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

Core Viewpoint - Bragar Eagel & Squire, P.C. is investigating potential claims against Savara, Inc. due to a class action complaint alleging breaches of fiduciary duties by the company's board of directors during a specified class period [2]. Group 1: Company Overview - Savara, Inc. is facing legal scrutiny following a class action complaint filed on September 8, 2025, concerning events that occurred between March 7, 2024, and May 23, 2025 [2]. - The complaint alleges that Savara's board failed to disclose critical information regarding the MOLBREEVI Biologics License Application (BLA), which lacked sufficient details on chemistry, manufacturing, and controls [8]. Group 2: Financial Impact - On May 27, 2025, Savara announced it received a refusal to file (RTF) letter from the FDA regarding the MOLBREEVI BLA, leading to a significant stock price drop of $0.90 per share, or 31.69%, closing at $1.94 per share [8]. - The delay in regulatory approval for MOLBREEVI increased the likelihood that Savara would need to raise additional capital [8]. Group 3: Legal Actions - Investors who suffered losses during the class period are encouraged to contact Bragar Eagel & Squire for discussions regarding their legal rights and options [1][4]. - The law firm represents both individual and institutional investors in various litigation matters, indicating a broad scope of legal expertise [5].

Company Overview - Savara is focused on building a world-class experienced orphan rare disease company with a team that has extensive experience in the field [3] - The company operates as a single-asset entity with one late-stage product, MOLBREEVI, which is a novel inhaled biologic [3] Product Development - Savara has submitted a Biologics License Application (BLA) in the U.S. for MOLBREEVI's application for use in autoimmune conditions [3]

Core Viewpoint - Savara Inc. has resubmitted the MOLBREEVI Biologics License Application (BLA) to the FDA for the treatment of autoimmune PAP, a rare lung disease [1] Group 1: Company Developments - The resubmission of the MOLBREEVI BLA is in collaboration with Fujifilm as the drug substance manufacturer [1] - The treatment targets autoimmune PAP, which is characterized by the abnormal build-up of surfactant in the alveoli [1]

Core Viewpoint - Savara Inc. announced that the European Patent Office (EPO) intends to grant a patent application for the liquid formulation of MOLBREEVI, which is an orally inhaled recombinant human granulocyte-macrophage colony-stimulating factor (GM-CSF) [1] Group 1 - The patent will provide protection for the liquid formulation and drug-device patents in Europe until March 2041 [1]

Summary of Savara (NasdaqGS:SVRA) FY Conference Call - December 02, 2025 Company Overview - **Company**: Savara - **Product**: Molgramostim (MOLBREEVI) - **Market**: Autoimmune Pulmonary Alveolar Proteinosis (APAP) Key Points BLA Resubmission and Regulatory Timeline - The BLA resubmission for Molgramostim is on track for December 2025, with a 60-day review anticipated, leading to a PDUFA date around August 2026 [4][5] - Submissions for MAAs in Europe and the U.K. are expected by the end of Q1 2026 [4][32] Market Opportunity and Patient Population - Approximately 5,500 diagnosed APAP patients identified in the U.S. through claims database analysis [8][9] - The company has confirmed 1,000 patients that are actively managed and have "line of sight" for the U.S. launch [8][9] - Patient concentration is noted in major centers of excellence and large group practices, facilitating a robust launch trajectory [10] Commercial Strategy and Team Preparation - A commercial team of about 30 customer-facing individuals is being established, with hiring planned to be completed post-approval [14][16] - The team is focused on building relationships with healthcare professionals and preparing for patient education and prescription processes upon approval [11][12] Distribution and Payer Mix - A single exclusive specialty pharmacy will manage claims adjudication and patient services, providing a "white glove" service model [17] - Anticipated payer mix includes approximately 60% commercial payers, one-third Medicare, and the remainder Medicaid [18] Pricing and Market Access - Pricing for Molgramostim is expected to be between $400,000 and $500,000 per patient per year, with payers showing understanding of the product's value [19][20] - Prior authorization will likely require proof of diagnosis, with no significant concerns from payers regarding budget impact due to the small patient population [19][23] Diagnostic Testing and Patient Identification - Implementation of a no-cost dry blood spot test for diagnosing autoimmune PAP is ongoing, with high sensitivity and specificity [28][29] - The test aims to identify undiagnosed patients, particularly in ILD clinics, enhancing the understanding of the patient population [30] European Market Strategy - The company plans to independently launch in Europe and the U.K., with a patient population size similar to that in the U.S. [33][34] - The recent financing positions the company well for both U.S. and European launches, with over $260 million in cash and additional royalty financing [35] Advocacy and Awareness - Support groups such as the PAP Foundation and PAP Alliance are active in raising awareness for autoimmune PAP, contributing to patient advocacy efforts [31] Additional Insights - The company emphasizes the importance of hiring experienced personnel for the commercialization of rare disease drugs, particularly in navigating the complexities of the orphan drug market [16] - The long-term strategy includes continuous education for payers and healthcare professionals about the disease burden and the clinical benefits of Molgramostim [19][20]

Core Viewpoint - Savara Inc. has received a new patent from the European Patent Office for its investigational therapy MOLBREEVI, which is a significant development in the treatment of rare respiratory diseases [1] Group 1: Patent Announcement - The European Patent Office has issued patent No. 4 496 611 titled "Drug-Device Combination Comprising a Liquid Solution and a Nebulizer for Aerosolization of the Liquid Solution" [1] - The patent is jointly held by Savara and PARI, indicating a collaboration between the two companies [1] - The patent covers the combination of Savara's investigational therapy MOLBREEVI and PARI's investigational device [1]

Core Viewpoint - Rosen Law Firm is reminding investors of Savara Inc. (NASDAQ: SVRA) about the November 7, 2025 deadline to join a securities class action lawsuit related to the company's alleged misleading statements during the class period from March 7, 2024, to May 23, 2025 [1][2]. Group 1: Class Action Details - Investors who purchased Savara securities during the specified class period may be entitled to compensation without any out-of-pocket fees through a contingency fee arrangement [2]. - A class action lawsuit has already been filed, and interested parties must move the court to serve as lead plaintiff by the November 7, 2025 deadline [3]. - The Rosen Law Firm emphasizes the importance of selecting qualified legal counsel with a successful track record in securities class actions [4]. Group 2: Allegations Against Savara Inc. - The lawsuit alleges that Savara made false and misleading statements regarding the MOLBREEVI Biologics License Application (BLA) for a treatment of a rare lung disease, including insufficient information on its chemistry and manufacturing [5]. - It is claimed that the FDA was unlikely to approve the MOLBREEVI BLA in its current form, which could delay Savara's submission timeline and increase the need for additional capital [5]. - The lawsuit asserts that these misleading public statements resulted in investor damages when the true information became known [5].

Core Viewpoint - Savara Inc. is facing a federal securities class action due to allegations of misleading statements regarding its Biologics License Application (BLA) for MOLBREEVI, which has led to significant investor losses [3][4]. Group 1: Allegations Against Savara - The complaint claims that Savara and its executives violated federal securities laws by making false or misleading statements about the MOLBREEVI BLA, including insufficient information regarding its chemistry and manufacturing [3]. - It is alleged that the FDA was unlikely to approve the MOLBREEVI BLA in its current form, which would delay Savara's submission timeline and increase the need for additional capital [3]. - The public statements made by Savara were deemed materially false and misleading throughout the relevant period [3]. Group 2: Stock Price Impact - Following the announcement of a refusal to file letter from the FDA regarding the MOLBREEVI BLA, Savara's stock price dropped by $0.90, or 31.69%, closing at $1.94 per share on May 27, 2025 [4]. Group 3: Legal Proceedings - Investors who suffered losses in Savara between March 7, 2024, and May 23, 2025, are encouraged to contact Faruqi & Faruqi, LLP to discuss their legal rights and options [1][5]. - The deadline for seeking the role of lead plaintiff in the class action is November 7, 2025 [1].

Core Viewpoint - Rosen Law Firm is encouraging investors of Savara Inc. to secure legal counsel before the November 7, 2025 deadline related to a securities class action lawsuit [1][2]. Group 1: Class Action Details - The class action pertains to Savara securities purchased between March 7, 2024, and May 23, 2025, with a lead plaintiff deadline set for November 7, 2025 [1]. - Investors who purchased Savara securities during the specified period may be entitled to compensation without any out-of-pocket fees through a contingency fee arrangement [2]. Group 2: Legal Representation - Investors are advised to select qualified legal counsel with a proven track record in securities class actions, as many firms may lack the necessary experience and resources [4]. - The Rosen Law Firm has a history of significant settlements, including the largest securities class action settlement against a Chinese company at the time, and has recovered hundreds of millions of dollars for investors [4]. Group 3: Case Allegations - The lawsuit alleges that Savara made false or misleading statements regarding the MOLBREEVI Biologics License Application, which lacked sufficient information for FDA approval [5]. - It is claimed that the delay in regulatory approval increased the likelihood of Savara needing to raise additional capital, and that the public statements made by the defendants were materially false and misleading [5].