BioCentury
ARTICLE | Company News

Telesta cancer news

March 21, 2016 7:00 AM UTC

Telesta reduced headcount by about 9 (15%) to about 50 to conserve cash while it conducts a full review of strategic options “over the next few months.” Most of the cuts came from Telesta’s Montreal manufacturing facility. In February, FDA issued a complete response letter to Telesta for a BLA for MCNA ( EN3348) to treat high-risk non-muscle invasive bladder cancer (NMIBC) in patients who have failed first-line treatment with bacille Calmette-Guerin (BCG) therapy. The company said FDA asked for an additional Phase III trial of the mycobacterial cell wall-DNA complex (MCC). Telesta said its top priority is to determine the regulatory pathway in the U.S. and EU for MCNA and requested a meeting with FDA to gain clarity on the letter (see BioCentury, Feb. 8). ...