Disc Medicine's Bitopertin Approval Delayed, Stock Drops
Written by Emily J. Thompson, Senior Investment Analyst
Updated: Jan 15 2026
0mins
Should l Buy IRON?
Source: stocktwits
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.
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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 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
13 Buy
0 Hold
0 Sell
Strong Buy
Current: 78.330
Low
100.00
Averages
120.20
High
154.00
Current: 78.330
Low
100.00
Averages
120.20
High
154.00
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.
Pomerantz LLP Investigates Securities Fraud Claims Against Disc Medicine
- Securities Fraud Investigation: Pomerantz LLP is investigating claims of securities fraud against Disc Medicine, Inc., focusing on whether the company and its executives engaged in unlawful business practices that could lead to significant investor losses.
- FDA Review Delay: On January 15, 2026, it was reported that a drug under development by Disc faced a delay in its review timeline due to safety and efficacy concerns raised by FDA scientists, directly impacting market confidence in the company.
- Significant Stock Drop: Following the FDA news, Disc's stock price fell by $6.04, or 7.84%, closing at $71.04 per share on January 15, 2026, reflecting investor concerns about the company's future prospects.
- Potential Legal Action: Pomerantz LLP is advising affected investors to reach out, indicating the possibility of a class action lawsuit, which could further exacerbate Disc's legal and financial pressures in the market.
See More
Disc Medicine's Drug Approval Delayed to Feb 10, Stock Rises 2.59%
- Approval Delay: The FDA has postponed its decision on Disc Medicine's experimental treatment bitopertin to February 10, yet the stock rose 2.59%, indicating market optimism about its future prospects.
- Efficacy Concerns: FDA reviewers questioned the statistical reliability of the secondary endpoint “pain-free time in the sun,” which could impact the drug's approval process and add regulatory uncertainty.
- Internal Review: The FDA has requested an evaluation of bitopertin's potential for abuse, complicating the review process, although analysts believe this may just be noise and unlikely to significantly affect the outcome.
- Market Expectations: H.C. Wainwright maintains a “Buy” rating on Disc Medicine with a price target of $118, reflecting strong market confidence in the company's future.
See More
FDA Delays Disc Medicine's Bitopertin Drug Review, Analysts See Minor Impact
- 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.
See More
Disc Medicine's Bitopertin Approval Delayed to February
- FDA Review Delay: Disc Medicine's Bitopertin drug approval has been postponed to February 10, despite being selected for fast track review, resulting in a 7% drop in stock price on Thursday due to safety and efficacy concerns.
- Rare Disease Context: Bitopertin targets Erythropoietic Protoporphyria (EPP), a rare metabolic disorder causing extreme sensitivity to sunlight, with the FDA currently assessing its abuse risks and the statistical validity of its efficacy measures.
- Other Drug Approval Updates: Sanofi's Tzield drug review has been delayed by over a month due to adverse event reports, originally set for a decision by November 21, while Lilly's weight-loss drug is now expected to be approved by April 10, later than its initial Q1 estimate.
- Market Sentiment Analysis: On Stocktwits, retail sentiment around Disc Medicine and Sanofi stocks remained neutral, while Lilly's sentiment rose from 'bullish' to 'extremely bullish', indicating market optimism regarding its weight-loss drug approval.
See More
FDA Delays Review of Fast-Track Drugs Under Trump Administration, Impacting Multiple New Treatments
- Review Delays: The FDA has postponed the review of several drugs, notably Disc Medicine's bitopertin, due to safety and efficacy concerns, extending the review period to February 10, which may impact its market launch.
- New Drug Selection: Merck's cholesterol treatment and cancer therapy have been selected for the CNPV program, and if finalized, they will become the 17th and 18th drugs in the program, significantly shortening review times to one to two months.
- Adverse Event Concerns: The FDA delayed its review of Sanofi's Tzield by over a month due to reports of adverse events including seizures and blood clotting, potentially affecting its expanded-use application progress.
- Market Reaction: The review delays have led to declines in premarket trading for Disc Medicine, Eli Lilly, and Sanofi, reflecting market uncertainty regarding drug approvals.
See More
Disc Medicine (IRON) and Sanofi (SNY) Drug Review Delays Exceed 12 Months
- Review Delays: Disc Medicine's rare disease therapy bitopertin faces a two-month delay in its review due to concerns over potential abuse and trial data issues, which could postpone its market launch and impact revenue generation.
- Safety Concerns: Sanofi's Tzield (teplizumab-mzwv) is experiencing over a 12-month delay in its U.S. expansion bid due to adverse event reports, including seizures, blood clotting, and mortality, potentially undermining its competitive position in the diabetes market.
- FDA Priority Review Program: The FDA's National Priority Review voucher program, launched last year to expedite review times from 10-12 months to just 1-2 months, is currently hindered by these delays, reflecting the agency's heightened scrutiny on safety and efficacy, which may affect future drug development strategies.
- Industry Impact: As early recipients of the priority review vouchers, Disc Medicine and Sanofi's delays could lead to decreased investor confidence in their R&D pipelines, potentially impacting stock performance and market expectations.
See More
Pomerantz LLP Investigates Securities Fraud Claims Against Disc Medicine
- Securities Fraud Investigation: Pomerantz LLP is investigating claims of securities fraud against Disc Medicine, Inc., focusing on whether the company and its executives engaged in unlawful business practices that could lead to significant investor losses.
- FDA Review Delay: On January 15, 2026, it was reported that a drug under development by Disc faced a delay in its review timeline due to safety and efficacy concerns raised by FDA scientists, directly impacting market confidence in the company.
- Significant Stock Drop: Following the FDA news, Disc's stock price fell by $6.04, or 7.84%, closing at $71.04 per share on January 15, 2026, reflecting investor concerns about the company's future prospects.
- Potential Legal Action: Pomerantz LLP is advising affected investors to reach out, indicating the possibility of a class action lawsuit, which could further exacerbate Disc's legal and financial pressures in the market.
See More
Disc Medicine's Drug Approval Delayed to Feb 10, Stock Rises 2.59%
- Approval Delay: The FDA has postponed its decision on Disc Medicine's experimental treatment bitopertin to February 10, yet the stock rose 2.59%, indicating market optimism about its future prospects.
- Efficacy Concerns: FDA reviewers questioned the statistical reliability of the secondary endpoint “pain-free time in the sun,” which could impact the drug's approval process and add regulatory uncertainty.
- Internal Review: The FDA has requested an evaluation of bitopertin's potential for abuse, complicating the review process, although analysts believe this may just be noise and unlikely to significantly affect the outcome.
- Market Expectations: H.C. Wainwright maintains a “Buy” rating on Disc Medicine with a price target of $118, reflecting strong market confidence in the company's future.
See More
FDA Delays Disc Medicine's Bitopertin Drug Review, Analysts See Minor Impact
- 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.
See More
Disc Medicine's Bitopertin Approval Delayed to February
- FDA Review Delay: Disc Medicine's Bitopertin drug approval has been postponed to February 10, despite being selected for fast track review, resulting in a 7% drop in stock price on Thursday due to safety and efficacy concerns.
- Rare Disease Context: Bitopertin targets Erythropoietic Protoporphyria (EPP), a rare metabolic disorder causing extreme sensitivity to sunlight, with the FDA currently assessing its abuse risks and the statistical validity of its efficacy measures.
- Other Drug Approval Updates: Sanofi's Tzield drug review has been delayed by over a month due to adverse event reports, originally set for a decision by November 21, while Lilly's weight-loss drug is now expected to be approved by April 10, later than its initial Q1 estimate.
- Market Sentiment Analysis: On Stocktwits, retail sentiment around Disc Medicine and Sanofi stocks remained neutral, while Lilly's sentiment rose from 'bullish' to 'extremely bullish', indicating market optimism regarding its weight-loss drug approval.
See More
FDA Delays Review of Fast-Track Drugs Under Trump Administration, Impacting Multiple New Treatments
- Review Delays: The FDA has postponed the review of several drugs, notably Disc Medicine's bitopertin, due to safety and efficacy concerns, extending the review period to February 10, which may impact its market launch.
- New Drug Selection: Merck's cholesterol treatment and cancer therapy have been selected for the CNPV program, and if finalized, they will become the 17th and 18th drugs in the program, significantly shortening review times to one to two months.
- Adverse Event Concerns: The FDA delayed its review of Sanofi's Tzield by over a month due to reports of adverse events including seizures and blood clotting, potentially affecting its expanded-use application progress.
- Market Reaction: The review delays have led to declines in premarket trading for Disc Medicine, Eli Lilly, and Sanofi, reflecting market uncertainty regarding drug approvals.
See More
Disc Medicine (IRON) and Sanofi (SNY) Drug Review Delays Exceed 12 Months
- Review Delays: Disc Medicine's rare disease therapy bitopertin faces a two-month delay in its review due to concerns over potential abuse and trial data issues, which could postpone its market launch and impact revenue generation.
- Safety Concerns: Sanofi's Tzield (teplizumab-mzwv) is experiencing over a 12-month delay in its U.S. expansion bid due to adverse event reports, including seizures, blood clotting, and mortality, potentially undermining its competitive position in the diabetes market.
- FDA Priority Review Program: The FDA's National Priority Review voucher program, launched last year to expedite review times from 10-12 months to just 1-2 months, is currently hindered by these delays, reflecting the agency's heightened scrutiny on safety and efficacy, which may affect future drug development strategies.
- Industry Impact: As early recipients of the priority review vouchers, Disc Medicine and Sanofi's delays could lead to decreased investor confidence in their R&D pipelines, potentially impacting stock performance and market expectations.
See More
