Tag Archives: Alexion

December, 2018

26 December
Alexion Receives Early FDA Approval for Ultomiris in Adults with Paroxysmal Nocturnal Hemoglobinuria

BOSTON–(BUSINESS WIRE)–Alexion Pharmaceuticals, Inc. (NASDAQ:ALXN) announced today that the U.S. Food and Drug Administration (FDA) has approved ULTOMIRIS™ (ravulizumab-cwvz), the first and only long-acting C5 complement inhibitor administered every eight weeks, for the treatment of adult patients with paroxysmal nocturnal hemoglobinuria (PNH), a debilitating ultra-rare blood disorder characterized by complement-mediated destruction …
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24 October
Alexion and Dicerna Collaborate to Discover and Develop RNAi Therapies for Complement-Mediated Diseases

BOSTON & CAMBRIDGE, Mass.–(BUSINESS WIRE)–Alexion Pharmaceuticals, Inc.(NASDAQ:ALXN) and Dicerna Pharmaceuticals, Inc. (NASDAQ:DRNA) today announced a collaboration to discover and develop RNA interference (RNAi) therapies for complement-mediated diseases. An RNAi-based approach to blocking the production of complement pathway factors offers the potential to inhibit the uncontrolled complement activation that leads to many diseases. …
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27 September
Alexion to Acquire Syntimmune for up to $1.2 Billion

BOSTON–(BUSINESS WIRE)–Alexion Pharmaceuticals, Inc. (NASDAQ:ALXN) and Syntimmune today announced that they have entered into a definitive agreement for Alexion to acquire Syntimmune, a clinical-stage biotechnology company developing antibody therapeutics targeting the neonatal Fc receptor (FcRn). SYNT001 – a humanized monoclonal antibody that inhibits the interaction of FcRn with Immunoglobulin G (IgG) …
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25 September
Alexion’s Soliris Demonstrates Positive Results in Phase 3 Study in Patients with Neuromyelitis Optica Spectrum Disorder

BOSTON–(BUSINESS WIRE)–Alexion Pharmaceuticals, Inc. (NASDAQ: ALXN) today announced positive topline results from the Phase 3 PREVENT study of Soliris® (eculizumab) in patients with anti-aquaporin-4 (AQP4) auto antibody-positive neuromyelitis optica spectrum disorder (NMOSD). NMOSD is a rare, devastating, complement-mediated disorder of the central nervous system characterized by relapses. Each relapse results in stepwise …
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20 August
FDA Accepts Priority Review of Alexion’s ALXN1210 as a Treatment for Paroxysmal Nocturnal Hemoglobinuria

BOSTON–(BUSINESS WIRE)–Alexion Pharmaceuticals, Inc. (NASDAQ:ALXN) announced today that the U.S. Food and Drug Administration (FDA) has accepted for review the Company’s Biologics License Application (BLA) for approval of ALXN1210, the Company’s investigational long-acting C5 complement inhibitor, for the treatment of patients with paroxysmal nocturnal hemoglobinuria (PNH). The FDA set a …
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11 June
Alexion and Complement Pharma Partner to Develop Complement Inhibitor for Neurodegenerative Disorders

NEW HAVEN, Conn., & AMSTERDAM–(BUSINESS WIRE)–Alexion Pharmaceuticals, Inc. (NASDAQ:ALXN) and Complement Pharma today announced a partnership to co-develop the preclinical C6 complement inhibitor CP010 for neurodegenerative disorders. C6 inhibition prevents the formation of the destructive membrane attack complex (MAC), a complex of terminal complement proteins that mediate cellular injury following …
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12 April
Alexion to Acquire Wilson Therapeutics and its Rare Liver Disorder Drug

NEW HAVEN, Conn.–(BUSINESS WIRE)–Alexion Pharmaceuticals, Inc. (NASDAQ:ALXN) and Wilson Therapeutics AB (publ) announced today that Alexion has made a recommended public cash offer to the shareholders in Wilson Therapeutics to acquire all outstanding shares in Wilson Therapeutics by way of a tender offer, through a wholly-owned subsidiary. Wilson Therapeutics is …
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3 November
New Interim Data Shows Survival Beyond 1 Year of Age in Infants with LAL-D Treated with Alexion’s Kanuma

NEW HAVEN, Conn.–(BUSINESS WIRE)–Alexion Pharmaceuticals, Inc. (NASDAQ: ALXN) announced today that new interim data show that 80% of infants (8 out of 10) with rapidly progressive lysosomal acid lipase deficiency (LAL-D) treated with Kanuma® (sebelipase alfa) survived beyond 1 year of age.1 Patients also benefited from improvements in a number of …
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25 October
FDA Approves Alexion’s Soliris for Treatment of Generalized Myasthenia Gravis

NEW HAVEN, Conn.–(BUSINESS WIRE)–Alexion Pharmaceuticals, Inc. (NASDAQ:ALXN) announced today that the U.S. Food and Drug Administration (FDA) has approved Soliris® (eculizumab) as a treatment for adult patients with generalized myasthenia gravis (gMG) who are anti-acetylcholine receptor (AchR) antibody-positive. In the Phase 3 REGAIN study and its ongoing open-label extension study, Soliris …
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14 September
Alexion’s Soliris Demonstrates Positive Results in Phase 3 Open-Label Extension Study in Refractory Generalized Myasthenia Gravis

NEW HAVEN, Conn.–(BUSINESS WIRE)–Alexion Pharmaceuticals, Inc. (NASDAQ:ALXN) announced today results from an interim analysis of an ongoing Phase 3 open-label extension study of the pivotal, placebo-controlled REGAIN study of Soliris® (eculizumab) for the treatment of patients with refractory generalized myasthenia gravis (gMG) who are anti-acetylcholine receptor (AChR) antibody-positive. The new results …
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