THOUSAND OAKS, Calif. - Atara Biotherapeutics, Inc. (NASDAQ:ATRA), a pioneer in T-cell immunotherapy, has announced that the U.S. Food and Drug Administration (FDA) has accepted its Biologics License Application (BLA) for tabelecleucel (tab-cel®).
The therapy is designed for the treatment of Epstein-Barr virus positive post-transplant lymphoproliferative disease (EBV+ PTLD) in adult and pediatric patients two years and older who have undergone at least one prior therapy. The BLA submission has been granted Priority Review status with a target action date set for January 15, 2025.
The acceptance of the BLA by the FDA marks a significant milestone for Atara, potentially positioning tab-cel as the first approved therapy in the U.S. for EBV+ PTLD. Pascal Touchon, President and CEO of Atara, highlighted the urgency of addressing the unmet medical need for patients suffering from this severe condition. Priority Review underscores the FDA's recognition of the therapy's potential impact.
Tab-cel is an allogeneic, EBV-specific T-cell immunotherapy aimed at targeting and eliminating EBV-infected cells. The application is supported by data from over 430 patients treated with tab-cel across various life-threatening diseases, including results from the pivotal ALLELE study which demonstrated a 48.8% Objective Response Rate (ORR) and a safety profile consistent with previous findings.
The company's collaboration with Pierre Fabre Laboratories has been strengthened by the acceptance of the BLA, triggering a $20 million milestone payment to Atara. Additionally, a future milestone payment of $60 million is contingent upon FDA approval of tab-cel. Atara is also set to receive sales milestones and royalties on net sales of tab-cel in the U.S. and other global markets.
Previously, tab-cel was granted marketing authorization in the European Union, the United Kingdom, and Switzerland under the brand name Ebvallo™. It also received the 2024 Prix Galien International Award for Best Product for Orphan/Rare Diseases.
In other recent news, Atara Biotherapeutics, a biopharmaceutical company, has initiated a 1-for-25 reverse stock split, aiming to increase the market price of the company's common stock and meet the continued listing requirements on The Nasdaq Stock Market LLC.
The company's shareholders approved this action at the annual meeting, and the Board of Directors implemented it. This move will reduce the number of outstanding common shares from approximately 122.6 million to around 4.9 million.
Atara Biotherapeutics has also reported significant progress on its allogeneic anti-CD19 chimeric antigen receptor (CAR) T-cell therapy candidate, ATA3219.
The preclinical data revealed the potential of ATA3219 for treating B-cell driven autoimmune diseases, showing potent B-cell depletion with a reduced inflammatory profile. The therapy is currently under investigation in a Phase 1 trial for relapsed/refractory B-cell non-Hodgkin’s lymphoma.
In addition, Atara Biotherapeutics has submitted a Biologics License Application (BLA) to the U.S. Food and Drug Administration for its product, tabelecleucel (tab-cel®). This submission could result in a $20 million milestone payment from Pierre Fabre Laboratories upon FDA acceptance, with an additional $60 million upon FDA approval.
InvestingPro Insights
Atara Biotherapeutics, Inc. (NASDAQ:ATRA) is on the cusp of a potential breakthrough with its tab-cel® therapy, but what does the financial landscape look like for this pioneering biotech company? According to the latest metrics from InvestingPro, Atara has a market capitalization of $59.1 million USD, reflecting the market's current valuation of the company. Despite the promise of tab-cel®, the company's financials show a significant net loss with a negative gross profit margin of -504.47% for the last twelve months as of Q1 2024.
Investors are keeping a close eye on Atara's cash burn, as the company is quickly depleting its cash reserves, a common challenge for firms in the biotech sector. This is indicated by a negative Price to Earnings (P/E) ratio of -0.24 and an adjusted P/E ratio of -0.26, suggesting that the company is not yet profitable. Moreover, Atara's revenue has declined by 39.63% over the last twelve months, which may raise concerns about its financial sustainability.
On the brighter side, Atara has experienced a significant return over the last week, with a 36.03% price total return, hinting at investor optimism following the FDA's acceptance of the BLA for tab-cel®. This optimism is also reflected in a strong return over the last month, with a 15.62% price total return.
For those interested in a deeper investment analysis of Atara Biotherapeutics, there are additional InvestingPro Tips available that could provide further insights into the company's financial health and future prospects. Readers can access these tips by visiting https://www.investing.com/pro/ATRA and can benefit from a special offer using the coupon code PRONEWS24 to get up to 10% off a yearly Pro and a yearly or biyearly Pro+ subscription. There are 11 more InvestingPro Tips listed for Atara, offering a comprehensive analysis for potential investors.
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