Stifel analyst Stephen Willey notes that a Reuters article is speculating about a potential delay on the review of Disc Medicine’s (IRON) bitopertin by two weeks amid what they describe are efficacy and abuse concerns. Reuters cites internal documents they have seen, while the company is appropriately not commenting on what remains an active NDA review process, Stifel adds. The firm believes the delay of any potential approval into late-May based on traditional accelerated approval represents an insignificant impact to its current valuation framework. Stifel acknowledges it’s hard to have a read on potential efficacy and risk for abuse concerns mentioned in the article. However, it views this stock weakness as a buying opportunity given the positive FDA feedback previously received by Disc on the use of endpoints where bitopertin has demonstrated meaningful differences; and the fact that abuse concerns were evaluated by Roche (RHHBY) and deemed to be a non-issue. The firm has a Buy rating on Disc Medicine.
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