Shares of Sesen Bio Inc.
was rocked for a greater than 75.4% loss on huge quantity in afternoon buying and selling Friday, after the corporate centered on most cancers therapies shocked buyers by saying it acquired a Full Response Letter (CRL) from the U.S. Meals and Drug Administration. Buying and selling quantity spiked to 54.5 million shares, in contrast with the full-day common of about 6.5 tens of millions shares. The CRL was concerning its Biologics License Utility (BLA) for Vicineum for the remedy of unresponsive non-muscle invasive bladder most cancers (NMIBC). The FDA decided that it might’t approve the BLA for Vicineum in its current kind. “We’re deeply dissatisfied by this surprising outcome, and it’s an unlucky day for sufferers affected by BCG-unresponsive NMIBC,” mentioned Sesen Chief Govt Dr. Thomas Cannell. The corporate mentioned it plans to request a gathering with the FDA “as quickly as doable” to debate the following steps wanted for the BLA to be authorized. The inventory was buying and selling round $5.92 simply previous to a buying and selling halt for information, to mark a 20.6% intraday achieve, and a 51.0% rally for the reason that Aug. 9 shut. In its second-quarter earnings report earlier than the Aug. 9 open, the corporate mentioned in a July assembly with the FDA concerning the BLA for Vicineum, there was no Advisory Committee assembly deliberate at the moment, and that no post-marketing necessities had been recognized, and mentioned an FDA choice on the BLA was anticipated by Aug. 18. The inventory has now misplaced 10.4% 12 months up to now, whereas the iShares Biotechnology ETF
has gained 11.8% and the S&P 500
has superior 18.8%.