Tes­sa gets RMAT des­ig­na­tion for new CAR-T; FDA ad­comm nar­row­ly votes to ex­pand Eli Lil­ly NSCLC la­bel

→ Tes­sa Ther­a­peu­tics has re­ceived a Re­gen­er­a­tive Med­i­cine Ad­vanced Ther­a­py des­ig­na­tion for its ex­per­i­men­tal CAR-T ther­a­py. The ther­a­py, which showed a 67% com­plete re­sponse rate in two tri­als cov­er­ing 27 pa­tients, is be­ing de­vel­oped for re­lapsed and re­frac­to­ry Hodgkin’s lym­phoma. A piv­otal Phase II tri­al is ex­pect­ed for fall of this year.

→ Jim Wil­son’s pre­clin­i­cal biotech — fo­cused on de­vel­op­ing gene ther­a­pies for rare CNS dis­or­ders — has ex­pand­ed its pro­posed share of­fer­ing for its up­com­ing IPO. It now plans to raise $170 mil­lion by of­fer­ing 10 mil­lion shares at a price range of $16 to $18. Pre­vi­ous­ly it had set the goal at $126 mil­lion by of­fer­ing 7.4 mil­lion shares with­in the same price range. At the mid­point, the Philadel­phia, PA-based com­pa­ny could com­mand a ful­ly di­lut­ed mar­ket val­ue of $757 mil­lion, ac­cord­ing to Re­nais­sance Cap­i­tal. Found­ed in 2017, Pas­sage Bio will make its de­but on the Nas­daq un­der the sym­bol $PASG.

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