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FDA accepts resubmitted BLA for Atara's tabelecleucel with 2027 target date

Wed, 14 Oct 2026 08:06:02 -0400

Atara Biotherapeutics (Nasdaq: ATRA) announced that the U.S. Food and Drug Administration has accepted a resubmitted Biologics License Application (BLA) for tabelecleucel, a therapy proposed for treating Epstein-Barr virus positive post-transplant lymphoproliferative disease (EBV+ PTLD) in adult and pediatric patients two years of age and older who have received at least one prior therapy.

The BLA was submitted by Atara's partner, Pierre Fabre Pharmaceuticals, Inc., and has been classified as a Class 2 Resubmission. The FDA has set a Prescription Drug User Fee Act (PDUFA) target action date of March 31, 2027.

If approved, tabelecleucel would be the first therapy available in

Atara Biotherapeutics Reports that the Resubmitted Tabelecleucel (Tab-cel®) Biologics License Application Has Been Accepted by the U.S. Food and Drug Administration

Wed, 14 Oct 2026 08:05:00 -0400

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

Atara Biotherapeutics Reports that the Resubmitted Tabelecleucel (Tab-cel®) Biologics License Application Has Been Accepted by the U.S. Food and Drug Administration

Wed, 14 Oct 2026 08:05:00 -0400

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

Atara Biotherapeutics Reports that the Tabelecleucel Biologics License Application Has Been Resubmitted to the U.S. Food and Drug Administration

Wed, 30 Sep 2026 08:05:00 -0400

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 provided an update that its partner, Pierre Fabre Pharmaceuticals, Inc. (PFP), has resubmitted the tabelecleucel Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA).

“We are grateful to the Agency for their continued guidance and engagement with our partner, PFP, and us,” said Cokey Nguyen, President and Chief Executive Officer of Atara. “We will continue to

Atara Biotherapeutics Reports that the Tabelecleucel Biologics License Application Has Been Resubmitted to the U.S. Food and Drug Administration

Wed, 30 Sep 2026 08:05:00 -0400

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 provided an update that its partner, Pierre Fabre Pharmaceuticals, Inc. (PFP), has resubmitted the tabelecleucel Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA).

Form 144 Atara Biotherapeutics, Filed by: Nguyen AnhCo

Wed, 26 Aug 2026 19:47:00 -0400

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Form 144 Atara Biotherapeutics, Filed by: Nguyen AnhCo

Wed, 26 Aug 2026 19:47:00 -0400

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Form 4 Atara Biotherapeutics, For: Aug 17 Filed by: Nguyen AnhCo

Wed, 26 Aug 2026 19:46:00 -0400

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Form 4 Atara Biotherapeutics, For: Aug 17 Filed by: Nguyen AnhCo

Wed, 26 Aug 2026 19:46:00 -0400

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TD Cowen Assumes Atara Biotherapeutics (ATRA) at Buy

Sat, 22 Aug 2026 07:54:54 -0400

TD Cowen analyst Phil Nadeau assumes coverage on Atara Biotherapeutics (NASDAQ: ATRA) with a Buy rating.

For an analyst ratings summary and ratings history on Atara Biotherapeutics click here. For more ratings news on Atara Biotherapeutics click here.

Shares of Atara Biotherapeutics closed at $9.70 yesterday.

Form SCHEDULE 13G/A Atara Biotherapeutics, Filed by: Point72 Asset Management, L.P.

Fri, 14 Aug 2026 16:11:00 -0400

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Form SCHEDULE 13G/A Atara Biotherapeutics, Filed by: Point72 Asset Management, L.P.

Fri, 14 Aug 2026 16:11:00 -0400

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Form 10-Q Atara Biotherapeutics, For: Jun 30

Wed, 12 Aug 2026 16:17:00 -0400

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Form 10-Q Atara Biotherapeutics, For: Jun 30

Wed, 12 Aug 2026 16:17:00 -0400

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ATARA Biotherapeutics (ATRA) Misses Q2 EPS by 10c

Wed, 12 Aug 2026 16:14:49 -0400

ATARA Biotherapeutics (NASDAQ: ATRA) reported Q2 EPS of ($0.32), $0.10 worse than the analyst estimate of ($0.22). Revenue for the quarter came in at $630 thousand versus the consensus estimate of $2.55 million.

For earnings history and earnings-related data on ATARA Biotherapeutics (ATRA) click here.

Form 8-K Atara Biotherapeutics, For: Aug 12

Wed, 12 Aug 2026 16:11:00 -0400

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Form 8-K Atara Biotherapeutics, For: Aug 12

Wed, 12 Aug 2026 16:11:00 -0400

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Atara Biotherapeutics Announces Second Quarter 2026 Financial Results and Operational Progress

Wed, 12 Aug 2026 16:05:00 -0400

Productive Type A Meeting with FDA for tabelecleucel

FDA guidance provided on resubmission of tabelecleucel BLA

Year over Year costs and operating expenses reduction of 87%

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 2026 and business updates.

“This was an important quarter for Atara. We and our partners, Pierre Fabre Pharmaceuticals (PFP), had a productive Type A meeting with

Atara Biotherapeutics Announces Second Quarter 2026 Financial Results and Operational Progress

Wed, 12 Aug 2026 16:05:00 -0400

Productive Type A Meeting with FDA for tabelecleucel

FDA guidance provided on resubmission of tabelecleucel BLA

Year over Year costs and operating expenses reduction of 87%

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 2026 and business updates.

“This was an important quarter for Atara. We and our partners, Pierre Fabre Pharmaceuticals (PFP), had a productive Type A meeting with

Atara Biotherapeutics Announces Second Quarter 2026 Financial Results and Operational Progress

Wed, 12 Aug 2026 16:05:00 -0400

Productive Type A Meeting with FDA for tabelecleucel

FDA guidance provided on resubmission of tabelecleucel BLA

Year over Year costs and operating expenses reduction of 87%

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 2026 and business updates.

“This was an important quarter for Atara. We and our partners, Pierre Fabre Pharmaceuticals (PFP), had a productive Type A meeting with

Atara Biotherapeutics Announces Second Quarter 2026 Financial Results and Operational Progress

Wed, 12 Aug 2026 16:05:00 -0400

Productive Type A Meeting with FDA for tabelecleucel

FDA guidance provided on resubmission of tabelecleucel BLA

Year over Year costs and operating expenses reduction of 87%

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 2026 and business updates.

“This was an important quarter for Atara. We and our partners, Pierre Fabre Pharmaceuticals (PFP), had a productive Type A meeting with

Atara Biotherapeutics Announces Second Quarter 2026 Financial Results and Operational Progress

Wed, 12 Aug 2026 16:05:00 -0400

Productive Type A Meeting with FDA for tabelecleucel

FDA guidance provided on resubmission of tabelecleucel BLA

Year over Year costs and operating expenses reduction of 87%

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 2026 and business updates.

“This was an important quarter for Atara. We and our partners, Pierre Fabre Pharmaceuticals (PFP), had a productive Type A meeting with

Atara Biotherapeutics Announces Second Quarter 2026 Financial Results and Operational Progress

Wed, 12 Aug 2026 16:05:00 -0400

Productive Type A Meeting with FDA for tabelecleucel

FDA guidance provided on resubmission of tabelecleucel BLA

Year over Year costs and operating expenses reduction of 87%

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 2026 and business updates.

“This was an important quarter for Atara. We and our partners, Pierre Fabre Pharmaceuticals (PFP), had a productive Type A meeting with

Atara Biotherapeutics Announces Second Quarter 2026 Financial Results and Operational Progress

Wed, 12 Aug 2026 16:05:00 -0400

Productive Type A Meeting with FDA for tabelecleucel

FDA guidance provided on resubmission of tabelecleucel BLA

Year over Year costs and operating expenses reduction of 87%

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 2026 and business updates.

“This was an important quarter for Atara. We and our partners, Pierre Fabre Pharmaceuticals (PFP), had a productive Type A meeting with

Atara Biotherapeutics Announces Second Quarter 2026 Financial Results and Operational Progress

Wed, 12 Aug 2026 16:05:00 -0400

Productive Type A Meeting with FDA for tabelecleucel

FDA guidance provided on resubmission of tabelecleucel BLA

Year over Year costs and operating expenses reduction of 87%

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 2026 and business updates.

“This was an important quarter for Atara. We and our partners, Pierre Fabre Pharmaceuticals (PFP), had a productive Type A meeting with