SVRA

DEFA14A - Savara Inc (0001160308) (Filer)

DEF 14A - Savara Inc (0001160308) (Filer)

Oppenheimer resumed coverage of Savara with a rating of Outperform and set a new price target of $11.00 from $9.00 previously

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) covering 141,000 shares of the Company's common stock, and performance stock units (PSUs) covering 85,000 shares of the Company's common stock. These equity awards were granted under the Savara Inc. 2021 Inducement Equity Incentive Plan

-- Prescription Drug User Fee Act (PDUFA) Target Action Date Extended by Three Months to November 22, 2026 -- 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 constituted a major amendment to the BLA, resulting in a three-month extension of the PDUFA date. The Agency did not cite an

-- 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 Autoimmu

PRE 14A - Savara Inc (0001160308) (Filer)

-- 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

-- 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)

4 - Savara Inc (0001160308) (Issuer)

8-K - Savara Inc (0001160308) (Filer)

10-K - Savara Inc (0001160308) (Filer)

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 up

-- 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 Ap

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 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)

-- 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 autoimmu

SCHEDULE 13G/A - Savara Inc (0001160308) (Subject)

4 - Savara Inc (0001160308) (Issuer)

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 t

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 11th at 12:30pm ET Oppenheimer 36th Annual Healthcare Life Sciences Conference February 25th 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 biopharmaceuti

8-K - Savara Inc (0001160308) (Filer)

-- 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 d

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 Listi

8-K - Savara Inc (0001160308) (Filer)

--Savara Submitted the MOLBREEVI Biologics License Application (BLA) in December 2025 for the Potential Treatment of Autoimmune Pulmonary Alveolar Proteinosis (Autoimmune PAP)-- PANTHERx® Rare Pharmacy, the trusted leader and innovator in patient access and support services for personalized rare disease care, and Savara Inc. (NASDAQ:SVRA), a clinical stage biopharmaceutical company focused on rare respiratory diseases, announced an exclusive distribution agreement for MOLBREEVI. Savara submitted the MOLBREEVI BLA to the U.S. Food and Drug Administration (FDA) in December 2025 for the treatment of autoimmune PAP. Priority Review was requested. If approved, PANTHERx and its team of rare c