ATRA Stock Down After FDA Issues CRL for Rare Blood Cancer Candidate

FDA CRL Impact on Atara Biotherapeutics - Shares of Atara Biotherapeutics (ATRA) plunged 40.5% after the FDA issued a complete response letter (CRL) against the company's biologics license application (BLA) for tabelecleucel (tab-cel) [1] - The CRL was linked to observations from a routine pre-license inspection of a third-party manufacturing facility, with no issues raised regarding manufacturing process, clinical efficacy, or safety data [3] - The FDA did not request additional clinical studies to support Ebvallo's approval [3] Ebvallo's Market and Clinical Data - Tab-cel, marketed as Ebvallo in the EU, is a novel T-cell immunotherapy for EBV+ PTLD, a rare hematologic malignancy with high mortality rates [2] - The BLA submission was based on the pivotal phase III ALLELE study, which showed a statistically significant 50% objective response rate in EBV+ PTLD patients [4] Financial and Operational Implications - The CRL has delayed Ebvallo's U.S. market entry, resulting in lost revenue potential [7] - Atara is eligible for a $60 million milestone payment from Pierre Fabre upon FDA approval, which has also been delayed, impacting operational funding [8] - The company reported preliminary cash, cash equivalents, and short-term investments of approximately $43 million as of Dec 31, 2024 [9] Strategic Alternatives and Funding - Atara is exploring strategic alternatives, including acquisition, merger, reverse merger, or sale of assets, to advance its CAR-T assets [11] - The company has signed a non-binding term sheet with Redmile Group for up to $15 million in equity funding to support Ebvallo BLA approval efforts [10] - If additional funding is not secured by Q1 2025, Atara plans to halt all CAR-T activities and focus solely on Ebvallo's approval [10] Industry Comparison - In the past three months, Atara shares have lost 16.8%, compared to the industry's 12.2% decline [2] - Castle Biosciences (CSTL), CytomX Therapeutics (CTMX), and BioMarin Pharmaceutical (BMRN) are better-ranked stocks in the sector, each sporting a Zacks Rank 1 (Strong Buy) [12] - Castle Biosciences' shares have plunged 23.2% in the past three months, while CytomX Therapeutics and BioMarin Pharmaceutical have lost 28.2% and 12.6%, respectively [13][14][15]