Atara Biotherapeutics, Inc. ATRA
Atara Biotherapeutics, Inc. (Nasdaq: ATRA) is an oncology drug developer. Its lead program, Tabelecleucel (tab-cel, Ebvallo), is in Phase 3 for EBV+ post-transplant lymphoproliferative disease (EBV+ PTLD) after rituximab +/- chemotherapy.
Upcoming catalysts
No catalyst is dated to the next 30 days or to an FDA action date.
Pipeline
| Program | Indication | Modality | Stage |
|---|---|---|---|
| Tabelecleucel (tab-cel) | EBV+ PTLD (ALLELE Phase 3; US BLA with second CRL) | cell therapy | Phase 3 |
| Tabelecleucel multi-cohort study | Other EBV+ diseases | cell therapy | Phase 2 |
Recent results and decisions
- May 7, 2026positive After the Type A meeting, FDA agreed a single-arm study with an appropriate historical control could serve as an adequate and well-controlled study, supporting a tab-cel BLA resubmission.
The FDA agreed that a single arm study using an appropriate historical control applicable to the trial population, conducted in a pre-specified manner, could serve as an adequate and well controlled study and provide safety and efficacy data in support of a future marketing application of tab-cel fo
Filing - Jan 12, 2026CRL FDA issued a second Complete Response Letter for the tab-cel BLA: GMP issues resolved, but FDA now says single-arm ALLELE trial is inadequate evidence of effectiveness for accelerated approval and its interpretability is confounded.
The CRL indicates that the FDA is unable to approve the EBVALLO™ BLA in its present form.
Filing - Nov 12, 2025accepted FDA accepted the tab-cel BLA resubmission with Priority Review and a Class 2 resubmission PDUFA target action date of January 10, 2026; approval would trigger a $40M Pierre Fabre milestone.
The BLA has been granted Priority Review with a Class 2 Resubmission Prescription Drug User Fee Act (PDUFA) target action date of January 10, 2026.
Filing
For subscribers
- Cash runway against each catalyst, with the company's own runway statement
- Track record: every Phase 3 readout, FDA decision and guidance slip since 2014
- Expected move for each dated catalyst, from comparable past events
- Phase 2 evidence behind each Phase 3 readout
- Companies on the same target or class
- Full catalyst list with filing sentences, deals, registered trials, Excel export
Other phase 3 oncology companies
- Merck & Co., Inc. MRK
- Astrazeneca PLC AZN
- Bristol Myers Squibb Co BMY
- BeOne Medicines Ltd. ONC
- Revolution Medicines, Inc. RVMD
- Genmab A/S GMAB
- BioNTech SE BNTX
- Exelixis, Inc. EXEL
The free Monday brief
Last week's readouts and FDA decisions and the dated catalysts in the week ahead, each with its filing sentence.