Disc Medicine: Downgrading As CRL Puts APOLLO Study Into Question

2026-02-19 12:26:54 ET

The last time I spoke about Disc Medicine, Inc. ( IRON ), it was with respect to a Seeking Alpha article entitled " Disc Medicine: NDA Submission And CNPV For Bitopertin Further Boost Shareholder Value ". With that article, I had rated the stock a "Strong Buy" because I believed that the AURORA and BEACON studies would be sufficient enough to allow for Accelerated Approval by the FDA for bitopertin for the treatment of patients with Erythropoietic protoporphyria ((EPP)). Unfortunately, the company received a complete response letter ((CRL)) for bitopertin for the treatment of these patients. The FDA noted that these studies do provide evidence of lower PPIX but still want to see the results from the phase 3 APOLLO study before making a decision. I don't foresee any major issues, but now the risk has somewhat increased as everything hinges on data from this late-stage APOLLO study. With that being said, I believe the stock should be downgraded from a "Strong Buy" rating to a "Hold" rating....

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