By Owen Tucker-Smith

Atara Biotherapeutics said Thursday that the FDA has turned down its request to start selling its Ebvallo drug across state lines in a complete response letter.

The biotechnology company said the Food and Drug Administration's notice was based on observations from an inspection of a third-party manufacturing facility, and that the agency did not spot deficiencies in the drug's manufacturing process or in the drug's efficacy or safety. Evballo targets a rare blood cancer that develops after transplants.

Atara said it had received the complete response letter, which the FDA uses to indicate that the review cycle for an application has finished and that the application is not ready to be approved. Atara noted that the agency didn't ask for the company to conduct any new clinical trials. It said it will file for a resubmission and expects potential approval within six months of that resubmission.

Atara also said it is continuing to review strategic alternatives, is in "active discussions with several potential parties," and is evaluating options including but not limited to an acquisition, merger, reverse merger or other sales of assets or transactions.

The company has entered a non-binding term sheet with Redmile Group, a San Francisco-based hedge fund and private equity manager, to provide up to $15 million in funding. The company said it thinks those funds will help it take the necessary steps to get approval from the FDA.

Shares of the company were recently down 47% at $7.93 in premarket trading. The stock is down 28% over the last 52 weeks.

Write to Owen Tucker-Smith at owen.tucker-smith@wsj.com

(END) Dow Jones Newswires

January 16, 2025 09:16 ET (14:16 GMT)

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