Shares of Atara Biotherapeutics (ATRA, Financials) dropped 38.15% to $8.14 in trading Thursday at 12:14 p.m. ET after the company announced it had received a Complete Response Letter from the U.S. Food and Drug Administration regarding its Biologics License Application for EBVALLO. The business said the letter included remarks from a pre-licensing examination of a third-party production facility but omitted any flaws pertaining to clinical effectiveness, safety data, or manufacturing technique. Atara pointed that the agency asked for no further clinical research.
To solve the FDA-identified problems, Atara stated it is collaborating with third-party manufacturer and partner Pierre Fabre Laboratories. With a possible approval period of six months after resubmission, the business said it aims to resubmit the application after compliance with Good Manufacturing Practice criteria. Atara disclosed these specifics in their release.
Already authorized in the European Union,EBVALLO is based on data from the key ALLELE trial. According to Atara's announcement, the study revealed a 50% objective response rate and safety statistics comparable with past studies.
Atara also said it is looking at strategic substitutes to maximize value for its owners. Under discussion are possible mergers, acquisitions, or other deals. The business said it hired a financial adviser to help with this procedure. The statement claims that Atara is in talks with many entities but that no guarantees have been given on the result of these conversations.
Atara also claimed it signed a non-binding term sheet with Redmile Group to use an equity line of credit to get up to $15 million in financing. According to the firm, this money is meant to sustain continuous operations needed for EBVALLO clearance. Atara also pointed out that should further funding not be obtained in the first quarter of 2025, its CAR-T research initiatives might be suspended. The introduction of the firm includes this material.
Atara said as of Dec. 31, 2024, around $43 million in cash, cash equivalents, and short-term investments. According to its statement, the corporation underlined that this number is just preliminary and unaccurate.
Based in Southern California, Atara works on creating cell treatments for autoimmune diseases and difficult-to-treat tumors.
