相关临床试验
11
1 进行中
药物批准
0
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监管机构
0
监管机构数
成立时间
N/A
进行中（未招募）
1
9.1%
Available
1
9.1%
已完成
6
54.5%
招募中
1
9.1%
终止
2
18.2%
暂无批准数据
- Savara CFO David Lowrance exercised 580,187 options and sold 394,528 shares at approximately $5.68 per share on June 22, 2026, generating roughly $2.24 million. - The transaction occurred amid a 166.97% one-year stock return and two weeks after Lowrance announced his planned departure for health-related reasons. - Savara's BLA for MOLBREEVI (molgramostim), an inhaled GM-CSF therapy, has been accepted by the FDA with a PDUFA target action date of November 22, 2026. - If approved, MOLBREEVI would become the first approved treatment for autoimmune pulmonary alveolar proteinosis, a rare respiratory disease with no current approved therapies.
- The American Lung Association has launched a new educational campaign to raise awareness about expanded access programs (EAPs) for patients with severe lung diseases who have exhausted standard treatment options. - EAPs, also known as compassionate use, provide an alternative pathway to investigational treatments when clinical trial participation is not possible due to eligibility barriers or geographic limitations. - Findings from the Lung Association's social listening efforts reveal a significant awareness gap, with many patients and caregivers unaware that EAPs exist as a potential option. - The Lung Association has partnered with Savara Inc. to provide educational resources, including the Lung HelpLine, to help patients understand, evaluate, and navigate EAPs with their healthcare providers.
- The European Patent Office intends to grant Savara a patent for MOLBREEVI's liquid formulation, providing protection until March 2041 for this investigational autoimmune PAP therapy. - Savara was also recently granted a European patent covering the drug-device combination of MOLBREEVI with PARI's eFlow nebulizer system, extending protection through March 2043. - The company expects to resubmit its BLA to the FDA this month and plans to submit MAA applications in the EU and UK by the end of Q1 2026. - MOLBREEVI has received multiple regulatory designations including FDA Fast Track and Breakthrough Therapy status for treating autoimmune pulmonary alveolar proteinosis.
- Savara Inc. secured FDA alignment on its Biologics License Application for MOLBREEVI, a treatment for autoimmune pulmonary alveolar proteinosis, with resubmission planned by December 2025. - The company completed a $149.5 million public offering and partnered with Fujifilm Diosynth Biotechnologies as its primary drug manufacturer to address previous regulatory challenges. - Guggenheim raised Savara's price target to $11 from $8 while Oppenheimer increased its target to $9, reflecting analyst confidence in the billion-dollar commercial potential of MOLBREEVI. - Stock price climbed 15.76% following the positive developments, trading from $5.16 to a high of $6.22 amid increased investor optimism.
- Savara's updated health claims analysis identifies approximately 5,500 autoimmune PAP patients in the U.S., representing a 50% increase from the company's previous 2023 estimate of 3,600 patients. - The revised analysis used a more comprehensive dataset with over three times the number of records compared to the previous study, suggesting improved awareness and diagnosis rates for this rare lung disease. - The company plans to resubmit its Biologics License Application for MOLBREEVI to the FDA in December 2025 with priority review request, following publication of positive Phase 3 IMPALA-2 trial results in the New England Journal of Medicine. - With no approved medicines currently available in the U.S. for autoimmune PAP, the increased patient population estimate reinforces the significant unmet medical need for this debilitating condition.
- Savara Inc. will present three research abstracts at the European Respiratory Society Congress 2025, including new data from the Phase 3 IMPALA-2 trial of inhaled molgramostim for autoimmune pulmonary alveolar proteinosis. - The presentations will showcase findings on disease burden, treatment efficacy across varying severity levels, and the relationship between pulmonary function and quality of life in aPAP patients. - Partner company TrilliumBiO will introduce a new dried serum assay for detecting GM-CSF antibodies to improve diagnostic accuracy for aPAP. - Savara will host an Industry Evening Mini Symposium titled "Advances in Autoimmune Pulmonary Alveolar Proteinosis" featuring international experts discussing disease pathophysiology and evolving treatment strategies.
- Savara's Phase 3 IMPALA-2 trial demonstrated that inhaled molgramostim significantly improved lung function by 9.8% at 24 weeks compared to 3.8% with placebo in autoimmune pulmonary alveolar proteinosis patients. - The treatment showed sustained benefits through 48 weeks with 11.6% improvement in gas transfer, while also enhancing quality of life and exercise capacity in the largest clinical trial conducted in this rare disease. - Results from the 43-site global study will be published in the New England Journal of Medicine, marking a potential breakthrough for patients with this chronic rare lung condition.
- Savara will showcase new data from its pivotal Phase 3 IMPALA-2 trial of molgramostim for autoimmune pulmonary alveolar proteinosis (aPAP) at the American Thoracic Society International Conference in May 2025. - Two poster presentations will highlight how molgramostim reduces surfactant burden, decreases whole lung lavage procedures, and improves respiratory health-related quality of life in aPAP patients. - The company will host an Industry Theater featuring world-renowned experts Dr. Bruce Trapnell and Dr. Cormac McCarthy to discuss advances in aPAP diagnosis and management.
- Savara Inc. has begun a rolling submission of a Biologics License Application (BLA) to the FDA for MOLBREEVI, a treatment for autoimmune pulmonary alveolar proteinosis (aPAP). - MOLBREEVI has received Fast Track, Breakthrough Therapy, and Orphan Drug Designations, potentially expediting its review and approval process. - The company anticipates completing the BLA submission by the end of Q1 2025 and will request a priority review for the treatment. - Phase 3 trial data supports MOLBREEVI's favorable benefit-risk profile, offering a potential first-in-class treatment for aPAP in the U.S. and Europe.
- Savara Inc. presented results from the Phase 3 IMPALA-2 trial of molgramostim inhalation solution for autoimmune pulmonary alveolar proteinosis (aPAP). - The presentation highlighted molgramostim's ability to improve pulmonary gas exchange and respiratory health-related quality of life in aPAP patients. - The data was presented at the British Thoracic Society Winter Meeting 2024, with slides available on Savara's website. - Molgramostim is a recombinant human granulocyte-macrophage colony-stimulating factor (GM-CSF) delivered via eFlow Nebulizer System.
