BofA warns Fed risks policy mistake with early rate cuts
Investing.com - Mizuho (NYSE:MFG) has lowered its price target on Atara Biotherapeutics (NASDAQ:ATRA) to $16.00 from $18.00 while maintaining an Outperform rating on the stock. The company, currently trading at $12.29 with a market cap of $83.52 million, has shown strong momentum with a 19% gain over the past week. According to InvestingPro analysis, the stock appears undervalued based on its Fair Value metrics.
The adjustment reflects Mizuho’s revised timeline for the potential U.S. launch of tab-cel, now aligned with the PDUFA date of January 10, 2026, rather than earlier expectations.
Mizuho’s model changes include removing ATA3219 and ATA3431 programs from the pipeline and reducing R&D and SG&A expense projections due to the pausing of CAR-T pipeline programs, workforce reductions, and the transfer of tab-cel operational activities to Pierre Fabre Laboratories.
Despite the price target reduction, Mizuho remains optimistic about tab-cel’s approval prospects, noting that the Complete Response Letter (CRL) from the FDA was related to third-party manufacturer GMP compliance issues rather than the safety or efficacy of the therapy itself.
The firm highlighted that FDA approval of tab-cel would trigger a $40 million milestone payment from Pierre Fabre Laboratories, which would "materially extend" Atara’s cash runway.
In other recent news, Atara Biotherapeutics, Inc. announced that the U.S. Food and Drug Administration (FDA) has accepted its Biologics License Application for tabelecleucel (tab-cel) with priority review status. This application seeks approval for tab-cel as a monotherapy for both adult and pediatric patients with Epstein-Barr virus positive post-transplant lymphoproliferative disease (EBV+ PTLD) who have undergone at least one prior therapy. The FDA has set a target action date for January 10, 2026, under the Prescription Drug User Fee Act. Currently, there are no FDA-approved therapies for this indication, highlighting the potential significance of this development. Atara had previously resubmitted the BLA to address manufacturing facility observations noted in a Complete Response Letter from January 2025. Approval of tab-cel would trigger a $40 million milestone payment to Atara from its partner, Pierre Fabre Laboratories. The acceptance of the BLA marks an important step forward for Atara, especially as it could lead to the first FDA-approved therapy for this condition.
This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.