10:42 AM EDT, 09/16/2024 (MT Newswires) -- Poseida Therapeutics ( PSTX ) said Monday the US Food and Drug Administration granted regenerative medicine advanced therapy designation to the experimental P-BCMA-ALLO1 therapy in phase 1/1b clinical development to treat relapsed or refractory multiple myeloma, a type of cancer.
The designation encompasses all the advantages of the fast track and breakthrough therapy designation programs, including early interactions with the FDA.
Poseida said it will report new clinical data from the phase 1 study at the 21st International Myeloma Society Annual Meeting, scheduled for Sept. 25-28.
The company plans additional clinical updates for the second half of 2024, subject to coordination with Roche, which has a collaboration with Poseida covering P-BCMA-ALLO1 and other multiple investigational allogeneic CAR-T therapies targeting blood cancers.
Poseida shares were up 5% in recent trading.
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