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Monday, December 30, 2019 5:51:49 PM
http://ih.advfn.com/stock-market/NASDAQ/savara-SVRA/stock-news/81438175/statement-of-beneficial-ownership-sc-13d
http://ih.advfn.com/stock-market/NASDAQ/savara-SVRA/stock-news/81434542/savara-granted-breakthrough-therapy-designation-fo
"....The Molgradex Breakthrough Therapy designation is based on data from IMPALA, a pivotal Phase 3 clinical study evaluating Molgradex for the treatment of aPAP. Data from the study was recently presented in an oral session at the 2019 European Respiratory Society (ERS) International Congress in Madrid, Spain.
“We are pleased that the FDA recognized Molgradex as a breakthrough therapy for the treatment of aPAP, a debilitating rare lung disease with no approved pharmacologic treatment options,” said Rob Neville, Chief Executive Officer, Savara. “We believe this designation reflects the significance of Molgradex as an investigational product that, based on the IMPALA study, has been demonstrated to improve patient outcomes. Breakthrough designation is designed to provide increased collaboration and more frequent dialogue with the FDA and is an important milestone as we work to determine the best path forward for this product.”
About Savara
Savara is an orphan lung disease company. Savara’s pipeline comprises Molgradex, an inhaled granulocyte-macrophage colony-stimulating factor (GM-CSF) in Phase 3 development for autoimmune pulmonary alveolar proteinosis (aPAP), in Phase 2a development for nontuberculous mycobacterial (NTM) lung infection in both non-cystic fibrosis (CF) and CF-affected individuals with chronic NTM lung infection; and AeroVanc, a Phase 3-stage inhaled vancomycin for treatment of persistent methicillin-resistant Staphylococcus aureus (MRSA) lung infection in CF. Savara’s strategy involves expanding its pipeline of potentially best-in-class products through indication expansion, strategic development partnerships and product acquisitions, with the goal of becoming a leading company in its field. Savara’s management team has significant experience in orphan drug development and pulmonary medicine, identifying unmet needs, developing and acquiring new product candidates, and effectively advancing them to approvals and commercialization. More information can be found at www.savarapharma.com. (Twitter: @SavaraPharma, LinkedIn: www.linkedin.com/company/savara-pharmaceuticals/)....."
Recent SVRA News
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- Savara to Present New Data from Pivotal Phase 3 IMPALA-2 Trial of Molgramostim Nebulizer Solution (Molgramostim) in Patients with Autoimmune Pulmonary Alveolar Proteinosis (aPAP) at the European Respiratory Society (ERS) Congress 2024 • Business Wire • 08/15/2024 12:05:00 PM
- Form SC 13D/A - General Statement of Acquisition of Beneficial Ownership: [Amend] • Edgar (US Regulatory) • 08/15/2024 12:45:41 AM
- Form 10-Q - Quarterly report [Sections 13 or 15(d)] • Edgar (US Regulatory) • 08/12/2024 08:05:21 PM
- Savara Reports Second Quarter 2024 Financial Results and Provides Business Update • Business Wire • 08/12/2024 08:05:00 PM
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- Savara Announces Molgramostim Nebulizer Solution (Molgramostim) Achieved Statistical Significance for Primary Endpoint and Multiple Secondary Endpoints in IMPALA-2, a Pivotal Phase 3 Clinical Trial in Autoimmune Pulmonary Alveolar Proteinosis (aPAP) • Business Wire • 06/26/2024 10:30:00 AM
- Savara to Host Investor Call to Discuss Top Line Results From Pivotal Phase 3 IMPALA-2 Trial of Molgramostim Nebulizer Solution (Molgramostim) in Patients With Autoimmune Pulmonary Alveolar Proteinosis (aPAP) • Business Wire • 06/26/2024 12:05:00 AM
- Form 8-K/A - Current report: [Amend] • Edgar (US Regulatory) • 06/10/2024 09:07:03 PM
- Savara to Present at the Jefferies Global Healthcare Conference • Business Wire • 05/29/2024 12:05:00 PM
- Form EFFECT - Notice of Effectiveness • Edgar (US Regulatory) • 05/22/2024 04:15:18 AM
- Savara Presented New Data on Autoimmune Pulmonary Alveolar Proteinosis (aPAP) at the American Thoracic Society (ATS) International Conference 2024 • Business Wire • 05/19/2024 04:15:00 PM
- Savara Announces New Employment Inducement Grant • Business Wire • 05/16/2024 08:05:00 PM
- Form S-3 - Registration statement under Securities Act of 1933 • Edgar (US Regulatory) • 05/09/2024 08:46:49 PM
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- Savara Announces New Employment Inducement Grant • Business Wire • 03/22/2024 08:05:00 PM
- Form S-8 - Securities to be offered to employees in employee benefit plans • Edgar (US Regulatory) • 03/07/2024 09:26:08 PM
- Form 10-K - Annual report [Section 13 and 15(d), not S-K Item 405] • Edgar (US Regulatory) • 03/07/2024 09:05:33 PM
- Savara Reports Fourth Quarter/Year-End 2023 Financial Results and Provides Business Update • Business Wire • 03/07/2024 09:05:00 PM
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