Overview
Stifel has trimmed its price target for Disc Medicine (NASDAQ:IRON) to $110 from $125 but maintained a Buy rating, following the U.S. Food and Drug Administration’s issuance of a Complete Response Letter for the bitopertin New Drug Application. The company’s shares were trading at $63.51, down from a prior close of $71.65, reflecting a one-week decline of roughly 25.15%.
Regulatory trigger and model changes
The brokerage said the revision follows the FDA’s CRL tied to bitopertin, the investigational therapy seeking accelerated approval for erythropoietic protoporphyria (EPP) and X-linked protoporphyria (XLP). Stifel noted that, over the past 15 months, the agency had engaged positively across three formal regulatory interactions and granted a CNPV designation, but ultimately cited uncertainty about whether the magnitude of bitopertin-mediated reductions in protoporphyrin IX (PPIX) observed in the Phase 2 AURORA and BEACON trials is likely to translate into clinical benefit.
As a result, Stifel adjusted its internal modeling to reflect a later launch window. The firm now anticipates commercialization in mid-fiscal year 2027, moving away from its previous expectation of a late first quarter 2026 market entry. Despite the timing adjustment, Stifel left its projected uptake trajectory and its U.S. peak sales estimate at approximately $1 billion largely unchanged.
Analyst and market context
Even with the regulatory setback, the broader analyst consensus remains tilted toward optimism. Coverage shows a consensus rating of Strong Buy and price targets across the analyst community that span from $75 to $128. Other firms have updated their views in light of the FDA decision: Cantor Fitzgerald cut its target from $153 to $125 while keeping an Overweight rating; BMO Capital reiterated an Outperform rating with a $120 target; and Morgan Stanley maintained an Overweight rating and a $120 target.
Market participants have reacted to the developments, driving near-term volatility in the equity. The immediate downward move in the share price reflects the reassessment of timing and regulatory risk by investors.
Upcoming catalysts and balance sheet position
Stifel highlighted that disclosures expected in the second half of 2026 for two other programs in Disc Medicine’s pipeline, DISC-0974 and DISC-3405, have grown in importance as potential catalysts. The firm also pointed to the company’s liquidity profile: Disc Medicine reportedly holds more cash than debt and displays a strong current ratio of 23.45, suggesting it has financial resources to continue advancing development programs while the regulatory pathway for bitopertin plays out.
Additional regulatory detail
Separately, the FDA’s CRL specifically requested results from the ongoing Phase 3 APOLLO study before approval could be considered. While the agency acknowledged that bitopertin lowers PPIX levels, it judged that prior trials did not sufficiently link those biomarker reductions to outcomes measured by sunlight exposure, which the agency views as central to demonstrating clinical benefit in EPP and XLP.
Implications for investors
The regulatory decision and subsequent analyst adjustments have produced a mixed picture: the timeline to potential approval and commercialization has shifted later, yet consensus peak sales and uptake forecasts by at least some analysts remain materially unchanged. Investor focus is likely to remain on the APOLLO Phase 3 readout and the second-half 2026 data releases for DISC-0974 and DISC-3405, alongside cash runway metrics that could determine how the company funds ongoing programs.
Conclusion
Stifel’s move to lower its price target while keeping a Buy rating underscores a recalibration of near-term expectations rather than a wholesale change to the medium-term revenue outlook for bitopertin. The FDA’s request for Phase 3 results introduces clearer sequencing risk and a later commercialization date, making upcoming clinical readouts and the company’s cash position central to how investors reprice risk in the shares.