Atara's New Drug Applications Placed on Hold by FDA

Atara Biotherapeutics, Inc. (ATRA) shareholders woke up to some disappointing news this morning as the company announced that the U.S. Food and Drug Administration (FDA) has placed a clinical hold on its active Investigational New Drug (IND) applications. The INDs include the EBVALLOTM (tabelecleucel) program for the treatment of Epstein-Barr virus positive post-transplant lymphoproliferative disease (EBV+ PTLD) and ATA3219, an allogeneic CD19-targeted CAR-T therapy for non-Hodgkin’s lymphoma and systemic lupus erythematosus. The clinical hold is linked to inadequately addressed GMP compliance issues identified during a pre-license inspection of a third-party manufacturing facility.



Atara's shares fell 4.3% to $6.29 in premarket trading Tuesday, reflecting investor concerns about the potential impact of the clinical hold on the company's development timelines and commercialization prospects. The pause in new enrollment for both programs will likely extend the completion of clinical trials and push back the potential approval and launch of these therapies.



The GMP compliance issues at the third-party manufacturing facility are a significant setback for Atara, as they could delay the company's ability to bring these promising therapies to market. However, Atara is taking a proactive approach to addressing the issues and working closely with the FDA to find a resolution. The company has agreed upon necessary actions to release the clinical holds and is committed to maintaining the highest standards for its programs.

Atara's CEO, Cokey Nguyen, stated, "We intend to work closely with the FDA to address these issues as expeditiously as possible. We are encouraged with ongoing correspondence with the Agency and a potential path to submitting the necessary data to release the clinical hold. Patient safety remains our priority and maintaining the highest standards for our programs."



While the clinical hold is a setback for Atara, it is essential to remember that the company's pipeline is diverse, and it is actively developing other therapies that could mitigate the impact of this delay. Additionally, Atara has entered a non-binding term sheet with Redmile Group for funding of up to $15 million to support its efforts to get FDA approval, indicating that the company is taking steps to address any strain on financial resources resulting from the delay in clinical development.

In conclusion, the clinical hold on Atara's new drug applications is a significant setback for the company, but it is not insurmountable. Atara is taking a proactive approach to addressing the GMP compliance issues and working closely with the FDA to find a resolution. While the delay in clinical development will likely impact the company's development timelines and potential commercialization prospects, Atara's diverse pipeline and proactive approach to addressing financial strain provide reasons for cautious optimism. As an investor, it is essential to monitor the situation closely and consider the potential impact on Atara's financial performance and stock price.