Atara Biotherapeutics Inc.’s allogeneic T-cell immunotherapy, Ebvallo (tabelecleucel), for Epstein-Barr virus-positive post-transplant lymphoproliferative disease isn’t out of the running yet. Despite grim predictions in the wake of the U.S. FDA’s second complete response letter for the drug in January, Atara and partner Pierre Fabre Pharmaceuticals Inc. reached agreement with the regulator on a path for resubmitting the BLA.
A second complete response letter issued by the U.S. FDA for Atara Biotherapeutics Inc.’s allogeneic T-cell immunotherapy Ebvallo (tabelecleucel) for Epstein-Barr virus positive post-transplant lymphoproliferative disease is “a complete reversal of position” by the agency, which had previously confirmed the single arm Allele trial was enough to support a BLA under the accelerated approval pathway, the company said.
The BioWorld Cancer Index closed the third quarter (Q3) of 2025 with a 24.15% gain, marking its highest level of the year. The climb reversed earlier declines, including a 12.81% drop at the end of Q1, and half-year performance of 2.21%. Broader markets showed a similar rebound, with the Nasdaq Biotechnology Index up 13.21% and the Dow Jones Industrial Average rising 9.06%, both finishing Q3 at their highest points of 2025.
The BioWorld Cancer Index ended the first quarter (Q1) of 2025 down 4.74%, retreating after a promising start that saw the index rise 5.78% by the end of January. In the first quarter, 20 stocks declined in value while just nine posted gains.
The BioWorld Cancer Index (BCI) experienced a steep decline in 2024, closing the year down 17.32%. After peaking in late February with an 11.16% gain, the index steadily trended downward, with only brief recoveries that failed to push it back into positive territory. This marked a sharp contrast to 2023, when the BCI soared 76.26% by year-end. In comparison, 2022 saw the index drop by 41.98%, while 2021 closed with a decline of 36.34%.
Atara Biotherapeutics Inc. received a complete response letter (CRL) from the U.S. FDA for its lead product, Ebvallo (tabelecleucel), a breakthrough therapy for Epstein-Barr virus positive post-transplant lymphoproliferative disease that is already approved in the EU, the U.K. and Switzerland.
Chimeric antigen receptor (CAR) therapies targeted against CD19 have been widely used for the treatment of B-cell malignancies. However, the down-regulation of CD19 can lead to relapse, and autologous CAR T therapies have limitations that need to be addressed.
Nearly a year and a half after an interim analysis cast doubt on the future of Atara Biotherapeutics Inc.’s phase II study of ATA-188 in treating non-active progressive multiple sclerosis (PMS), the newly released primary analysis didn’t change much.
All gains made throughout the summer have vanished as the BioWorld Cancer Index (BCI) has hit its lowest point in 2022. Down 41.9% this year, BCI diverged in October from the path taken by both the Nasdaq Biotechnology Index (NBI) and the Dow Jones Industrial Average (DJIA), both of which are moving upward. Still, NBI is down 7.8% and DJIA is down 5.4% for the year.
A vaccine for dengue fever, an advanced therapy for a complication after transplants, and a potential first-in-class drug for a form of psoriasis were among medicines recommended for approval by European regulators on Oct. 14.
