Tabelecleucel

Atara renegotiates one-time milestone payment with HCRx THOUSAND OAKS, Calif.--(BUSINESS WIRE)-- Atara Biotherapeutics, Inc. (Nasdaq: ATRA), a leader in T-cell immunotherapy, leveraging its novel allogeneic Epstein-Barr virus (EBV) T-cell platform to develop transformative therapies for patients with cancer and autoimmune diseases, today announced that the Company entered into an amendment (the Amendment) to the Purchase and Sale Agreement dated as of December 20, 2022 with a fund managed by HealthCare Royalty (“HCRx”). Under the terms of the Amendment, HCRx agreed to amend the due date of the one-time of $9.0 million cash payment associated with the achievement of a certain milestone within the Amended and Restated Commercialization Agreement dated October 31, 2023, with Pierre Fabre Medicament, as amended, from June 30, 2026 to January 1, 2028. “We are thankful for this extension to our one-time cash payment to HCRx,“ said Cokey Nguyen, President and Chief Executive Officer of Atara. “This flexibility allows us to focus on addressing the concerns in the latest CRL with the agency, supporting our partners, Pierre Fabre. We believe in the potential of tabelecleucel and are optimistic about the path forward.” In connection with the Amendment, the Company issued a warrant to purchase up to 400,000 shares of the Company’s Common Stock. The exercise price of the Warrant is equal to $0.0001 per share, subject to adjustment as provided therein, and the Warrants will be exercisable immediately and have no expiration date. The exercise of the Warrant is subject to a beneficial ownership limit as set forth in the Warrant. “Tabelecleucel is proving to be an important option for European patients suffering from relapsed or refractory EBV+ PTLD, an ultra-rare and aggressive lymphoma,“ said Clarke Futch, Chairman and Chief Executive Officer at HCRx. “This amendment to our agreement provides Atara and their partner time to work with the FDA for a path to approval in the United States, where there remain limited treatment options and significant unmet need.” About Atara Biotherapeutics, Inc. Atara is harnessing the natural power of the immune system to develop off-the-shelf cell therapies for difficult-to-treat cancers and autoimmune conditions that can be rapidly delivered to patients from inventory. With cutting-edge science and differentiated approach, Atara is the first company in the world to receive regulatory approval of an allogeneic T-cell immunotherapy. Our advanced and versatile T-cell platform does not require T-cell receptor or HLA gene editing and forms the basis of a diverse portfolio of investigational therapies that target EBV, the root cause of certain diseases. Atara is headquartered in Southern California. For more information, visit atarabio.com and follow @Atarabio on X and LinkedIn . Forward-Looking Statements This press release contains or may imply "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. For example, forward-looking statements include statements regarding: (1) the development, timing, and progress of tab-cel; and (2) the timing of the $9.0 million cash payment to HCRx. Because such statements deal with future events and are based on Atara’s current expectations, they are subject to various risks and uncertainties and actual results, performance, or achievements of Atara could differ materially from those described in or implied by the statements in this press release. These forward-looking statements are subject to risks and uncertainties, including, without limitation, risks and uncertainties associated with our year-end the costly and time-consuming pharmaceutical product development process and the uncertainty of clinical success; risks related to FDA’s review of tab-cel; our ability to access capital, and the sufficiency of Atara’s cash resources and access to additional capital on favorable terms or at all; and other risks and uncertainties affecting Atara, including those discussed in Atara’s filings with the Securities and Exchange Commission, including in the “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” sections of the Company’s most recently filed periodic reports on Form 10-K and Form 10-Q and subsequent filings and in the documents incorporated by reference therein. Except as otherwise required by law, Atara disclaims any intention or obligation to update or revise any forward-looking statements, which speak only as of the date hereof, whether as a result of new information, future events, or circumstances or otherwise. Contacts Investor and Media Relations Amber Daugherty Sr. Director, Strategy and Operations adaugherty@atarabio.com

iStock, Yutthana Gaetgeaw Regulatory uncertainty is no longer background noise. It is a material investment risk that reshapes how capital is deployed and pipelines are prioritized. In the more than 40 years I have been in the life science industry, companies and their investors have operated under the assumption that while regulatory review may be rigorous, the rules of the game are generally known. That assumption is now being tested. Changes in leadership at the FDA, less predictable policy signals and evolving approval standards have introduced a new level of uncertainty, one that directly affects development strategy, valuation models and investor appetite for risk. On a positive note, the potential to approve a drug based on a single Phase 3 trial—a change touted by the FDA last year—is explicitly designed to reduce development time and cost, accelerating the time it takes to go from clinical testing to the market. But other recent developments, such as issuing rejections based on unexpected changes to new drug approval criteria, may have far-reaching negative consequences for companies with new products in their pipelines, including affecting how their investors take risk into account in their valuation models. The FDA is not signaling a retreat from innovation, but companies and investors need to weigh the impact these new policies may have on how therapies are developed, financed and ultimately delivered to patients. FDA Moderna’s Outright Flu Refusal Just the Latest Case of Crossed FDA Signals The FDA’s refusal to review Moderna’s mRNA-based flu vaccine is part of a larger communications crisis unfolding at the agency over the past nine months that has also ensnarled Sarepta, Capricor, uniQure and many more. February 13, 2026 · 6 min read · Heather McKenzie Read more Potential Impact of the One-Trial Standard According to FDA Commissioner Marty Makary, the agency plans to move toward requiring a single pivotal clinical study , rather than the traditional two, for many medical products. The stated goal is to accelerate approvals by reducing time and cost, based on the premise that a well-designed trial, supported by robust confirmatory evidence, can provide sufficient statistical confidence. Industry reaction has been cautiously optimistic. Faster paths to approval and greater flexibility in trial design are welcome developments. However, I heard two concerns from executives at the J.P. Morgan Healthcare Conference and Biotech Showcase this year: A single trial default could reduce the breadth and generalizability of clinical evidence. Narrower datasets may lead to weaker labels, negatively affecting physician prescribing behavior and market access. To explore whether the new single-trial standard could indeed increase adoption risk, Litmys , the commercial strategy consulting firm where I work, partnered with Doximity , the largest digital professional network for U.S. healthcare professionals, and physician Nicole Chase to conduct a survey of 100 primary care and family practice physicians. The results were instructive. Physicians were largely indifferent to whether approval was based on one trial or two, provided the product was adequately studied. What mattered most to them was safety pro duration of patient exposure, followed by meaningful endpoints, robustness of clinical benefit and the overall number of study participants. Interestingly, most of the physicians don’t evaluate trial data thoroughly on their own but rely on data summaries, guideline bodies and the experience of KOLs and peers. Specialists may view the issue differently, but these findings suggest that a one-trial standard may not, by itself, be a commercial impediment in primary care. Surprise CRLs: When the FDA Pulls the Rug Out On New Year’s Eve, I received a call from a venture capitalist friend. “What’s going on with Corcept?” he asked. “They hit their endpoint, still got a CRL, and the stock’s down 50%.” On December 31, Corcept Therapeutics announced it had received a complete response letter (CRL) for relacorilant in hypertension secondary to hypercortisolism. While the FDA acknowledged that the pivotal GRACE trial met its primary endpoint and the GRADIENT study provided confirmatory evidence, the agency concluded it could not reach a favorable benefit-risk determination without additional evidence of effectiveness. Just a week earlier, Sanofi received a surprise CRL for tolebrutinib in non-relapsing secondary progressive multiple sclerosis. Despite prior feedback, the FDA determined that even with Risk Evaluation and Mitigation Strategies (REMS), the risk of severe drug-induced liver injury could not be mitigated for any identifiable patient population. These cases followed similar stories from Replimmune, Capricor and Biohaven, and the trouble has continued into 2026. In January, it was Atara Biotherapeutics and Pierre Fabre who received a surprise CRL, this one for Ebvallo, a T cell therapy for EBV-positive post-transplant lymphoproliferative disease. And then in February, the FDA shocked the industry by refusing to even review Moderna’s investigational mRNA-based flu vaccine, despite having agreed to the trial design that supported the application. FDA FDA Reversals Send UniQure, Biohaven, Capricor, More Into a ‘Tailspin’ Since July, several biotechs have been forced to pivot as previous agreements with the FDA around evidence required for approval were reversed, a phenomenon that, according to experts, could portend a more restrictive regulator. November 24, 2025 · 7 min read · Heather McKenzie Read more In each case, sponsors met predefined clinical objectives, yet approval and even review was denied based on evolving benefit-risk interpretations rather than on any new negative data. Industry reaction has been sharply critical and increasingly anxious that the FDA is applying more conservative, less predictable benefit‑risk standards even when pivotal trials meet their primary endpoints. These recent CRLs following seemingly successful Phase 3 trials suggest a tougher, less forgiving interpretation of benefit-risk and higher expectations for trial robustness, safety margins and execution quality. The rejections could also undermine confidence in the value of earlier advice from the agency. For investors and CEOs, these new clinical requirements and their implications for a new drug’s approval challenge a foundational assumption of investors around valuing biotechs. Repricing Regulatory Risk The FDA is signaling a shift toward a greater emphasis on safety and robust real world evidence updates to its benefit-risk framework (BRF). The BRF now directs reviewers to document residual safety uncertainties, therapeutic context and risk management options, making “durable” and well-characterized safety a more visible driver of decisions. The BRF guidance emphasizes that the benefit must outweigh risk given disease severity and unmet need. Uncertainty around long term or off-target safety can block approval even when primary efficacy endpoints are met. Recent CRLs where sponsors hit their prespecified endpoints but FDA cited inability to conclude a favorable benefit-risk balance demonstrate that this framework is being applied more stringently. Valuation models going forward will need to assume a higher probability of CRLs and account for the impact on decisions to conduct a single Phase 3 trial. Will longer and more expensive clinical trials be needed to justify approval? For CEOs, this environment demands both earlier and deeper FDA engagement and greater transparency with investors about agreed-upon endpoints, inclusion criteria and sources of regulatory risk. Notably, recent CRLs show that demonstrating a drug’s incremental clinical value is no longer primarily a post-approval marketing exercise. Sponsors must now establish early and credibly that a product meaningfully improves upon the existing standard of care for a serious disease. This clarity should make the FDA more willing to accept uncertainty, single pivotal trials and narrower safety margins. Regulatory uncertainty is no longer background noise. It is a material investment risk that reshapes how capital is deployed and pipelines are prioritized, and which companies ultimately succeed. Those that integrate regulatory realism into development strategy and investor communication will be better positioned than those that continue to play by the old rules.