THOUSAND OAKS, Calif. - Atara Biotherapeutics, Inc. (NASDAQ:ATRA) has announced the submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for its product, tabelecleucel (tab-cel®), aimed at treating Epstein-Barr virus positive post-transplant lymphoproliferative disease (EBV+ PTLD). If approved, tab-cel® would become the first therapy of its kind in the United States for adult and pediatric patients aged two and older who have undergone at least one prior therapy.
This submission could mark a pivotal moment for Atara and its partner Pierre Fabre Laboratories, as well as for the field of allogeneic T-cell therapy. Upon FDA acceptance of the BLA, Atara is set to receive a $20 million milestone payment from Pierre Fabre, with an additional $60 million upon FDA approval.
Tab-cel® is designed as an off-the-shelf immunotherapy targeting EBV-infected cells. The BLA is backed by data from over 430 patients, including results from the ALLELE study, which showed a 48.8% Objective Response Rate (ORR) and a safety profile consistent with prior analyses. The therapy has already been granted Breakthrough Therapy Designation by the FDA for certain EBV-associated conditions and has orphan drug designation.
The announcement follows the European Commission's approval of tab-cel® under the brand name Ebvallo™ in December 2022, with subsequent authorizations by the United Kingdom and Switzerland's regulatory agencies. Ebvallo™ is indicated for similar EBV+ PTLD conditions in those regions.
InvestingPro Insights
As Atara Biotherapeutics, Inc. (NASDAQ:ATRA) makes strides with its recent submission of a Biologics License Application for tab-cel®, investors are closely watching the company's financial health and market performance. According to real-time data from InvestingPro, Atara has a market capitalization of $73.45 million, indicating its size within the biotech sector. Despite a notable one-week price total return of 9.63%, the company's one-year price total return reflects a steep decline of -71.09%, suggesting significant volatility and investor caution over the past year.
An InvestingPro Tip highlights that analysts do not anticipate the company will be profitable this year, which aligns with the reported gross profit margin of -504.47% for the last twelve months as of Q1 2024. This underlines the challenges Atara faces in terms of profitability and cost management. Moreover, the company's short-term obligations exceeding its liquid assets may raise concerns about its financial agility in the near term. This is particularly relevant as the company navigates the regulatory landscape and invests in the commercial potential of tab-cel®.
For investors seeking a deeper dive into Atara's financials and market prospects, InvestingPro offers additional insights and metrics. There are currently 10 more InvestingPro Tips available at https://www.investing.com/pro/ATRA, which could provide further clarity on Atara's investment potential. Interested readers can use the coupon code PRONEWS24 to get an additional 10% off a yearly or biyearly Pro and Pro+ subscription, unlocking valuable information that could shape investment decisions.
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