TD Cowen says Disc Medicine remains confident, bito timeline under CNPV intact

Keeping a Buy rating on Disc Medicine (IRON), TD Cowen says the firm believes skepticism on the CNPV path is overblown. Disc’s management remains confident, and TD Cowen’s Prevision Policy experts suggest that “transactional” approvals – while likely a risk for the broader regulatory landscape should indeed benefit therapies/sponsors that the Agency is clearly excited about. FDA resources are shifting to programs like bitopertin, and the firm’s confidence in accelerated approval remains high. Of note, a recent article on the FDA’s CNPV program framed Disc’s bitopertin as part of broader concerns around the compressed review timelines and governance structure.