Dec 23, 2025 • Simply Wall Street
BEARISH
Disc Medicine (IRON) Is Down 13.5% After FDA Scrutiny Clouds Bitopertin Pathway And Insider Sales - What's Changed
Disc Medicine's stock has dropped 13.5% due to FDA scrutiny over its lead EPP candidate, bitopertin, and recent insider share sales, raising concerns about its efficacy and accelerated review pathway. Despite this, regulatory interactions are described as collaborative, and the company's investment narrative relies heavily on bitopertin's success, which now faces elevated regulatory risk. Investors are urged to consider multiple viewpoints given the wide gap in fair value estimates and the uncertainty surrounding the FDA outcome.
Dec 23, 2025 • BioSpace
BEARISH
Disc Shares Slip Amid Report FDA’s Prasad is Skeptical of Bitopertin’s Efficacy
Disc Medicine's shares dropped after a report indicated FDA biologics center director Vinay Prasad is skeptical about the efficacy of bitopertin, a drug candidate for porphyria. Prasad reportedly became personally involved in the review, prompting analysts to express caution, though they voiced optimism for the drug's eventual approval. Disc management was "blindsided" by the report and stated the FDA had not communicated efficacy concerns directly to them.
Dec 23, 2025 • The Globe and Mail
SOMEWHAT-BULLISH
Analysts Conflicted on These Healthcare Names: Moderna (MRNA), Disc Medicine (IRON) and Sagimet Biosciences, Inc. Class A (SGMT)
Analysts have issued various ratings for several healthcare sector companies. Moderna (MRNA) received a Hold rating from Bernstein and Jefferies, with a consensus price target indicating a 30.4% upside. Disc Medicine (IRON) was rated a Strong Buy by Stifel Nicolaus and LifeSci Capital, with an average price target showing a 30.3% upside, while Sagimet Biosciences, Inc. Class A (SGMT) also received a Strong Buy consensus, with JonesTrading and Wedbush maintaining Buy ratings and projecting a 382.6% upside.
Dec 23, 2025 • Simply Wall Street
BEARISH
Disc Medicine (IRON) Is Down 13.5% After FDA Scrutiny Clouds Bitopertin Pathway And Insider Sales - What's Changed
Disc Medicine's stock dropped 13.5% following FDA official questioning and media reports that cast doubt on the efficacy and accelerated review pathway of its lead EPP candidate, bitopertin, alongside insider share sales. Despite this, management and analysts maintain that FDA interactions are collaborative, framing current inquiries as procedural rather than formal challenges. This scrutiny elevates regulatory risk for Disc Medicine, whose investment narrative heavily relies on bitopertin's success, even though other pipeline data like DISC-0974 shows promise.
Dec 20, 2025 • ts2.tech
SOMEWHAT-BEARISH
Disc Medicine (NASDAQ: IRON) Stock Drops on FDA Voucher Speculation: Latest News, Analyst Forecasts, and What Investors Watch Next
Disc Medicine Inc. (NASDAQ: IRON) stock experienced significant volatility, dropping around 11.5% after speculation arose regarding potential issues with the FDA's fast-track voucher process for its lead drug candidate, bitopertin. Concerns mainly stem from reports questioning bitopertin's effectiveness and potential political interference within the FDA's Commissioner’s National Priority Voucher program. Despite this, analysts largely maintain positive ratings, emphasizing Disc Medicine's strong balance sheet and promising "second act" pipeline, particularly with DISC-0974.
Dec 19, 2025 • Investing.com
BULLISH
Stifel reaffirms Buy rating on Disc Medicine stock amid FDA review speculation
Stifel reiterated its Buy rating and $125.00 price target on Disc Medicine (NASDAQ:IRON) amidst speculation about potential FDA concerns regarding the accelerated review of bitopertin for erythropoietic protoporphyria (EPP). The company maintains its guidance for a potential launch by January 2026, with FDA interactions progressing "seamlessly." Several other analysts also maintain Buy or Outperform ratings with varying price targets, following positive interim study data and the FDA's acceptance of the New Drug Application for bitopertin.