Replies to post #24026 on Vlispxpert's Underground

[cheynew]

Unfavorable decision. Ugh.

Sesen Bio Receives Complete Response Letter from FDA for Vicineum™ (oportuzumab monatox-qqrs)
Mentioned: SESN
Company to host conference call on Monday, August 16 at 8:00 a.m. ET

Sesen Bio (NASDAQ:SESN), a late-stage clinical company developing targeted fusion protein therapeutics for the treatment of patients with cancer, today announced that it received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) regarding its Biologics License Application (BLA) for Vicineumâ?¢ (oportuzumab monatox-qqrs) for the treatment of BCG-unresponsive non-muscle invasive bladder cancer (NMIBC).

The FDA has determined that it cannot approve the BLA for Vicineum in its present form and has provided recommendations specific to additional clinical/statistical data and analyses in addition to Chemistry, Manufacturing and Controls (CMC) issues pertaining to a recent pre-approval inspection and product quality.

"We are deeply disappointed by this unexpected result, and it is an unfortunate day for patients suffering from BCG-unresponsive NMIBC," said Dr. Thomas Cannell, president, and chief executive officer of Sesen Bio. "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."

The Company plans to request a Type A meeting as soon as possible with the FDA to discuss the next steps that are needed before the application may be approved.

As of June 30, 2021, the Company had $151.1 million in cash, cash equivalents and restricted cash.

Conference Call and Webcast Information

Members of the Sesen Bio management team will host a conference call Monday, August 16, 2021, at 8:00 AM ET. To participate in the conference call, please dial [phone] (domestic) or [phone] (international) and refer to conference ID 2772032. The teleconference details can be accessed in the Investor Relations section of the Company's website at www.sesenbio.com. A replay of the teleconference will be available in the investor section of the Company's website at www.sesenbio.com for 60 days following the call.

© 2021 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.