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Sesen Bio (SESN) reported the grant of non-statutory stock options to three new employees, marking the beginning of its transformation into a commercial-stage company. This step is part of preparations ahead of the PDUFA date of August 18, 2021, for its lead product, Vicineum™, aimed at treating BCG-unresponsive non-muscle invasive bladder cancer. Up to 160,000 shares are available upon vesting, with an exercise price of $3.02 per share. Sesen is also in a Phase 3 trial for Vicineum and has received FDA Priority Review for its BLA submission.
Sesen Bio, focused on cancer therapeutics, reported its 2020 financial results, highlighting its lead program, Vicineum, which is in Phase 3 trials for BCG-unresponsive bladder cancer.
The FDA accepted Vicineum's Biologics License Application for Priority Review, with a decision expected by August 18, 2021. The company's cash position improved to $55.4 million, while the net loss for 2020 was $22.5 million, significantly lower than 2019's $107.5 million. Partnerships in MENA and China have been established to aid in Vicineum's global commercialization efforts.
Sesen Bio (SESN) has submitted a Marketing Authorization Application (MAA) to the European Medicines Agency for its lead product, Vicineum, which treats high-risk, BCG-unresponsive non-muscle invasive bladder cancer (NMIBC). This submission is backed by Phase 3 VISTA trial data indicating a favorable risk-benefit profile. If approved, Vicineum could be the first treatment for this condition in over 20 years in Europe, addressing a significant unmet need among the 124,000 annual cases of bladder cancer.
Sesen Bio (Nasdaq: SESN) announced a conference call on March 15, 2021, at 8:00 a.m. ET to discuss Vicineum, its drug for high-risk, BCG-unresponsive non-muscle invasive bladder cancer (NMIBC). Dr. Neal Shore, an expert in Urologic Oncology, will provide insights on Vicineum's clinical perspective. The FDA accepted Sesen's BLA for Vicineum and granted it Priority Review, with a PDUFA date set for August 18, 2021. Sesen Bio retains global rights to Vicineum, except in Greater China and MENA. The company is monitoring potential COVID-19 impacts on operations.
Sesen Bio (Nasdaq: SESN) announced that the FDA has accepted its Biologics License Application (BLA) for Vicineum, aimed at treating high-risk, BCG-unresponsive non-muscle invasive bladder cancer (NMIBC), granting it Priority Review. This designation reduces the review time from 10 months to 6 months, with a decision expected by August 18, 2021. The company plans to submit a Marketing Authorization Application (MAA) to the EMA shortly. Sesen Bio is focused on launching Vicineum, which it believes represents a substantial advancement over existing treatments.
Sesen Bio (Nasdaq: SESN) announced a conference call on February 16, 2021, at 8:00 a.m. ET, hosted by Dr. Thomas Cannell, President and CEO, to provide a business update. Participants can join by dialing (844) 831-3025 for domestic or (315) 625-6887 for international access, with conference ID 1290313. The call will also be webcast on the company's website, with a 60-day replay available. Sesen Bio is advancing Vicineum™, its lead therapy for high-risk, BCG-unresponsive non-muscle invasive bladder cancer, with a recent BLA submission to the FDA.
Sesen Bio (Nasdaq: SESN) reported a successful Application Orientation Meeting with the FDA regarding its Biologic License Application (BLA) for Vicineum, aimed at treating BCG-unresponsive non-muscle invasive bladder cancer (NMIBC). This meeting, held on January 29, 2021, involved discussions on application datasets and clinical risk-benefit. The FDA will announce on February 16, 2021, if the BLA is accepted for filing, which could lead to decisions on review type, PDUFA date, and the need for an Advisory Committee meeting. Sesen Bio's Vicineum is currently in a Phase 3 trial.
Sesen Bio (Nasdaq: SESN) announced the acceptance of its partner Qilu Pharmaceutical's IND application by the China National Medical Products Administration. This approval will allow clinical trials of VicineumTM for non-muscle invasive bladder cancer (NMIBC) in Greater China. The company anticipates a $3M milestone payment upon IND approval, part of a total of $23M. Vicineum aims to address the unmet treatment needs due to limited BCG use in China, with potential peak year sales estimated between $155M and $418M.
Sesen Bio has submitted a Biologics License Application (BLA) for its cancer treatment, Vicineum, aimed at high-risk, BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) to the FDA on December 18, 2020. Following submission, the FDA is expected to decide on the acceptance and priority review within 60 days. The BLA is backed by the Phase 3 VISTA trial, demonstrating a favorable benefit-risk profile. With bladder cancer being prevalent, Vicineum could become a preferred treatment option, as studies show over 80% of doctors favor Vicineum over Keytruda.
Sesen Bio (Nasdaq: SESN) announced positive findings regarding the cost-effectiveness of Vicineum based on an independent analysis by ICER. The report indicates that Vicineum demonstrates superior health benefits for patients with BCG-unresponsive high-risk non-muscle invasive bladder cancer (NMIBC) compared to best supportive care. Estimated costs per patient in the first year are approximately $123,000, leading to a projected cumulative healthcare cost reduction of about $101,000 by year five. The company aims to submit its Biologics License Application for Vicineum to the FDA soon.
