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Kamada announced that the Company has submitted to the U.S. Food and Drug Administration (FDA) for review a proposed pivotal Phase 3 protocol for its proprietary inhaled Alpha-1 Antitrypsin (AAT) therapy (Inhaled AAT) for the treatment of Alpha-1 Antitrypsin Deficiency (AATD).
Kamada announced that the Company has withdrawn the Marketing Authorization Application (MAA) for its proprietary inhaled Alpha-1 Antitrypsin (AAT) therapy for the treatment of Alpha-1 Antitrypsin Deficiency (AATD) with the European Medicines Agency (EMA).
Kamada announced the receipt of an undisclosed additional milestone payment under the supply and distribution agreement with Shire for GLASSIA®, Kamada's intravenous (IV) alpha-1 antitrypsin (AAT).
Kamada announced that Kamada and Shire have agreed that the Investigational New Drug (IND) application approved by the U.S. Food and Drug Administration (FDA) for the Phase 2/3 study evaluating Alpha-1 Antitrypsin (G1-AAT IV) for the treatment of acute Graft-Versus-Host Disease (GvHD) will be transferred from Shire to Kamada, who will take full ownership and responsibility for the clinical development of the product in this indication.
Kamada announced today the appointment of Michal Stein, M.D., as Vice President and Medical Director for Immunology.
Kamada announced that a poster comprising updated data from the Company's U.S. Phase 2 clinical trial of its proprietary inhaled Alpha-1 Antitrypsin (AAT) therapy for the treatment of Alpha-1 Antitrypsin Deficiency (AATD) was presented by Professor Mark Brantly, M.D., Vice Chair of Research, Department of Medicine, Chief Division of Pulmonary, Critical Care and Sleep Medicine, Professor of Medicine, Molecular Genetics and Microbiology at the University of Florida College of Medicine and Alpha One Foundation Research Professor, at the 2017 American Thoracic Society (ATS) International Conference, being held May 19-24 in Washington, D.C.
Reaffirms revenue guidance of $100 million for 2017
Proprietary Products segment for 2017 projected at $76-$78 million, up at least 36% compared to
Kamada management will host an investment community conference call on Tuesday, May 16 at 8:30am Eastern Time to discuss these results and answer questions.
This week's top- story is about Kamada's GVHD clinical program and other interesting clinical implications of its AAT pipeline.
The company will host a Research and Development Day to highlight Graft versus Host Disease (GvHD) in New York City on March 3 from 12:00pm to 1:30pm Eastern Time.