Did Gedatolisib’s Phase 3 PFS and Tolerability Data Just Shift Celcuity’s (CELC) Investment Narrative?

Simply Wall St.

12/16

Celcuity Inc. recently reported updated Phase 3 VIKTORIA-1 results for its PAM inhibitor gedatolisib in HR+/HER2-, PIK3CA wild-type advanced breast cancer, highlighting substantial progression-free ...

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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: 12.5px; color: #7E829C; margin: 0;}\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\">\nDid Gedatolisib’s Phase 3 PFS and Tolerability Data Just Shift Celcuity’s (CELC) Investment Narrative?\n</h2>\n<h4 class=\"meta\">\n<p class=\"head\">\n<strong class=\"h-name small\">Simply Wall St.</strong><span class=\"h-time small\">2025-12-16 03:24</span>\n</p>\n</h4>\n</header>\n<article>\n<div>\n<p>Celcuity Inc. recently reported updated Phase 3 VIKTORIA-1 results for its PAM inhibitor gedatolisib in HR+/HER2-, PIK3CA wild-type advanced breast cancer, highlighting substantial progression-free ...</p>\n\n<a href=\"https://simplywall.st/stocks/us/pharmaceuticals-biotech/nasdaq-celc/celcuity/news/did-gedatolisibs-phase-3-pfs-and-tolerability-data-just-shif\">网页链接</a>\n\n</div>\n\n<div class=\"bt-text\">\n\n\n<p> 來源：<a href=\"https://simplywall.st/stocks/us/pharmaceuticals-biotech/nasdaq-celc/celcuity/news/did-gedatolisibs-phase-3-pfs-and-tolerability-data-just-shif\">Simply Wall St.</a></p>\n<p>為提升您的閱讀體驗，我們對本頁面進行了排版優化</p>\n\n\n</div>\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-celc/celcuity/news/did-gedatolisibs-phase-3-pfs-and-tolerability-data-just-shif","article_id":"2591262060","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-celc/celcuity/news/did-gedatolisibs-phase-3-pfs-and-tolerability-data-just-shif","rn_cache_url":null,"directOrigin":true},"url":"https://stock-news.laohu8.com/highlight/detail?id=2591262060","pubTimestamp":1765826696,"columns":[],"sourceInfo":{"source_id":"simplywall_highlight","name":"Simply Wall St."},"weMediaInfo":null,"summary":"Celcuity Inc. recently reported updated Phase 3 VIKTORIA-1 results for its PAM inhibitor gedatolisib in HR+/HER2-, PIK3CA wild-type advanced breast cancer, highlighting substantial progression-free survival benefits over fulvestrant in multiple patient sub-groups and geographies.\nAn interesting feature of the data is the combination of extended progression-free survival with stable glucose levels and manageable stomatitis, underscoring a differentiated tolerability profile versus many...","collect":0,"end_time":0,"defaultTopTitle":"simplywall.st","property":[],"viewcount":null,"language":"en","relate_stocks":{"BK4139":"生物科技","BK4195":"互助储蓄与抵押信贷金融服务","CELC":"Celcuity Inc","BK4211":"区域性银行","PFS":"Provident Financial Services Inc"},"translate_title":"Gedatolisib的3期PFS和耐受性数据是否改变了Celcuity(CELC)的投资叙事？","themeId":null,"isJumpTheme":false,"ttsUrl":null,"symbols_score_info":{"CELC":1.5,"PFS":1.5},"content_text":"Celcuity Inc. recently reported updated Phase 3 VIKTORIA-1 results for its PAM inhibitor gedatolisib in HR+/HER2-, PIK3CA wild-type advanced breast cancer, highlighting substantial progression-free survival benefits over fulvestrant in multiple patient sub-groups and geographies. An interesting feature of the data is the combination of extended progression-free survival with stable glucose levels and manageable stomatitis, underscoring a differentiated tolerability profile versus many targeted therapies in this setting. We’ll now examine how gedatolisib’s progression-free survival gains and manageable side effects shape Celcuity’s investment narrative following the recent news. These 11 companies survived and thrived after COVID and have the right ingredients to survive Trump's tariffs. Discover why before your portfolio feels the trade war pinch.What Is Celcuity's Investment Narrative?To own Celcuity, you have to believe gedatolisib can convert its late-stage clinical momentum into an approved, commercially meaningful therapy before funding and competition pressures bite too hard. The updated VIKTORIA-1 data from SABCS strengthens the near-term story by reinforcing earlier progression-free survival gains with cleaner safety, which supports the ongoing rolling NDA under the FDA’s RTOR program and keeps regulatory milestones front and center as the key catalysts. At the same time, the stock’s very large 12‑month move and premium price-to-book multiple suggest a lot of optimism is already reflected, while the company remains pre-revenue, loss-making and reliant on external capital. The new data may ease some efficacy and tolerability concerns, but it does little to lessen binary regulatory and financing risks. However, investors should also recognise how much future success is already priced in.\n\nCelcuity's shares have been on the rise but are still potentially undervalued. Find out how large the opportunity might be.Exploring Other PerspectivesCELC 1-Year Stock Price Chart The Simply Wall St Community’s single fair value estimate of US$488.70 per share contrasts sharply with Celcuity’s current pre-revenue status and rich valuation, inviting you to weigh breakthrough breast cancer data against ongoing approval, dilution and execution risks.Explore another fair value estimate on Celcuity - why the stock might be worth just $488.70!Build Your Own Celcuity NarrativeDisagree with this assessment? Create your own narrative in under 3 minutes - extraordinary investment returns rarely come from following the herd.A great starting point for your Celcuity research is our analysis highlighting 2 key rewards and 3 important warning signs that could impact your investment decision.Our free Celcuity research report provides a comprehensive fundamental analysis summarized in a single visual - the Snowflake - making it easy to evaluate Celcuity's overall financial health at a glance.Contemplating Other Strategies?Right now could be the best entry point. These picks are fresh from our daily scans. Don't delay:Rare earth metals are the new gold rush. Find out which 36 stocks are leading the charge.Find companies with promising cash flow potential yet trading below their fair value.Uncover the next big thing with financially sound penny stocks that balance risk and reward.  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.Mobile Infrastructure for Defense and DisasterThe next wave in robotics isn't humanoid. Its fully autonomous towers delivering 5G, ISR, and radar in under 30 minutes, anywhere.Get the investor briefing before the next round of contractsSponsored On Behalf of CiTechNew: 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":null,"editions":null,"column":"","sentiment":"1","news_tag":"dataReport","news_rank":0,"symbols":[],"gpt_button":0,"need_auth":false,"code":"91000000","status":"200"}}}