LANGHORNE, Pa.--(BUSINESS WIRE)--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 present and host one on one meetings at the 44th Annual J.P. Morgan Healthcare Conference. Date/Time of Presentation: Wednesday, January 14, 5:15pm PT/8:15pm ET Presenter: Matt Pauls, Chair and Chief Executive Officer, Savara Location: Westin St. Francis, San Francisco, Elizabethan B. ...

LANGHORNE, Pa.--(BUSINESS WIRE)--Savara Inc. (Nasdaq: SVRA) (the Company), a clinical stage biopharmaceutical company focused on rare respiratory diseases, today announced the EPO notified the Company of its intention to grant a patent application covering the liquid formulation of MOLBREEVI, an orally inhaled recombinant human granulocyte-macrophage colony-stimulating factor (GM-CSF). "The liquid formulation and drug-device patents will provide protection in Europe through March 2041 and March. ...

Summary of Savara Management Conference Call Company Overview - Savara is a single-asset company focused on orphan rare diseases, specifically in the rare lung disease space with an inhaled biologic called Molbrivi [2][3] - The company has positive Phase III data for autoimmune pulmonary alveolar proteinosis (autoimmune PAP) and plans to submit a Biologics License Application (BLA) this month, with Marketing Authorization Applications (MAAs) in Europe and the U.K. by the end of Q1 [2][3] Indication and Treatment - Autoimmune PAP is characterized by symptoms such as shortness of breath, cough, and fatigue, with patients typically undergoing a procedure called whole lung lavage, which is a complex and rarely performed procedure [4][7] - Current treatment options are limited, with steroids being ineffective and Rituximab used off-label without proven efficacy [9][10] Patient Population and Prevalence - The estimated prevalence of autoimmune PAP ranges from 6 to 26 per million, with a more robust U.S. claims database analysis suggesting approximately 5,500 patients diagnosed with PAP [12][13][15] - There is a small patient registry with about 150 patients, primarily adults [11] Clinical Data and Efficacy - The primary endpoint in clinical trials is the Diffusing Capacity of the Lungs for Carbon Monoxide (DLCO), which is a surrogate marker for gas transfer [34] - The trial showed a significant difference in DLCO change from baseline, with a 9.8 percentage point improvement, which resonates with physicians despite not having a defined minimal clinically important difference (MCID) for autoimmune PAP [39][42] - Secondary endpoints, such as the St. George's Respiratory Questionnaire (SGRQ), also showed significant benefits [42] Pricing Strategy - Preliminary pricing analysis suggests a range of $400,000 to $500,000 per patient per year, with potential for pricing power based on the clinical benefits demonstrated [33] Safety and Tolerability - The trial reported no significant safety signals, and patient feedback indicated a positive response to the treatment, with all trial completers opting for an open-label extension [43][44] Manufacturing and Quality Control - The company is aligned with Fujifilm as its primary drug substance partner and is resubmitting documentation this month [50][51] Key Takeaways - Savara is positioned to address a significant unmet need in the treatment of autoimmune PAP with its inhaled biologic, Molbrivi - The company is actively working on regulatory submissions and has demonstrated promising clinical data that may support its market entry - The pricing strategy reflects the rarity of the condition and the potential for substantial clinical benefits, which could facilitate payer acceptance and coverage [32][33]

Savara (NasdaqGS:SVRA) FY Conference December 02, 2025 02:30 PM ET Company ParticipantsBraden Parker - Chief Commercial OfficerMatt Pauls - CEOConference Call ParticipantsYasmeen Rahimi - Senior Biotech AnalystYasmeen RahimiPiper Sandler Healthcare Conference. My name is Yasmeen Rahimi. I'm a Senior Biotech Analyst at Piper. This is our five-year anniversary, Matt, as we're both at this healthcare conference, and I get to host you for a fireside chat. What can I say? An incredible journey over the five year ...

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LANGHORNE, Pa.--(BUSINESS WIRE)--Savara Inc. (Nasdaq: SVRA) (the Company), a clinical stage biopharmaceutical company focused on rare respiratory diseases, announced the European Patent Office (EPO) has issued patent No. 4 496 611 titled, "Drug-Device Combination Comprising a Liquid Solution and a Nebulizer for Aerosolization of the Liquid Solution.†The patent is jointly held by Savara and PARI and covers the combination of Savara's investigational therapy, MOLBREEVI, and PARI's investigationa. ...

We recently published 10 Small Caps With Big Double-Digit Gains. Savara Inc. (NASDAQ:SVRA) is one of the top performers of last week. Savara soared by 27.84 percent week-on-week, as investors positioned their portfolios ahead of business updates from its participation in two conferences this week. According to the company, members of its management team will host one-on-one meetings and participate in fireside chats at the Piper Sandler 37th Annual Healthcare Conference on Tuesday, December 2, and at the ...

Group 1 - U.S. stocks experienced an upward trend, with the Dow Jones increasing by approximately 300 points on Friday [1] - Micron Technology, Inc. shares rose sharply by 2.5% to $235.92, driven by positive sentiment following Dell's strong third-quarter earnings and guidance [1] - Investors perceive Dell's results as indicative of broader strength in the technology sector, contributing to Micron's stock performance [1] Group 2 - DeFi Technologies Inc. shares surged by 20.5% to $1.6750 after the approval of QCAD as Canada's first compliant CAD stablecoin [3] - YD Bio Ltd saw a 13.7% increase in shares to $11.96, following the announcement of 510(k) clearance and plans for a clinical trial in Taiwan [3] - Other notable gainers included Savara Inc. (+12.3% to $6.02), TMC the metals company Inc. (+12.2% to $6.54), and ImmunityBio, Inc. (+10.7% to $2.3586) [3] - Precious metals stocks, including First Majestic Silver Corp. (+8.3% to $14.64) and Endeavour Silver Corp. (+10% to $9.47), rose amid increasing gold and silver prices [3] - Intel Corporation shares jumped by 7.8% to $39.65, reflecting positive market trends [3] - Crypto-linked stocks, such as Applied Digital Corporation, gained 6.8% to $26.61, following Bitcoin's rise above $90,000 [3]

Savara (NasdaqGS:SVRA) 2025 Conference Summary Company Overview - Savara is a single-asset rare disease company focused on the orphan pulmonary respiratory space, specifically targeting autoimmune pulmonary alveolar proteinosis (aPAP) with its product Molrivi (molgramostim inhalation solution) [4][5] Key Points Product Development and Milestones - Positive phase three data for Molrivi was reported in summer 2024 for the treatment of autoimmune PAP [4] - The company plans to submit a Biologics License Application (BLA) next month and Marketing Authorization Applications (MAAs) in the EU and U.K. in the first quarter of 2025 [4] - The U.S. launch is anticipated around August or September 2025 [5] Market Opportunity - The estimated diagnosed prevalence of aPAP in the U.S. ranges from 6-26 per million, with Savara's analysis suggesting approximately 5,500 patients diagnosed with aPAP [6][8] - The pricing corridor for Molrivi is expected to be between $400,000-$500,000 per patient per year, reflecting strong pricing power due to clinical data [12] Patient Population Insights - The analysis identified over 6,100 patients with a PAP diagnosis, with a focus on ensuring unique patient counts and accurate diagnoses [7][9] - There is potential for a significant number of undiagnosed patients, with estimates suggesting the total could reach 9,000-10,000 based on literature [14] Compliance and Adherence - High compliance is expected due to the favorable safety profile of Molrivi, with 159 out of 164 patients completing the IMPALA-2 trial [15][16] - The once-daily dosing and ease of use of the nebulizer are anticipated to enhance patient adherence [17] Regulatory Confidence - The company is confident in addressing previous regulatory issues related to manufacturing, having transitioned to Fujifilm for production [18][20] - The BLA resubmission is on track for December, with expectations for FDA acceptance in February 2025 [19] Market Preparedness - Savara plans to launch independently in the U.S., Europe, and U.K., leveraging existing relationships with key opinion leaders and reference centers [22][23] - The company is building a market development team ahead of the launch to ensure readiness [24] Financial Position - Savara currently has approximately $264 million on its balance sheet, providing a strong financial foundation for its upcoming initiatives [4] Intellectual Property and Market Exclusivity - Molrivi is expected to receive 12 years of regulatory exclusivity in the U.S. and 10 years in Europe, with additional patents in place for the drug-device combination and formulation [31][32] Additional Insights - The company emphasizes the importance of early intervention in aPAP treatment to prevent severe complications, such as lung lavages [29] - There is a commitment to educating payers about the disease and the clinical benefits of Molrivi to facilitate reimbursement [12][21] This summary encapsulates the critical aspects of Savara's conference call, highlighting the company's strategic direction, market potential, and operational readiness for the upcoming product launch.

Core Insights - Savara, Inc. (SVRA) shares have rebounded over 100% following a refuse-to-file letter from the FDA regarding its clinical candidate molgramostim in May 2025 [2] Company Overview - Savara, Inc. is focused on respiratory diseases and has seen significant stock price recovery after regulatory challenges [2] Market Analysis - The rebound in Savara's stock is attributed to the company's strategic alignment and market sentiment, indicating potential investor interest in biotech stocks [2]