H.C. Wainwright says Capricor path to approval ‘sharpens’ with inspection done

H.C. Wainwright notes that Capricor Therapeutics (CAPR) announced that the FDA has completed its pre-license inspection of the company’s San Diego manufacturing facility for Deramiocel and said that observations primarily related to routine quality systems and documentation practices. “Importantly,” no material changes to the cGMP process or facility were required, according to the analyst, who also says Capricor “expressed confidence” that the facility is well-positioned to meet FDA requirements. Barring future unforeseen issues, the firm believes any current concerns regarding manufacturing are “unwarranted” and looks forward to the July Advisory Committee meeting, while noting that the BLA remains under priority review with a PDUFA date of August 31. H.C. Wainwright maintains a Buy rating and $77 price target on Capricor shares.