Cullinan Therapeutics (CGEM) Starts Zipalertinib NDA Submission, Is The Stock Still 52% Undervalued?

Simply Wall St.10-07

Cullinan Therapeutics (CGEM) drew fresh attention after launching a New Drug Application submission for zipalertinib plus platinum chemotherapy, using the FDA’s Real-Time Oncology Review program and ...

Source Link

Disclaimer: Investing carries risk. This is not financial advice. The above content should not be regarded as an offer, recommendation, or solicitation on acquiring or disposing of any financial products, any associated discussions, comments, or posts by author or other users should not be considered as such either. It is solely for general information purpose only, which does not consider your own investment objectives, financial situations or needs. TTM assumes no responsibility or warranty for the accuracy and completeness of the information, investors should do their own research and may seek professional advice before investing.

Comments

We need your insight to fill this gap

Leave a comment

{"i18n":{"language":"en_US"},"isChannel":false,"data":{"share":"https://ttm.financial/m/news/2673606807?lang=en_US&edition=fundamental","thumbnail":"https://simplywall.st/cdn-cgi/image/fit=cover,format=auto,width=320,height=180/https://images.simplywall.st/asset/industry/6111000-choice2-card/1788928698944","is_english":true,"pubTime":"2026-10-07 01:25","share_image_url":"https://static.laohu8.com/e9f99090a1c2ed51c021029395664489","id":"2673606807","market":"us","top_or_hot":-1,"title":"Cullinan Therapeutics (CGEM) Starts Zipalertinib NDA Submission, Is The Stock Still 52% Undervalued?","media":"Simply Wall St.","content":"<div>\n<p>Cullinan Therapeutics (CGEM) drew fresh attention after launching a New Drug Application submission for zipalertinib plus platinum chemotherapy, using the FDA’s Real-Time Oncology Review program and ...</p>\n\n<a href=\"https://simplywall.st/stocks/us/pharmaceuticals-biotech/nasdaq-cgem/cullinan-therapeutics/news/cullinan-therapeutics-cgem-starts-zipalertinib-nda-submissio\">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>Cullinan Therapeutics (CGEM) Starts Zipalertinib NDA Submission, Is The Stock Still 52% Undervalued?</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\">\nCullinan Therapeutics (CGEM) Starts Zipalertinib NDA Submission, Is The Stock Still 52% Undervalued?\n</h2>\n\n<h4 class=\"meta\">\n\n\n2026-10-07 01:25 GMT+8&nbsp;&nbsp;&nbsp;<a href=https://simplywall.st/stocks/us/pharmaceuticals-biotech/nasdaq-cgem/cullinan-therapeutics/news/cullinan-therapeutics-cgem-starts-zipalertinib-nda-submissio><strong>Simply Wall St.</strong></a>\n\n\n</h4>\n\n</header>\n<article>\n<div>\n<p>Cullinan Therapeutics (CGEM) drew fresh attention after launching a New Drug Application submission for zipalertinib plus platinum chemotherapy, using the FDA’s Real-Time Oncology Review program and ...</p>\n\n<a href=\"https://simplywall.st/stocks/us/pharmaceuticals-biotech/nasdaq-cgem/cullinan-therapeutics/news/cullinan-therapeutics-cgem-starts-zipalertinib-nda-submissio\">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":"BK4139","symbol_name":"生物科技","start_time":0,"source_url":"https://simplywall.st/stocks/us/pharmaceuticals-biotech/nasdaq-cgem/cullinan-therapeutics/news/cullinan-therapeutics-cgem-starts-zipalertinib-nda-submissio","article_id":"2673606807","we_media_id":null,"thumbnails":["https://simplywall.st/cdn-cgi/image/fit=cover,format=auto,width=320,height=180/https://images.simplywall.st/asset/industry/6111000-choice2-card/1788928698944"],"rights":{"source":"simplywall_highlight","url":"https://simplywall.st/stocks/us/pharmaceuticals-biotech/nasdaq-cgem/cullinan-therapeutics/news/cullinan-therapeutics-cgem-starts-zipalertinib-nda-submissio","rn_cache_url":null,"directOrigin":true},"url":"https://stock-news.laohu8.com/highlight/detail?id=2673606807","pubTimestamp":1791307518,"columns":[],"sourceInfo":{"source_id":"simplywall_highlight","name":"Simply Wall St."},"weMediaInfo":null,"summary":"Cullinan Therapeutics (CGEM) drew fresh attention after launching a New Drug Application submission for zipalertinib plus platinum chemotherapy, using the FDA’s Real-Time Oncology Review program and Phase 3 REZILIENT3 progression-free survival data.\nCullinan Therapeutics now trades at US$16.04, with the stock gaining 3.42% on a 1-day share price return and 5.32% over seven days, even though the 30-day share price return is down 27.39% and the 90-day return is down 12.97%.\nSet against that...","collect":0,"end_time":0,"defaultTopTitle":"simplywall.st","property":[],"viewcount":null,"language":"en","relate_stocks":{"BK4139":"生物科技","CGEM":"Cullinan Therapeutics"},"translate_title":"库里南治疗（CGEM）开始齐帕勒替尼NDA提交，该股仍被低估52%吗？","themeId":null,"isJumpTheme":false,"ttsUrl":null,"symbols_score_info":{"CGEM":1.5},"content_text":"Cullinan Therapeutics (CGEM) drew fresh attention after launching a New Drug Application submission for zipalertinib plus platinum chemotherapy, using the FDA’s Real-Time Oncology Review program and Phase 3 REZILIENT3 progression-free survival data. Cullinan Therapeutics now trades at US$16.04, with the stock gaining 3.42% on a 1-day share price return and 5.32% over seven days, even though the 30-day share price return is down 27.39% and the 90-day return is down 12.97%. Set against that short-term volatility, the year-to-date share price return of 58.50% and a 1-year total shareholder return of 172.33% point to strong momentum over the past year. By contrast, the 3-year total shareholder return of 80.63% and 5-year total shareholder return decline of 30.23% show how quickly sentiment around a pipeline story like this can change when key regulatory milestones such as the zipalertinib NDA move into focus. Scan beyond Cullinan Therapeutics and line up other biotech stories with binary catalysts using our curated list of 19 high quality undiscovered gems Cullinan Therapeutics now carries a late stage asset, a sharp share price reset, and a near US$1.0b market value. The key question is straightforward: does that mix still leave enough upside in the current valuation? AdvertisementMost Popular Narrative: 52% Undervalued The most followed narrative sees fair value for Cullinan Therapeutics at about $33.55 per share, compared with the last close at $16.04. This puts the entire argument on whether its late stage and autoimmune pipeline can justify that gap.  Progress of zipalertinib plus platinum chemotherapy in first line EGFR exon 20 insertion NSCLC, supported by a 50% reduction in risk of progression or death and a 6 month median PFS benefit in a large Phase III trial, could open a new revenue stream in a U.S. patient population that management sizes as a $1b plus addressable market across treatment lines.  See why 1 investors see Cullinan Therapeutics as 52% undervalued. The narrative builds this valuation using a $33.55 consensus target, a 7.46% discount rate and analyst assumptions that revenue rises from zero today to $70.9 million by September 2029, with profit margins eventually aligning with the 17.2% industry average. To match that profile, the stock would need to trade on a future P/E of 268.3x based on projected 2029 earnings of $12.2 million and earnings per share of $0.16, which is far above the current 18.1x P/E for the wider US biopharma peer group. Analysts in that framework are effectively saying investors must be comfortable with a long period of losses, no product revenue for now and ongoing share count growth of roughly 7% a year in exchange for the prospect of multiple T cell engager and EGFR exon 20 NSCLC franchises maturing at once. Given the wide spread between the most bullish $42.00 target and the most cautious $27.00 view, the price you see today reflects how differently the market is weighing the same zipalertinib, CLN 978, CLN 049 and velinotamig catalysts against the clinical, safety and execution risks outlined in the narrative. Result: Fair Value of $33.55 (UNDERVALUED) Still, the narrative around Cullinan Therapeutics can crack if safety concerns around zipalertinib combinations persist or if forecast revenue and earnings trajectories fall short. Find out about the key risks to this Cullinan Therapeutics narrative. Next Steps If the bullish tone around Cullinan Therapeutics feels compelling but incomplete, move fast and test that story against the balance of 1 key reward and 3 important warning signs. Looking for more investment ideas beyond Cullinan Therapeutics? Do not stop with Cullinan Therapeutics. Broaden your watchlist with a few focused stock sets that match different risk profiles and income goals.  Target resilient cash generators by scanning a list of solid balance sheet and fundamentals (25 results) that already pair stronger finances with sturdier fundamentals. Hunt for quality at a discount by reviewing a 27 high quality undervalued stocks that blend robust cash flows with appealing valuations. Prioritise stability and income potential by checking a 7 dividend fortresses designed for investors who want higher yields with support from underlying fundamentals.   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: AI Stock Screener & AlertsOur new AI Stock Screener scans the market every day to uncover opportunities.• Dividend Powerhouses (3%+ Yield)• Undervalued Small Caps with Insider Buying• High growth Tech and AI CompaniesOr build your own from over 50 metrics.Explore Now 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":false,"editions":null,"column":"","sentiment":"1","news_tag":"corporation","news_rank":0,"isVideo":false,"video":null,"symbols":[],"gpt_button":0,"need_auth":false,"need_login_tip":false,"code":"91000000","status":"200"},"commentList":[],"isCommentEnd":true,"newsSizeData":{"likeSize":0,"commentSize":0,"repostSize":0,"favoriteSize":0,"likeStatus":false,"favoriteStatus":false},"APP":{"userAgent":"Mozilla/5.0 AppleWebKit/537.36 (KHTML, like Gecko; compatible; ClaudeBot/1.0; +claudebot@anthropic.com)","isDev":false,"isTTM":true,"isLaohu8Offline":false,"tenantId":"TBGLOBAL","deviceId":"web-server-community-laohu8-v3","version":"4.52.0","shortVersion":"4.52.0","platform":"web","vendor":"web","appName":"ttm","isIOS":false,"isAndroid":false,"isTiger":false,"isTHS":false,"isWeiXin":false,"isWeiXinMini":false,"isWeiBo":false,"isQQ":false,"isBaiduSwan":false,"isBaiduBox":false,"isDingTalk":false,"isToutiao":false,"isOnePlus":false,"isHuaWei":false,"isXiaomi":false,"isXiaomiWebView":false,"isOppo":false,"isVivo":false,"isSamsung":false,"isMobile":false},"href":"/m/news/2673606807","isCrawlerRequest":true}