Atara Biotherapeutics, Inc. (ATRA - Free Report) announced an important update regarding the regulatory pathway for the impending biologics license application (BLA) submission for the company’s lead product candidate, tabelecleucel (tab-cel), in the United States.
Per the press release, Atara and the FDA have reached an alignment regarding the analytical comparability between manufacturing process versions of tab-cel. This alignment allows ATRA to include data regarding different process versions of tab-cel, from its pivotal phase III ALLELE study of the candidate, in the regulatory filing seeking approval for the same.
ATRA expects the BLA submission for tab-cel in the second quarter of 2024, which will include the latest tab-cel pivotal ALLELE study data.
The company’s stock rose 11.4% on Wednesday, in response to the encouraging news. Year to date, shares of Atara have plunged 46.3% compared with the industry’s 14.2% fall.
Tab-cel is the company’s novel T-cell immunotherapy, which is currently being evaluated in the late-stage ALLELE study, 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.
EBV+ PTLD impacts two types of patients — those who have undergone solid organ transplant (SOT) or allogeneic hematopoietic cell transplant (HCT). The median survival of 0.7 months and 4.1 months for HCT and SOT patients, respectively, after failing standard-of-care treatment, is extremely poor. This represents a serious unmet medical need.
Tabelecleucel received marketing authorization from the European Commission in December 2022, as a monotherapy for the treatment of adult and pediatric patients aged two years and older with relapsed or refractory EBV+ PTLD who have received at least one prior therapy. It is currently marketed in the EU under the brand name, Ebvallo.
Atara is also looking to expand tab-cel’s indication. The company’s phase II multi-cohort study is currently evaluating tab-cel in other EBV-associated diseases, expecting to report top-line results in the fourth quarter of 2023.
Beside tab-cel, Atara has other candidates in its pipeline, which are currently under early-stage development in cancer and autoimmune disease indications.
Zacks Rank and Stocks to Consider
Atara currently has a Zacks Rank #3 (Hold).
Some better-ranked stocks in the overall medical sector, worth mentioning, are Dynavax Technologies (DVAX - Free Report) , Corcept Therapeutics (CORT - Free Report) and Better Therapeutics (BTTX - Free Report) , each carrying a Zacks Rank #2 (Buy) at present.
You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
In the past 30 days, the Zacks Consensus Estimate for Dynavax’s 2023 loss per share has narrowed from 24 cents to 23 cents. The estimate for Dynavax’s 2024 earnings per share is currently pegged at 3 cents. Year to date, shares of DVAX have risen by 26.8%.
DVAX’s earnings beat estimates in two of the trailing four quarters and missed the mark in the other two, delivering an average surprise of 25.78%.
In the past 30 days, the Zacks Consensus Estimate for Corcept’s 2023 earnings per share has remained constant at 78 cents. The estimate for Corcept’s 2024 earnings per share has also remained constant at 83 cents. Year to date, shares of CORT have climbed 57.8%.
CORT’s earnings beat estimates in two of the trailing four quarters and missed the mark in the other two, delivering an average surprise of 6.99%.
In the past 30 days, the Zacks Consensus Estimate for Better Therapeutics’ 2023 loss per share has remained constant at 98 cents. During the same period, Better Therapeutics’ 2024 loss per share has also remained constant at 80 cents. Year to date, shares of BTTX have lost 63.8%.
BTTX’s earnings beat estimates in each of the trailing four quarters, delivering an average surprise of 24.22%.
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Atara Biotherapeutics, Inc. (ATRA - Free Report) announced an important update regarding the regulatory pathway for the impending biologics license application (BLA) submission for the company’s lead product candidate, tabelecleucel (tab-cel), in the United States.
Per the press release, Atara and the FDA have reached an alignment regarding the analytical comparability between manufacturing process versions of tab-cel. This alignment allows ATRA to include data regarding different process versions of tab-cel, from its pivotal phase III ALLELE study of the candidate, in the regulatory filing seeking approval for the same.
ATRA expects the BLA submission for tab-cel in the second quarter of 2024, which will include the latest tab-cel pivotal ALLELE study data.
The company’s stock rose 11.4% on Wednesday, in response to the encouraging news. Year to date, shares of Atara have plunged 46.3% compared with the industry’s 14.2% fall.
Tab-cel is the company’s novel T-cell immunotherapy, which is currently being evaluated in the late-stage ALLELE study, 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.
EBV+ PTLD impacts two types of patients — those who have undergone solid organ transplant (SOT) or allogeneic hematopoietic cell transplant (HCT). The median survival of 0.7 months and 4.1 months for HCT and SOT patients, respectively, after failing standard-of-care treatment, is extremely poor. This represents a serious unmet medical need.
Tabelecleucel received marketing authorization from the European Commission in December 2022, as a monotherapy for the treatment of adult and pediatric patients aged two years and older with relapsed or refractory EBV+ PTLD who have received at least one prior therapy. It is currently marketed in the EU under the brand name, Ebvallo.
Atara is also looking to expand tab-cel’s indication. The company’s phase II multi-cohort study is currently evaluating tab-cel in other EBV-associated diseases, expecting to report top-line results in the fourth quarter of 2023.
Beside tab-cel, Atara has other candidates in its pipeline, which are currently under early-stage development in cancer and autoimmune disease indications.
Zacks Rank and Stocks to Consider
Atara currently has a Zacks Rank #3 (Hold).
Some better-ranked stocks in the overall medical sector, worth mentioning, are Dynavax Technologies (DVAX - Free Report) , Corcept Therapeutics (CORT - Free Report) and Better Therapeutics (BTTX - Free Report) , each carrying a Zacks Rank #2 (Buy) at present.
You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
In the past 30 days, the Zacks Consensus Estimate for Dynavax’s 2023 loss per share has narrowed from 24 cents to 23 cents. The estimate for Dynavax’s 2024 earnings per share is currently pegged at 3 cents. Year to date, shares of DVAX have risen by 26.8%.
DVAX’s earnings beat estimates in two of the trailing four quarters and missed the mark in the other two, delivering an average surprise of 25.78%.
In the past 30 days, the Zacks Consensus Estimate for Corcept’s 2023 earnings per share has remained constant at 78 cents. The estimate for Corcept’s 2024 earnings per share has also remained constant at 83 cents. Year to date, shares of CORT have climbed 57.8%.
CORT’s earnings beat estimates in two of the trailing four quarters and missed the mark in the other two, delivering an average surprise of 6.99%.
In the past 30 days, the Zacks Consensus Estimate for Better Therapeutics’ 2023 loss per share has remained constant at 98 cents. During the same period, Better Therapeutics’ 2024 loss per share has also remained constant at 80 cents. Year to date, shares of BTTX have lost 63.8%.
BTTX’s earnings beat estimates in each of the trailing four quarters, delivering an average surprise of 24.22%.
4 Oil Stocks with Massive Upsides
Global demand for oil is through the roof... and oil producers are struggling to keep up. So even though oil prices are well off their recent highs, you can expect big profits from the companies that supply the world with "black gold."
Zacks Investment Research has just released an urgent special report to help you bank on this trend.
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