IMPALA

Savara Completes Enrollment of Pivotal Phase 3 IMPALA-2 Trial of Molgramostim Nebulizer Solution (Molgramostim) in Autoimmune Pulmonary Alveolar Proteinosis (aPAP)

Retrieved on: 
Monday, June 26, 2023
Health, FDA, Other Health, General Health, Clinical Trials, Pharmaceutical, Biotechnology, APAP, The New England Journal of Medicine, Inc., Food, COVID-19, IMPALA, MHRA, Patient, PIM, Medicines and Healthcare products Regulatory Agency, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Safety, Chair, Pharmaceutical industry

Savara Inc. (Nasdaq: SVRA), a clinical stage biopharmaceutical company focused on rare respiratory diseases, today announced that enrollment has been completed for the pivotal Phase 3 IMPALA-2 trial.

Key Points: 
  • Savara Inc. (Nasdaq: SVRA), a clinical stage biopharmaceutical company focused on rare respiratory diseases, today announced that enrollment has been completed for the pivotal Phase 3 IMPALA-2 trial.
  • Target enrollment for the trial was 160 patients.
  • IMPALA-2 is a global, 48-week, placebo-controlled clinical trial evaluating molgramostim, a novel inhaled biologic, for the treatment of aPAP, a rare lung disease with no approved pharmacological treatments.
  • “Enrollment completion marks an important milestone in the molgramostim development program,” said Matt Pauls, Chair and CEO, Savara.

IEEE-ISTO Announces Formation of the Inter Company Quality Analytics (IMPALA) Consortium

Retrieved on: 
Thursday, November 3, 2022
Good clinical practice, VP, Bristol Myers Squibb, IEEE, Board, Industry, Solution, Love, GLOBE, Biopharmaceutical, Merck Group, Consortium, Biogen, Knowledge, Certification, Johnson & Johnson, Friends, Merck & Co., Organization, Adoption, Quality assurance, Novartis, Risk, Dubai Health Authority, Roche, QA, Disease, Technology, IMPALA, Astellas Pharma, Patient, Program, Efficiency, Fine chemical, Pharmaceutical industry, Audit, Consumer electronics, Pfizer, Bayer

"Data and technology are at the forefront of every industry today, says Board Director Peter Alain, VP Head of Clinical Quality Assurance at Astellas.

Key Points: 
  • "Data and technology are at the forefront of every industry today, says Board Director Peter Alain, VP Head of Clinical Quality Assurance at Astellas.
  • We have a tremendous opportunity with the IMPALA Consortium to collaborate and incorporate advanced analytics capabilities to drive innovation and advancement of Quality Assurance across the pharmaceutical industry."
  • "One of the key advantages of the IMPALA consortium is the health authority engagement, adds Board Director Peter Alain.
  • IEEE-ISTO President Adam Newman states IEEE-ISTO welcomes the IMPALA Consortium as a new member program of IEEE-ISTO Federation of Programs.

Savara Presented Data at the European Respiratory Society (ERS) International Congress 2022

Retrieved on: 
Tuesday, September 6, 2022
Biotechnology, Pharmaceutical, Health, Clinical Trials, People, WLL, Fatigue, Fever, Article, Sex, Safety, Lipid, PAP, Degenerative disease, Chest (journal), Protein, Macrophage, Chronic cough, Exercise, Carbon monoxide, LinkedIn, GM-CSF, Granulocyte-macrophage colony-stimulating factor, APAP, ERJ, Antibody, Inc., Patient, Health status of Asian Americans, European Respiratory Journal, Respiratory tract infection, Pulmonary alveolar proteinosis, Twitter, Yolk sac, Congress, Clinical trial, Pulmonology, Common, Pharmaceutical industry, Vaccine, Medical imaging, Publication, Savara, IMPALA

Savara Inc. (Nasdaq: SVRA), a clinical stage biopharmaceutical company focused on rare respiratory diseases, presented three posters at the ERS International Congress 2022 that took place September 4-6th in Barcelona, Spain.

Key Points: 
  • Savara Inc. (Nasdaq: SVRA), a clinical stage biopharmaceutical company focused on rare respiratory diseases, presented three posters at the ERS International Congress 2022 that took place September 4-6th in Barcelona, Spain.
  • Additionally, patients reported improved health status, as measured by St. Georges Respiratory Questionnaire-Total and -Activity, when compared with placebo-treated patients .
  • Abstract #1154: Safety and Tolerability of Inhaled Molgramostim in Autoimmune Pulmonary Alveolar Proteinosis (aPAP) presented by F. Bonella, M.D., Ph.D.
  • Additionally, the posters are scheduled to be published in a supplement of the European Respiratory Journal (ERJ) by the end of November 2022.

Savara Reports Second Quarter 2021 Financial Results and Provides Business Update

Retrieved on: 
Thursday, August 12, 2021
Biotechnology, Pharmaceutical, Health, Clinical Trials, Forward-looking statement, Pulmonology, Form, CMC, Wind, Research, Company, Private Securities Litigation Reform Act, LinkedIn, COVID-19, Twitter, APAP, Granulocyte-macrophage colony-stimulating factor, Vancomycin, SEC, Patient, Investment, Efficiency, Degenerative disease, Inc., IMPALA, GM-CSF, Therapy, Review, Pharmaceutical industry

Savara Inc. (Nasdaq: SVRA), a clinical stage biopharmaceutical company focused on rare respiratory diseases, today reported financial results for the second quarter ending June 30, 2021 and provided a business update.

Key Points: 
  • Savara Inc. (Nasdaq: SVRA), a clinical stage biopharmaceutical company focused on rare respiratory diseases, today reported financial results for the second quarter ending June 30, 2021 and provided a business update.
  • Importantly, we continue to leverage key learnings from the first IMPALA trial so that we can execute IMPALA 2 with the highest efficiency and quality.
  • As of June 30, 2021, Savara had cash, cash equivalents, and short-term investments of approximately $181 million and debt of approximately $25 million.
  • Savara undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made, except as may be required by law.

Savara Reports Fourth Quarter / Year-End 2019 Financial Results and Provides Business Update

Retrieved on: 
Thursday, March 12, 2020
Health, Infectious diseases, Clinical trials, Research, Science, Pharmaceutical, Biotechnology, Goodwill, IMPALA, OPTIMA, AVAIL, Savara

Savara Inc. (Nasdaq: SVRA), an orphan lung disease company, today reported financial results for the fourth quarter and full year ending December 31, 2019 and provided a business update.

Key Points: 
  • Savara Inc. (Nasdaq: SVRA), an orphan lung disease company, today reported financial results for the fourth quarter and full year ending December 31, 2019 and provided a business update.
  • Savara's net loss for the fourth quarter of 2019 was $31.7 million, or $(0.72) per share, compared with a net loss of $10.5 million, or $(0.29) per share, for the fourth quarter of 2018.
  • Research and development expenses were $8.7 million for the fourth quarter of 2019, compared with $9.9 million for the fourth quarter of 2018.
  • Operating expenses for the fourth quarter of 2019 were approximately $31.5 million which included $19.4 million in noncash goodwill impairment charges.