BeiGene and Mus­tang nail down spe­cial FDA sta­tus for top drugs; Roche bags added cov­er­age for Hem­li­bra

→ BeiGene $BGNE is get­ting a boost in its dri­ve to field a ri­val to Im­bru­vi­ca. The FDA has of­fered an ac­cel­er­at­ed re­view to zanubru­ti­nib, a BTK in­hibitor that has post­ed pos­i­tive re­sults for man­tle cell lym­phoma. The PDU­FA date lands on Feb­ru­ary 27, 2020. The drug scored break­through sta­tus at the be­gin­ning of the year.

→ BeiGene isn’t the on­ly bio­phar­ma com­pa­ny to gain spe­cial reg­u­la­to­ry sta­tus to­day. Mus­tang Bio $MBIO and St. Jude Chil­dren’s Re­search Hos­pi­tal an­nounced that MB-107, a lentivi­ral gene ther­a­py for the treat­ment of X-linked se­vere com­bined im­mun­od­e­fi­cien­cy, al­so known as bub­ble boy dis­ease, has been grant­ed Re­gen­er­a­tive Med­i­cine Ad­vanced Ther­a­py sta­tus.

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