Atara Biotherapeutics (ATRA) stock rocketed higher on Thursday after the immunotherapy company announced a regulatory update. The company highlighted a meeting from partner Pierre Fabre Pharmaceuticals with the U.S. Food & Drug Administration. The focus of this meeting was the Complete Response Letter (CRL) for the Biologics License Application (BLA) for tabelecleucel.
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The result of this meeting was that the FDA provided guidance to Pierre Fabre Pharmaceuticals and Atara Biotherapeutics for the resubmission of the BLA for tabelecleucel. The FDA agreed that the companies could resubmit the BLA with additional evidence from a single-arm study of tabelecleucel using an appropriate historical control applicable to the trial population.
Cokey Nguyen, president and CEO of Atara Biotherapeutics, said, “We are grateful to the agency for engaging in a collaborative conversation with our partners, Pierre Fabre, and us. We appreciate the FDA’s continued engagement with PFP and Atara, and we believe the Type A Meeting provided helpful alignment on the regulatory framework to resubmit. We will continue to support Pierre Fabre as it prepares the resubmission and anticipate providing a further regulatory update in the third quarter.”
Atara Biotherapeutics Stock Movement Today
Atara Biotherapeutics stock was up 45.44% in premarket trading on Thursday, following an 8.19% rally yesterday. However, the stock was down 71.53% year-to-date and 30.59% over the past 12 months.
ATRA stock trading activity today saw some 14 million shares change hands, compared to a three-month average daily trading volume of about 342,000 shares.
Is Atara Biotherapeutics Stock a Buy, Sell, or Hold?
Turning to Wall Street, the analysts’ consensus rating for Atara Biotherapeutics is Moderate Buy, based on one Buy and one Hold rating over the past three months. With that comes an average ATRA stock price target of $12, representing a potential 133.01% upside for the shares.
