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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 reported financial results for the second quarter 2025 and business updates. Tabelecleucel (tab-cel® or Ebvallo™) for Post-Transplant Lymphoproliferative Disease (PTLD) The U.S. Food and Drug Administration (FDA) has.
First allogeneic T-Cell therapy BLA offers hope to EBV+ PTLD patients who have limited treatment options and lifespan measured in only a few weeks to months following failure of initial treatment 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 Tabelecleucel has a Prescription Drug User Fee Act (PDUFA) target action date of January 10, 2026 and would be the first approved therapy in the U.S. for EBV+ PTLD SECAUCUS, N.J. , July 24, 2025 /PRNewswire/ -- Pierre Fabre Pharmaceuticals Inc. (PFP) announces the acceptance by U.S. Food and Drug Administration (FDA) of the Biologics License Application (BLA) and Priority Review of tabelecleucel, indicated 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) wh
Pierre Fabre Laboratories is now responsible for all global clinical trial activities for the tabelecleucel clinical program Enrollment is ongoing for pivotal, Phase 3 ALLELE Study (NCT03394365) investigating tabelecleucel in patients with EBV+PTLD in Solid Organ Transplant and Allogeneic Hematopoietic Cell Transplant after failure of standard therapy NCT04554914 also open for enrollment to patients with EBV-associated diseases Atara Biotherapeutics resubmitted the tabelecleucel Biologics License Application (BLA) to the U.S. Food and Drug Administration on July 11 SECAUCUS, N.J. , July 15, 2025 /PRNewswire/ -- Pierre Fabre Pharmaceuticals, Inc. today announced the transfer of the Investigational New Drug Application for tabelecleucel from its partner, Atara Biotherapeutics, Inc. (Nasdaq: ATRA).
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 it has resubmitted a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for tabelecleucel (EBVALLO™ or tab-cel®) indicated as monotherapy for treatment of adult and pedi.
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, announced the appointment of James Huang and Nachi Subramanian to its Board of Directors, effective following the completion the Company's previously announced $16 million offering that was announced on May 15, 2025. The o.
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 reported financial results for the first quarter 2025 and business updates. “We are pleased that we have secured additional financing that is expected to extend our cash runway through the first quarter of 2026,” sai.
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 the pricing of an offering of 834,237 shares of its common stock at an offering price of $6.61 per share and pre-funded warrants to purchase 1,587,108 shares of its common stock at an offering price of $6.6.
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 U.S. Food and Drug Administration (FDA) has lifted the clinical hold on Atara's active Investigational New Drug (IND) applications for the EBVALLO™ (tabelecleucel) program. “We are very pleased to.
Atara Biotherapeutics (ATRA) might move higher on growing optimism about its earnings prospects, which is reflected by its upgrade to a Zacks Rank #2 (Buy).
Atara Biotherapeutics (ATRA) came out with a quarterly loss of $1.19 per share versus the Zacks Consensus Estimate of a loss of $3.82. This compares to loss of $14 per share a year ago.