- Atara said that its partner Pierre Fabre Pharmaceuticals submitted a briefing to the FDA addressing its concerns.
- Atara had transferred its application seeking approval for tabelecleucel to a U.S. pharma unit of Pierre Fabre Laboratories in November.
Shares of Atara Biotherapeutics, Inc. (ATRA) rose 7% on Tuesday after the company said that its partner has sought a meeting with the U.S. Food and Drug Administration to address the concerns raised by the agency while it refused approval for its immunotherapy tabelecleucel in January.
FDA refused approval for tabelecleucel in treating patients two years of age and older with Epstein-Barr virus positive post-transplant lymphoproliferative disease (PTLD) earlier this year.
The FDA said in a letter to the company that it is unable to approve the application in present form, stating that the trial conducted by the company is not adequate to provide evidence of effectiveness for accelerated approval. The authority also stated that the trial’s interpretability is confounded due to trial study design, conduct, and analysis.
Atara Pushes Back
On Tuesday, Atara said that its partner Pierre Fabre Pharmaceuticals submitted a briefing to the FDA addressing its concerns and provided additional context and clarification that the study was indeed adequate, well-controlled, and sufficient to support the tabelecleucel application.
The firm also provided summaries of updated, longer-term efficacy data from the study, additional supportive data from the tab-cel development program and post-marketing data in Europe that will be included in a potential resubmission, it said.
“With our partners at Pierre Fabre Pharmaceuticals, we are eager to engage in a constructive discussion with the FDA to reach a path forward for tabelecleucel,” said Atara CEO Cokey Nguyen while also noting the “ultra-rare nature” of PTLD.
Epstein-Barr Virus (EBV)-positive Post-Transplant Lymphoproliferative Disorder (PTLD) is a serious, often life-threatening complication after organ or stem cell transplantation, characterized by uncontrolled growth of EBV-infected B-cells due to suppressed immunity, ranging from mononucleosis-like illness to aggressive lymphoma.
Atara had transferred its application seeking approval for tabelecleucel to a U.S. pharma unit of Pierre Fabre Laboratories in November.
How Did Stocktwits Users React?
On Stocktwits, retail sentiment around ATRA rose from ‘bullish’ to ‘extremely bullish’ territory over the past 24 hours, while message volume remained at ‘high’ levels.
ATRA stock has fallen 25% over the past 12 months.
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