Allogene Therapeutics (ALLO) said Tuesday that the US Food and Drug Administration has granted Regenerative Medicine Advanced Therapy, or RMAT, designation to its allogeneic CAR T candidate, ALLO-316, for treating adult patients with a type of advanced renal cell carcinoma.
The designation follows data from a phase 1 trial showing potential benefits for patients who have not responded to standard therapies, Allogene Therapeutics said. The ongoing trial is evaluating the safety and efficacy of ALLO-316, supported by Allogene's Dagger technology for enhanced CAR T cell expansion in solid tumors.
The RMAT designation aims to expedite the development and review process of ALLO-316, the company said.
Allogene shares rose 6.5% in recent trading.
Price: 2.86, Change: +0.18, Percent Change: +6.53
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