FDA Delays Disc Medicine's Bitopertin Drug Review, Analysts See Minor Impact

Written by Emily J. Thompson, Senior Investment Analyst

IRON-0.15%

Source: Newsfilter

Updated: 12h ago

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Source: Newsfilter

Review Delay: The FDA has postponed its decision on Disc Medicine's rare disease drug bitopertin, raising review questions; however, analysts generally believe this setback will have a limited impact on the company.
Market Reaction: Analysts indicate that while the FDA's delay may affect short-term market expectations, it does not pose a substantial threat to Disc Medicine's long-term outlook, with investor sentiment remaining stable.
Drug Potential: If approved, bitopertin, aimed at treating rare diseases, could open new revenue streams for the company, and analysts believe the market demand for this drug remains strong.
Strategic Adjustment: Disc Medicine may need to reassess its marketing strategy to address the uncertainties brought by the FDA review delay, ensuring it maintains a competitive edge in the future.

IRON

$70.93+Infinity%1D

Analyst Views on IRON

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 114.91 USD with a low forecast of 91.00 USD and a high forecast of 153.00 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.

12 Analyst Rating

12 Buy

0 Hold

0 Sell

Strong Buy

Current: 71.040

Low

91.00

Averages

114.91

High

153.00

Current: 71.040

Low

91.00

Averages

114.91

High

153.00

Morgan Stanley

Overweight

maintain

$115 -> $120

Al Analysis

2026-01-08

Reason

Morgan Stanley

Price Target

$115 -> $120

Al 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

Buy

maintain

2025-12-19

Reason

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.