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Sesen Bio (Nasdaq: SESN) reported its Q3 2020 results, highlighting revenue of $11.2 million from a license agreement with Qilu Pharmaceutical. The lead program, VicineumTM, is in the follow-up stage of a Phase 3 trial for high-risk, BCG-unresponsive NMIBC. The company completed its BLA submission to the FDA and a successful Pre-Submission meeting with EMA, with potential approvals expected in early 2021 and early 2022, respectively. Cash and equivalents stand at $42.0 million, with a net loss of $22.6 million for the quarter.
Sesen Bio (SESN) will hold a conference call on November 9, 2020, at 8:00 a.m. ET to review its Q3 operating results. The call will also provide updates on the analytical comparability studies for Vicineum, which is crucial for the Biologics License Application (BLA) submission. Vicineum targets EpCAM antigens in treating high-risk non-muscle invasive bladder cancer (NMIBC) and is currently in a Phase 3 trial. The results are anticipated to support its registration for patients who are BCG-unresponsive.
Sesen Bio (Nasdaq: SESN) announced a successful pre-submission meeting with the European Medicines Agency (EMA) for Vicineum, targeting BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) in Europe. Insights from the meeting will aid the Marketing Authorization Application (MAA) validation and regulatory process. This follows EMA's confirmation of Vicineum's eligibility for MAA submission. The company aims to complete all pre-submission activities by the end of 2020. Vicineum is in a Phase 3 trial for NMIBC, addressing a significant unmet medical need.
Sesen Bio (Nasdaq:SESN) announced a partnership with Cardinal Health for exclusive 3PL and specialty pharmaceutical distribution of its lead program, Vicineum, in the U.S. Vicineum, currently in a Phase 3 trial targeting high-risk, BCG-unresponsive non-muscle invasive bladder cancer (NMIBC), utilizes a unique fusion protein approach. The collaboration with Cardinal Health, strategically located near a FedEx hub, enhances supply chain efficiency. Sesen retains worldwide rights for Vicineum, excluding Greater China, where it partners with Qilu Pharmaceutical.
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