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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

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

LANGHORNE, Pa.--(BUSINESS WIRE)--Savara Inc. (Nasdaq: SVRA) (the Company), a clinical stage biopharmaceutical company focused on rare respiratory diseases, presented a poster at the ATS 2026 International Conference that is taking place May 15-20, 2026, in Orlando, Florida. The poster reported new biomarker data from the double-blind period of the IMPALA-2 Phase 3 clinical trial evaluating molgramostim for the treatment of aPAP. Below is a summary of the poster presented. Poster Board 401: “Rel.

May 20, 2026 04:15 AM businesswire.com
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)

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)

LANGHORNE, Pa.--(BUSINESS WIRE)--Savara Inc. (Nasdaq: SVRA) (the Company), a clinical stage biopharmaceutical company focused on rare respiratory diseases, presented a poster at the ATS 2026 International Conference that is taking place May 15-20, 2026, in Orlando, Florida. The poster reports long-term efficacy and safety data from the first 48 weeks of the ongoing OL treatment period of the IMPALA-2 Phase 3 clinical trial evaluating molgramostim for the treatment of aPAP. IMPALA-2 is the longe.

May 19, 2026 10:15 AM businesswire.com
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)

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)

LANGHORNE, Pa.--(BUSINESS WIRE)--Savara Inc. (Nasdaq: SVRA) (the Company), a clinical stage biopharmaceutical company focused on rare respiratory diseases, sponsored an oral presentation at the ATS 2026 International Conference that is taking place May 15-20, 2026, in Orlando, Florida. The presentation reported new exercise capacity data from the double-blind period of the IMPALA-2 Phase 3 clinical trial evaluating molgramostim for the treatment of aPAP. Below is a summary of the data presented.

May 18, 2026 10:55 AM businesswire.com
Savara Reports First Quarter Financial Results and Provides Business Update

Savara Reports First Quarter Financial Results and Provides Business Update

LANGHORNE, Pa.--(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 prepa.

May 12, 2026 12:05 PM businesswire.com
Savara Announces Participation in the H.C. Wainwright & Co. 4th Annual BioConnect Investor Conference

Savara Announces Participation in the H.C. Wainwright & Co. 4th Annual BioConnect Investor Conference

LANGHORNE, Pa.--(BUSINESS WIRE)--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 H.C. Wainwright & Co. 4th Annual BioConnect Investor Conference on Tuesday, May 19th at 10:00am ET in New York, NY at the NASDAQ headquarters. The live webcast and subsequent replay will be available on the “Events & Presentations” sectio.

May 11, 2026 12:05 PM businesswire.com
Savara Announces New Employment Inducement Grant

Savara Announces New Employment Inducement Grant

LANGHORNE, Pa.--(BUSINESS WIRE)--Savara Inc. (Nasdaq: SVRA), a clinical stage biopharmaceutical company focused on rare respiratory diseases, today announced the grant of inducement awards to new employees. On April 14, 2026, the Compensation Committee of Savara's Board of Directors granted the inducement awards to 24 new employees who recently joined the Company. The inducement awards consist of options to purchase 18,500 shares of the Company's common stock, restricted stock units (RSUs) cove.

Apr 17, 2026 12:05 PM businesswire.com
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)

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)

LANGHORNE, Pa.--(BUSINESS WIRE)--Savara Inc. (Nasdaq: SVRA) (the Company), a clinical stage biopharmaceutical company focused on rare respiratory diseases, today announced that the FDA has extended the review period for the molgramostim BLA in autoimmune PAP by three months. The Agency is reviewing the molgramostim BLA under Priority Review and the new PDUFA target action date is November 22, 2026. The FDA determined that the Company's responses to recent information requests by the Agency cons.

Apr 15, 2026 12:05 PM businesswire.com
Savara To Present New Data at the American Thoracic Society (ATS) 2026 International Conference

Savara To Present New Data at the American Thoracic Society (ATS) 2026 International Conference

LANGHORNE, Pa.--(BUSINESS WIRE)--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 Sympo.

Apr 14, 2026 04:05 AM businesswire.com
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)

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)

LANGHORNE, Pa.--(BUSINESS WIRE)--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.

Apr 07, 2026 04:05 AM businesswire.com
Savara Announces European Medicines Agency (EMA) Validation of Marketing Authorization Application (MAA) for MOLBREEVI* in Autoimmune Pulmonary Alveolar Proteinosis (Autoimmune PAP)

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

LANGHORNE, Pa.--(BUSINESS WIRE)--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 M.

Mar 30, 2026 04:05 AM businesswire.com
Savara Reports Fourth Quarter and Year End 2025 Financial Results and Provides Business Update

Savara Reports Fourth Quarter and Year End 2025 Financial Results and Provides Business Update

LANGHORNE, Pa.--(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 submiss.

Mar 13, 2026 04:05 AM businesswire.com
Savara Provides Regulatory Update on the MOLBREEVI* Development Program in Autoimmune Pulmonary Alveolar Proteinosis (Autoimmune PAP)

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

LANGHORNE, Pa.--(BUSINESS WIRE)--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 submitt.

Mar 06, 2026 11:05 AM businesswire.com
Savara Announces Participation in 2026 Citizens Life Sciences Conference

Savara Announces Participation in 2026 Citizens Life Sciences Conference

LANGHORNE, Pa.--(BUSINESS WIRE)--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 11th 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 archiv.

Mar 04, 2026 11:05 AM businesswire.com
Savara Highlights FDA Priority Review for Molbreevi as Aug. 22 PDUFA Date Nears

Savara Highlights FDA Priority Review for Molbreevi as Aug. 22 PDUFA Date Nears

Savara (NASDAQ: SVRA) executives highlighted recent regulatory and commercial milestones for its lead program, molgramostim inhalation solution (Molbreevi), during a discussion at Oppenheimer's 36th Annual Healthcare Life Science Conference. Management said the U.S. Food and Drug Administration (FDA) has accepted and filed the company's biologics license application (BLA) for Molbreevi in autoimmune pulmonary alveolar proteinosis (aPAP),

Mar 02, 2026 11:31 PM defenseworld.net
Savara Announces the U.S. Food and Drug Administration (FDA) Filed the MOLBREEVI* Biologics License Application (BLA) in Autoimmune Pulmonary Alveolar Proteinosis (Autoimmune PAP)

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

LANGHORNE, Pa.--(BUSINESS WIRE)--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.

Feb 20, 2026 11:15 AM businesswire.com

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