Atara Biotherapeutics (ATRA – Free Report) is a nimble allogeneic T cell immunotherapy company with several near-term catalysts. This Zacks Rank #2 (Buy) company boasts a pipeline of differentiated therapies across a range of oncology and autoimmune indications from its proven EBV T cell platform.
FDA Decision on ATRA’s Tab-cel Expected Next Week
The company’s biologics license application (BLA) seeking approval for its lead product candidate, tabelecleucel (tab-cel), in the United States is under priority review with the FDA. A decision is expected on Jan. 15.
Tab-cel is the company’s novel T-cell immunotherapy, which has been developed for the treatment of Epstein-Barr virus-positive post-transplant lymphoproliferative disease (EBV+ PTLD).
EBV+ PTLD is a rare hematologic malignancy (blood cancer) with a high mortality rate and occurs after patients undergo transplantation when their T-cell immune responses are compromised by immunosuppression.
Deal With Pierre Fabre Strengthens ATRA’s Cash Position
Tab-cel is already marketed in the EU under the brand name, Ebvallo, by Atara’s partner Pierre Fabre Medicament under an exclusive commercialization and license agreement. In 2023, Atara expanded its partnership with Pierre Fabre to commercialize tab-cel in the United States and all remaining global markets.
If the drug is approved in the United States, Atara will be eligible to receive an additional $60 million milestone payment from Pierre Fabre, which should strengthen its cash position.
With the FDA approval of tab-cel, the product will be transitioned to Pierre Fabre, repositioning Atara as a fully focused allogeneic CAR-T company with multiple near-term data milestones for its lead CAR T program, ATA3219, in oncology and autoimmune indications.
ATRA Makes Rapid Progress on ATA3219’s Development
In 2025, Atara plans to report preliminary phase I data on ATA3219 in non-Hodgkin’s lymphoma in the first quarter of 2025, which will provide a read-through for ATA3219’s potential in autoimmune disease.
ATRA also expects to report initial data from a phase I study on ATA3219 in lupus nephritis and extrarenal systemic lupus erythematosus by mid-2025.
ATRA’s Rising Stock Price & Narrowing Loss Estimates
ATRA’s shares have risen 108.1% in the past six months against a decrease of 7.3% for the industry.
Image Source: Zacks Investment Research
In the past 60 days, loss estimates for 2025 have improved from $14.68 per share to $13.20 per share.
Atara Biotherapeutics, Inc. Price and Consensus
Atara Biotherapeutics, Inc. price-consensus-chart | Atara Biotherapeutics, Inc. Quote
Other Stocks to Consider
Some other top-ranked stocks from the biotech sector are Halozyme Therapeutics (HALO – Free Report) , Castle Biosciences (CSTL – Free Report) and Puma Biotechnology (PBYI – Free Report) , each sporting a Zacks Rank #1 (Strong Buy) at present.
In the past 60 days, estimates for Halozyme Therapeutics’ 2025 earnings per share have increased from $4.80 to $4.81. In the past year, shares of HALO have risen 44.2%.
HALO’s earnings beat estimates in three of the trailing four quarters while meeting the same on the remaining occasion, the average surprise being 14.86%.
In the past 60 days, estimates for Castle Biosciences’ 2025 bottom line have narrowed from a loss of $1.88 per share to a loss of $1.84 per share. In the past year, shares of CSTL have surged 47.1%.
CSTL’s earnings beat estimates in each of the trailing four quarters, the average surprise being 172.72%.
In the past 60 days, estimates for Puma Biotechnology’s 2025 earnings per share have increased from 42 cents to 54 cents. In the past year, shares of PBYI have declined 22.4%.
PBYI’s earnings beat estimates in three of the trailing four quarters while missing the same on the remaining occasion, the average surprise being 32.78%.
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