Atara and Pierre Fabre Submit FDA Meeting Request
Written by Emily J. Thompson, Senior Investment Analyst
Updated: Mar 03 2026
0mins
Should l Buy ATRA?
Atara Biotherapeutics announced that its partner Pierre Fabre Pharmaceuticals has submitted a request to the FDA for a Type A meeting. Pierre Fabre Pharmaceuticals, in partnership with Atara, submitted a briefing book to the FDA addressing the points from the complete response letter dated January 9, providing additional context and clarification that the ALLELE study was adequate, well-controlled, and sufficient to support the tabelecleucel biologics license application. In addition, the briefing book includes summaries of updated, longer-term efficacy data from ALLELE, additional supportive data from the tab-cel development program and post-marketing data in Europe that will be included in a potential resubmission. "With our partners at Pierre Fabre Pharmaceuticals, we are eager to engage in a constructive discussion with the FDA to reach a path forward for tabelecleucel," said Cokey Nguyen, president and CEO of Atara. "The PTLD community, including physicians and patient advocacy groups have emphasized the urgent need for tabelecleucel and its ability to address a dire unmet medical need in this ultra-rare disease."
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Analyst Views on ATRA
Wall Street analysts forecast ATRA stock price to rise
2 Analyst Rating
2 Buy
0 Hold
0 Sell
Moderate Buy
Current: 6.290
Low
18.00
Averages
21.50
High
25.00
Current: 6.290
Low
18.00
Averages
21.50
High
25.00
About ATRA
Atara Biotherapeutics, Inc. is an allogeneic T-cell immunotherapy company. The Company is a developer of T-cell immunotherapy, leveraging its novel allogeneic Epstein-Barr virus (EBV) T-cell platform to develop transformative therapies for patients with serious diseases. Its pipeline products include Ebvallo (Tab-cel), ATA3219, and ATA3431. The Company’s T-cell immunotherapy, tab-cel (tabelecleucel), is in Phase III development for patients with EBV-driven post-transplant lymphoproliferative disease (EBV+ PTLD) who have failed rituximab or rituximab plus chemotherapy, as well as other EBV-driven diseases. Its ATA3219 allogeneic CD19 CAR T immunotherapy, targeting B-cell malignancies and autoimmune diseases, is based on a next-generation 1XX CAR co-stimulatory domain and EBV T-cell platform and does not require TCR or HLA gene editing. ATA3431 is an allogeneic, bispecific CAR directed against CD19 and CD20 for B-cell malignancies and autoimmune disease.
About the author
Emily J. Thompson
Emily J. Thompson, a Chartered Financial Analyst (CFA) with 12 years in investment research, graduated with honors from the Wharton School. Specializing in industrial and technology stocks, she provides in-depth analysis for Intellectia’s earnings and market brief reports.
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- Impact of Privatization: The acquisition will result in Lisata Therapeutics delisting from public markets, potentially providing the company with greater flexibility to focus on long-term strategic goals while mitigating the impact of market volatility on its operations.
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- Stock Price Plummets: Following the FDA's CRL announcement, Atara's stock price fell by $7.79, a decline of 56.99%, closing at $5.88 per share, reflecting market pessimism regarding the company's outlook.
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- Acquisition Agreement: Lisata Therapeutics Inc has agreed to be taken private by Kuva Labs, offering shareholders $5.00 per share along with a $1.00 contingent value right per share, indicating recognition of the company's future potential.
- Significant Stock Surge: Following the acquisition announcement, Lisata Therapeutics' shares rose 20.3% in pre-market trading to $5.03, reflecting positive market reaction and increased investor confidence in the deal.
- Impact of Privatization: The acquisition will result in Lisata Therapeutics delisting from public markets, potentially providing the company with greater flexibility to focus on long-term strategic goals while mitigating the impact of market volatility on its operations.
- Market Dynamics Shift: The announcement of this deal has sparked interest in other related stocks, demonstrating investor enthusiasm for M&A activity in the biotech sector, which may influence future investment decisions and market trends.
See More
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- FDA Submission Update: Atara's partner Pierre Fabre submitted a briefing to the FDA to address concerns regarding the immunotherapy tabelecleucel, demonstrating the company's proactive approach in navigating regulatory challenges.
- Stock Price Surge: Following the announcement of the partner's request for a meeting with the FDA, Atara's shares rose 7% on Tuesday, reflecting market optimism about the company's future, despite a 25% decline in stock price over the past year.
- Clinical Trial Data: Atara provided updated long-term efficacy data and additional supportive information, emphasizing the adequacy and control of its clinical trials, aiming to lay the groundwork for a potential resubmission of tabelecleucel, showcasing the company's confidence in the product's success.
- Market Sentiment Shift: On the Stocktwits platform, retail sentiment around ATRA shifted from 'bullish' to 'extremely bullish', indicating increased investor confidence in the company's future prospects, despite the FDA's rejection decision.
See More
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- FDA Rejection: Atara Biotherapeutics' cell therapy tabelecleucel was rejected by the FDA despite internal recommendations for approval, leading to a significant drop in the company's stock price in January, highlighting the impact of regulatory uncertainty on market confidence.
- Insufficient Clinical Data: Although the FDA's Center for Biologics Evaluation and Research suggested approval for late 2024 to early 2025, the rejection due to inadequate clinical data under the new leadership indicates a tightening of regulatory standards, which may affect future R&D directions.
- Leadership Changes Impact: The rejection of tabelecleucel under the leadership of new FDA head Vinay Prasad is seen as a reflection of policy shifts at the FDA, potentially leading to greater approval challenges for Atara and affecting its market positioning.
- Market Reaction Volatility: Following the news of the FDA rejection, Atara's shares rebounded on Wednesday, indicating a reassessment of the company's future potential by investors, although the overall outlook remains uncertain.
See More
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Company Announcement: Atara Biotherapeutics has announced an amendment to its agreement with HCRX regarding a cash payment.
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See More
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- FDA Rejection: On January 12, 2026, Atara announced that the FDA issued a Complete Response Letter for its EBVALLO™ Biologics License Application, indicating that the application cannot be approved in its current form due to the inadequacy of the single-arm ALLELE trial, which jeopardizes the company's future product launch plans.
- Stock Price Plunge: Following the FDA announcement, Atara's stock price plummeted by $7.79, a staggering 56.99% drop, closing at $5.88 per share, which may undermine investor confidence and impact the company's ability to raise funds.
- Legal Investigation Initiated: Pomerantz LLP is investigating whether Atara and its executives have engaged in securities fraud or other unlawful business practices, advising investors to contact the firm to join the class action, which could exacerbate the legal risks facing the company.
- Market Reaction Intensifies: The FDA's rejection and the subsequent stock collapse have created significant uncertainty regarding Atara's future prospects, potentially affecting its reputation and attractiveness to investors in the biopharmaceutical industry.
See More
Pomerantz LLP Investigates Securities Fraud Claims Against Atara Biotherapeutics
- Investigation Launched: Pomerantz LLP is investigating claims on behalf of Atara Biotherapeutics investors regarding potential securities fraud or other unlawful business practices, indicating serious concerns about the company's governance.
- FDA Application Denied: On January 12, 2026, Atara announced that its EBVALLO™ Biologics License Application was rejected by the FDA via a Complete Response Letter (CRL), indicating that the application is currently inadequate for approval, which impacts the company's future product launch plans.
- Stock Price Plummets: Following the FDA's CRL announcement, Atara's stock price fell by $7.79, a decline of 56.99%, closing at $5.88 per share, reflecting market pessimism regarding the company's outlook.
- Legal Implications: Pomerantz LLP, recognized for its expertise in securities litigation, may provide legal support to affected investors, further intensifying the legal and financial pressures faced by Atara.
See More
