Shares of Sesen Bio Inc. SESN, -57.23% was rocked for a much than 75.4% nonaccomplishment connected monolithic measurement successful day trading Friday, aft the institution focused connected crab treatments shocked investors by saying it received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration. Trading measurement spiked to 54.5 cardinal shares, compared with the full-day mean of astir 6.5 millions shares. The CRL was regarding its Biologics License Application (BLA) for Vicineum for the attraction of unresponsive non-muscle invasive bladder crab (NMIBC). The FDA determined that it can't o.k. the BLA for Vicineum successful its contiguous form. "We are profoundly disappointed by this unexpected result, and it is an unfortunate time for patients suffering from BCG-unresponsive NMIBC," said Sesen Chief Executive Dr. Thomas Cannell. The institution said it plans to petition a gathering with the FDA "as soon arsenic possible" to sermon the adjacent steps needed for the BLA to beryllium approved. The banal was trading astir $5.92 conscionable anterior to a trading halt for news, to people a 20.6% intraday gain, and a 51.0% rally since the Aug. 9 close. In its second-quarter net study earlier the Aug. 9 open, the institution said successful a July gathering with the FDA regarding the BLA for Vicineum, determination was nary Advisory Committee gathering planned astatine that time, and that nary post-marketing requirements had been identified, and said an FDA determination connected the BLA was expected by Aug. 18. The banal has present mislaid 10.4% twelvemonth to date, portion the iShares Biotechnology ETF IBB, +0.05% has gained 11.8% and the S&P 500 SPX, +0.08% has precocious 18.8%.
Sesen Bio's stock rocked on heavy volume after shock FDA decision on BLA for cancer treatment
2 months ago 19