Cantor Fitzgerald cut its price objective on Disc Medicine (NASDAQ: IRON) to $125 from $153 on Monday, while keeping an Overweight rating on the stock. The revised target remains materially above the name's most recent market price of $63.66 and lies within the broader analyst range of $75 to $128.
The move follows a complete response letter from the U.S. Food and Drug Administration relating to bitopertin, an oral GlyT1 inhibitor that the company is developing for erythropoietic protoporphyria (EPP) and X-linked protoporphyria (XLP). Both conditions are rare disorders characterized by extreme light sensitivity. The regulatory communication told Disc Medicine that additional evidence will be required to show a benefit on a clinical endpoint associated with the surrogate endpoint used in prior studies.
The FDA acknowledged that bitopertin significantly lowers protoporphyrin IX levels, but noted that earlier trials did not adequately demonstrate a corresponding effect on endpoints tied to sunlight exposure. As a result, the agency asked for results from another trial before it would move forward with a determination on approval. Management has indicated it will provide further updates once there is greater clarity with the agency.
Market reaction to the FDA notification has been sharp. According to data cited by market research services, IRON shares dropped roughly 25% over the prior week following the regulatory news. Analysts and investors are now looking to the ongoing APOLLO Phase 3 study for the evidence the agency requested; Cantor Fitzgerald and others expect the APOLLO readout to supply the necessary clinical endpoint data.
Cantor Fitzgerald described the price-target reduction as reflecting the updated regulatory timeline, but the firm also characterized the pullback in the shares as a buying opportunity. The analyst team said it remains highly confident in the design and prospects of the Phase 3 APOLLO trial, noting that the study specifically aims to evaluate treatment effects during the final month of observation - a period the firm believes is less affected by placebo responses and more likely to capture the onset of bitopertin's clinical activity.
Other firms covering Disc Medicine have maintained constructive stances despite the FDA correspondence. BMO Capital reiterated an Outperform rating with a $120.00 price target, and Morgan Stanley has held onto an Overweight rating with the same $120 target, after discussions that included the potential for review timing extensions. Stifel likewise remained positive on the stock amid reports of a possible two-week delay in the FDA review process.
On Disc Medicine's balance sheet and financial health, data referenced by analysts point to a strong cash position and low leverage. One corporate-health metric highlighted in research showed an Altman Z-Score of 21.29, and the company was reported to hold more cash than debt.
The APOLLO Phase 3 study's results are expected in the fourth quarter of 2026. Investors monitoring Disc Medicine's development pathway are advised to watch the ongoing trial readout and subsequent communications from the company regarding its discussions with the FDA.
Key takeaways and context
- Cantor Fitzgerald reduced its price target on Disc Medicine to $125 from $153 but maintained an Overweight rating.
- The FDA issued a complete response letter requesting additional trial evidence linking surrogate and clinical endpoints for bitopertin in EPP and XLP.
- The APOLLO Phase 3 study is the intended source of the data the agency requested, with results expected in Q4 2026.