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ATRA Stock Shoots Up 82% in a Month: Here's What You Should Know
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Key Takeaways
Atara shares jumped 82.4% in a month after a positive FDA update on tab-cel.
The FDA said a single-arm study with a historical control could support a future filing.
Atara expects another regulatory update on the tab-cel BLA resubmission in Q3 2026.
Atara Biotherapeutics (ATRA - Free Report) shares have rallied 82.4% in a month, primarily driven by a positive regulatory update earlier in May on its lead product candidate, tabelecleucel (tab-cel). The update followed a Type A meeting with the FDA to discuss the second complete response letter (CRL) issued in early January for the biologics license application (BLA) for tab-cel, which is held by Atara’s partner, Pierre Fabre Pharmaceuticals.
The therapy was being reviewed as a monotherapy for adult and pediatric patients aged two years and older with Epstein-Barr virus-positive post-transplant lymphoproliferative disease (EBV+ PTLD) who have received at least one prior therapy, including an anti-CD20 regimen. Currently, there are no FDA-approved therapies in this treatment setting, leaving patients with limited options and a high unmet medical need. Tab-cel is an allogeneic, EBV-specific T-cell immunotherapy designed to recognize and eliminate EBV-infected cells.
Following the Type A meeting, the FDA agreed that a single-arm study using an appropriate historical control applicable to the study population and conducted in a pre-specified manner could serve as an adequate and well-controlled study to provide safety and efficacy data in support of a future marketing application of tab-cel for the EBV+ PTLD indication.
Pierre Fabre, with Atara’s support, now intends to submit an updated dataset with additional patients and longer follow-up from the single-arm pivotal phase III ALLELE study of tab-cel, along with supportive data. Atara expects to provide another regulatory update regarding the tab-cel BLA resubmission in the third quarter of 2026.
Year to date, Atara shares have plunged 47.8% compared with the industry’s 2.8% decline.
Image Source: Zacks Investment Research
ATRA’s Tab-Cel BLA Faces a Rocky Regulatory Journey
Atara’s regulatory journey for tab-cel has been lengthy and uneven. The FDA first issued a CRL in January 2025, citing a single deficiency related to Good Manufacturing Practice (GMP) compliance. Importantly, the earlier CRL did not raise concerns about the therapy’s safety, efficacy or clinical study design, keeping the main clinical case for tab-cel largely intact at the time.
Following remediation efforts, the BLA was resubmitted in 2025 after Atara reached alignment with the FDA on the acceptability of the resubmission criteria and the conditions identified in the first CRL. The BLA package was backed by pivotal and supportive data from more than 430 patients treated with tab-cel across multiple life-threatening diseases. This included updated data from the pivotal phase III ALLELE study, which showed a statistically significant objective response rate of 48.8%, along with a favorable safety profile consistent with earlier analyses.
However, the FDA issued another CRL in January 2026, stating that the BLA could not be approved in its then-current form. While the agency confirmed that the earlier GMP compliance issues had been satisfactorily resolved and did not identify new safety concerns, it took a different position on the clinical evidence package. The FDA stated that the single-arm ALLELE study was no longer adequate to support evidence of effectiveness for accelerated approval and raised concerns about the interpretability of the study due to design, conduct and analysis issues.
This marked a major setback for Atara and Pierre Fabre, particularly because the FDA’s position differed from prior regulatory alignment over several years. The companies then planned to engage urgently with the agency through a Type A meeting to determine a viable path forward for tab-cel, given the severity of EBV+ PTLD and the lack of approved therapies for these patients. The latest May update, following the completion of the Type A meeting, appears to have restored some investor confidence.
Over the past 60 days, estimates for Liquidia Corporation’s 2026 EPS have increased from $1.50 to $2.97. Over the same period, EPS estimates for 2027 have also increased from $2.91 to $4.81. LQDA shares have rallied 79.1% year to date.
Liquidia Corporation’searnings beat estimates in three of the trailing four quarters and missed in the remaining one, with the average surprise being 54.40%.
Over the past 60 days, estimates for Indivior Pharmaceuticals’ 2026 earnings per share have increased from $3.10 to $3.35. Over the same period, EPS estimates for 2027 have risen to $3.69 from $3.47. INDV shares have risen 4.8% year to date.
Indivior Pharmaceuticals’ earnings beat estimates in each of the trailing four quarters, with the average surprise being 65.44%.
Over the past 60 days, estimates for Immunocore’s 2026 loss per share have narrowed from 97 cents to 16 cents. On the other hand, its 2026 EPS is currently pegged at 11 cents. IMCR shares have lost 14.9% year to date.
Immunocore’s earnings beat estimates in three of the trailing four quarters, while missing the same on the remaining occasion, with the average surprise being 46.66%.
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ATRA Stock Shoots Up 82% in a Month: Here's What You Should Know
Key Takeaways
Atara Biotherapeutics (ATRA - Free Report) shares have rallied 82.4% in a month, primarily driven by a positive regulatory update earlier in May on its lead product candidate, tabelecleucel (tab-cel). The update followed a Type A meeting with the FDA to discuss the second complete response letter (CRL) issued in early January for the biologics license application (BLA) for tab-cel, which is held by Atara’s partner, Pierre Fabre Pharmaceuticals.
The therapy was being reviewed as a monotherapy for adult and pediatric patients aged two years and older with Epstein-Barr virus-positive post-transplant lymphoproliferative disease (EBV+ PTLD) who have received at least one prior therapy, including an anti-CD20 regimen. Currently, there are no FDA-approved therapies in this treatment setting, leaving patients with limited options and a high unmet medical need. Tab-cel is an allogeneic, EBV-specific T-cell immunotherapy designed to recognize and eliminate EBV-infected cells.
Following the Type A meeting, the FDA agreed that a single-arm study using an appropriate historical control applicable to the study population and conducted in a pre-specified manner could serve as an adequate and well-controlled study to provide safety and efficacy data in support of a future marketing application of tab-cel for the EBV+ PTLD indication.
Pierre Fabre, with Atara’s support, now intends to submit an updated dataset with additional patients and longer follow-up from the single-arm pivotal phase III ALLELE study of tab-cel, along with supportive data. Atara expects to provide another regulatory update regarding the tab-cel BLA resubmission in the third quarter of 2026.
Year to date, Atara shares have plunged 47.8% compared with the industry’s 2.8% decline.
Image Source: Zacks Investment Research
ATRA’s Tab-Cel BLA Faces a Rocky Regulatory Journey
Atara’s regulatory journey for tab-cel has been lengthy and uneven. The FDA first issued a CRL in January 2025, citing a single deficiency related to Good Manufacturing Practice (GMP) compliance. Importantly, the earlier CRL did not raise concerns about the therapy’s safety, efficacy or clinical study design, keeping the main clinical case for tab-cel largely intact at the time.
Following remediation efforts, the BLA was resubmitted in 2025 after Atara reached alignment with the FDA on the acceptability of the resubmission criteria and the conditions identified in the first CRL. The BLA package was backed by pivotal and supportive data from more than 430 patients treated with tab-cel across multiple life-threatening diseases. This included updated data from the pivotal phase III ALLELE study, which showed a statistically significant objective response rate of 48.8%, along with a favorable safety profile consistent with earlier analyses.
However, the FDA issued another CRL in January 2026, stating that the BLA could not be approved in its then-current form. While the agency confirmed that the earlier GMP compliance issues had been satisfactorily resolved and did not identify new safety concerns, it took a different position on the clinical evidence package. The FDA stated that the single-arm ALLELE study was no longer adequate to support evidence of effectiveness for accelerated approval and raised concerns about the interpretability of the study due to design, conduct and analysis issues.
This marked a major setback for Atara and Pierre Fabre, particularly because the FDA’s position differed from prior regulatory alignment over several years. The companies then planned to engage urgently with the agency through a Type A meeting to determine a viable path forward for tab-cel, given the severity of EBV+ PTLD and the lack of approved therapies for these patients. The latest May update, following the completion of the Type A meeting, appears to have restored some investor confidence.
Atara Biotherapeutics, Inc. Price and Consensus
Atara Biotherapeutics, Inc. price-consensus-chart | Atara Biotherapeutics, Inc. Quote
ATRA’s Zacks Rank & Stocks to Consider
Atara Biotherapeutics currently carries a Zacks Rank #3 (Hold).
Some better-ranked stocks in the biotech sector are Liquidia Corporation (LQDA - Free Report) , Indivior Pharmaceuticals (INDV - Free Report) and Immunocore (IMCR - Free Report) , each sporting a Zacks Rank #1 (Strong Buy) at present. You can see the complete list of today’s Zacks #1 Rank stocks here.
Over the past 60 days, estimates for Liquidia Corporation’s 2026 EPS have increased from $1.50 to $2.97. Over the same period, EPS estimates for 2027 have also increased from $2.91 to $4.81. LQDA shares have rallied 79.1% year to date.
Liquidia Corporation’searnings beat estimates in three of the trailing four quarters and missed in the remaining one, with the average surprise being 54.40%.
Over the past 60 days, estimates for Indivior Pharmaceuticals’ 2026 earnings per share have increased from $3.10 to $3.35. Over the same period, EPS estimates for 2027 have risen to $3.69 from $3.47. INDV shares have risen 4.8% year to date.
Indivior Pharmaceuticals’ earnings beat estimates in each of the trailing four quarters, with the average surprise being 65.44%.
Over the past 60 days, estimates for Immunocore’s 2026 loss per share have narrowed from 97 cents to 16 cents. On the other hand, its 2026 EPS is currently pegged at 11 cents. IMCR shares have lost 14.9% year to date.
Immunocore’s earnings beat estimates in three of the trailing four quarters, while missing the same on the remaining occasion, with the average surprise being 46.66%.