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. ...

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. ...

Summary of Savara's Conference Call Company Overview - **Company**: Savara - **Focus**: Single asset company specializing in orphan rare pulmonary diseases - **Key Asset**: MOLBREEVI, targeting autoimmune pulmonary alveolar proteinosis (APAP) [3][4] Core Points and Arguments - **Regulatory Progress**: - Resubmitted Biologics License Application (BLA) for MOLBREEVI in December, expecting FDA acceptance soon [3][4] - Anticipates priority review due to Breakthrough Therapy Designation, with PDUFA date projected for August [4] - Plans to file Marketing Authorization Applications (MAAs) in Europe and the UK by the end of Q1 [4] - **Manufacturing Changes**: - Shifted to Fujifilm as the primary drug substance manufacturer after a refusal to file due to manufacturing data issues [5][6] - Alignment achieved with FDA on analytical comparability protocol with Fujifilm [6][8] - **Clinical Data**: - Strong Phase 3 results published in the New England Journal, with DLCO as the primary endpoint showing statistical significance at 24 weeks [9][10] - Key secondary endpoints also demonstrated clinical benefit, including SGRQ and exercise tolerance tests [10][11] - **Market Potential**: - Identified approximately 5,500 diagnosed patients in the U.S., with a goal to confirm 1,000 patients by the end of 2025 [18][19] - Market is concentrated, with top 500 accounts representing about two-thirds of the market [19][20] - **Commercial Strategy**: - Partnering with PANTHERx, a specialty pharmacy, to facilitate product launch and patient access [21] - Ongoing disease awareness campaigns targeting both physicians and patients to increase diagnosis and treatment uptake [24][25] - **Pricing Strategy**: - Pricing corridor established between $400,000 and $500,000 per patient per year, with payers showing willingness to cover under typical prior authorization criteria [32] - **International Plans**: - Plans to commercialize in Europe and the UK independently, with a similar market opportunity as the U.S. [33] - Japan's market strategy remains under evaluation, with potential differences in approach compared to Europe and the UK [35] Additional Important Information - **Patient Awareness**: - Disease awareness campaigns have successfully identified newly diagnosed patients, indicating a potential for higher prevalence than previously estimated [25][27] - **Financial Position**: - Well-funded with $264 million on the balance sheet and potential for $75 million in royalties upon FDA approval [39] - Restructured debt facility allows for up to $150 million in non-dilutive capital upon FDA approval [39] - **Upcoming Catalysts**: - Anticipated updates regarding FDA decision by the end of January, with a focus on maintaining communication with stakeholders [38]

Core Viewpoint - Savara Inc. has amended its loan and security agreement with Hercules Capital, enhancing its financial position and liquidity [1] Financial Strengthening - The amended loan agreement allows for an additional $75 million to be available upon FDA approval of MOLBREEVI, Savara's investigational therapy for autoimmune pulmonary diseases [1]

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]

Summary of Savara's Conference Call Company Overview - **Company**: Savara - **Focus**: Orphan-rare disease company with a single late-stage product, Mobrevi, a novel inhaled biologic for autoimmune pulmonary alveolar proteinosis (autoimmune PAP) [2][3] Industry Context - **Disease**: Autoimmune PAP is a severe, rare lung disease with no approved therapeutic options in the U.S., Europe, or the U.K. [3] - **Current Treatment**: Patients undergo a lengthy diagnostic journey, often requiring a lung lavage procedure, which is not a sustainable long-term solution [5][6][7] Product Details - **Product**: Mobrevi (molgramostim inhalation solution) - **Administration**: Delivered via nebulization, once daily at 300 micrograms using a proprietary eFlow nebulizer system [10] - **Clinical Trials**: - BLA submitted in December based on positive results from the IMPALA-2 trial, which enrolled 164 subjects [11][15] - Primary endpoint (DLCO) showed statistically significant improvement at 24 weeks compared to placebo [12] - Secondary endpoints included SGRQ and exercise capacity, also showing significant improvement [12][13] Market Opportunity - **Patient Population**: Estimated 5,500 diagnosed autoimmune PAP patients in the U.S., equating to approximately 16 patients per million [17][31] - **Market Dynamics**: The U.S. PAP market is concentrated, with the top 500 accounts managing about 65% of identified patients [17] - **Pricing Strategy**: Anticipated pricing corridor of $400,000-$500,000 per patient per year, with expected coverage under typical prior authorization criteria [22][35] Regulatory and Commercial Strategy - **Regulatory Designations**: Mobrevi has received breakthrough designation in the U.S. and orphan drug designation in Europe, providing 12 and 10 years of exclusivity, respectively [16] - **Commercial Preparation**: Active recruitment of a market development team to prepare for potential approval and launch later this year [18][20] - **Diagnostic Test**: Development of a free blood test for diagnosing autoimmune PAP, with 100% sensitivity and specificity [19] Financial Position - **Capitalization**: Company is well-capitalized with approximately $264 million in cash [24] - **Investment Thesis**: Significant unmet need in the market, with potential for blockbuster revenue given the pricing and patient population [24] Additional Insights - **Patient Experience**: The journey to diagnosis can take years, with significant physical and emotional impacts on patients [9] - **Commercial Strategy**: Focus on both moderate and severe patients, emphasizing the importance of early intervention [32] Conclusion - Savara is positioned to address a significant unmet need in the treatment of autoimmune PAP with Mobrevi, supported by strong clinical data and a robust commercial strategy aimed at improving patient outcomes and accelerating diagnosis [24][36]

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. is a clinical stage biopharmaceutical company focused on rare respiratory diseases and will present at the 44th Annual J.P. Morgan Healthcare Conference [1] Group 1: Company Presentation Details - The presentation will take place on Wednesday, January 14, at 5:15 PM PT / 8:15 PM ET [1] - Matt Pauls, the Chair and Chief Executive Officer of Savara, will be the presenter [1] - The location of the presentation is the Westin St. Francis, San Francisco, Elizabethan B [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]