Akari Therapeutics PLC
F:CLA
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Akari Therapeutics PLC
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Akari Therapeutics PLC
Akari Therapeutics Plc is a clinical-stage biopharmaceutical company, which engages in the development and commercialization of therapeutics to treat orphan autoimmune and inflammatory diseases. The company is headquartered in New York City, New York and currently employs 9 full-time employees. The company went IPO on 2014-01-31. The firm is focused on developing inhibitors of acute and chronic inflammation, specifically the complement system, the eicosanoid or leukotriene system and the bioamine system for the treatment of rare and orphan diseases. Its lead product candidate, nomacopan inhibits both terminal complement activation and leukotriene B4 (LTB4). The company inhibits terminal complement activation by tightly binding to C5 and preventing its cleavage and activation by complement. The company inhibits LTB4 by capturing the fatty acid within the body of the nomacopan protein. The anaphylatoxin (C5a) and the membrane attack complex (MAC) cause and maintain a proinflammatory and prothrombotic state. LTB4 also activates cells via two separate GPCRs and can independently cause and maintain a proinflammatory state.
Akari Therapeutics Plc is a clinical-stage biopharmaceutical company, which engages in the development and commercialization of therapeutics to treat orphan autoimmune and inflammatory diseases. The company is headquartered in New York City, New York and currently employs 9 full-time employees. The company went IPO on 2014-01-31. The firm is focused on developing inhibitors of acute and chronic inflammation, specifically the complement system, the eicosanoid or leukotriene system and the bioamine system for the treatment of rare and orphan diseases. Its lead product candidate, nomacopan inhibits both terminal complement activation and leukotriene B4 (LTB4). The company inhibits terminal complement activation by tightly binding to C5 and preventing its cleavage and activation by complement. The company inhibits LTB4 by capturing the fatty acid within the body of the nomacopan protein. The anaphylatoxin (C5a) and the membrane attack complex (MAC) cause and maintain a proinflammatory and prothrombotic state. LTB4 also activates cells via two separate GPCRs and can independently cause and maintain a proinflammatory state.
Clinical progress: Akari said Coversin continues to advance, with regulatory clearance to open the first European site for the Phase 3 CAPSTONE PNH trial and a completed Phase 2 COBALT study that met its primary endpoint.
Dose selection: The company said the 45 mg per day dose produced faster and more durable LDH reductions than 30 mg per day, and it expects to use 45 mg per day in future PNH studies.
Pipeline expansion: Beyond PNH, Akari has started Phase 2 work in aHUS and plans to begin Phase 2 studies in AKC and bullous pemphigoid in H1 2018.
Safety profile: Management said Coversin was well tolerated in COBALT, with good compliance and no drug-related adverse events reported in the study.
Cash runway: The company ended 2017 with $28.1 million in cash and said that is enough to start CAPSTONE, but likely not enough to finish it without additional financing.
Analyst focus: Questions centered on whether Akari has enough capital for CAPSTONE, the trial design and patient availability, compliance in COBALT, and how Coversin could compete with Alexion’s upcoming PNH data.
