AveX­is wins the in­side track at the FDA with gene ther­a­py ‘break­through’

Chica­go-based AveX­is has lined up the lat­est break­through ther­a­py des­ig­na­tion from the FDA, gain­ing an in­side track at the agency for its ear­ly-stage gene ther­a­py for lethal cas­es of spinal mus­cu­lar at­ro­phy in chil­dren. The biotech says it won that mark of dis­tinc­tion af­ter reg­u­la­tors got a pre­lim­i­nary look at the re­sults from their Phase I study.

AveX­is was able to score a $95 mil­lion IPO last Feb­ru­ary as it joined the first wave of biotechs to hit the pub­lic mar­ket this year, a lit­tle af­ter the once red-hot gene ther­a­py field had be­gun to cool some­what. The of­fer­ing fol­lowed a $65 mil­lion crossover round last fall which was joined by Roche.

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