Disc Medicine Inc's stock fell by 7.72% as it crossed below the 5-day SMA, reflecting investor concerns following the FDA's delay in approving Bitopertin, now rescheduled for February 10.
The delay in the approval of Bitopertin, which targets Erythropoietic Protoporphyria, is attributed to safety and efficacy concerns raised by the FDA. This postponement has led to a significant drop in stock price, highlighting the market's reaction to the uncertainty surrounding the drug's launch. Additionally, the company has been preparing for commercialization, but this setback may impact its market readiness and investor confidence.
The implications of this delay could be substantial for Disc Medicine, as it not only affects the anticipated revenue from Bitopertin but also raises questions about the company's overall strategy and market position in the competitive biopharmaceutical landscape.
Wall Street analysts forecast IRON stock price to rise over the next 12 months. According to Wall Street analysts, the average 1-year price target for IRON is 120.20 USD with a low forecast of 100.00 USD and a high forecast of 154.00 USD. However, analyst price targets are subjective and often lag stock prices, so investors should focus on the objective reasons behind analyst rating changes, which better reflect the company's fundamentals.
13 Analyst Rating
Wall Street analysts forecast IRON stock price to rise over the next 12 months. According to Wall Street analysts, the average 1-year price target for IRON is 120.20 USD with a low forecast of 100.00 USD and a high forecast of 154.00 USD. However, analyst price targets are subjective and often lag stock prices, so investors should focus on the objective reasons behind analyst rating changes, which better reflect the company's fundamentals.
13 Buy
0 Hold
0 Sell
Strong Buy
Current: 77.540
Low
100.00
Averages
120.20
High
154.00
Current: 77.540
Low
100.00
Averages
120.20
High
154.00
Morgan Stanley
Overweight
maintain
$115 -> $120
2026-01-08
Reason
Morgan Stanley
Price Target
$115 -> $120
AI Analysis
2026-01-08
maintain
Overweight
Reason
Morgan Stanley raised the firm's price target on Disc Medicine to $120 from $115 and keeps an Overweight rating on the shares. The firm sees a continuation of U.S. small-to-mid cap biotech's outperformance in 2026 as commercial names transition from "capital consumers to producers" and Large Cap Biopharma faces a looming patent cliff, the analyst tells investors in an outlook note for the group.
TD Cowen
TD Cowen
Buy
maintain
2025-12-19
Reason
TD Cowen
TD Cowen
Price Target
2025-12-19
maintain
Buy
Reason
Keeping a Buy rating on Disc Medicine, TD Cowen says the firm believes skepticism on the CNPV path is overblown. Disc's management remains confident, and TD Cowen's Prevision Policy experts suggest that "transactional" approvals - while likely a risk for the broader regulatory landscape should indeed benefit therapies/sponsors that the Agency is clearly excited about. FDA resources are shifting to programs like bitopertin, and the firm's confidence in accelerated approval remains high. Of note, a recent article on the FDA's CNPV program framed Disc's bitopertin as part of broader concerns around the compressed review timelines and governance structure.
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BMO Capital
Outperform
maintain
$120
2025-12-19
Reason
BMO Capital
Price Target
$120
2025-12-19
maintain
Outperform
Reason
BMO Capital notes that a STAT article appeared to raise concerns about the feasibility of FDA's Commissioner's National Priority Voucher approval timelines. The same article indicated that CBER director Vinay Prasad had indicated concerns about bitopertin's efficacy. The firm says that discussion with Disc Medicine's management post-STAT article highlights lack of interactions with Prasad but robust active dialogue with FDA. While Prasad may have speculated efficacy concerns related to bitopertin, these have not been communicated to Disc, no adcom has been noted as necessary, and no clear concerning questions around efficacy have been raised, BMO adds. Some procedural questions have been asked by FDA in trying to understand the bitopertin data package and how it may translate to clinical benefit. The firm has an Outperform rating on the shares with a price target of $120.
Jefferies
Roger Song
Buy
maintain
$154
2025-12-19
Reason
Jefferies
Roger Song
Price Target
$154
2025-12-19
maintain
Buy
Reason
After attending Disc Medicine's analyst call in response to the media article that expressed concerns regarding CNPV program and mentioned potential timeline extension on the company's Bitopertin/Erythropoietic Protoporphyria approval and skepticism on efficacy by FDA leader, Jefferies analyst Roger Song says that while the CNPV program's timeline may be under pressure with increasing demand, the firm remains confident on Bitopertin's approval in EPP under CNPV, based on robust efficacy/safety, significant unmet needs, and to-date review experience. The firm sees today's movement as a stock overreaction. Jefferies has a Buy rating on the shares with a price target of $154.
About IRON
Disc Medicine, Inc. is a clinical-stage biopharmaceutical company focused on the discovery, development, and commercialization of novel treatments for patients suffering from serious hematologic diseases. The Company's pipeline includes bitopertin for the treatment of erythropoietic porphyrias (Eps), including erythropoietic protoporphyria (EPP) and X-linked protoporphyria (XLP), and Diamond-Blackfan Anemia (DBA); DISC-0974 for the treatment of anemia of myelofibrosis (MF), and anemia of chronic kidney disease (CKD), and DISC-3405 (formerly MWTX-003) for the treatment of polycythemia vera (PV) and other hematologic disorders. In addition, its preclinical programs also include DISC-0998, for the treatment of anemia associated with inflammatory diseases. Bitopertin is the lead product candidate in the Company's heme biosynthesis modulation portfolio. It is developing DISC-3405, a monoclonal antibody against Transmembrane Serine Protease 6 that it licensed from Mabwell Therapeutics, Inc.
About the author
Emily J. Thompson
Emily J. Thompson, a Chartered Financial Analyst (CFA) with 12 years in investment research, graduated with honors from the Wharton School. Specializing in industrial and technology stocks, she provides in-depth analysis for Intellectia’s earnings and market brief reports.
