Assessing Disc Medicine (IRON) Valuation After FDA Review Delay And Heightened Regulatory Focus

Simply Wall St.

Jan 18

Disc Medicine (IRON) is back in focus after the FDA extended its review of the company’s experimental therapy bitopertin, citing questions around trial data integrity and potential abuse risk. See our...

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See our...</p>\n\n<a href=\"https://simplywall.st/stocks/us/pharmaceuticals-biotech/nasdaq-iron/disc-medicine/news/assessing-disc-medicine-iron-valuation-after-fda-review-dela\">Source Link</a>\n\n</div>\n","source":"simplywall_highlight","html":"<!DOCTYPE html>\n<html>\n<head>\n<meta http-equiv=\"Content-Type\" content=\"text/html; charset=utf-8\" />\n<meta name=\"viewport\" content=\"width=device-width,initial-scale=1.0,minimum-scale=1.0,maximum-scale=1.0,user-scalable=no\"/>\n<meta name=\"format-detection\" content=\"telephone=no,email=no,address=no\" />\n<title>Assessing Disc Medicine (IRON) Valuation After FDA Review Delay And Heightened Regulatory Focus</title>\n<style type=\"text/css\">\na,abbr,acronym,address,applet,article,aside,audio,b,big,blockquote,body,canvas,caption,center,cite,code,dd,del,details,dfn,div,dl,dt,\nem,embed,fieldset,figcaption,figure,footer,form,h1,h2,h3,h4,h5,h6,header,hgroup,html,i,iframe,img,ins,kbd,label,legend,li,mark,menu,nav,\nobject,ol,output,p,pre,q,ruby,s,samp,section,small,span,strike,strong,sub,summary,sup,table,tbody,td,tfoot,th,thead,time,tr,tt,u,ul,var,video{ font:inherit;margin:0;padding:0;vertical-align:baseline;border:0 }\nbody{ font-size:16px; line-height:1.5; color:#999; background:transparent; }\n.wrapper{ overflow:hidden;word-break:break-all;padding:10px; }\nh1,h2{ font-weight:normal; line-height:1.35; margin-bottom:.6em; }\nh3,h4,h5,h6{ line-height:1.35; margin-bottom:1em; }\nh1{ font-size:24px; }\nh2{ font-size:20px; }\nh3{ font-size:18px; }\nh4{ font-size:16px; }\nh5{ font-size:14px; }\nh6{ font-size:12px; }\np,ul,ol,blockquote,dl,table{ margin:1.2em 0; }\nul,ol{ margin-left:2em; }\nul{ list-style:disc; }\nol{ list-style:decimal; }\nli,li p{ margin:10px 0;}\nimg{ max-width:100%;display:block;margin:0 auto 1em; }\nblockquote{ color:#B5B2B1; border-left:3px solid #aaa; padding:1em; }\nstrong,b{font-weight:bold;}\nem,i{font-style:italic;}\ntable{ width:100%;border-collapse:collapse;border-spacing:1px;margin:1em 0;font-size:.9em; }\nth,td{ padding:5px;text-align:left;border:1px solid #aaa; }\nth{ font-weight:bold;background:#5d5d5d; }\n.symbol-link{font-weight:bold;}\n/* header{ border-bottom:1px solid #494756; } */\n.title{ margin:0 0 8px;line-height:1.3;color:#ddd; }\n.meta {color:#5e5c6d;font-size:13px;margin:0 0 .5em; }\na{text-decoration:none; color:#2a4b87;}\n.meta .head { display: inline-block; overflow: hidden}\n.head .h-thumb { width: 30px; height: 30px; margin: 0; padding: 0; border-radius: 50%; float: left;}\n.head .h-content { margin: 0; padding: 0 0 0 9px; float: left;}\n.head .h-name {font-size: 13px; color: #eee; margin: 0;}\n.head .h-time {font-size: 11px; color: #7E829C; margin: 0;line-height: 11px;}\n.small {font-size: 12.5px; display: inline-block; transform: scale(0.9); -webkit-transform: scale(0.9); transform-origin: left; -webkit-transform-origin: left;}\n.smaller {font-size: 12.5px; display: inline-block; transform: scale(0.8); -webkit-transform: scale(0.8); transform-origin: left; -webkit-transform-origin: left;}\n.bt-text {font-size: 12px;margin: 1.5em 0 0 0}\n.bt-text p {margin: 0}\n</style>\n</head>\n<body>\n<div class=\"wrapper\">\n<header>\n<h2 class=\"title\">\nAssessing Disc Medicine (IRON) Valuation After FDA Review Delay And Heightened Regulatory Focus\n</h2>\n\n<h4 class=\"meta\">\n\n\n2026-01-18 13:19 GMT+8&nbsp;&nbsp;&nbsp;<a href=https://simplywall.st/stocks/us/pharmaceuticals-biotech/nasdaq-iron/disc-medicine/news/assessing-disc-medicine-iron-valuation-after-fda-review-dela><strong>Simply Wall St.</strong></a>\n\n\n</h4>\n\n</header>\n<article>\n<div>\n<p>Disc Medicine (IRON) is back in focus after the FDA extended its review of the company’s experimental therapy bitopertin, citing questions around trial data integrity and potential abuse risk. See our...</p>\n\n<a href=\"https://simplywall.st/stocks/us/pharmaceuticals-biotech/nasdaq-iron/disc-medicine/news/assessing-disc-medicine-iron-valuation-after-fda-review-dela\">Source Link</a>\n\n</div>\n\n\n</article>\n</div>\n</body>\n</html>\n","isBrief":false,"type":0,"news_type":1,"symbol":"DCF","symbol_name":"Dreyfus Alcentra Global Credit Income 2024 Target Term Fund, Inc","start_time":0,"source_url":"https://simplywall.st/stocks/us/pharmaceuticals-biotech/nasdaq-iron/disc-medicine/news/assessing-disc-medicine-iron-valuation-after-fda-review-dela","article_id":"2604392797","we_media_id":null,"thumbnails":["https://images.simplywall.st/asset/industry/6111000-choice1-main-header/1585186710114"],"rights":{"source":"simplywall_highlight","url":"https://simplywall.st/stocks/us/pharmaceuticals-biotech/nasdaq-iron/disc-medicine/news/assessing-disc-medicine-iron-valuation-after-fda-review-dela","rn_cache_url":null,"directOrigin":true},"url":"https://stock-news.laohu8.com/highlight/detail?id=2604392797","pubTimestamp":1768713554,"columns":[],"sourceInfo":{"source_id":"simplywall_highlight","name":"Simply Wall St."},"weMediaInfo":null,"summary":"Disc Medicine (IRON) is back in focus after the FDA extended its review of the company’s experimental therapy bitopertin, citing questions around trial data integrity and potential abuse risk.\nSee our latest analysis for Disc Medicine.\nThose FDA questions and the recent executive hire have played out against a softer tape, with the 7 day share price return of 9.23% and 90 day share price return of 18.63% contrasting with a 1 year total shareholder return of 21.78% and a very large 3 year...","collect":0,"end_time":0,"defaultTopTitle":"simplywall.st","property":[],"viewcount":null,"language":"en","relate_stocks":{"DCF":"Dreyfus Alcentra Global Credit Income 2024 Target Term Fund, Inc","BK4139":"生物科技","IRON":"Disc Medicine","LU0053671581.USD":"摩根大通美国小盘成长股 A(dist)"},"translate_title":"在FDA审查延迟和监管重点加强后评估椎间盘药物（铁）的估值","themeId":null,"isJumpTheme":false,"ttsUrl":null,"symbols_score_info":{"DCF":1,"IRON":1.5},"content_text":"Disc Medicine (IRON) is back in focus after the FDA extended its review of the company’s experimental therapy bitopertin, citing questions around trial data integrity and potential abuse risk. See our latest analysis for Disc Medicine. Those FDA questions and the recent executive hire have played out against a softer tape, with the 7 day share price return of 9.23% and 90 day share price return of 18.63% contrasting with a 1 year total shareholder return of 21.78% and a very large 3 year total shareholder return around 3.3x. This suggests long term holders have still seen strong gains even as near term momentum has cooled. If regulatory headlines around Disc Medicine have you rethinking your watchlist, this could be a good moment to scan other healthcare stocks that might fit your risk and return preferences. With Disc Medicine trading at US$70.93 versus an average analyst target around US$122, and an intrinsic value estimate suggesting an even deeper discount, you have to ask: is this a genuine mispricing, or is the market already incorporating the growth story into the price? AdvertisementPrice to Book of 4.7x: Is it justified? Disc Medicine closed at US$70.93, and on a P/B of 4.7x it is described as expensive relative to the broader US biotech group, but cheaper than its closer peer set. P/B compares the market value of the company to the book value of its net assets. It is a common yardstick for early stage biopharma that does not yet produce meaningful revenue or profits. For a clinical stage name like Disc Medicine, that ratio often reflects how investors weigh the pipeline, balance sheet and expected dilution. Here, the picture is mixed. The stock is flagged as expensive versus the US Biotechs industry average P/B of 2.6x, which suggests investors are paying a higher price than the sector norm for each dollar of net assets. At the same time, it is described as good value against a peer average P/B of 12.8x. This wide gap highlights how differently the market can price similar companies in the same space. See what the numbers say about this price — find out in our valuation breakdown. Result: Price to book of 4.7x (ABOUT RIGHT) However, you also have to weigh the risk that ongoing FDA scrutiny of bitopertin and the company’s US$181.11 million net loss could keep pressure on sentiment. Find out about the key risks to this Disc Medicine narrative. Another Take: DCF Paints a Very Different Picture While the 4.7x P/B points to a mixed picture, our DCF model presents a different view, with an estimated fair value of about US$571.45 per share versus the current US$70.93. That is a very large implied gap. This raises the question of whether this is a sign of opportunity or a sign that the model is too optimistic for a zero revenue, loss making biotech. Look into how the SWS DCF model arrives at its fair value. IRON Discounted Cash Flow as at Jan 2026Simply Wall St performs a discounted cash flow (DCF) on every stock in the world every day (check out Disc Medicine for example). We show the entire calculation in full. You can track the result in your watchlist or portfolio and be alerted when this changes, or use our stock screener to discover 873 undervalued stocks based on their cash flows. If you save a screener we even alert you when new companies match - so you never miss a potential opportunity.  Build Your Own Disc Medicine Narrative If this view does not quite match your own, or you would prefer to test the assumptions yourself, you can build a personalised story in just a few minutes with Do it your way. A great starting point for your Disc Medicine research is our analysis highlighting 3 key rewards and 3 important warning signs that could impact your investment decision. Looking for more investment ideas? If Disc Medicine is on your radar, do not stop there. Use this moment to round out your watchlist with a few focused ideas that match your style.  Target high potential upstarts by scanning these 3529 penny stocks with strong financials that pair smaller market caps with stronger financial foundations. Tap into the AI trend across healthcare by checking out these 109 healthcare AI stocks and see which businesses align with your thesis. Prioritise cash flow support by reviewing these 12 dividend stocks with yields > 3% that currently offer yields above 3%.   This article by Simply Wall St is general in nature. We provide commentary based on historical data\n    and analyst forecasts only using an unbiased methodology and our articles are not intended to be financial advice. It does not constitute a recommendation to buy or sell any stock, and does not take account of your objectives, or your\n    financial situation. We aim to bring you long-term focused analysis driven by fundamental data.\n    Note that our analysis may not factor in the latest price-sensitive company announcements or qualitative material.\n    Simply Wall St has no position in any stocks mentioned.New: Manage All Your Stock Portfolios in One PlaceWe've created the ultimate portfolio companion for stock investors, and it's free.• Connect an unlimited number of Portfolios and see your total in one currency• Be alerted to new Warning Signs or Risks via email or mobile• Track the Fair Value of your stocksTry a Demo Portfolio for FreeHave feedback on this article? Concerned about the content? Get in touch with us directly. Alternatively, email editorial-team@simplywallst.com","kind":"highlight","is_publish_news":true,"is_publish_highlight":false,"is_publish_live":false,"is_publish_wemedia":null,"editions":null,"column":"","sentiment":"-1","news_tag":"policyRegulatory","news_rank":0,"symbols":[],"gpt_button":0,"need_auth":false,"code":"91000000","status":"200"}}}