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Disc Medicine

65.57

+9.6217.19%

Post-market: 61.80-3.7700-5.75%16:06 EST

Volume:3.58M

Turnover:226.43M

Market Cap:2.48B

PE:-12.09

High:67.27

Open:55.67

Low:55.51

Close:55.95

52wk High:99.50

52wk Low:30.82

Shares:37.75M

Float Shares:32.58M

Volume Ratio:2.70

T/O Rate:11.00%

Dividend:- -

Dividend Rate:- -

EPS(TTM):-5.4247

EPS(LYR):-3.9613

ROE:-34.78%

ROA:-22.61%

PB:4.32

PE(LYR):-16.55

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Overview Company News Filings

Disc Medicine's Multiple Catalysts Provide Runway Despite Bitopertin Delay, Morgan Stanley Says

MT Newswires Live

Wedbush Adjusts Price Target on Disc Medicine to $88 From $110, Maintains Outperform Rating

MT Newswires Live

Disc Medicine Inc. i details bitopertin regulatory update and clinical trial progress

Disc Medicine Is Maintained at Overweight by Wells Fargo

Disc Medicine eyes standard US approval for drug after FDA denies fast-track nod

Disc Medicine price target lowered to $75 from $120 at Morgan Stanley

Disc Medicine Exec Says That IF Late-Stage Trial Succeeds, Co Will Seek Approval Through the Traditional Pathway Rather Than the Accelerated Route – Conf Call

THOMSON REUTERS

Disc Medicine Exec Says It Expects Late-Stage Data for Bitopertin in Q4 This Year – Conf Call

THOMSON REUTERS

Disc Medicine Exec Says the Policy Debate Over Accelerated Approval Has Stretched Across Multiple Administrations, and Recent Decisions Show Regulators Are Taking an "Increasingly Stringent" View of When Such Approvals Are Appropriate – Conf Call

THOMSON REUTERS

Disc Medicine Addresses FDA Rejection of Bitopertin Filing

Disc Medicine (IRON) Receives a Buy from Cantor Fitzgerald

Disc Medicine: Long‑Term Value Intact as Bitopertin Shifts to Lower‑Risk Traditional Approval Path

FDA Delays Disc Medicine's Rare Disease Drug

Benzinga_recent_news

Analysts Have Conflicting Sentiments on These Healthcare Companies: Crispr Therapeutics AG (CRSP), Moderna (MRNA) and Disc Medicine (IRON)

Disc Medicine EPP Treatment Fails to Get FDA Accelerated Approval

BUZZ-Disc Medicine dives as FDA declines to approve rare disease drug

Disc Medicine down 32% to $49 after confirming rejection letter from FDA

Disc Medicine confirms complete response letter from FDA for bitopertin

Disc Medicine says issue raised by FDA ‘readily addressable’

US FDA declines to approve Disc Medicine's rare disease drug

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Medicine's Multiple Catalysts Provide Runway Despite Bitopertin Delay, Morgan Stanley Says","url":"https://stock-news.laohu8.com/highlight/detail?id=2612466849","media":"MT Newswires Live","labels":[],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2612466849?lang=en_us&edition=fundamental","pubTime":"2026-02-18 00:22","pubTimestamp":1771345334,"startTime":"0","endTime":"0","summary":"Disc Medicine  faces a delayed timeline for bitopertin after receiving a complete response letter from the US Food and Drug Administration, but the company has enough runway and multiple upcoming pipeline catalysts, Morgan Stanley said in a Monday note.The firm said the regulator requested data from a confirmatory phase 3 trial to support traditional approval of bitopertin, with data readout now expected in Q4 and a potential updated FDA decision by mid-2027.Morgan Stanley noted the company ended 2025 with about $791 million in cash and cash equivalents, providing runway into 2029, and is well-capitalized even without near-term bitopertin revenue.The firm highlighted multiple upcoming catalysts, including phase 3 topline data on bitopertin, regulatory interactions with the FDA, and multiple pipeline readouts, including updated data for DISC-0974 in anemia of myelofibrosis as well as data for DISC-3405 in polycythemia vera and sickle cell disease.Morgan Stanley maintained its overweight","market":"us","thumbnail":null,"type":0,"news_type":0,"thumbnails":[],"rights":null,"property":[],"language":"en","translate_title":"","themeId":null,"theme_name":"","theme_type":"","isJumpTheme":false,"source_url":"https://www.mtnewswires.com/","is_publish_highlight":false,"source_rank":0,"column":"","sentiment":"1","news_top_title":null,"news_tag":"","news_rank":0,"length":0,"strategy_id":0,"source":"mtnewswires_news","symbols":["LU1668664300.SGD","LU1732799900.SGD","LU0234570918.USD","LU0267386448.USD","LU1720051017.SGD","LU0106831901.USD","LU1989772840.SGD","LU1989772923.USD","LU0320765646.SGD","LU1244550494.USD","LU2023251221.USD","BK4127","LU2089284900.SGD","LU2271345857.HKD","MS","IE00BZ1G4Q59.USD","LU1363072403.SGD","LU1732800096.USD","LU2028103732.USD","LU0158827948.USD","LU0098860793.USD","LU0971096721.USD","LU2347655156.SGD","LU1791710582.SGD","LU0557290698.USD","LU0106261372.USD","LU2133065610.SGD","LU0225283273.USD","BK4585","LU0795875086.SGD","LU1244550577.SGD","LU0314104364.USD","LU0882574139.USD","BK4534","BK4139","LU0053671581.USD","LU0158827781.USD","LU2089283258.USD","LU0528227936.USD","LU2357305700.SGD","LU0795875169.SGD","LU0912757837.SGD","LU1720051108.HKD","LU1791710400.SGD","LU2111349929.HKD","BK4581","BK4504","IRON","LU0006306889.USD","IE00BKVL7J92.USD"],"gpt_icon":0},{"id":"2612465657","title":"Wedbush Adjusts Price Target on Disc Medicine to $88 From $110, Maintains Outperform Rating","url":"https://stock-news.laohu8.com/highlight/detail?id=2612465657","media":"MT Newswires Live","labels":[],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2612465657?lang=en_us&edition=fundamental","pubTime":"2026-02-17 23:52","pubTimestamp":1771343541,"startTime":"0","endTime":"0","summary":"Disc Medicine (IRON) has an average rating of buy and mean price target of $102.58, according to analysts polled by FactSet.(MT Newswires covers equity, commodity and economic research from major bank","market":"hk","thumbnail":null,"type":0,"news_type":0,"thumbnails":[],"rights":null,"property":["rate"],"language":"en","translate_title":"","themeId":null,"theme_name":"","theme_type":"","isJumpTheme":false,"source_url":"https://www.mtnewswires.com/","is_publish_highlight":false,"source_rank":0,"column":"","sentiment":"-1","news_top_title":null,"news_tag":"","news_rank":0,"length":0,"strategy_id":0,"source":"mtnewswires_news","symbols":["IRON"],"gpt_icon":0},{"id":"2612946556","title":"Disc Medicine Inc. i details bitopertin regulatory update and clinical trial progress","url":"https://stock-news.laohu8.com/highlight/detail?id=2612946556","media":"Reuters","labels":[],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2612946556?lang=en_us&edition=fundamental","pubTime":"2026-02-17 23:46","pubTimestamp":1771343161,"startTime":"0","endTime":"0","summary":"Disc Medicine Inc. provided an update on the regulatory status of bitopertin for erythropoietic porphyrias. The company received a Complete Response Letter from the FDA, which requested additional evidence of efficacy based on clinical endpoints and results from the ongoing Phase 3 APOLLO study. Disc Medicine plans to complete the APOLLO study and submit the data, including updated safety information, in response to the FDA’s request. You can access the full presentation through the link below.Disclaimer: This news brief was created by Public Technologies  using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Disc Medicine Inc. i published the original content used to generate this news brief on February 17, 2026, and is solely responsible for the information contained therein.","market":"fut","thumbnail":null,"type":0,"news_type":0,"thumbnails":[],"rights":null,"property":[],"language":"en","translate_title":"","themeId":null,"theme_name":"","theme_type":"","isJumpTheme":false,"source_url":"https://api.refinitiv.com/data/news/v1/stories/urn:newsml:reuters.com:20260217:nNDL5y52Lz:1","is_publish_highlight":false,"source_rank":0,"column":"","sentiment":"1","news_top_title":null,"news_tag":"","news_rank":0,"length":0,"strategy_id":0,"source":null,"symbols":["LU0053671581.USD","IRON","BK4139"],"gpt_icon":0},{"id":"2612046858","title":"Disc Medicine Is Maintained at Overweight by Wells Fargo","url":"https://stock-news.laohu8.com/highlight/detail?id=2612046858","media":"Dow Jones","labels":[],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2612046858?lang=en_us&edition=fundamental","pubTime":"2026-02-17 22:29","pubTimestamp":1771338540,"startTime":"0","endTime":"0","summary":"Ratings actions from Benzinga: https://www.benzinga.com/quote/IRON/analyst-ratings \n\n\n \n\n\n  (END) Dow Jones Newswires\n\n\n  February 17, 2026 09:29 ET (14:29 GMT)","market":"hk","thumbnail":null,"type":0,"news_type":0,"thumbnails":[],"rights":null,"property":["rate"],"language":"en","translate_title":"","themeId":null,"theme_name":"","theme_type":"","isJumpTheme":false,"source_url":"https://dowjonesnews.com/newdjn/logon.aspx?AL=N","is_publish_highlight":false,"source_rank":0,"column":"","sentiment":"1","news_top_title":null,"news_tag":"","news_rank":0,"length":0,"strategy_id":0,"source":null,"symbols":["IRON"],"gpt_icon":0},{"id":"2612450820","title":"Disc Medicine eyes standard US approval for drug after FDA denies fast-track nod","url":"https://stock-news.laohu8.com/highlight/detail?id=2612450820","media":"Reuters","labels":["policyRegulatory"],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2612450820?lang=en_us&edition=fundamental","pubTime":"2026-02-17 21:52","pubTimestamp":1771336323,"startTime":"0","endTime":"0","summary":"UPDATE 3-Disc Medicine eyes standard US approval for drug after FDA denies fast-track nodUpdates shares, adds analyst comment in paragraph 5 and 12By Siddhi Mahatole. Most companies then seek traditional approval from the agency, which typically leads to higher use and better insurance coverage.While the policy debate around accelerated approval has been going on for years, \"recent decisions have indicated an increasingly stringent approach to this question of when an accelerated approval is appropriate,\" CEO John Quisel said.Quisel said he expects a potential decision on traditional approval around mid-2027.The company expects late-stage data on the drug in the fourth quarter this year, but modifying the trial \"is not on the menu right now,\" he added.Seigerman said that late-stage trial design \"gives us confidence in the potential for positive results in late 2026.\"Quisel said that \"there was no obvious skepticism apparent in information requests as we went along\" and added that the f","market":"nz","thumbnail":null,"type":0,"news_type":0,"thumbnails":[],"rights":null,"property":[],"language":"en","translate_title":"","themeId":null,"theme_name":"","theme_type":"","isJumpTheme":false,"source_url":"https://api.refinitiv.com/data/news/v1/stories/urn:newsml:reuters.com:20260217:nL4N3ZD10R:1","is_publish_highlight":false,"source_rank":0,"column":"","sentiment":"-1","news_top_title":null,"news_tag":"policyRegulatory","news_rank":0,"length":0,"strategy_id":0,"source":null,"symbols":["BK4139","LU0053671581.USD","IRON"],"gpt_icon":0},{"id":"2612045782","title":"Disc Medicine price target lowered to $75 from $120 at Morgan Stanley","url":"https://stock-news.laohu8.com/highlight/detail?id=2612045782","media":"TIPRANKS","labels":[],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2612045782?lang=en_us&edition=fundamental","pubTime":"2026-02-17 21:15","pubTimestamp":1771334139,"startTime":"0","endTime":"0","summary":"Morgan Stanley lowered the firm’s price target on Disc Medicine (IRON) to $75 from $120 and keeps an Overweight rating on the shares. While the fir...","market":"us","thumbnail":null,"type":0,"news_type":0,"thumbnails":[],"rights":{"source":"tipranks_highlight","url":"https://www.tipranks.com/news/the-fly/disc-medicine-price-target-lowered-to-75-from-120-at-morgan-stanley-thefly-news?utm_source=itigerup.com&utm_medium=referral","rn_cache_url":null,"directOrigin":true},"property":["rate"],"language":"en","translate_title":"","themeId":null,"theme_name":"","theme_type":"","isJumpTheme":false,"source_url":"https://www.tipranks.com/news/the-fly/disc-medicine-price-target-lowered-to-75-from-120-at-morgan-stanley-thefly-news?utm_source=itigerup.com&utm_medium=referral","is_publish_highlight":false,"source_rank":0,"column":"","sentiment":"-1","news_top_title":null,"news_tag":"","news_rank":0,"length":0,"strategy_id":0,"source":"tipranks_highlight","symbols":["IRON"],"gpt_icon":0},{"id":"2612452776","title":"Disc Medicine Exec Says That IF Late-Stage Trial Succeeds, Co Will Seek Approval Through the Traditional Pathway Rather Than the Accelerated Route – Conf Call","url":"https://stock-news.laohu8.com/highlight/detail?id=2612452776","media":"THOMSON REUTERS","labels":[],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2612452776?lang=en_us&edition=fundamental","pubTime":"2026-02-17 21:11","pubTimestamp":1771333892,"startTime":"0","endTime":"0","summary":null,"market":"fut","thumbnail":null,"type":0,"news_type":0,"thumbnails":[],"rights":null,"property":[],"language":"en","translate_title":"","themeId":null,"theme_name":"","theme_type":"","isJumpTheme":false,"source_url":"https://api.refinitiv.com/data/news/v1/stories/urn:newsml:reuters.com:20260217:nFWN3ZD0SB:2","is_publish_highlight":false,"source_rank":0,"column":"","sentiment":"0","news_top_title":null,"news_tag":"","news_rank":0,"length":0,"strategy_id":0,"source":"reuters_en_live","symbols":["IRON","BK4139","LU0053671581.USD"],"gpt_icon":0},{"id":"2612452089","title":"Disc Medicine Exec Says It Expects Late-Stage Data for Bitopertin in Q4 This Year – Conf Call","url":"https://stock-news.laohu8.com/highlight/detail?id=2612452089","media":"THOMSON REUTERS","labels":[],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2612452089?lang=en_us&edition=fundamental","pubTime":"2026-02-17 21:11","pubTimestamp":1771333892,"startTime":"0","endTime":"0","summary":null,"market":"nz","thumbnail":null,"type":0,"news_type":0,"thumbnails":[],"rights":null,"property":[],"language":"en","translate_title":"","themeId":null,"theme_name":"","theme_type":"","isJumpTheme":false,"source_url":"https://api.refinitiv.com/data/news/v1/stories/urn:newsml:reuters.com:20260217:nFWN3ZD0SB:3","is_publish_highlight":false,"source_rank":0,"column":"","sentiment":"0","news_top_title":null,"news_tag":"","news_rank":0,"length":0,"strategy_id":0,"source":"reuters_en_live","symbols":["LU0053671581.USD","IRON","BK4139"],"gpt_icon":0},{"id":"2612246452","title":"Disc Medicine Exec Says the Policy Debate Over Accelerated Approval Has Stretched Across Multiple Administrations, and Recent Decisions Show Regulators Are Taking an \"Increasingly Stringent\" View of When Such Approvals Are Appropriate – Conf Call","url":"https://stock-news.laohu8.com/highlight/detail?id=2612246452","media":"THOMSON REUTERS","labels":[],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2612246452?lang=en_us&edition=fundamental","pubTime":"2026-02-17 21:11","pubTimestamp":1771333892,"startTime":"0","endTime":"0","summary":null,"market":"nz","thumbnail":null,"type":0,"news_type":0,"thumbnails":[],"rights":null,"property":[],"language":"en","translate_title":"","themeId":null,"theme_name":"","theme_type":"","isJumpTheme":false,"source_url":"https://api.refinitiv.com/data/news/v1/stories/urn:newsml:reuters.com:20260217:nFWN3ZD0SB:1","is_publish_highlight":false,"source_rank":0,"column":"","sentiment":"0","news_top_title":null,"news_tag":"","news_rank":0,"length":0,"strategy_id":0,"source":"reuters_en_live","symbols":["BK4139","LU0053671581.USD","IRON"],"gpt_icon":0},{"id":"2612745264","title":"Disc Medicine Addresses FDA Rejection of Bitopertin Filing","url":"https://stock-news.laohu8.com/highlight/detail?id=2612745264","media":"TIPRANKS","labels":["policyRegulatory"],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2612745264?lang=en_us&edition=fundamental","pubTime":"2026-02-17 20:57","pubTimestamp":1771333073,"startTime":"0","endTime":"0","summary":"Disc Medicine ( ($IRON) ) just unveiled an announcement. Disc Medicine, Inc., a biopharmaceutical company developing therapies for hematologic dise...","market":"fut","thumbnail":null,"type":0,"news_type":0,"thumbnails":[],"rights":{"source":"tipranks_highlight","url":"https://www.tipranks.com/news/company-announcements/disc-medicine-addresses-fda-rejection-of-bitopertin-filing?utm_source=itigerup.com&utm_medium=referral","rn_cache_url":null,"directOrigin":true},"property":[],"language":"en","translate_title":"","themeId":null,"theme_name":"","theme_type":"","isJumpTheme":false,"source_url":"https://www.tipranks.com/news/company-announcements/disc-medicine-addresses-fda-rejection-of-bitopertin-filing?utm_source=itigerup.com&utm_medium=referral","is_publish_highlight":false,"source_rank":0,"column":"","sentiment":"-1","news_top_title":null,"news_tag":"policyRegulatory","news_rank":0,"length":0,"strategy_id":0,"source":"tipranks_highlight","symbols":["BK4139","LU0053671581.USD","IRON"],"gpt_icon":0},{"id":"2612452644","title":"Disc Medicine (IRON) Receives a Buy from Cantor Fitzgerald","url":"https://stock-news.laohu8.com/highlight/detail?id=2612452644","media":"TIPRANKS","labels":[],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2612452644?lang=en_us&edition=fundamental","pubTime":"2026-02-17 20:55","pubTimestamp":1771332950,"startTime":"0","endTime":"0","summary":"Cantor Fitzgerald analyst Kristen Kluska maintained a Buy rating on Disc Medicine on February 13 and set a price target of $125.00. The company’s s...","market":"nz","thumbnail":null,"type":0,"news_type":0,"thumbnails":[],"rights":{"source":"tipranks_highlight","url":"https://www.tipranks.com/news/blurbs/disc-medicine-iron-receives-a-buy-from-cantor-fitzgerald-blurbs-news?utm_source=itigerup.com&utm_medium=referral","rn_cache_url":null,"directOrigin":true},"property":[],"language":"en","translate_title":"","themeId":null,"theme_name":"","theme_type":"","isJumpTheme":false,"source_url":"https://www.tipranks.com/news/blurbs/disc-medicine-iron-receives-a-buy-from-cantor-fitzgerald-blurbs-news?utm_source=itigerup.com&utm_medium=referral","is_publish_highlight":false,"source_rank":0,"column":"","sentiment":"1","news_top_title":null,"news_tag":"","news_rank":0,"length":0,"strategy_id":0,"source":"tipranks_highlight","symbols":["BK4139","LU0053671581.USD","IRON"],"gpt_icon":0},{"id":"2612545628","title":"Disc Medicine: Long‑Term Value Intact as Bitopertin Shifts to Lower‑Risk Traditional Approval Path","url":"https://stock-news.laohu8.com/highlight/detail?id=2612545628","media":"TIPRANKS","labels":["productRelease"],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2612545628?lang=en_us&edition=fundamental","pubTime":"2026-02-17 19:16","pubTimestamp":1771326961,"startTime":"0","endTime":"0","summary":"H.C. Wainwright analyst Douglas Tsao has maintained their bullish stance on IRON stock, giving a Buy rating yesterday. Douglas Tsao has given his B...","market":"nz","thumbnail":null,"type":0,"news_type":0,"thumbnails":[],"rights":{"source":"tipranks_highlight","url":"https://www.tipranks.com/news/ratings/disc-medicine-long‑term-value-intact-as-bitopertin-shifts-to-lower‑risk-traditional-approval-path-ratings-news?utm_source=itigerup.com&utm_medium=referral","rn_cache_url":null,"directOrigin":true},"property":[],"language":"en","translate_title":"","themeId":null,"theme_name":"","theme_type":"","isJumpTheme":false,"source_url":"https://www.tipranks.com/news/ratings/disc-medicine-long‑term-value-intact-as-bitopertin-shifts-to-lower‑risk-traditional-approval-path-ratings-news?utm_source=itigerup.com&utm_medium=referral","is_publish_highlight":false,"source_rank":0,"column":"","sentiment":"1","news_top_title":null,"news_tag":"productRelease","news_rank":0,"length":0,"strategy_id":0,"source":"tipranks_highlight","symbols":["BK4139","LU0053671581.USD","IRON"],"gpt_icon":0},{"id":"2612455078","title":"FDA 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Have Conflicting Sentiments on These Healthcare Companies: Crispr Therapeutics AG (CRSP), Moderna (MRNA) and Disc Medicine (IRON)","url":"https://stock-news.laohu8.com/highlight/detail?id=2611485675","media":"TIPRANKS","labels":[],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2611485675?lang=en_us&edition=fundamental","pubTime":"2026-02-16 21:10","pubTimestamp":1771247427,"startTime":"0","endTime":"0","summary":"Companies in the Healthcare sector have received a lot of coverage today as analysts weigh in on Crispr Therapeutics AG (CRSP – Research Report), M...","market":"fut","thumbnail":null,"type":0,"news_type":0,"thumbnails":[],"rights":{"source":"tipranks_highlight","url":"https://www.tipranks.com/news/blurbs/analysts-have-conflicting-sentiments-on-these-healthcare-companies-crispr-therapeutics-ag-crsp-moderna-mrna-and-disc-medicine-iron-blurbs-news?utm_source=itigerup.com&utm_medium=referral","rn_cache_url":null,"directOrigin":true},"property":[],"language":"en","translate_title":"","themeId":null,"theme_name":"","theme_type":"","isJumpTheme":false,"source_url":"https://www.tipranks.com/news/blurbs/analysts-have-conflicting-sentiments-on-these-healthcare-companies-crispr-therapeutics-ag-crsp-moderna-mrna-and-disc-medicine-iron-blurbs-news?utm_source=itigerup.com&utm_medium=referral","is_publish_highlight":false,"source_rank":0,"column":"","sentiment":"0","news_top_title":null,"news_tag":"","news_rank":0,"length":0,"strategy_id":0,"source":"tipranks_highlight","symbols":["CRSP","BK4611","HCSG","BK4568","BK4556","XBI","IRON","BK4548","LU1861559042.SGD","LU0128526141.USD","BK4210","LU1861558580.USD","LU0029874061.USD","LU0053671581.USD","BK4139","BK4534","MRNA","BK4532","BK4137","BK4501","AG","BK4533","BK4581","BK4585","XLV","LABU","BK4551","BK4588"],"gpt_icon":0},{"id":"2611193362","title":"Disc Medicine EPP Treatment Fails to Get FDA Accelerated Approval","url":"https://stock-news.laohu8.com/highlight/detail?id=2611193362","media":"Dow Jones","labels":["policyRegulatory"],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2611193362?lang=en_us&edition=fundamental","pubTime":"2026-02-14 05:14","pubTimestamp":1771017240,"startTime":"0","endTime":"0","summary":"Disc Medicine received a complete response letter from the Food and Drug Administration denying it accelerated approval of its bitopertin treatment for erythropoietic protoporphyria, a metabolic disorder causing photosensitivity.The FDA said results of the company's ongoing Phase 3 study could serve as evidence to support traditional approval. Topline data from the study is expected in the fourth quarter.Following the trial, Disc would then file a response to the complete response letter and expect an updated FDA ruling by mid-2027.\"We are committed to delivering bitopertin to patients, knowing how critical this potentially disease-modifying therapy is to the EPP community. While our efforts at utilizing expedited pathways to get bitopertin to patients quickly have not come to fruition, we are continuing to pursue all avenues in support of FDA approval,\" said Chief Executive John Quisel.","market":"us","thumbnail":null,"type":0,"news_type":0,"thumbnails":[],"rights":null,"property":[],"language":"en","translate_title":"","themeId":null,"theme_name":"","theme_type":"","isJumpTheme":false,"source_url":"https://dowjonesnews.com/newdjn/logon.aspx?AL=N","is_publish_highlight":false,"source_rank":0,"column":"","sentiment":"-2","news_top_title":null,"news_tag":"policyRegulatory","news_rank":0,"length":0,"strategy_id":0,"source":null,"symbols":["BK4582","LU0053671581.USD","IRON","BK4139","EPP"],"gpt_icon":0},{"id":"2611198827","title":"BUZZ-Disc Medicine dives as FDA declines to approve rare disease drug","url":"https://stock-news.laohu8.com/highlight/detail?id=2611198827","media":"Reuters","labels":["policyRegulatory"],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2611198827?lang=en_us&edition=fundamental","pubTime":"2026-02-14 04:27","pubTimestamp":1771014475,"startTime":"0","endTime":"0","summary":"BUZZ-Disc Medicine dives as FDA declines to approve rare disease drug** Disc Medicine's IRON.O shares down 28.4% at $51.3** Blood disease-focused biopharma says U.S. FDA has declined to approve Bitopertin, its rare genetic disorder treatment** Bitopertin has been under review for accelerated approval and as part of the Commissioner's National Priority Voucher pilot program** FDA indicated a need to see the results of the ongoing late-stage APOLLO study before making a decision - IRON** Topline data from APOLLO study expected in Q4** Including session losses, stock down roughly 41% YTD","market":"us","thumbnail":null,"type":0,"news_type":0,"thumbnails":[],"rights":null,"property":[],"language":"en","translate_title":"","themeId":null,"theme_name":"","theme_type":"","isJumpTheme":false,"source_url":"https://api.refinitiv.com/data/news/v1/stories/urn:newsml:reuters.com:20260213:nL4N3Z91UL:1","is_publish_highlight":false,"source_rank":0,"column":"","sentiment":"-2","news_top_title":null,"news_tag":"policyRegulatory","news_rank":0,"length":0,"strategy_id":0,"source":null,"symbols":["LU0053671581.USD","IRON","BK4139"],"gpt_icon":0},{"id":"2611160024","title":"Disc Medicine down 32% to $49 after confirming rejection letter from FDA","url":"https://stock-news.laohu8.com/highlight/detail?id=2611160024","media":"TIPRANKS","labels":["policyRegulatory"],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2611160024?lang=en_us&edition=fundamental","pubTime":"2026-02-14 04:15","pubTimestamp":1771013712,"startTime":"0","endTime":"0","summary":"15:10 EST Disc Medicine (IRON) down 32% to $49 after confirming rejection letter from FDA Published first on TheFly – the ultimate source for real-...","market":"fut","thumbnail":null,"type":0,"news_type":0,"thumbnails":[],"rights":{"source":"tipranks_highlight","url":"https://www.tipranks.com/news/the-fly/disc-medicine-down-32-to-49-after-confirming-rejection-letter-from-fda-thefly?utm_source=itigerup.com&utm_medium=referral","rn_cache_url":null,"directOrigin":true},"property":[],"language":"en","translate_title":"","themeId":null,"theme_name":"","theme_type":"","isJumpTheme":false,"source_url":"https://www.tipranks.com/news/the-fly/disc-medicine-down-32-to-49-after-confirming-rejection-letter-from-fda-thefly?utm_source=itigerup.com&utm_medium=referral","is_publish_highlight":false,"source_rank":0,"column":"","sentiment":"-2","news_top_title":null,"news_tag":"policyRegulatory","news_rank":0,"length":0,"strategy_id":0,"source":"tipranks_highlight","symbols":["BK4139","LU0053671581.USD","IRON"],"gpt_icon":0},{"id":"2611198882","title":"Disc Medicine confirms complete response letter from FDA for bitopertin","url":"https://stock-news.laohu8.com/highlight/detail?id=2611198882","media":"TIPRANKS","labels":["policyRegulatory"],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2611198882?lang=en_us&edition=fundamental","pubTime":"2026-02-14 04:10","pubTimestamp":1771013417,"startTime":"0","endTime":"0","summary":"Disc Medicine (IRON) announced that the Food and Drug Administration issued a complete response letter for for bitopertin as a treatment for patien...","market":"nz","thumbnail":null,"type":0,"news_type":0,"thumbnails":[],"rights":{"source":"tipranks_highlight","url":"https://www.tipranks.com/news/the-fly/disc-medicine-confirms-complete-response-letter-from-fda-for-bitopertin-thefly?utm_source=itigerup.com&utm_medium=referral","rn_cache_url":null,"directOrigin":true},"property":[],"language":"en","translate_title":"","themeId":null,"theme_name":"","theme_type":"","isJumpTheme":false,"source_url":"https://www.tipranks.com/news/the-fly/disc-medicine-confirms-complete-response-letter-from-fda-for-bitopertin-thefly?utm_source=itigerup.com&utm_medium=referral","is_publish_highlight":false,"source_rank":0,"column":"","sentiment":"0","news_top_title":null,"news_tag":"policyRegulatory","news_rank":0,"length":0,"strategy_id":0,"source":"tipranks_highlight","symbols":["LU0053671581.USD","IRON","BK4139"],"gpt_icon":0},{"id":"2611016000","title":"Disc Medicine says issue raised by FDA ‘readily 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market...","market":"fut","thumbnail":null,"type":0,"news_type":0,"thumbnails":[],"rights":{"source":"tipranks_highlight","url":"https://www.tipranks.com/news/the-fly/disc-medicine-says-issue-raised-by-fda-readily-addressable-thefly?utm_source=itigerup.com&utm_medium=referral","rn_cache_url":null,"directOrigin":true},"property":[],"language":"en","translate_title":"","themeId":null,"theme_name":"","theme_type":"","isJumpTheme":false,"source_url":"https://www.tipranks.com/news/the-fly/disc-medicine-says-issue-raised-by-fda-readily-addressable-thefly?utm_source=itigerup.com&utm_medium=referral","is_publish_highlight":false,"source_rank":0,"column":"","sentiment":"0","news_top_title":null,"news_tag":"policyRegulatory","news_rank":0,"length":0,"strategy_id":0,"source":"tipranks_highlight","symbols":["LU0053671581.USD","BK4139","IRON"],"gpt_icon":0},{"id":"2611116026","title":"US FDA declines to approve Disc Medicine's rare disease 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