Investing.com -- Shares of Atara Biotherapeutics, Inc. (NASDAQ:ATRA) tumbled 51% after the company disclosed receiving a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) for its EBVALLOTM (tabelecleucel) treatment. The CRL, which pertains to a monotherapy for certain patients with Epstein-Barr virus positive post-transplant lymphoproliferative disease (EBV+ PTLD), was tied to inspection findings at a third-party manufacturing facility and not to the drug’s clinical efficacy or safety data.
The FDA’s letter did not point out any deficiencies in the manufacturing process nor did it demand new clinical studies for the approval of EBVALLO. Despite the setback, Atara emphasized its commitment to working with the FDA, Pierre Fabre Laboratories, and the third-party manufacturer to resolve the issues and secure approval for EBVALLO in the U.S. The company has also stated its intention to explore strategic options with the assistance of a financial advisor and has secured a non-binding term sheet with Redmile Group for up to $15 million in funding, believed to be sufficient for the ongoing activities required for BLA approval.
Atara’s CEO, Cokey Nguyen, Ph.D., expressed confidence in eventually obtaining marketing approval for EBVALLO and filing for a resubmission, which could potentially be approved within six months of resubmission. The European Commission granted marketing authorization for EBVALLO in December 2022, and Atara, along with its partner Pierre Fabre, remains optimistic about the drug’s potential in the U.S. market.
EBVALLO is an allogeneic, EBV-specific T-cell immunotherapy designed to target and eliminate EBV-infected cells. Its U.S. BLA is based on the pivotal ALLELE study, which demonstrated a 50% Objective Response Rate (ORR) and a favorable safety profile. Additionally, a second third-party manufacturer, FUJIFILM Diosynth Biotechnologies (FDB), has been approved by the EMA to manufacture EBVALLO, which is considered a key part of the long-term global manufacturing strategy for the drug.
While the CRL has led to a significant drop in Atara’s stock, the company’s proactive approach to addressing the FDA’s concerns and its financial strategy to support BLA approval may provide a path forward for EBVALLO’s eventual introduction to the U.S. market.
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