FDA Rejects Atara's Ebvallo Cancer Therapy

Atara Biotherapeutics' application for its T cell therapy, Ebvallo, was rejected by the FDA due to issues identified at a third-party manufacturing facility, not due to safety or efficacy concerns. This rejection led to a significant drop in Atara's stock value, with shares plummeting over 40%. Despite the setback, Atara plans to address the FDA's concerns and resubmit the application, with potential approval anticipated within six months post-resubmission. To support these efforts, Atara has secured a non-binding term sheet with Redmile Group for up to $15 million in funding. The company is also exploring strategic alternatives, including mergers or acquisitions, to maximize shareholder value. Ebvallo has already been approved in the EU and UK for treating a rare post-transplant blood cancer, highlighting its potential impact once approved in the US.