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llllllllll setanaxib (GKT831) / GenkyotexGenkyotex Announces Agreement for Calliditas Therapeutics to Acquire Controlling Interest in Genkyotex SA (Businesswire) - Aug 13, 2020 - "Genkyotex...today announced an agreement for Calliditas Therapeutics AB...to acquire a controlling interest in Genkyotex SA....Total acquisition cost would thus amount to a maximum of approximately €87.9m including contingent rights subject to future regulatory approvals of setanaxib....€30m on approval of setanaxib for a first indication by the US Food and Drug Administration (FDA); €15m on approval of setanaxib for a first indication by the European Commission (EC); and €10m on approval of setanaxib by the FDA or the EC for either idiopathic pulmonary fibrosis (IPF)..."llllllllll Yeliva (opaganib) / RedHillRedHill Biopharma Provides Q2/2020 Financial Results and Operational Highlights (RedHill Press Release) - Aug 13, 2020 - "Ongoing global COVID-19 Phase 2/3 and U.S. Phase 2 studies with opaganib planned to deliver preliminary data for potential emergency use applications as early as Q4/2020; Research and Development Expenses were $3.2 million, compared to $2.8 million in the first quarter of 2020. The increase was primarily attributable to the initiation of studies with opaganib for COVID-19."llllllllll Xolair (omalizumab) / Roche, NovartisFDA Accepts Application for Xolair (omalizumab) Prefilled Syringe for Self-Administration Across All Indications (Businesswire) - Aug 13, 2020 - "Genentech...today announced that the U.S. Food and Drug Administration (FDA) accepted the company’s supplemental Biologics License Application (sBLA) for a new self-administration option for Xolair® (omalizumab) across all approved U.S. indications...A decision on approval is anticipated by Q1 2021..."llllllllll citoplurikin (IRX-2) / Brooklyn ImmunoTherapNTN Buzztime, Inc. and Brooklyn ImmunoTherapeutics LLC Enter into Definitive Merger Agreement (PRNewswire) - Aug 13, 2020 - "NTN Buzztime, Inc...and Brooklyn ImmunoTherapeutics LLC...announced that the companies have entered into a definitive merger agreement...Brooklyn will merge with a wholly-owned subsidiary of NTN Buzztime in an all-stock transaction. Following closing, which the parties expect will occur in the fourth quarter of 2020, the combined company will continue under the Brooklyn ImmunoTherapeutics name...Brooklyn is focused on exploring the role that IRX-2, a cytokine-based investigational therapy, can have on the immune system in treating patients with cancer..."llllllllll AK104 / AkesobioANTI-PD-1/CTLA-4 Bi-specific Antibody (AK104) of Akeso Granted FDA Fast Track Designation for Recurrent and Metastatic Cervical Cancer (PRNewswire) - Aug 13, 2020 - "Akeso, Inc…announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation for AK104, a novel anti-PD-1/CTLA-4 bi-specific antibody, as monotherapy for the treatment of patients with recurrent or metastatic squamous cervical cancer who have disease progression on or after platinum-based chemotherapy."
