LOS ANGELES--(BUSINESS WIRE)---- $SVRA--SVRA Investors Have Opportunity to Lead Savara Inc. Securities Fraud Lawsuit with the Schall Law Firm. ...

Core Viewpoint - A class action lawsuit has been filed against Savara Inc. and certain officers for alleged violations of federal securities laws during the Class Period from March 7, 2024, to May 23, 2025 [1][2]. Group 1: Lawsuit Details - The lawsuit seeks to recover damages for investors who purchased Savara securities during the specified Class Period [2]. - The complaint alleges that the defendants made materially false and misleading statements regarding the company's business and operations, particularly concerning the MOLBREEVI Biologics License Application (BLA) [3]. - Specific allegations include the lack of sufficient information regarding MOLBREEVI's chemistry and manufacturing, the unlikelihood of FDA approval in its current form, and the potential need for Savara to raise additional capital due to delays in regulatory approval [3]. Group 2: Next Steps for Investors - Investors who suffered losses in Savara have until November 7, 2025, to request appointment as lead plaintiff in the class action [4]. - Participation in any recovery does not require serving as lead plaintiff [4]. Group 3: Legal Representation - The law firm Bronstein, Gewirtz & Grossman, LLC operates on a contingency fee basis, meaning they will only seek reimbursement for expenses and attorneys' fees if successful [5]. - The firm has a history of recovering hundreds of millions of dollars for investors in securities fraud class actions [6].

Core Viewpoint - A class action lawsuit has been filed against Savara Inc. and certain officers for alleged violations of federal securities laws during the Class Period from March 7, 2024, to May 23, 2025, seeking damages for affected investors [1][6]. Company Overview - Savara Inc. is a clinical-stage biopharmaceutical company focused on rare respiratory diseases, with its lead product candidate being MOLBREEVI (molgramostim), currently in a Phase 3 clinical trial for autoimmune pulmonary alveolar proteinosis (aPAP) [4]. - The company has claimed it is "sufficiently capitalized" through 2026 or into the second half of 2027 based on investments in MOLBREEVI and its fiscal discipline [4]. Regulatory Developments - In December 2024, Savara began a rolling submission of a Biologics License Application (BLA) to the FDA for MOLBREEVI, expecting to complete the submission by the end of Q1 2025 [5]. - The BLA submission must include detailed information regarding MOLBREEVI's chemistry, manufacturing, and controls (CMC) [5]. Allegations in the Lawsuit - The lawsuit alleges that Savara's executives made materially false and misleading statements about the company's business and prospects, including claims about the sufficiency of the BLA and the likelihood of FDA approval [6]. - Specific allegations include that the BLA lacked sufficient information regarding CMC, making FDA approval unlikely in its current form [6]. Market Reaction - Following the announcement of a refusal to file letter from the FDA on May 27, 2025, Savara's stock price fell by $0.90, or 31.69%, closing at $1.94 per share [7][9]. - Analysts, such as Guggenheim, revised their price target for Savara from $9.00 to $8.00, predicting that the company may not be profitable until 2028 and may need to raise additional capital [8]. Financial Updates - After the Class Period, Savara announced on August 13, 2025, that it plans to resubmit the MOLBREEVI BLA in December 2025, contrary to previous statements about completing the submission in Q1 2025 [10].

SAN DIEGO, Sept. 09, 2025 (GLOBE NEWSWIRE) -- Robbins LLP reminds stockholders that a class action was filed on behalf of persons and entities that purchased or otherwise acquired Savara Inc. (NASDAQ: SVRA) securities between March 7, 2024 and May 23, 2025. Savara is a clinical-stage biopharmaceutical company focused on rare respiratory diseases. The Company’s lead product candidate is MOLBREEVI (also referred to as “molgramostim”), an inhaled granulocyte-macrophage colony-stimulating (“GM-CSF”) factor. For ...

Core Viewpoint - A class action lawsuit has been filed against Savara Inc. for failing to disclose critical information regarding the MOLBREEVI Biologics License Application, which led to significant investor losses during the class period from March 7, 2024, to May 23, 2025 [2][4]. Group 1: Lawsuit Details - The lawsuit is on behalf of all individuals and entities who purchased Savara securities during the specified class period [2]. - Investors have until November 7, 2025, to apply to the Court to be appointed as lead plaintiff in the lawsuit [2]. - The complaint alleges that Savara did not disclose that the MOLBREEVI BLA lacked sufficient information, making FDA approval unlikely [4]. Group 2: Impact on Stock Price - On May 27, 2025, Savara announced it received a refusal to file letter from the FDA regarding the MOLBREEVI BLA, causing the stock price to drop by $0.90 per share, or 31.69%, closing at $1.94 per share [5]. Group 3: Legal Representation - Bragar Eagel & Squire, P.C. is representing the investors and encourages those who suffered losses to contact them for more information [6][7].

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]