Abivax SA has confirmed plans to submit a new drug application for obefazimod, its candidate product for ulcerative colitis, to the US Food and Drug Administration late in the fourth quarter. This follows results from a Phase 3 trial that showed strong efficacy. The small molecule drug upregulates a microRNA known as miR124 in order to stabilise the immune response in patients with ulcerative colitis, a disease that affects the colon.
Les Laboratoires Servier SAS of France has extended its reach into the rare disease space with the acquisition of the muscular dystrophy business of Edgewise Therapeutics Inc of Boulder Colorado, US. The lead asset is sevasemten, a small molecule drug that is being developed for both Becker muscular dystrophy and Duchene muscular dystrophy. The two disorders are caused by mutations in the DMD gene which encodes for the dystrophin protein.
Following a European Commission announcement in March of a proposed new legal framework for start-up companies, Germany has reportedly lifted its opposition to giving more powers to an EU financial regulator – an important step towards creating a capital markets union. According to The Financial Times, the German finance minister Lars Klingbeil signalled his support for the centralised supervision of a unified capital market, which would effectively mean ceding powers from the German regulator to the European Securities and Markets Authority (ESMA), based in Paris.
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