2023-06-15 07:51:04 ET
- Mersana Therapeutics ( NASDAQ: MRSN ) lost ~60% pre-market Thursday after announcing that the FDA issued a partial clinical hold halting the enrollment in its UP-NEXT and UPGRADE-A trials for lead asset UpRi in platinum-sensitive ovarian cancer.
- The decision follows bleeding events reported from about 560 patients who received UpRi, an antibody-drug conjugate. The reason for the bleeding remains under investigation, Mersana ( MRNS ) said.
- However, there were five (<1%) Grade 5 (fatal) bleeding events though most of the events were low-grade. Patients in the UP-NEXT and UPGRADE-A trials can continue to receive the therapy.
- Despite the setback, the company intends to report topline data from its UPLIFT trial for UpRi in platinum-resistant ovarian cancer by early August.
For further details see:
Mersana sheds 60% on FDA partial hold on trials for lead asset