On Tuesday, the U.S. Meals and Drug Administration (FDA) positioned a scientific maintain on Atara Biotherapeutics, Inc.’s ATRA lively Investigational New Drug (IND) functions.
These INDs embrace the EBVALLO (tabelecleucel) program for sufferers two years of age and older with Epstein-Barr virus-positive post-transplant lymphoproliferative illness (EBV+ PTLD), in addition to ATA3219, a CAR-T remedy for non-Hodgkin’s lymphoma and systemic lupus erythematosus.
Particularly, recognized topics presently enrolled within the scientific research who’ve the potential to derive scientific profit might proceed to obtain therapy.
Screening and enrollment of latest individuals in each applications have been paused.
The scientific maintain for EBVALLO is immediately linked to inadequately addressed GMP compliance points recognized throughout the pre-license inspection of the third-party manufacturing facility referenced within the Full Response Letter (CRL) for EBVALLO that was introduced final week.
Whereas the ATA3219 drug product is manufactured at a separate, absolutely compliant GMP-certified facility, the compliance points on the identical third-party facility referenced within the CRL have an effect on the beginning supplies utilized in its manufacturing.
These points, which underlie each the CRL and the scientific maintain, are particular to the referenced third-party manufacturing facility and don’t have an effect on Atara’s second third-party producer, FUJIFILM Diosynth Biotechnologies (FDB) facility in Thousand Oaks, California.
The FDB facility stays a essential part of Atara’s long-term manufacturing technique for each belongings.
Final week, Atara engaged a monetary advisor to assist the evaluation of alternatives to advance and understand worth from Atara’s CAR-T belongings.
Atara says it stays eligible to obtain a $60 million milestone cost from Pierre Fabre upon FDA approval of the EBVALLO BLA, in addition to important double-digit tiered royalties as a share of web gross sales and milestones associated to EBVALLO’s business gross sales.
The corporate added that if a strategic decision is just not reached to supply funding for its CAR-T improvement applications within the first quarter of 2025, Atara plans to droop all CAR-T actions and considerably scale back firm bills and actions to solely people who assist the approval of EBVALLO, together with by way of a near-term progressive switch of all operational actions associated to EBVALLO to Pierre Fabre.
Atara has entered right into a non-binding time period sheet with Redmile Group to supply as much as $15 million in funding by way of an fairness line of credit score.
Value Motion: ATRA inventory is down 4.09% at $6.302 eventually verify Tuesday.
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