, the Company Believes it is Sufficiently Capitalized through 2Q 2027, Excluding the Recent Debt Financing of Up To $200M -- LANGHORNE, Pa., March 27, 2025--(BUSINESS WIRE)--Savara Inc. (Nasdaq: SVRA) (the Company), a clinical stage biopharmaceutical company focused on rare respiratory diseases, reported financial results for the fourth quarter and full year ending December 31, 2024 and provided a business update. "Completing submission of the BLA is an important milestone in potentially addressing the significant unmet need of people living with aPAP, a rare and debilitating lung disease," said Matt Pauls, Chair and Chief Executive Officer, Savara. "MOLBREEVI has the potential to be the first and only approved therapy for aPAP in the U.S. and Europe and could redefine the standard of care for the disease. If granted Priority Review, we could have a PDUFA date by the end of the year and are preparing for a commercial launch in early 2026. Lastly, with approximately $196 million in cash, we are in a strong financial position and believe our cash runway extends through 2Q 2027, excluding our recent debt financing which adds additional low-cost capital options to further finance the Company." In addition to Fast Track and Breakthrough Therapy Designations, MOLBREEVI has been granted Orphan Drug Designation for the treatment of aPAP by the FDA and the European Medicines Agency (EMA), as well as Innovation Passport (IP) and Promising Innovative Medicine (PIM) designations by the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA). Fourth Quarter Financial Results (Unaudited) Savara's net loss for the fourth quarter of 2024 was $29.0 million, or $(0.13) per share, compared with a net loss of $16.1 million, or $(0.09) per share, for the fourth quarter of 2023. Research and development expenses for the fourth quarter of 2024 and 2023 were $23.3 million and $12.7 million, respectively. General and administrative expenses for the fourth quarter of 2024 and 2023 were $7.8 million and $4.9 million, respectively. As...