Mersana sheds 14% as FDA places clinical hold on cancer study
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- 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.”