Disc Medicine (IRON): Constructive FDA Dialogue and APOLLO Progress Support Buy Rating Despite Volatility

Analyst Evan Seigerman from BMO Capital maintained a Buy rating on Disc Medicine and keeping the price target at $120.00.

Evan Seigerman has given his Buy rating due to a combination of factors that, in his view, reinforce the strength of the Disc Medicine investment thesis despite recent volatility. After speaking with management, he concluded that the concerns raised in the external article about FDA timing and bitopertin’s efficacy have not translated into formal regulatory pushback. Management reported no direct engagement with the individual cited as questioning efficacy and no indication that a formal advisory committee or other extraordinary review step has been requested. In Seigerman’s assessment, the questions posed by the FDA thus far appear focused on clarifying how reductions in PPIX may translate into clinical benefit rather than signaling fundamental doubts about the drug.

Seigerman also highlights that the tone of communication between Disc and the FDA remains constructive, with regulators showing urgency in reviewing the data, which supports his view that the approval process is progressing as expected. While he acknowledges some risk around the exact timing of approval, he does not see any new issues that materially alter the likelihood of regulatory success. Additionally, the ongoing APOLLO study, which is enrolling well as a confirmatory trial under the accelerated approval pathway, provides a further layer of support for eventual full approval. Taken together, these elements underpin his conviction that the recent share-price dislocation is more noise than a signal of increased fundamental risk, justifying a Buy recommendation on IRON.