2023-03-13 08:40:34 ET
- Mersana Therapeutics, a biotech focused on antibody-drug conjugates (ADC) fell ~14% Monday in the pre-market trading after announcing that the FDA has placed a clinical hold on its Phase 1 trial for cancer candidate XMT-2056.
- The decision comes after investigators recently came across a fatal Grade 5 serious adverse event (SAE) linked to XMT-2056.
- As a result of the clinical hold, Mersana ( NASDAQ: MRSN ) will not proceed with patient recruitment and dosing in the study, while SAE and its cause remain under investigation.
- The SAE was detected in a patient who had received the initial dose level in the dose escalation portion of the trial, which involves previously treated patients with HER2+ recurrent or metastatic solid tumors.
- Seeking Alpha contributor Avisol Capital Partners argued in January that the currently available data on Mersana’s ( MRSN ) ADC technology “leaves a lot to be desired.”
For further details see:
Mersana sheds 14% as FDA places clinical hold on cancer study