"This significant achievement for Kamada represents the second FDA approval for the Company," said Amir London, Kamada's Chief Executive Officer. "We are proud that our unique and advanced immune globulin purification technology was used in the development of KEDRAB, and look forward to a successful launch of the product with Kedrion Biopharma."
Kamada announced financial results for the three and six months ended June 30, 2017.
Kamada announced that it intends to offer and sell its ordinary shares in an underwritten public offering.
Kamada announced that it has priced its previously announced underwritten public offering of 3,333,334 of its ordinary shares at a price of $4.50 per share.
Kamada Expects to Report Full Financial Results for Second Quarter and Six Months Ended June 30, 2017, and Host Conference Call on August 1, 2017.
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Kamada announced that the Company has withdrawn the Marketing Authorization Application (MAA) for its proprietary inhaled Alpha-1 Antitrypsin (AAT) therapy for the treatment of Alpha-1 Antitrypsin Deficiency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.