FDA lifts clinical hold on Atara’s Ebvallo

7 May 2025

California-based Atara Biotherapeutics (Nasdaq: ATRA) revealed that the US Food and Drug Administration (FDA) has lifted the clinical hold on its active Investigational New Drug (IND) applications for the Ebvallo (tabelecleucel) program, sending the firm’s share up 5.8% to $7.67.

The T-cell immunotherapy company is leveraging its novel allogeneic Epstein-Barr virus (EBV) T-cell platform to develop transformative therapies for patients with cancer and autoimmune diseases.

While the therapy was approved in Europe in 2022 for EBV+ PTLD - where it is commercialized by French drugmaker Pierre Fabre Laboratories - US regulators rejected a similar marketing application this past January.

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