Atara Stock Plunges To 3-Month Low After FDA Blocks Blood Cancer Drug: Retail's Buying The Dip

Atara Biotherapeutics Inc. shares tumbled over 35% on Thursday afternoon, reaching their lowest intraday levels since mid-October. 

The sharp decline followed the announcement that the U.S. Food and Drug Administration (FDA) issued a Complete Response Letter (CRL) for the company's Biologics License Application (BLA) for EBVALLO (tabelecleucel). 

The treatment is intended as a monotherapy for adults and children over two years old with Epstein-Barr virus-positive post-transplant lymphoproliferative disease (EBV+ PTLD) who have already received one prior therapy.

A CRL indicates that the FDA cannot approve the application in its current form. In this case, the CRL was related to observations from a pre-license inspection of a third-party manufacturing facility and did not cite deficiencies in the drug's clinical efficacy, safety data, or Atara's manufacturing process. 

Crucially, no new clinical trials were requested, the company said.

Atara CEO Cokey Nguyen expressed confidence in resolving the issue, expecting resubmission and potential approval within six months of addressing the manufacturing compliance concerns. 

Atara's partner, Pierre Fabre Laboratories, reaffirmed its commitment to bringing the drug to U.S. patients facing significant unmet medical needs.

Despite the regulatory setback, retail sentiment on Stocktwits climbed further into the 'extremely bullish' territory as users interpreted the CRL as a temporary hurdle. 

Many viewed the stock's plunge as an overreaction, with some citing the drug's "in principle FDA approval" and emphasizing its undervalued price. Several investors posted about taking advantage of the dip, noting the potential for substantial returns once the issues are resolved.

EBVALLO received marketing authorization from the European Commission in December 2022. 

Atara added that the European Medicines Agency (EMA) has already approved the FUJIFILM Diosynth Biotechnologies facility in California to produce EBVALLO.

Atara's stock has shed over 55% of its value in the past 12 months. However, retail interest has surged, with message volume on Stocktwits climbing by 1,450% and follower counts growing nearly 10%.

For updates and corrections, email newsroom[at]stocktwits[dot]com.

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