Sesen Bio, Inc. Stock Price, News & Analysis

Sesen Bio (SESN) has expanded its executive leadership team with John Knighton appointed as Vice President and Chief Compliance Officer, effective August 16, 2021. This change supports the company's transformation into a commercial-stage entity as it anticipates a decision on its Biologics License Application (BLA) for Vicineum, targeting BCG-unresponsive non-muscle invasive bladder cancer (NMIBC), with a PDUFA date of August 18, 2021. Knighton brings over 20 years of compliance experience in the life sciences sector.

Sesen Bio (Nasdaq: SESN) reported Q2 2021 results, highlighting significant regulatory progress for Vicineum, targeted for BCG-unresponsive NMIBC. The FDA's decision on the Biologics License Application (BLA) is expected by August 18, 2021, following a successful Late-Cycle Meeting. The cash position increased to $151.1 million, while R&D and G&A expenses rose significantly, reflecting pre-commercialization efforts. The net loss narrowed to $25.4 million or $0.15 per share, compared to $26.3 million last year. Sesen anticipates potential approvals in Europe and MENA markets in 2022.

Sesen Bio (SESN) has partnered with Eczacibasi Pharmaceuticals to license and commercialize Vicineum for treating BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) in Turkey. The FDA has granted Priority Review for Vicineum's Biologics License Application (BLA), with a target decision date of August 18, 2021. Sesen Bio will receive an upfront payment of $1.5 million and a 30% royalty on net sales in Turkey. With around 75% of bladder cancer patients diagnosed with NMIBC, Vicineum could significantly impact patient care in Turkey, the first treatment for this condition in over 20 years.

Sesen Bio (NASDAQ: SESN) has expanded its leadership team with the appointment of Amy Ponpipom as Vice President, Assistant General Counsel, supporting its transition to a commercial company. This move coincides with the Priority Review status of the Biologics License Application (BLA) for Vicineum, targeting non-muscle invasive bladder cancer (NMIBC), with an FDA decision expected by August 18, 2021. Ponpipom's 17 years in pharmaceutical law, including significant roles at AstraZeneca, is anticipated to bolster Sesen's commercialization efforts.

Sesen Bio (SESN) announced the completion of its commercial build phase for the anticipated launch of Vicineum, which is under FDA Priority Review for treating BCG-unresponsive non-muscle invasive bladder cancer (NMIBC). The target PDUFA date is August 18, 2021. The company has hired approximately 25 internal employees and 34 sales representatives to promote Vicineum, targeting 2,000 high-prescribers. Sesen Bio aims to ensure product reimbursement through a focused market access strategy, with Vicineum expected to be available by Q4 2021.

Sesen Bio (NASDAQ: SESN) announced the appointments of Dr. Peter K Honig and Dr. Michael A.S. Jewett to its Board of Directors, enhancing its leadership ahead of the FDA's Priority Review of its Biologics License Application (BLA) for Vicineum, targeting BCG-unresponsive non-muscle invasive bladder cancer (NMIBC). The target PDUFA date for Vicineum is August 18, 2021. Dr. Honig brings extensive regulatory experience from Pfizer, while Dr. Jewett is a recognized oncologist with significant expertise in bladder cancer.

Sesen Bio (SESN) announced the enrollment of the first patient in China for the clinical trial assessing Vicineum in patients with BCG-unresponsive non-muscle invasive bladder cancer (NMIBC). This milestone follows the IND approval by the China National Medical Products Administration, generating a $3M milestone payment from Qilu Pharmaceutical. The trial aims to evaluate Vicineum's efficacy and safety in about 53 patients, with promising market potential in China expected between $155M-$418M. The FDA's decision on Vicineum in the U.S. is anticipated by August 18, 2021.

Sesen Bio (SESN) held a productive Late-Cycle Meeting with the FDA on July 13, 2021, concerning its Biologics License Application (BLA) for Vicineum to treat BCG-unresponsive non-muscle invasive bladder cancer. The FDA confirmed no significant risks have been identified, and no Advisory Committee meeting is scheduled. The review remains on track for a decision by the target PDUFA date of August 18, 2021. Sesen Bio aims to improve patient outcomes and reduce healthcare costs with Vicineum's targeted therapy.

Sesen Bio (SESN) has granted stock options to four new employees as part of its transition to a commercial-stage company. This move supports the upcoming PDUFA date of August 18, 2021, for its lead product, Vicineum™, aimed at treating BCG-unresponsive non-muscle invasive bladder cancer. A total of 206,000 shares are available for purchase upon vesting over four years. Vicineum targets EpCAM antigens and is believed to minimize toxicity to healthy tissues. The company is also in a Phase 3 trial in the US, with FDA Priority Review status granted.