- The shares of cancer-focused biotech Sesen Bio ( NASDAQ: SESN ) traded lower in the pre-market Monday after the company announced its decision to pause the further development of its lead asset Vicineum in the U.S.
- Sesen ( SESN ) noted that after discussions with the FDA, the company reassessed the development path for Vicineum, including a Phase 3 trial for the treatment of non-muscle invasive bladder cancer (NMIBC).
- The decision to pause further studies allows the company to save cash as it explores potential strategic alternatives to maximize shareholder value. Additionally, Sesen ( SESN ) expects to form a partnership for the further development of Vicineum.
- However, the company’s Chief Executive, Dr. Thomas Cannell, noted that the current commercial environment of NMIBC also led to its decision.
- “We have also recently observed an evolution of the current treatment paradigm in NMIBC, with substantial uptake of intravesical chemotherapy (monotherapy and combination therapy) during the ongoing BCG shortage,” he said.
- In Aug. 2021, the FDA declined to approve Vicineum for the treatment of BCG-unresponsive NMIBC.
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Sesen Bio slips after decision to pause U.S. studies for lead asset