What's Happening?
Atara Biotherapeutics Inc., an immunotherapy company based in Thousand Oaks, faced a significant setback as the U.S. Food and Drug Administration rejected its lead drug candidate, Ebvallo, for the second
time in less than a year. The rejection, announced on January 12, led to a dramatic 57% drop in Atara's share price, further declining by 26% the following day. The FDA's decision was unexpected, with the agency citing deficiencies in the clinical trial structure as inadequate for accelerated approval. The drug, targeting post-transplant lymphoma linked to the Epstein Barr virus, had previously been approved in the European Union. Atara's future hinges on a forthcoming meeting with the FDA to address concerns and seek a path forward for approval.
Why It's Important?
The FDA's rejection of Atara's drug platform poses significant challenges for the company, which relies heavily on the approval of Ebvallo for its financial viability. The decision impacts Atara's market capitalization and raises existential questions about its future operations. The rejection highlights the FDA's increasingly rigorous standards for clinical trial designs, affecting bioscience companies' ability to bring new therapies to market. The situation underscores the challenges faced by pharmaceutical companies in navigating regulatory environments and the potential consequences of changing approval criteria.
What's Next?
Atara and its partner, Pierre Fabre Laboratories, plan to request a 'Type A' meeting with the FDA to discuss the agency's concerns and explore a path to approval. The meeting, expected within 45 days of the request, is crucial for Atara's future, as the company faces a cash crunch and has limited revenue sources. The outcome of the meeting will determine whether Atara can continue its operations or explore alternative strategies, such as seeking approvals in other international markets or considering a reverse merger.
