Thinly traded nano cap Mereo BioPharma Group plc (MREO +31.1%) is up on almost a 13x surge in volume, albeit on turnover of only 261K shares, in response to its announcement that the FDA is on board with a potential accelerated approval pathway for bispecific antibody navicixizumab for the treatment of ovarian cancer.
The agency has signed off, at least in principle, on the design of a Phase 2 study with a primary endpoint of confirmed overall response rate (ORR) [the unconfirmed ORR at the latest data cutoff in its Phase 1b trial was 41% (n=18/44)].
On the safety front, the most common treatment-related adverse events in the Phase 1b study were hypertension (68%), fatigue (46%), headache (25%), neutropenia (21%) and diarrhea (18%). 17% (n=5/29) of treated patients developed antibodies to navicixizumab (anti-drug antibodies or ADAs).
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