BMO Capital says call with Disc management clarifies active FDA dialogue

BMO Capital notes that a STAT article appeared to raise concerns about the feasibility of FDA’s Commissioner’s National Priority Voucher approval timelines. The same article indicated that CBER director Vinay Prasad had indicated concerns about bitopertin’s efficacy. The firm says that discussion with Disc Medicine’s (IRON) management post-STAT article highlights lack of interactions with Prasad but robust active dialogue with FDA. While Prasad may have speculated efficacy concerns related to bitopertin, these have not been communicated to Disc, no adcom has been noted as necessary, and no clear concerning questions around efficacy have been raised, BMO adds. Some procedural questions have been asked by FDA in trying to understand the bitopertin data package and how it may translate to clinical benefit. The firm has an Outperform rating on the shares with a price target of $120.