ATRA Atara Biotherapeutics

Atara Biotherapeutics: FDA Accepts Resubmitted Tab-cel BLA with March 31, 2027 PDUFA

The FDA accepted the Class 2 resubmission of the tabelecleucel BLA for EBV+ PTLD. This sets a PDUFA target action date of March 31, 2027. Atara is eligible for a $31M milestone upon approval under its agreement with Pierre Fabre.

Atara Biotherapeutics: tabelecleucel BLA resubmitted to FDA by partner Pierre Fabre

Pierre Fabre has resubmitted the tabelecleucel BLA to the FDA following a Type A meeting. The resubmission includes updated data from the Phase 3 ALLELE study with additional patients and longer follow-up, plus supplemental data from expanded access programs, another study, and European commercial experience. Atara is eligible for a $31 million milestone upon FDA approval.

Atara: FDA Type A meeting confirms path to resubmit tab-cel BLA

Atara and partner Pierre Fabre received FDA guidance confirming that the existing Phase 3 ALLELE trial data can support a resubmission of the tabelecleucel BLA. The resubmission will include an updated dataset with additional patients and longer follow-up. Atara remains eligible for a $31 million milestone upon FDA approval and double-digit royalties on net sales.

Atara: FDA meeting held; PFP plans tab-cel BLA resubmission

Pierre Fabre Pharmaceuticals held a productive FDA meeting and received agreement that a single-arm study with historical control could support a marketing application. PFP intends to submit an updated ALLELE dataset with additional patients and longer follow-up as part of the resubmission plan. Atara expects to provide a further regulatory update in the third quarter.

Atara: FDA Type A meeting on tab-cel CRL; resubmission path defined

The FDA agreed that a single-arm study with a pre-specified historical control can serve as an adequate and well-controlled study to support resubmission of the tab-cel BLA. PFP plans to submit an updated ALLELE dataset with additional patients and longer follow-up plus supportive data. Atara expects a further regulatory update in Q3.

Atara schedules Type A FDA meeting for tab-cel CRL

FDA has scheduled a Type A meeting with Pierre Fabre to discuss the January 9, 2026 CRL for the tab-cel BLA. The meeting will address CRL points and explore resubmission with newly collected efficacy data. Atara expects to provide a regulatory update in Q2 2026.

Atara Biotherapeutics: Partner Requests FDA Type A Meeting on tab-cel CRL

Pierre Fabre Pharmaceuticals submitted a Type A meeting request and briefing book to FDA addressing the January 9, 2026 CRL for the tab-cel BLA. The submission provides additional context on the ALLELE study plus updated efficacy and supportive data for potential resubmission.

Atara: tab-cel PDUFA set for January 10, 2026

FDA accepted the BLA resubmission for tab-cel and granted Priority Review with a Class 2 Resubmission PDUFA target action date of January 10, 2026. Atara has transferred BLA sponsorship and substantially all tab-cel activities to Pierre Fabre Laboratories; approval would trigger a $40 million milestone payment to Atara.