Atara to file T cell immunotherapy in the US in 2024; RayzeBio closes $358M IPO

Atara Bio­ther­a­peu­tics said Tues­day that it plans to sub­mit its T cell im­munother­a­py for ap­proval in the US next year.

The ther­a­py was ap­proved last year in the EU, where it is mar­ket­ed as Ebval­lo. For its US ap­pli­ca­tion, Atara said it can now pool piv­otal clin­i­cal tri­al da­ta from dif­fer­ent man­u­fac­tur­ing process­es af­ter dis­cussing with the FDA whether those process­es were com­pa­ra­ble.

The biotech said it ex­pects to sub­mit its mar­ket­ing ap­pli­ca­tion for tab­ele­cleu­cel as a treat­ment for Ep­stein-Barr virus-as­so­ci­at­ed post-trans­plant lym­pho­pro­lif­er­a­tive dis­ease in the sec­ond quar­ter of 2024.

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