BMO Capital has reaffirmed an Outperform rating on Disc Medicine (NASDAQ: IRON) and kept its $120.00 price target despite recent swings in the stock. That target implies roughly a 50% upside from the then-current share price of $80.01, and sits within a broader analyst landscape that carries a Strong Buy consensus with price targets spanning $109 to $154.
The research firm pointed to three main factors underpinning its positive stance toward bitopertin, the company’s lead investigational therapy for erythropoietic protoporphyria and X-linked protoporphyria (EPP/XLP): prior affirmative alignment with the U.S. Food and Drug Administration on the New Drug Application submission requirements, strong safety observations drawn from Roche’s data set, and observed correlations between reductions in protoporphyrin IX (PPIX) levels and improved tolerance to sunlight exposure.
BMO’s modelling assumes approval with a broad label for bitopertin, a scenario that the firm judges could lift Disc Medicine shares into the mid-to-high $90s in its base case. On the probability front, BMO assigned a 60% chance that this approval outcome will be achieved for the clinical-stage biopharmaceutical company concentrated on treatments for serious hematologic conditions.
The stock has displayed notable market momentum, returning approximately 43% over the past year by InvestingPro data, even as recent news cycles have included critical commentary about the drug’s efficacy and safety profile. Those published concerns have contributed to volatility but have not, in BMO’s view, materially altered the approval prospects.
Disc Medicine has formally filed a New Drug Application for bitopertin, which is currently under an accelerated review by the FDA enabled by the Commissioner’s National Priority Review Voucher (CNPV). Nevertheless, there are reports indicating a potential two-week delay in the FDA review timeline linked to questions about efficacy and possible abuse, as reported by Reuters. Those reports represent an explicit source of regulatory timing uncertainty.
Other sell-side firms have maintained positive assessments during the review period. Morgan Stanley has reiterated an Overweight rating with a $120 price target, and Stifel has reaffirmed a Buy rating with a $125 target. Both firms continue to express confidence in the company’s prospects as the FDA evaluation proceeds.
On the corporate and leadership side, Disc Medicine has hired Lisa Amaya Price as Chief Human Resources Officer. Price brings more than 25 years of industry experience and is noted for her role at Deciphera, where she contributed to the integration with ONO Pharmaceuticals. The company also outlined strategic priorities for 2026 after characterizing 2025 as a transformative year, with foreseeable focus on potential commercialization activities for treatments targeting hematologic diseases.
As the review process advances, market participants will be watching both the regulatory feedback and subsequent commercial planning closely. For now, BMO’s stance signals that one influential research house sees a path to approval and material upside, even as other voices in the public domain have raised questions that could affect timing and perception.
Contextual note: The coverage of ratings and targets above reflects the current positions and published commentary of the respective research firms and the status of Disc Medicine’s NDA process as described.