H.C. Wainwright downgraded Sesen Bio (NASDAQ:SESN) to “neutral” from “buy” and removed its price target after the company on Aug. 13 received a complete response letter from the FDA. The stock closed at $2.11 on Aug. 13.
The FDA letter referred to a biologics license application for Vicineum for the treatment of BCG-unresponsive non-muscle invasive bladder cancer (NMIBC).
The agency requested additional clinical and statistical data and analyses, and cited chemistry, manufacturing and controls issues related to a recent pre-approval inspection and product quality, which together resulted in the complete response letter.
“We are disappointed by the regulator’s decision, as we believe Vicineum demonstrated a favorable risk/benefit profile in the Phase 3 VISTA study and the drug’s manufacturer, Fujifilm, successfully completed the process performance qualification batches for drug substance and demonstrated biological comparability to the Phase 3 clinical product,” writes analyst Swayampakula Ramakanth, Ph.D.
Sesen plans to request a Type A meeting with the FDA as soon as possible to discuss the specifics regarding the requirements for BLA resubmission.
“Because an additional clinical study is likely needed for the resubmission, we believe there is a low likelihood that a potential U.S. approval could be granted for Vicineum within 12 months, “ Dr. Ramakanth said. “As a result, we are moving to the sidelines for now.”