Grandbrothers
- Clinical-stage biotech Mersana Therapeutics, Inc. (NASDAQ:MRSN) added ~8% in the pre-market trading on the announcement that the FDA issued its Fast Track designation for the company’s antibody-drug conjugate XMT-1660 as a treatment for adults with triple-negative breast cancer (TNBC).
- The FDA offers the Fast Track designation to accelerate the development and review of drugs targeted at serious conditions with unmet medical needs. It allows developers to communicate frequently with the regulator on plans for clinical studies.
- If certain criteria are met, such programs will also be able to win the Accelerated Approval and Priority Review, enabling them to reach patients sooner.
- XMT-1660 is currently undergoing a Phase 1 study in patients with solid tumors, including breast, endometrial and ovarian cancers.