Sesen Bio Shares Fall 57% on Failing to Bag FDA Approval

Shares of Sesen Bio (SESN) plunged a whopping 57% in Friday’s trading session and another 17.5% in extended trade to close at $1.74 after the company announced that its Biologics License Application (BLA) for Vicineum failed to receive clearance from the U.S. Food and Drug Administration (FDA).

Sesen Bio engages in designing, engineering and developing targeted protein therapeutics. It develops antibody-drug conjugate therapies for the treatment of cancer.

Responding to Sesen Bio for its application regarding the treatment of BCG-unresponsive non-muscle invasive bladder cancer, the FDA, in a Complete Response Letter (CRL), stated that Vicineum could not be approved in its present form. (See Sesen Bio stock charts on TipRanks)

The President and CEO of Sesen Bio, Dr. Thomas Cannell, said, “We remain dedicated to our mission to save and improve the lives of patients by bringing new treatment options to patients, and we intend to work closely with the FDA to understand next steps.”

Markedly, Sesen Bio plans to request a Type A meeting with the FDA to discuss the moves that are needed for the application’s approval.

On August 16, H.C. Wainwright analyst Swayampakula Ramakanth downgraded the rating of the stock to a Hold. Ramakanth did not assign any price target.

“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,” the analyst noted.

The rest of the Street is cautiously optimistic about the stock with a Moderate Buy consensus based on 1 Buy and 1 Hold. The average Sesen Bio price target of $7 implies 231.8% upside potential.

TipRanks’ Stock Investors tool shows that investors currently have a Very Positive stance on Sesen Bio with 15.9% of investors on TipRanks increasing their exposure to SESN stock over the past 30 days.