Morgan Stanley says Regeneron likely to come under pressure after surprising CRL

Morgan Stanley maintained an Overweight rating and $927 price target on Regeneron following the company’s “surprising” Complete Response Letter, or CRL, for high-dose Eylea that it received from the FDA. The analyst sees the shares coming under pressure given this news will likely delay the potential launch of high-dose Eylea and allow Roche (RHHBY) to ramp Vabysmo. The analyst added that, importantly, the CRL is “solely due to an ongoing review of inspection findings at a third-party filler. The CRL did not identify any issues with the aflibercept 8 mg clinical efficacy or safety, trial design, labeling or drug substance manufacturing, and no additional clinical data or trials have been requested.”