FDA draft guidance favorable for Legend Biotech, says RBC Capital

The FDA issued draft guidance supporting the use of minimal residual disease negativity and complete response rate as accelerated approval endpoints in multiple myeloma, signaling an effort to speed drug development where traditional endpoints may be impractical, RBC Capital tells investors in a research note. The guidance appears favorable for Legend Biotech (LEGN) by validating its trial design and improving visibility into the near-term opportunity for CARTITUDE-6 in the frontline setting, the firm says. RBC has an Outperform rating and $66 price target on Legend Biotech shares.