Tabelecleucel

Prescription Drug User Fee Act (PDUFA) Target Action Date of March 31, 2027 If Approved, Tab-cel Would Be the First Therapy Available in the U.S. for EBV+ PTLD 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 its partner, Pierre Fabre Pharmaceuticals, Inc. (PFP), has received acceptance by the U.S. Food and Drug Administration (FDA) of the Biologics License Application (BLA) resubmission for tabelecleucel, with a proposed indication as monotherapy for treatment of adult and pediatric patients two years of age and older with Epstein-Barr virus positive post-transplant lymphoproliferative disease (EBV+ PTLD) who have received at least one prior therapy. The BLA has a Class 2 Resubmission Prescription Drug User Fee Act (PDUFA) target action date of March 31, 2027. “The acceptance of the tabelecleucel resubmission brings us one step closer to making this first-of-its-kind treatment available to patients in the U.S.,” said Cokey Nguyen, President and Chief Executive Officer of Atara. “We appreciate the Agency’s guidance and look forward to a collaborative review process. We will continue supporting PFP as it prepares for a potential U.S. launch.” Tab-cel has been granted Breakthrough Therapy Designation for the treatment of rituximab-refractory EBV-associated lymphoproliferative disease by the U.S. FDA and has orphan drug designation for the treatment of Epstein-Barr virus-positive post-transplant lymphoproliferative disorders. If tabelecleucel is approved, Atara would be eligible to receive a $31 million milestone payment under its commercialization agreement with Pierre Fabre Laboratories. Atara would also be eligible to receive significant double-digit tiered royalties on net sales and additional commercial sales milestones. 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, including the timing of FDA’s review of the resubmitted BLA and the PDUFA target action date and the potential characteristics and benefits of tab-cel; (2) the receipt of milestone and royalty payments, including the potential milestone payment upon FDA approval of the tabelecleucel BLA, and (3) the prospect of bringing tab-cel to U.S. patients with EBV+ PTLD. 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 the costly and time-consuming pharmaceutical product development process and the uncertainty of clinical success; risks related to FDA’s review of tab-cel, including the risk that the resubmission of the tab-cel BLA may not address the deficiencies identified in the second complete response letter received on January 9, 2026 or other issues that may be raised by the FDA on review; and that the FDA may not act by the PDUFA target action date, may extend its review period, or may issue another complete response letter; the fact that PFP, and not Atara, holds the tab-cel BLA and controls the content and strategy of the resubmission and related FDA interactions, and Atara's ability to influence the resubmission process is limited; 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 Atara’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

In the news release, Pierre Fabre Pharmaceuticals Announces FDA Acceptance of BLA Resubmission for Tabelecleucel for the Treatment of Epstein-Barr Virus-Positive Post-Transplant Lymphoproliferative Disease, issued 14-Oct-2026 by Pierre Fabre Pharmaceuticals over PR Newswire, we are advised by the company that changes have been made. The complete, corrected release follows, with additional details at the end: Pierre Fabre Pharmaceuticals Announces FDA Acceptance of BLA Resubmission for Tabelecleucel for the Treatment of Epstein-Barr Virus-Positive Post-Transplant Lymphoproliferative Disease The BLA has a Prescription Drug User Fee Act target action date of March 31, 2027 Accepted resubmission includes an updated dataset with additional patients and longer follow-up from the Phase 3 single-arm ALLELE study, as well as expansive supplemental data If approved, tabelecleucel will be the first FDA-authorized treatment for relapsed/refractory EBV+ PTLD patients whose survival is measured in only a few weeks to months following failure of initial therapy EBV+ PTLD is an ultra-rare, acute, and potentially deadly blood malignancy that occurs after hematopoietic cell transplant (HCT) or solid organ transplant (SOT) when T-cell activity is impaired by immunosuppression SECAUCUS, N.J. , Oct. 14, 2026 /PRNewswire/ -- Pierre Fabre Pharmaceuticals Inc. (PFP) announces the acceptance by U.S. Food and Drug Administration (FDA) of the Biologics License Application (BLA) resubmission for tabelecleucel, with a proposed indication as monotherapy for treatment of adult and pediatric patients two years of age and older with Epstein-Barr virus positive post-transplant lymphoproliferative disease (EBV+ PTLD) who have received at least one prior therapy. "People diagnosed with relapsed or refractory EBV+ PTLD urgently need new treatment options as they have no approved FDA therapies, and after failure of initial treatment their survival is limited, measured in only weeks to months," said Adriana Herrera, Chief Executive Officer of PFP, the Laboratoires Pierre Fabre Pharmaceutical subsidiary in the U.S. "We look forward to a collaborative review process focused on the growing body of evidence supporting tabelecleucel approval including more patients and increased follow-up within our pivotal study and extensive supplemental data primarily from our ongoing early access programs and commercial experience in Europe." PFP resubmitted the BLA based on April 2026 Type A meeting alignment with the FDA. The submission includes an updated dataset with additional patients and longer follow-up from the ongoing, pivotal Phase 3 single-arm ALLELE study of tabelecleucel in adults and children two years of age and older with relapsed/refractory EBV+ PTLD following SOT or HCT. The resubmission also includes additional supplemental data from expanded access programs, a separate clinical study, and commercial experience in Europe. "When your child receives a transplant, you celebrate. You breathe again. You start to imagine a future, but then sometimes, the phone rings with news that no parent should ever have to hear: your child has cancer," said Melissa McQueen, President of Transplant Families, a pediatric non-profit connecting heart, liver, kidney, and bone marrow transplant patients and families. "We are hopeful that following the extensive dialogue with FDA, this resubmission will result in a path to patient access for U.S. families." Tabelecleucel is an allogeneic, off-the-shelf, EBV-specific T-cell immunotherapy which is designed to target and attack EBV-infected cells. It was granted marketing authorization under the brand name EBVALLO™ in December 2022 by the European Commission. Marketing authorization was also granted by the Medicines and Healthcare Products Regulatory Agency in the United Kingdom in May 2023 and by Swissmedic in Switzerland in May 2024. In the U.S., tabelecleucel is investigational and has not yet been approved by the FDA. For eligible patients, it is available through clinical trials and expanded access programs. About EBV+PTLD EBV+ PTLD is an ultra-rare, acute, and potentially deadly hematologic malignancy that occurs after transplantation when patient T-cell immune responses are compromised by immunosuppression. It can impact patients who have undergone SOT or allogeneic HCT. SOT patients have a life-long risk of contracting the disease. Poor median survival of 3 weeks and 4.1 months for HCT and SOT, respectively, is reported in EBV+ PTLD patients for whom initial treatment failed, underscoring the significant need for new therapeutic options. About Pierre Fabre Pharmaceuticals and Laboratoires Pierre Fabre The mission of PFP is to deliver breakthrough therapies in oncology and rare diseases to patient populations with high unmet needs and limited treatment options. Our belief is that every time we care for a single person, we make the whole world better. PFP is the US pharmaceutical subsidiary of Laboratoires Pierre Fabre, a foundation-owned company with seven decades of impact. Laboratoires Pierre Fabre is a global healthcare company, established in 43 countries, with over 10,000 employees, and with products distributed in 120 territories across the globe. The Laboratoires Pierre Fabre foundation ownership enhances the ability of the company to create long-term value for patients. Partnerships and acquisitions drive its innovative precision treatment pipeline and are enabled by the unique corporate structure. Building on the legacy of Laboratoires Pierre Fabre, innovation is the lifeblood of PFP, and patient experience drives everything the company does. PFP aspires to design and develop therapeutic solutions inspired by patients and healthcare professionals; draw on science and nature as perpetual sources of inspiration; develop long-term partnerships with researchers and innovators worldwide; and place pharmaceutical ethics and climate transition at the heart of our action. Pierre Fabre Pharmaceuticals has therapies in development for Epstein-Barr virus positive post-transplant lymphoproliferative disease (EBV+ PTLD), NRAS-mutant melanoma, non-small cell lung cancer with mutation or amplification of MET, and X-Linked Hypohidrotic Ectodermal Dysplasia (XLHED). Pierre Fabre Pharmaceuticals is headquartered in Secaucus, NJ. For more information, visit , , @Pierre Fabre Oncology. Correction: The fifth paragraph has been updated to begin with Tabelecleucel. View original content to download multimedia: SOURCE Pierre Fabre Pharmaceuticals