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SVRA · Savara Inc

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$5.37 -0.03 (-0.46%)
Market Cap
$1.08B
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205.46M

Press releases and events scraped from the company's investor relations website. Past events open our own call or event page when we host one; otherwise listings link to the original source.

Recent news

Date Headline
2026-08-24 Savara Announces Encore Presentations of Results from the Phase 3 Clinical Trial of Molgramostim Inhalation Solution (Molgramostim) in Autoimmune Pulmonary Alveolar Proteinosis (APAP) at the European Respiratory Society (ERS) Congress 2026
2026-08-20 Savara Announces New Employment Inducement Grant
2026-08-11 Savara Reports Second Quarter 2026 Financial Results and Provides Business Update
2026-07-30 Savara Announces European and Australian Patent Offices Have Granted Patents for the Liquid Formulation of MOLBREEVI*, Providing Protection in Europe and Australia Until March 2041
2026-06-12 Savara Announces New Employment Inducement Grant
2026-06-08 Savara Announces Chief Financial and Administrative Officer Transition
2026-05-27 Savara Announces Participation in the 2026 Jefferies Global Healthcare Conference
2026-05-20 Savara Presented New Biomarker Data from the IMPALA-2 Phase 3 Clinical Trial of Molgramostim Inhalation Solution (Molgramostim) in Autoimmune Pulmonary Alveolar Proteinosis (aPAP) at the American Thoracic Society (ATS) International Conference 2026
2026-05-19 Savara Presented Long-Term Efficacy and Safety Data from the Ongoing IMPALA-2 Phase 3 Clinical Trial Open-Label (OL) Extension of Molgramostim Inhalation Solution (Molgramostim) in Autoimmune Pulmonary Alveolar Proteinosis (aPAP)
2026-05-18 Savara Announces New Exercise Capacity Data from the IMPALA-2 Phase 3 Clinical Trial of Molgramostim Inhalation Solution (Molgramostim) in Autoimmune Pulmonary Alveolar Proteinosis (aPAP)
2026-05-12 Savara Reports First Quarter Financial Results and Provides Business Update
2026-05-11 Savara Announces Participation in the H.C. Wainwright & Co. 4th Annual BioConnect Investor Conference
2026-04-17 Savara Announces New Employment Inducement Grant
2026-04-15 Savara Announces the U.S. Food & Drug Administration (FDA) Has Extended the Review Period for the Molgramostim Inhalation Solution (Molgramostim) Biologics License Application (BLA) in Autoimmune Pulmonary Alveolar Proteinosis (Autoimmune PAP)
2026-04-14 Savara To Present New Data at the American Thoracic Society (ATS) 2026 International Conference

- All Presentations Include New Data from the Phase 3 IMPALA-2 Clinical Trial of Molgramostim Inhalation Solution (Molgramostim) in Autoimmune Pulmonary Alveolar Proteinosis (aPAP), Including Data from the Ongoing Open-Label Treatment Period - - Company to Host Industry Theater on aPAP with Renowned Key Opinion Leaders - Savara Inc. (Nasdaq: SVRA), a clinical stage biopharmaceutical company focused on rare respiratory diseases, announced the acceptance of one oral presentation and two poster presentations at the ATS International Conference in Orlando, Florida, May 17-20, 2026. Oral Presentation Title: Molgramostim Improves Exercise Distance and Duration in Patients with Autoimmune Pulmonary Alveolar Proteinosis (aPAP): Results from the IMPALA-2 Phase 3 Clinical Trial Mini Symposium: B95 – Fibrosis, Cough, and Inflammation: Treatment Strategies in ILD Abstract Number: 9296 Date/Time: Monday, May 18, 2026, 2:51 - 3:03 PM EDT Location: W304 E-H Level III, Orange County

2026-04-07 Savara Announces the U.K. Medicines and Healthcare Products Regulatory Agency (MHRA) Has Accepted the MOLBREEVI* Marketing Authorisation Application (MAA) for Autoimmune Pulmonary Alveolar Proteinosis (Autoimmune PAP)

- MHRA’s Acceptance Follows Acceptance/Validation of MOLBREEVI Biologics License Application (BLA) and MAA in Autoimmune PAP by the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA), Respectively - Savara Inc. (Nasdaq: SVRA) (the Company), a clinical stage biopharmaceutical company focused on rare respiratory diseases, today announced that the MHRA has accepted the submission of the MOLBREEVI MAA for the treatment of autoimmune PAP in the U.K. The MAA was accepted under Accelerated Review and qualifies for a 150-day assessment duration. A decision on the application is expected in Q4 2026. In the U.S., the FDA is reviewing the MOLBREEVI BLA under Priority Review with an August 22, 2026 Prescription Drug User Fee Act (PDUFA) date. In Europe, the MOLBREEVI MAA is being reviewed by the Committee for Medicinal Products for Human Use (CHMP) with a decision expected in Q1 2027. “Marketing applications for MOLBREEVI in autoimmune PAP are now being reviewed by

2026-03-30 Savara Announces European Medicines Agency (EMA) Validation of Marketing Authorization Application (MAA) for MOLBREEVI* in Autoimmune Pulmonary Alveolar Proteinosis (Autoimmune PAP)

- EMA Review of MOLBREEVI MAA Has Now Initiated, Decision Expected in Q1 2027 - - MOLBREEVI Biologics License Application (BLA) is Currently Under Priority Review with the U.S. Food and Drug Administration (FDA), with an Action Date of August 22, 2026 - - MOLBREEVI MAA Was Submitted to the U.K. Medicines and Healthcare Products Regulatory Agency (MHRA) in March 2026 - Savara Inc. (Nasdaq: SVRA) (the Company), a clinical stage biopharmaceutical company focused on rare respiratory diseases, today announced that the EMA has validated the submission of the MOLBREEVI MAA in autoimmune PAP; the submission will now be reviewed by the Committee for Medicinal Products for Human Use (CHMP). In the U.S., the FDA is reviewing the MOLBREEVI BLA under Priority Review with an August 22, 2026 Action Date. “EMA’s validation of the MOLBREEVI MAA confirms the submission is complete and that the review of the application has begun,” said Matt Pauls, Chair and CEO, Savara. “This milestone represents an

2026-03-13 Savara Reports Fourth Quarter and Year End 2025 Financial Results and Provides Business Update

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 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.

2026-03-06 Savara Provides Regulatory Update on the MOLBREEVI* Development Program in Autoimmune Pulmonary Alveolar Proteinosis (Autoimmune PAP)

- Day 74 Letter Received from the U.S. Food and Drug Administration (FDA) Indicated the Agency Has No Plans to Convene an Advisory Committee - - Company has Submitted the Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) - - Submission of the MAA to the U.K. Medicines and Healthcare Products Regulatory Agency (MHRA) Remains on Track by the End of Q1 2026 - Savara Inc. (the “Company”) (Nasdaq: SVRA ), a clinical-stage biopharmaceutical company focused on rare respiratory diseases, today announced that it has received the Day 74 Letter from the FDA which indicated that an Advisory Committee meeting is not planned for the MOLBREEVI Biologics License Application (BLA) and the review is ongoing with a Prescription Drug User Fee Act (PDUFA) target action date of August 22, 2026. Additionally, the Company recently submitted the MAA to the EMA for MOLBREEVI for the treatment of autoimmune PAP and is on track to submit the MAA to the U.K.’s MHRA by the end of Q1

2026-03-04 Savara Announces Participation in 2026 Citizens Life Sciences Conference

Savara Inc. (Nasdaq: SVRA ) (the “Company”), a clinical stage biopharmaceutical company focused on rare respiratory diseases, today announced that members of the management team will participate in a fireside chat at the 2026 Citizens Life Sciences Conference on Wednesday, March 11 th at 10:10am ET in Miami, FL. The live webcast and subsequent replay will be available on the “Events & Presentations” section of the Company’s corporate website and will be archived for 90 days. About Savara Savara is a clinical stage biopharmaceutical company focused on rare respiratory diseases. Our lead program, MOLBREEVI*, is a recombinant human granulocyte-macrophage colony-stimulating factor (GM-CSF) in Phase 3 development for autoimmune pulmonary alveolar proteinosis (autoimmune PAP). Molgramostim is delivered via a proprietary investigational eFlow ® Nebulizer System (PARI Pharma GmbH) specifically developed for inhalation of MOLBREEVI. Our management team has significant experience in rare

2026-02-20 Savara Announces the U.S. Food and Drug Administration (FDA) Filed the MOLBREEVI* Biologics License Application (BLA) in Autoimmune Pulmonary Alveolar Proteinosis (Autoimmune PAP)

- Priority Review Granted, Prescription Drug User Fee Act (PDUFA) Target Action Date Set for August 22, 2026 - - Company Plans to Submit the MOLBREEVI Marketing Authorization Applications (MAAs) for Autoimmune PAP to the European Medicines Agency (EMA) and the Medicines and Healthcare Products Regulatory Agency (MHRA) By the End of Q1 2026 - - MOLBREEVI Has the Potential to Be the First and Only Approved Therapy for Autoimmune PAP in the U.S. and Europe - Savara Inc. (Nasdaq: SVRA) (the Company), a clinical-stage biopharmaceutical company focused on rare respiratory diseases, announced the FDA has filed for review the BLA for MOLBREEVI as a therapy to treat patients with autoimmune PAP. The FDA granted Priority Review with a PDUFA action date of August 22, 2026. “The FDA’s filing of the BLA marks another significant milestone for Savara and the autoimmune PAP community and brings us one step closer to a potential approval in the U.S. in August of this year,” said Matt Pauls, Chair and

2026-02-13 Savara Announces New Employment Inducement Grant

Savara Inc. (Nasdaq: SVRA), a clinical stage biopharmaceutical company focused on rare respiratory diseases, today announced the grant of inducement awards to a new employee. On February 10, 2026, the Compensation Committee of Savara's Board of Directors granted the inducement awards to a new employee who recently joined the Company. The inducement awards consist of options to purchase 7,500 shares of the Company’s common stock and restricted stock units (RSUs) covering 7,500 shares of the Company’s common stock. These equity awards were granted under the Savara Inc. 2021 Inducement Equity Incentive Plan pursuant to Rule 5635(c)(4) of the NASDAQ Listing Rules as an inducement material to the employees’ acceptance of employment with the Company. The options have an exercise price of $5.27 per share, the closing trading price of the Company's common stock on the NASDAQ Global Market on the grant date. Each option has a 10-year term and vests as to 1/16 th of the number of shares subject

2026-02-04 Savara Announces Participation in Upcoming Investor Healthcare Conferences

Savara Inc. (Nasdaq: SVRA ) (the “Company”), a clinical stage biopharmaceutical company focused on rare respiratory diseases, today announced that members of its management team will host one-on-one meetings and participate in fireside chats at two upcoming investor healthcare conferences. Fireside Chats: Guggenheim Emerging Outlook: Biotech Summit February 11 th at 12:30pm ET Oppenheimer 36th Annual Healthcare Life Sciences Conference February 25 th at 9:20am ET The live webcasts and subsequent replays will be available on the “Events & Presentations” section of the Company’s corporate website and will be archived for 90 days. About Savara Savara is a clinical stage biopharmaceutical company focused on rare respiratory diseases. Our lead program, MOLBREEVI* is a recombinant human granulocyte-macrophage colony stimulating factor (GM-CSF) in Phase 3 development for autoimmune pulmonary alveolar proteinosis (autoimmune PAP). MOLBREEVI is delivered via a proprietary investigational

2026-01-27 Savara Announces Amendment to Hercules Capital Debt Facility Providing up to $75M of Additional Debt Funding Upon U.S. Food and Drug Administration (FDA) Approval of MOLBREEVI*

- When Combined with Recently Announced $75M Royalty Financing, the Company Will Have Access to ~$150M of Non-Dilutive Capital for Launch of MOLBREEVI - Savara Inc. (Nasdaq: SVRA) (the Company), a clinical stage biopharmaceutical company focused on rare respiratory diseases, today announced the amendment of its loan and security agreement with Hercules Capital, Inc. (NYSE:HTGC), strengthening its balance sheet and liquidity. Under the terms of the amended loan agreement, up to an additional $75 million will become available upon FDA’s approval of MOLBREEVI, the Company’s investigational therapy in autoimmune pulmonary alveolar proteinosis (autoimmune PAP). The loan agreement maturity date and interest-only period remain unchanged. There are no warrants in connection with the agreement. “In anticipation of the potential approval of MOLBREEVI later this year, Savara will be well capitalized with ~$150 million of non-dilutive capital to support launch activities,” said Dave Lowrance,

2026-01-16 Savara Announces New Employment Inducement Grant

Savara Inc. (Nasdaq: SVRA), a clinical stage biopharmaceutical company focused on rare respiratory diseases, today announced the grant of inducement awards to two new employees. On January 15, 2026, the Compensation Committee of Savara's Board of Directors granted the inducement awards to two new employees who recently joined the Company. The inducement awards consist of options to purchase an aggregate of 17,500 shares of the Company’s common stock and restricted stock units (RSUs) covering an aggregate of 12,500 shares of the Company’s common stock. These equity awards were granted under the Savara Inc. 2021 Inducement Equity Incentive Plan pursuant to Rule 5635(c)(4) of the NASDAQ Listing Rules as an inducement material to the employees’ acceptance of employment with the Company. The options have an exercise price of $5.88 per share, the closing trading price of the Company's common stock on the NASDAQ Global Market on the grant date. Each option has a 10-year term and vests as to

Past events

Source: https://investors.savarapharma.com/overview/default.aspx

Key facts CIK 1160308 CUSIP 805111101 13F (30d) 164 filings 163 filers Visit website Investor relations