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ATRA Stock Down After FDA Issues CRL for Rare Blood Cancer Candidate
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Shares of Atara Biotherapeutics (ATRA - Free Report) plunged 40.5% on Thursday after the FDA issued a complete response letter (CRL) against the company’s biologics license application (BLA) seeking approval of lead product candidate, tabelecleucel (tab-cel), for the treatment of Epstein-Barr virus-positive post-transplant lymphoproliferative disease (EBV+ PTLD) in adult and pediatric patients aged two years and older. The intended patient population includes EBV+ PTLD patients, who have received at least one prior therapy, including an anti-CD20-containing regimen.
Tab-cel, the company’s novel T-cell immunotherapy, is already marketed in the EU under the brand name, Ebvallo, by Atara’s partner Pierre Fabre under an exclusive commercialization and license agreement.
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.
In the past three months, Atara shares have lost 16.8% compared with the industry’s 12.2% decline.
Image Source: Zacks Investment Research
More on the FDA’s CRL Issuance Against ATRA’s Ebvallo
Atara clarified that the FDA’s CRL was exclusively linked to observations from a routine pre-license inspection of a third-party manufacturing facility for Ebvallo. It did not highlight any issues with the manufacturing process, clinical efficacy, or clinical safety data included in the BLA. Moreover, the FDA did not ask for additional clinical studies to support Ebvallo’s approval.
Atara’s BLA submission in the United States seeking approval for Ebvallo to treat EBV+ PTLD was based on the pivotal phase III ALLELE study results. Per the data readout, a statistically significant 50% objective response rate was achieved upon treatment of EBV+ PTLD patients with the drug.
As the next steps in the regulatory process, Atara announced that it is working closely with its partner Pierre Fabre Laboratories, the FDA and the concerned third-party manufacturer to resolve the issues stated in the CRL to support Ebvallo’s approval for EBV+ PTLD. Subsequently, the company will be resubmitting the Ebvallo BLA to the FDA which it expects to be potentially approved within six months of resubmission.
The CRL for Ebvallo BLA has postponed the drug's U.S. market entry. This delay represents lost revenue potential, as the company could have begun capitalizing on market opportunities sooner in the absence of the CRL.
Atara is eligible to receive a $60 million milestone payment from Pierre Fabre upon FDA approval of the Ebvallo BLA, providing a critical cash infusion for the company. Additionally, it will be eligible for substantial double-digit tiered royalties based on net sales and further milestones tied to Ebvallo's commercial performance. However, the FDA's CRL has also delayed the milestone payment, impacting funds the company planned to allocate for supporting operational activities.
ATRA Seeking Strategic Alternatives Amid Severe Cash Crunch
The company’s pipeline also comprises several next-generation allogeneic CAR T programs, which are predominantly in the pre-clinical stage. One CAR T-cell therapy, ATA3219, is undergoing early-stage development for non-Hodgkin’s lymphoma. Atara deems its current cash position to be insufficient to support these pipeline programs without additional funding. This could have also contributed to the stock price decline. The company reported preliminary cash, cash equivalents and short-term investments of approximately $43 million as of Dec. 31, 2024.
If a strategic funding solution for its CAR-T development programs is not secured in first-quarter 2025, Atara plans to halt all CAR-T activities and significantly scale back its operations. The company would focus solely on supporting Ebvallo’s approval, including progressively transferring all related operational activities to Pierre Fabre in the near term. Atara has signed a non-binding term sheet with Redmile Group for up to $15 million in equity funding, deemed sufficient for Ebvallo BLA approval efforts, while also exploring alternative, including non-dilutive, financing options.
In the long term, Atara stated that it is looking into strategic alternatives, including acquisition, merger, reverse merger, other business combinations, sale of assets, or other strategic transactions to advance the development of its CAR-T assets. Although the company did not guarantee a deal, it is currently in talks with several potential parties.
In the past 30 days, Castle Biosciences’ earnings estimates for 2024 have remained constant at 34 cents per share. During the same timeframe, loss per share for 2025 has remained constant at $1.84. In the past three months, shares of Castle Biosciences have plunged 23.2%.
CSTL’s earnings beat estimates in each of the trailing four quarters, delivering an average surprise of 172.72%.
In the past 30 days, estimates for CytomX Therapeutics’ 2024 loss per share have remained constant at 5 cents. Estimates for 2025 loss per share have remained constant at 35 cents during the same timeframe. In the past three months, shares of CytomX Therapeutics have lost 28.2%.
CTMX’s earnings beat estimates in two of the trailing four quarters and missed the mark in the other two, delivering an average surprise of 115.70%.
In the past 30 days, estimates for BioMarin Pharmaceutical’s 2024 earnings per share have Improved from $3.28 to $3.29. Estimates for 2025 earnings per share have increased from $3.94 to $4.02 during the same timeframe. In the past three months, BioMarin Pharmaceutical shares have lost 12.6%.
BMRN’s earnings beat estimates in each of the trailing four quarters, delivering an average surprise of 28.7%.
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ATRA Stock Down After FDA Issues CRL for Rare Blood Cancer Candidate
Shares of Atara Biotherapeutics (ATRA - Free Report) plunged 40.5% on Thursday after the FDA issued a complete response letter (CRL) against the company’s biologics license application (BLA) seeking approval of lead product candidate, tabelecleucel (tab-cel), for the treatment of Epstein-Barr virus-positive post-transplant lymphoproliferative disease (EBV+ PTLD) in adult and pediatric patients aged two years and older. The intended patient population includes EBV+ PTLD patients, who have received at least one prior therapy, including an anti-CD20-containing regimen.
Tab-cel, the company’s novel T-cell immunotherapy, is already marketed in the EU under the brand name, Ebvallo, by Atara’s partner Pierre Fabre under an exclusive commercialization and license agreement.
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.
In the past three months, Atara shares have lost 16.8% compared with the industry’s 12.2% decline.
Image Source: Zacks Investment Research
More on the FDA’s CRL Issuance Against ATRA’s Ebvallo
Atara clarified that the FDA’s CRL was exclusively linked to observations from a routine pre-license inspection of a third-party manufacturing facility for Ebvallo. It did not highlight any issues with the manufacturing process, clinical efficacy, or clinical safety data included in the BLA. Moreover, the FDA did not ask for additional clinical studies to support Ebvallo’s approval.
Atara’s BLA submission in the United States seeking approval for Ebvallo to treat EBV+ PTLD was based on the pivotal phase III ALLELE study results. Per the data readout, a statistically significant 50% objective response rate was achieved upon treatment of EBV+ PTLD patients with the drug.
As the next steps in the regulatory process, Atara announced that it is working closely with its partner Pierre Fabre Laboratories, the FDA and the concerned third-party manufacturer to resolve the issues stated in the CRL to support Ebvallo’s approval for EBV+ PTLD. Subsequently, the company will be resubmitting the Ebvallo BLA to the FDA which it expects to be potentially approved within six months of resubmission.
The CRL for Ebvallo BLA has postponed the drug's U.S. market entry. This delay represents lost revenue potential, as the company could have begun capitalizing on market opportunities sooner in the absence of the CRL.
Atara is eligible to receive a $60 million milestone payment from Pierre Fabre upon FDA approval of the Ebvallo BLA, providing a critical cash infusion for the company. Additionally, it will be eligible for substantial double-digit tiered royalties based on net sales and further milestones tied to Ebvallo's commercial performance. However, the FDA's CRL has also delayed the milestone payment, impacting funds the company planned to allocate for supporting operational activities.
ATRA Seeking Strategic Alternatives Amid Severe Cash Crunch
The company’s pipeline also comprises several next-generation allogeneic CAR T programs, which are predominantly in the pre-clinical stage. One CAR T-cell therapy, ATA3219, is undergoing early-stage development for non-Hodgkin’s lymphoma. Atara deems its current cash position to be insufficient to support these pipeline programs without additional funding. This could have also contributed to the stock price decline. The company reported preliminary cash, cash equivalents and short-term investments of approximately $43 million as of Dec. 31, 2024.
If a strategic funding solution for its CAR-T development programs is not secured in first-quarter 2025, Atara plans to halt all CAR-T activities and significantly scale back its operations. The company would focus solely on supporting Ebvallo’s approval, including progressively transferring all related operational activities to Pierre Fabre in the near term. Atara has signed a non-binding term sheet with Redmile Group for up to $15 million in equity funding, deemed sufficient for Ebvallo BLA approval efforts, while also exploring alternative, including non-dilutive, financing options.
In the long term, Atara stated that it is looking into strategic alternatives, including acquisition, merger, reverse merger, other business combinations, sale of assets, or other strategic transactions to advance the development of its CAR-T assets. Although the company did not guarantee a deal, it is currently in talks with several potential parties.
Atara Biotherapeutics, Inc. Price and Consensus
Atara Biotherapeutics, Inc. price-consensus-chart | Atara Biotherapeutics, Inc. Quote
ATRA’s Zacks Rank & Stocks to Consider
Atara currently carries a Zacks Rank #3 (Hold).
Some better-ranked stocks from the sector are Castle Biosciences (CSTL - Free Report) , CytomX Therapeutics (CTMX - Free Report) and BioMarin Pharmaceutical (BMRN - Free Report) , each sportinga Zacks Rank #1 (Strong Buy) at present. You can see the complete list of today’s Zacks #1 Rank stocks here.
In the past 30 days, Castle Biosciences’ earnings estimates for 2024 have remained constant at 34 cents per share. During the same timeframe, loss per share for 2025 has remained constant at $1.84. In the past three months, shares of Castle Biosciences have plunged 23.2%.
CSTL’s earnings beat estimates in each of the trailing four quarters, delivering an average surprise of 172.72%.
In the past 30 days, estimates for CytomX Therapeutics’ 2024 loss per share have remained constant at 5 cents. Estimates for 2025 loss per share have remained constant at 35 cents during the same timeframe. In the past three months, shares of CytomX Therapeutics have lost 28.2%.
CTMX’s earnings beat estimates in two of the trailing four quarters and missed the mark in the other two, delivering an average surprise of 115.70%.
In the past 30 days, estimates for BioMarin Pharmaceutical’s 2024 earnings per share have Improved from $3.28 to $3.29. Estimates for 2025 earnings per share have increased from $3.94 to $4.02 during the same timeframe. In the past three months, BioMarin Pharmaceutical shares have lost 12.6%.
BMRN’s earnings beat estimates in each of the trailing four quarters, delivering an average surprise of 28.7%.