Sesen Bio Inc (merger with a company Carisma Therapeutics Inc (NASDAQ:CARM)) (SESN) Announces Regulatory Update
Sesen Bio Inc (merger with a company Carisma Therapeutics Inc (NASDAQ:CARM)) (SESN) provided an update on regulatory developments for its product portfolio.
Regulatory Update Details:
None
Clinical Development:
anticipated in such forward-looking statements as a result of these risks and uncertainties, including the risk that the request for a Type B Meeting may not occur within the anticipated timing, or at all, the risk that the Type B Meeting may not enable the Company to align with the FDA on the remaining outstanding items related to an additional Phase 3 clinical trial of Vicineum for the treatment of NMIBC, the risk that the Company may not continue its plans to conduct an additional Phase 3 clinical trial and pursue regulatory approval for Vicineum for the treatment of NMIBC in the US, the risk that an additional Phase 3 clinical trial of Vicineum for the treatment of NMIBC may fail to demonstrate safety and efficacy to the satisfaction of the FDA, or otherwise produce favorable results, the risk that the FDA may not approve the BLA for Vicineum for the treatment NMIBC if the Company resubmits the BLA at a future time, the risk that Vicineum for the treatment of NMIBC may cause undesirable side effects, serious adverse events or have other properties that could delay or halt clinical trials, delay or prevent its regulatory approval by the FDA, limit the commercial profile of its labeling, if approved, or result in significant negative consequences following any marketing approval, the risk that the Company may pursue one or more strategic alternatives instead of pursuing an additional Phase 3 clinical trial and the risk that the Company may not be successful in identifying one or more strategic alternatives or ultimately pursuing a strategic alternative that delivers the anticipated benefits or enhances shareholder value, among other risks and uncertainties. A further description of the risks and uncertainties relating to the business of the Company is contained in the Company’s most recent annual report on Form 10-K and the Company’s quarterly reports on Form 10-Q, as well as any amendments thereto reflected in subsequent filings with the Securities and Exchange Commission. The Company undertakes no duty or obligation to update any forward-looking statements contained in this report as a result of new information, future events or changes in its expectations.SIGNATUREPursuant to the requirements of the Securities Exchange Act of 1934
💼 Business Developments:
Partnership: Not available
Acquisition: Not available
Licensing: Not available
Regulatory Approval
Executive Changes: Not available
Structured Data:
Company Name: Sesen Bio Inc (merger with a company Carisma Therapeutics Inc (NASDAQ:CARM))
📋 SESEN BIO, INC. (SESN) - Regulatory Update
Filing Date: 2022-05-20
Accepted: 2022-05-20 08:00:24
Event Type: Regulatory Update
Event Details:
💼 Business Developments:
Structured Data: