Atara Biotherapeutics Stock (ATRA) Jumps as FDA Decision on Viral Therapy Nears

Atara Biotherapeutics’ (ATRA) shares glimmered on Thursday morning as investors anticipate the U.S. health watchdog will approve its living cell therapy. A decision on tabelecleucel is set to arrive on January 10, TipRanks’ FDA Calendar shows.

Tabelecleucel, which is designed to be administered intravenously, is targeted at treating EBV+PTLD, a cancer-like cell growth caused by the Epstein-Barr virus after organ or stem transplants. This type of cancer is considered highly aggressive and fatal as it compromises the immune system.

Atara Eyes Potential U.S. Launch of Tabelecleucel

In 2022, Atara secured marketing authorization for tabelecleucel from European regulators under the brand Ebvallo. It actively markets the brand in Germany and Austria, and in subsequent years has also gained authorization for the drug in the UK and Switzerland.

Atara announced in July last year the acceptance of its priority review application for the therapy by the U.S. Food and Drug Administration, noting that the regulator’s approval would make the drug the “first approved therapy in the U.S. for EBV+PTLD”.

The biotech company is working on the treatment in partnership with Pierre Fabre, one of France’s largest private pharmaceutical groups. Cokey Nguyen, Atara’s chief executive, last year noted that the firm was working closely with Pierre Fabre “to help prepare for the potential launch [of tabelecleucel] in the U.S.”

Analyst Sees Upside from FDA Approval

Recently, Canaccord Genuity analyst John Newman rated ATRA stock a Buy, noting that he sees a reasonable chance for FDA approval of tabelecleucel. Newmark, who raised his ATRA price target from $17 per share to $25 — implying about 61% upside — noted that milestone payments from Pierre Fabre for the approval would help to reinvigorate Atara’s portfolio.

Atara announced late last year that it expects to get about $31 million in milestone payments from Pierre Fabre for the approval. This came after the biotech amended the previous $40 million tied to the approval in exchange for the opportunity to earn an additional $15 million from hitting certain commercial milestones.

Is Atara a Buy, Hold, or Sell?

On Wall Street, Atara Biotherapeutics’ shares carry a Moderate Buy consensus rating based on two Buys issued over the past two months. In addition, the average ATRA price target of $21.50 implies about 33% upside from current trading levels.

Read about other upcoming FDA decisions here.