BENSALEM, Pa.--(BUSINESS WIRE)--Law Offices of Howard G. Smith announces an investigation on behalf of Savara Inc. ("Savara†or the "Company†) (NASDAQ: SVRA) investors concerning the Company's possible violations of federal securities laws. IF YOU ARE AN INVESTOR WHO SUFFERED A LOSS IN SAVARA (SVRA), CONTACT THE LAW OFFICES OF HOWARD G. SMITH ABOUT POTENTIALLY PURSUING CLAIMS TO RECOVER YOUR LOSS. Contact the Law Offices of Howard G. Smith to discuss your legal rights by email at howardsmith@ho. ...

LOS ANGELES--(BUSINESS WIRE)--Glancy Prongay & Murray LLP, a leading national shareholder rights law firm, today announced that it has commenced an investigation on behalf of Savara Inc. ("Savara†or the "Company†) (NASDAQ: SVRA) investors concerning the Company's possible violations of the federal securities laws. IF YOU ARE AN INVESTOR WHO LOST MONEY ON SAVARA (SVRA), CLICK HERE TO INQUIRE ABOUT POTENTIALLY PURSUING CLAIMS TO RECOVER YOUR LOSS. What Happened? On May 27, 2025, Savara issue. ...

LOS ANGELES--(BUSINESS WIRE)--The Law Offices of Frank R. Cruz announces an investigation of Savara Inc. ("Savara†or the "Company†) (NASDAQ: SVRA) on behalf of investors concerning the Company's possible violations of federal securities laws. IF YOU ARE AN INVESTOR WHO LOST MONEY ON SAVARA (SVRA), CLICK HERE TO INQUIRE ABOUT POTENTIALLY PURSUING A CLAIM TO RECOVER YOUR LOSS. What Is The Investigation About? On May 27, 2025, Savara issued a press release announcing that the U.S. Food and Drug A. ...

NEW YORK--(BUSINESS WIRE)---- $SVRA #ClassAction--Faruqi & Faruqi, LLP, a leading national securities law firm, is investigating potential claims against Savara Inc. ("Savara†or the "Company†) (NASDAQ: SVRA) and reminds investors of the November 7, 2025 deadline to seek the role of lead plaintiff in a federal securities class action that has been filed against the Company. Faruqi & Faruqi is a leading national securities law firm with offices in New York, Pennsylvania, California and Georgia. The firm has ...

Summary of Savara FY Conference Call - September 09, 2025 Company Overview - **Company**: Savara (NasdaqGS:SVRA) - **Focus**: Single-asset rare disease company targeting rare pulmonary diseases - **Key Asset**: Mobrevi (morgamostim inhalation solution) for autoimmune pulmonary alveolar proteinosis (autoimmune PAP) [1][2] Core Points and Arguments - **Disease Description**: Autoimmune PAP is a chronic lung disease caused by GMCSF autoantibodies leading to surfactant accumulation, resulting in symptoms like progressive shortness of breath, chronic cough, and fatigue [2][3] - **Current Treatment Landscape**: No approved drugs for autoimmune PAP in the U.S. or Europe; the only procedure available is whole lung lavage, which is invasive and does not address the underlying disease [3][4] - **Mobrevi Details**: - A novel inhaled biologic delivered via a proprietary eFlow nebulizer - Dosage: 300 micrograms inhaled once daily, with a nebulization time of approximately five minutes [4][5] - **Clinical Trial Results**: - Positive results from the global phase 3 trial (Impala 2) with statistically significant improvements in DLCO (gas exchange measurement) at both 24 and 48 weeks [5][6] - High patient retention with a 100% roll-over into the open-label extension phase [6][7] - **Regulatory Timeline**: - BLA resubmission in the U.S. expected in December 2025, with potential PDUFA date in August 2026 if priority review is granted [7][8] - MAA submission in the EU and UK planned for Q1 2026, with potential approval in Q1 2027 [8] Market Opportunity - **Patient Population**: - Revised analysis indicates approximately 5,500 identified autoimmune PAP patients in the U.S., a significant increase from previous estimates [11][12] - Estimated total addressable market in the EU and UK is over 5,000 patients [14] - **Pricing Strategy**: - Expected annual pricing for Mobrevi in the U.S. is between $400,000 to $500,000 per patient, indicating strong pricing power [10][15] - **Market Development Initiatives**: - Launch of APAP ClearPath, a no-charge testing program to increase disease awareness and facilitate diagnosis [9][10] Financial Position - **Cash Position**: As of Q2 2025, Savara reported $146 million on the balance sheet, with guidance indicating cash availability into Q1 2027 [14] - **Investor Support**: The company is well-covered and has strong investor backing [14][15] Additional Insights - **Regulatory Designations**: Mobrevi has received orphan drug, fast track, and breakthrough therapy designations in the U.S., along with similar designations in Europe [8] - **Long-term Revenue Potential**: The combination of regulatory exclusivity, patent prosecution, and a sizable patient population presents a robust opportunity for durable revenue generation upon approval [15]

NEW YORK, Sept. 09, 2025 (GLOBE NEWSWIRE) -- Gainey McKenna & Egleston announces that a securities class action lawsuit has been filed in the United States District Court for the Eastern District of Pennsylvania on behalf of all persons or entities who purchased or otherwise acquired Savara Inc. (“Savara” or the “Company”) (NASDAQ: SVRA) securities between March 7, 2024 and May 23, 2025, inclusive (the “Class Period”). The Complaint alleges that Defendants made false and/or misleading statements and/or fail ...

NEW YORK--(BUSINESS WIRE)--The law firm of Kirby McInerney LLP announces that a class action lawsuit has been filed on behalf of investors who acquired Savara Inc. ("Savara†or the "Company†) (NASDAQ:SVRA) securities during the period of March 7, 2024 through May 23, 2025, inclusive ("the Class Period†). If you suffered a loss on your Savara investments, you have until November 7, 2025 to request lead plaintiff appointment. Follow the link below for more information: [CONTACT THE FIRM IF YOU SU. ...

ATLANTA, Sept. 09, 2025 (GLOBE NEWSWIRE) -- A shareholder class action lawsuit has been filed against Savara Inc. (“Savara” or the “Company”) (NASDAQ: SVRA). The lawsuit alleges that Defendants made materially false and/or misleading statements and/or failed to disclose material adverse information, including allegations that: (i) the MOLBREEVI biologics license application (“BLA”) lacked sufficient information regarding MOLBREEVI’s chemistry, manufacturing, and/or controls; (ii) accordingly, the FDA was un ...

Core Viewpoint - A class action lawsuit has been filed against Savara Inc. for allegedly misleading investors regarding the viability of its lead drug candidate, MOLBREEVI, during the specified class period from March 7, 2024, to May 23, 2025 [1][2]. Allegations - The complaint states that Savara failed to disclose critical information about the MOLBREEVI Biologics License Application (BLA), including insufficient details on its chemistry, manufacturing, and controls, which made FDA approval unlikely in its current form [2]. - The company misrepresented the timeline for completing the BLA submission, leading to increased chances of needing additional capital due to delays in regulatory approval [2]. Stock Price Impact - Following the announcement of a refusal to file (RTF) letter from the FDA on May 27, 2025, Savara's stock price dropped by $0.90, or 31.69%, closing at $1.94 per share [3].

Financial Data and Key Metrics Changes - The company reported a cash runway into 2027 with approximately $146 million in cash as of the end of the second quarter [24] - The total addressable market in the U.S. is estimated at approximately 5,500 patients, with a pricing corridor of $400,000 to $500,000 per patient per year [25][26] Business Line Data and Key Metrics Changes - The company is focused on a single asset, Molbrivi (molgamostem inhalation solution), which is a novel inhaled biologic targeting autoimmune pulmonary alveolar proteinosis (aPAP) [3][8] - The Phase 3 study IMPALA 2 met its primary endpoint and showed durability of effect, with a safety profile indicating only about 3% of patients discontinued due to adverse events [10][11] Market Data and Key Metrics Changes - The recent claims database analysis identified over 5,500 patients in the U.S. with aPAP, a 50% increase from previous estimates [20][29] - In Europe, a similar number of diagnosed patients is projected, around 5,200, indicating a well-structured market for aPAP [23] Company Strategy and Development Direction - The company is preparing for the resubmission of the Biologics License Application (BLA) in December, anticipating a potential launch in the U.S. in the third quarter of next year [12][13] - The company has been actively raising disease state awareness among physicians and patients, which has positively impacted the identification of aPAP patients [15][29] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the increase of diagnosed patients due to investments in disease awareness and successful trial results [29] - The company believes that many physicians are now willing to offer Molbrivi to all confirmed diagnosed aPAP patients, regardless of disease severity [31] Other Important Information - The company has various regulatory designations for Molbrivi, including breakthrough therapy and orphan drug designations, which could provide significant market advantages [13] - The partnership with PARI for the eFlow nebulizer system is crucial for the delivery of Molbrivi, enhancing its market potential [8][14] Q&A Session Summary Question: Can you talk about the new health claims data that found over a 50% increase in the estimated number of aPAP patients? - Management attributed the increase to investments in disease awareness, trial enrollment, and positive results published in reputable journals [29] Question: What has physician feedback been like regarding disease awareness? - Feedback has evolved, with many physicians now considering offering Molbrivi to all diagnosed aPAP patients, not just those with severe symptoms [30][31] Question: How does the company plan to contact the 1,100 centers and gain visibility into actual aPAP patients? - The company has been generally well-received by pulmonologists, who are interested in discussing the disease and treatment options [35] Question: What is the visibility into undiagnosed patients and the antibody testing process? - The company is still assessing the market opportunity for undiagnosed patients, with ongoing efforts to validate claims data [36] Question: Are there any comparable orphan rare disease launches in terms of uptake curve? - Management indicated that each orphan rare disease launch is unique, making it difficult to find direct analogs [37] Question: What are the expectations for the label construction of Molbrivi? - Management refrained from speculating on label specifics, indicating that discussions will occur once the product is closer to approval [39] Question: Is the testing process with Fujifilm mostly complete for the BLA resubmission? - Management confirmed that the transition to Fujifilm addresses previous issues and positions the company well for the resubmission [40]