Atara Biotherapeutics

Atara Biotherapeutics replaces Carol Gallagher on its board with Brian Cherry, who brings more than 25 years of private-equity investing experience and service on multiple boards. Gallagher is leaving the board after 13 years. The announcement comes as the stock trades at $10.41 and, according to analysis, currently appears overvalued relative to its fair value. Atara develops allogeneic T‑cell immunotherapies for cancer and autoimmune diseases. » Więcej na de.investing.com

Atara Biotherapeutics shares jumped sharply after hours after the FDA provided Pierre Fabre with guidance for resubmitting the marketing application for tabelecleucel. The agency indicated that a single‑arm study with an appropriate historical control group could serve as an adequately controlled basis for safety and efficacy data. Pierre Fabre plans to submit an updated dataset with additional patients and longer follow‑up from the phase‑3 ALLELE study; Atara expects a regulatory update in the third quarter and supports the resubmission. » Więcej na de.investing.com

Atara Biotherapeutics amended its agreement with HealthCare Royalty, pushing a $9 million milestone payment due on June 30, 2026, to January 1, 2028. The payment is tied to a commercialization milestone with Pierre Fabre for the allogeneic T‑cell therapy Tabelecleucel, which is approved in Europe and under FDA review in the U.S. As part of the contract amendment, HealthCare Royalty received a warrant for up to 400,000 common shares at an exercise price of $0.0001 per share; the warrant is immediately exercisable and has no expiration date. Atara says the extension gives the company time to address concerns raised in the recent FDA Complete Response Letter; the stock is trading near its 52‑week low and the market capitalization is about $30 million. » Więcej na de.investing.com