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Avoro Capital Advisors LLC Acquires Significant Stake in Celcuit

https://www.gurufocus.com/news/8638228/avoro-capital-advisors-llc-acquires-significant-stake-in-celcuity-inc?mobile=true
Avoro Capital Advisors LLC has acquired 3,111,111 shares of Celcuity Inc. for $99.74 per share, making it a new addition to their biotechnology-focused portfolio. This acquisition represents 3.86% of Avoro's portfolio and reflects confidence in Celcuity's oncology developments despite the latter's low GF Score and profitability/growth rankings. Celcuity is a clinical-stage biotech company with a lead therapeutic candidate, gedatolisib, for advanced breast cancer.

Avoro Capital Advisors LLC Acquires Significant Stake in Celcuit Inc

https://www.gurufocus.com/news/8638228/avoro-capital-advisors-llc-acquires-significant-stake-in-celcuity-inc
Avoro Capital Advisors LLC has acquired 3,111,111 shares of Celcuity Inc. at $99.74 per share, marking a new strategic investment in the biotechnology sector. Celcuity Inc., a clinical-stage oncology company, despite financial challenges like a low GF Score and profitability/growth ranks, shows potential with its lead candidate gedatolisib and a significant price increase since its IPO. This acquisition represents 3.86% of Avoro's portfolio, reflecting the firm's confidence in Celcuity's long-term growth.

Celcuity Inc. (CELC) Stock Analysis: Biotechnology Innovator’s 9.29% Upside Captures Investor Attention

https://www.directorstalkinterviews.com/celcuity-inc-celc-stock-analysis-biotechnology-innovator-s-9-29-upside-captures-investor-attention/4121240890
Celcuity Inc. (CELC), a clinical-stage biotechnology company, is gaining investor attention due to its innovative cancer treatment focus and a potential 9.29% upside based on analyst consensus, with an average target price of $116.70. Despite strong analyst optimism and a strategic partnership with Pfizer, the company is not yet profitable, showing negative EPS and free cash flow common for biotech firms in development, signifying inherent risks for investors. Technical indicators suggest an upward trend and a nearing oversold territory, which could be a buying opportunity for risk-tolerant investors.

Celcuity, Inc. (NASDAQ:CELC) Given Average Rating of "Moderate Buy" by Brokerages

https://www.marketbeat.com/instant-alerts/celcuity-inc-nasdaqcelc-given-average-rating-of-moderate-buy-by-brokerages-2026-02-19/
Celcuity, Inc. (NASDAQ:CELC) has received an average "Moderate Buy" rating from ten brokerages, with an average 12-month price target of $105.25. Recent analyst reports show a mix of ratings, predominantly "buy" or "outperform," with one downgrade to "sell." Insider transactions reveal recent share sales by directors, while institutional investors have been actively trading the stock, with 63.33% owned by institutional investors and 15.77% by corporate insiders.

Is It Too Late To Consider Celcuity (CELC) After Its 7x One Year Surge

https://simplywall.st/stocks/us/pharmaceuticals-biotech/nasdaq-celc/celcuity/news/is-it-too-late-to-consider-celcuity-celc-after-its-7x-one-ye
Celcuity (CELC) has seen a significant 7x surge in its stock price over the past year, leading to questions about its current valuation. A Discounted Cash Flow (DCF) analysis suggests the stock is significantly undervalued, with an estimated intrinsic value of US$556.55 per share compared to its recent price of US$104.51. However, its Price-to-Book (P/B) ratio of 41.34x is a large premium compared to the biotech industry average, indicating a more complex valuation picture.
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Commit To Purchase Celcuity At $45, Earn 17.8% Using Options

https://www.nasdaq.com/articles/commit-purchase-celcuity-45-earn-178-using-options
Investors looking at Celcuity Inc (CELC) stock, currently trading at $105.84/share, can consider selling a January 2028 put option at the $45 strike price. This strategy offers an immediate premium of $8.00, representing a 17.8% return on the $45 commitment or a 9.2% annualized rate. The put seller would only acquire shares if CELC's price drops below $45, resulting in a cost basis of $37.00 per share.

Soleus Adds a Significant Number of Celcuity Shares

https://www.theglobeandmail.com/investing/markets/stocks/DXCM/pressreleases/205042/soleus-adds-a-significant-number-of-celcuity-shares/
Soleus Capital Management L.P. significantly increased its stake in Celcuity (NASDAQ: CELC) by purchasing an additional 629,398 shares, bringing its total holdings to over 1.8 million shares valued at $180.36 million. This move makes Celcuity Soleus's third-largest holding, despite the biotechnology company currently generating no revenue and experiencing a remarkable 745% stock price increase over the last year. The article highlights Celcuity's focus on cancer diagnostics and therapies but also cautions investors about the inherent risks due to its lack of current revenue.

Is Celcuity’s New Oncology Commercial Leader Appointment Reshaping the Investment Case for CELC?

https://simplywall.st/stocks/us/pharmaceuticals-biotech/nasdaq-celc/celcuity/news/is-celcuitys-new-oncology-commercial-leader-appointment-resh
Celcuity Inc. has appointed Charles (Chip) R. Romp, an experienced oncology commercial leader, to its Board of Directors. This move is seen as strengthening Celcuity's commercialization expertise as it develops its lead asset, gedatolisib, which is currently pre-revenue and loss-making. While not a transformational change on its own, Romp's background could improve confidence in the company's ability to prepare for future product launches if FDA approvals are secured.

Celcuity Appoints Charles Romp to its Board of Directors

https://www.globenewswire.com/fr/news-release/2026/02/12/3237672/0/en/celcuity-appoints-charles-romp-to-its-board-of-directors.html
Celcuity Inc. has appointed Charles (Chip) R. Romp to its Board of Directors. Mr. Romp brings over 25 years of pharmaceutical industry experience, particularly in oncology commercialization, which will be valuable as Celcuity advances its programs, including gedatolisib. He is currently the CEO of Secura Bio and previously held senior commercial roles at Seagen and Genentech.

Ex-Seagen oncology exec joins Celcuity board for breast cancer drug push

https://www.stocktitan.net/news/CELC/celcuity-appoints-charles-romp-to-its-board-of-k4l0s7f5e4f0.html
Celcuity (Nasdaq: CELC) has appointed Charles (Chip) R. Romp, an oncology veteran with over 25 years of pharmaceutical commercial experience, to its Board of Directors, effective February 12, 2026. Romp, currently CEO of Secura Bio and former EVP, Commercial U.S. at Seagen, is expected to leverage his expertise in commercializing oncology drugs to support Celcuity's programs, particularly the potential approval and launch of its lead therapeutic candidate, gedatolisib, later in 2026. Gedatolisib is being developed for advanced breast cancer and is currently undergoing Phase 3 clinical trials.
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Celcuity Appoints Charles Romp to its Board of Directors

https://finance.yahoo.com/news/celcuity-appoints-charles-romp-board-210500736.html
Celcuity Inc., a clinical-stage biotechnology company, announced the appointment of Charles R. Romp to its Board of Directors. Romp brings over 25 years of pharmaceutical industry experience, particularly in oncology commercialization, which will be valuable as Celcuity advances its programs and prepares for the potential launch of gedatolisib. His expertise is expected to significantly contribute to the company's efforts in developing targeted therapies for oncology.

Celcuity CEO Sets July 17 PDUFA for Gedatolisib, Teases VIKTORIA-1 Mutant Data at Conference

https://www.marketbeat.com/instant-alerts/celcuity-ceo-sets-july-17-pdufa-for-gedatolisib-teases-viktoria-1-mutant-data-at-conference-2026-02-11/
Celcuity's CEO, Brian Sullivan, announced a PDUFA date of July 17 for gedatolisib, anticipating a launch shortly after approval. The company also expects to release VIKTORIA-1 Phase 3 study data for both wild-type and PIK3CA mutant cohorts prior to launch, delayed due to slower event rates. Sullivan highlighted the drug's "unprecedented" clinical profile with a hazard ratio of 0.24 and significant PFS improvement, positioning it for a potential second-line market exceeding $6 billion.

Celcuity Appoints Charles Romp to its Board of Directors

https://sg.finance.yahoo.com/news/celcuity-appoints-charles-romp-board-210500736.html
Celcuity Inc. has appointed Charles (Chip) R. Romp to its Board of Directors, bringing over 25 years of pharmaceutical industry experience, particularly in oncology commercialization. Romp's expertise is expected to be invaluable as Celcuity advances its therapeutic programs, including the potential approval and launch of gedatolisib. Celcuity is a clinical-stage biotechnology company developing targeted therapies for solid tumor indications, with gedatolisib as its lead candidate.

Celcuity Appoints Charles Romp to its Board of Directors

https://www.globenewswire.com/news-release/2026/02/12/3237672/0/en/celcuity-appoints-charles-romp-to-its-board-of-directors.html
Celcuity Inc. has appointed Charles (Chip) R. Romp to its Board of Directors, bringing over 25 years of pharmaceutical industry experience, particularly in oncology commercialization. Mr. Romp's expertise is expected to provide valuable insight as Celcuity advances its programs, including the potential approval and launch of gedatolisib. Gedatolisib, a lead therapeutic candidate, is currently undergoing Phase 3 clinical trials for HR+/HER2- advanced breast cancer.

Discipline and Rules-Based Execution in CELC Response

https://news.stocktradersdaily.com/news_release/20/Discipline_and_Rules-Based_Execution_in_CELC_Response_021226062402_1770938642.html
This article provides an in-depth analysis of Celcuity Inc. (NASDAQ: CELC), highlighting weak near and mid-term sentiment despite a positive long-term outlook. It details three AI-generated trading strategies—Position Trading, Momentum Breakout, and Risk Hedging—along with multi-timeframe signal analysis indicating support and resistance levels. The piece emphasizes disciplined, rules-based execution for trading CELC.
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Celcuity at Guggenheim Summit: Biotech Innovations Unveiled

https://www.investing.com/news/transcripts/celcuity-at-guggenheim-summit-biotech-innovations-unveiled-93CH-4500679
Celcuity presented at the Guggenheim Securities Emerging Outlook: Biotech Summit 2026, highlighting their upcoming breast cancer drug, gedatolisib. The company is preparing for an FDA decision in July, anticipating multi-billion dollar sales and maintaining a strong financial position with $450 million in cash. They also discussed its efficacy, tolerability, and market potential compared to existing therapies.

Celcuity CEO Sets July 17 PDUFA for Gedatolisib, Teases VIKTORIA-1 Mutant Data at Conference

https://finance.yahoo.com/news/celcuity-ceo-sets-july-17-044249843.html
Celcuity's CEO, Brian Sullivan, announced a PDUFA date of July 17 for gedatolisib and anticipates launching the drug shortly after approval. The company also expects to release VIKTORIA-1 mutant cohort data before the launch, providing a full dataset to physicians. Sullivan highlighted the drug's "unprecedented" clinical profile, describing a 76% reduction in risk and a five-fold improvement in PFS versus endocrine therapy, and detailed the commercial preparations and significant market opportunity.

Celcuity at Guggenheim Summit: Biotech Innovations Unveiled By Investing.com

https://in.investing.com/news/transcripts/celcuity-at-guggenheim-summit-biotech-innovations-unveiled-93CH-5235552
Celcuity presented at the Guggenheim Securities Emerging Outlook: Biotech Summit 2026, highlighting the strategic potential of its upcoming breast cancer drug, gedatolisib. The company anticipates significant market potential for gedatolisib, projecting multi-billion dollar sales, and expects a PDUFA decision by July 17th. Celcuity is also preparing for the launch by building its commercial infrastructure and is confident in its ability to execute a successful commercial launch.

CELC: Gedatolisib nears approval with strong efficacy, broad utility, and major commercial potential

https://www.tradingview.com/news/urn:summary_document_transcript:quartr.com:2803872:0-celc-gedatolisib-nears-approval-with-strong-efficacy-broad-utility-and-major-commercial-potential/
Gedatolisib, developed by Celcuity Inc. (CELC), is nearing potential approval and launch in mid-2024 following positive phase 3 data and NDA acceptance. The drug is noted for its strong efficacy and tolerability, aiming to address a multi-billion dollar U.S. market. This information is based on an AI-generated summary of Celcuity Inc.'s presentation at the Guggenheim Securities Emerging Outlook: Biotech Summit 2026.

Candriam S.C.A. Increases Holdings in Celcuity, Inc. $CELC

https://www.marketbeat.com/instant-alerts/filing-candriam-sca-increases-holdings-in-celcuity-inc-celc-2026-02-10/
Candriam S.C.A. significantly increased its stake in Celcuity, Inc. (NASDAQ:CELC) during the third quarter, boosting its holdings by 48.3% to own 390,924 shares valued at $19.3 million. Other institutional investors like Soleus Capital Management and Ameriprise Financial also raised their positions, with hedge funds and institutional investors collectively owning 63.33% of the company. Despite mixed analyst ratings, the consensus remains a "Moderate Buy" with a target price of $105.25.
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Is It Too Late To Consider Celcuity (CELC) After An 8x One Year Surge

https://simplywall.st/stocks/us/pharmaceuticals-biotech/nasdaq-celc/celcuity/news/is-it-too-late-to-consider-celcuity-celc-after-an-8x-one-yea
This article analyzes Celcuity (CELC) after a significant one-year surge, examining its valuation using discounted cash flow (DCF) and price-to-book (P/B) ratio. The DCF analysis suggests CELC is significantly undervalued, while its P/B ratio is much higher than industry averages. The article concludes by introducing the "Narratives" approach on Simply Wall St, allowing investors to compare their own views on a company's future prospects.

Director Sells 20,000 Celcuity Shares for $2.4 Million Following 933% Share Price Jump

https://www.theglobeandmail.com/investing/markets/markets-news/motley/79707/director-sells-20-000-celcuity-shares-for-2-4-million-following-933-share-price-jump/
Celcuity Director David Dalvey indirectly sold 20,000 shares for approximately $2.4 million on January 27, 2026, via Brightstone Venture Capital Fund, LP. This transaction represented 18.18% of his indirect holdings, reducing them from 110,000 to 90,000 shares. The sale occurred after Celcuity's stock delivered a 933% total return over the past year, driven by positive clinical trial results for its breast cancer drug candidate.

Celcuity to Present at Upcoming Guggenheim Emerging Outlook: Biotech Summit 2026

https://finance.yahoo.com/news/celcuity-present-upcoming-guggenheim-emerging-120500919.html
Celcuity Inc., a clinical-stage biotechnology company, announced its participation in the Guggenheim Emerging Outlook: Biotech Summit 2026 in New York. CEO Brian Sullivan is scheduled for a fireside chat on February 11, 2026, which will be webcast live. The company is advancing several clinical trials, including Phase 3 trials for gedatolisib in HR+/HER2- ABC and a Phase 1/2 trial for metastatic castration-resistant prostate cancer.

Wealth Enhancement Advisory Services LLC Sells 10,476 Shares of Celcuity, Inc. $CELC

https://www.marketbeat.com/instant-alerts/filing-wealth-enhancement-advisory-services-llc-sells-10476-shares-of-celcuity-inc-celc-2026-02-04/
Wealth Enhancement Advisory Services LLC has reduced its stake in Celcuity, Inc. by 39.9%, selling 10,476 shares and retaining 15,793 shares valued at approximately $777,000. This comes amidst significant insider selling, with directors offloading 26,900 shares worth over $3 million in the past 90 days. Celcuity (NASDAQ:CELC) has a "Moderate Buy" consensus rating from Wall Street analysts, with an average target price of $105.25.

Wolfe Research recommends buying Celcuity stock on weakness related to external catalyst

https://m.investing.com/news/analyst-ratings/wolfe-research-recommends-buying-celcuity-stock-on-weakness-related-to-external-catalyst-93CH-4485515?ampMode=1
Wolfe Research has advised investors to buy Celcuity (NASDAQ:CELC) stock on any dips caused by external factors, despite cautioning that the persevERA trial is more challenging than previous studies. The firm's recommendation follows recent positive developments, including FDA acceptance of a New Drug Application for gedatolisib with Priority Review and promising Phase 3 trial results, leading to increased price targets from Leerink Partners and Jefferies. Celcuity's stock has seen a significant 787.29% return over the past year.
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Celcuity to Present at Upcoming Guggenheim Emerging Outlook: Biotech Summit 2026

https://sg.finance.yahoo.com/news/celcuity-present-upcoming-guggenheim-emerging-120500919.html
Celcuity Inc., a clinical-stage biotechnology company, announced its participation in the Guggenheim Emerging Outlook: Biotech Summit 2026. Brian Sullivan, CEO and Co-founder, is scheduled for a fireside chat on February 11, 2026, which will be webcast live. The company will discuss its targeted therapies for oncology, including its lead therapeutic candidate, gedatolisib, currently in multiple Phase 3 and Phase 1/2 clinical trials.

Celcuity to Present at Upcoming Guggenheim Emerging Outlook: Biotech Summit 2026

https://www.globenewswire.com/news-release/2026/02/04/3231917/0/en/celcuity-to-present-at-upcoming-guggenheim-emerging-outlook-biotech-summit-2026.html
Celcuity Inc. (Nasdaq: CELC) announced its participation in the Guggenheim Emerging Outlook: Biotech Summit 2026, where CEO Brian Sullivan will conduct a fireside chat on February 11, 2026. The company, a clinical-stage biotechnology firm focused on oncology, will discuss its targeted therapies, including gedatolisib, which is currently undergoing multiple Phase 3 and Phase 1/2 clinical trials. A webcast of the event will be available on the company's website.

Celcuity to Present at Upcoming Guggenheim Emerging Outlook: Biotech Summit 2026

https://www.globenewswire.com/news-release/2026/02/04/3231917/0/en/Celcuity-to-Present-at-Upcoming-Guggenheim-Emerging-Outlook-Biotech-Summit-2026.html
Celcuity Inc. (Nasdaq: CELC) announced its participation in the Guggenheim Emerging Outlook: Biotech Summit 2026, where CEO Brian Sullivan will deliver a fireside chat on February 11, 2026. The company is a clinical-stage biotechnology firm developing targeted oncology therapies, including its lead candidate gedatolisib, which is currently undergoing multiple Phase 1, 2, and 3 clinical trials for various cancers. A live webcast and replay of the presentation will be available through the company's website.

Celcuity (CELC) Draws Investor Attention as Precision Oncology Strategy Advances

https://www.insidermonkey.com/blog/celcuity-celc-draws-investor-attention-as-precision-oncology-strategy-advances-1681386/
Apis Capital Advisors' Apis Flagship Fund highlighted Celcuity Inc (NASDAQ: CELC) as a top contributor in its Q4 2025 investor letter, attributing significant performance to stock selection in healthcare. Celcuity is a clinical-stage biotechnology company focused on precision oncology therapies, with its stock closing at $109.42 on January 30, 2026, and a market capitalization of $5.06 billion. Despite its strong performance and being held by 31 hedge funds, Insider Monkey suggests other AI stocks might offer greater returns in a shorter timeframe.

Behavioral Patterns of CELC and Institutional Flows

https://news.stocktradersdaily.com/news_release/8/Behavioral_Patterns_of_CELC_and_Institutional_Flows_020126051602_1769984162.html
This article analyzes the behavioral patterns and institutional flows for Celcuity Inc. (NASDAQ: CELC), indicating a near-term neutral sentiment amidst mid and long-term strength. It highlights an exceptional risk-reward setup targeting a 19.7% gain and presents three AI-generated trading strategies tailored to various risk profiles. The analysis also includes multi-timeframe signal analysis with support and resistance levels.
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Atle Fund Management AB Takes $1.84 Million Position in Celcuity, Inc. $CELC

https://www.marketbeat.com/instant-alerts/filing-atle-fund-management-ab-takes-184-million-position-in-celcuity-inc-celc-2026-02-01/
Atle Fund Management AB has initiated a new position in Celcuity, Inc. (NASDAQ:CELC), purchasing 37,157 shares valued at approximately $1.84 million, representing about 0.09% ownership. This move comes amid significant insider selling of Celcuity stock, totaling $3.09 million in the past 90 days. Analyst sentiment towards CELC is mixed but generally positive, with a "Moderate Buy" consensus and a target price of $105.25.

Celcuity (NASDAQ:CELC) Director Sells $2,400,600.00 in Stock

https://www.marketbeat.com/instant-alerts/celcuity-nasdaqcelc-director-sells-240060000-in-stock-2026-01-29/
Celcuity (NASDAQ:CELC) Director David Dalvey sold 20,000 shares of the company's stock for $2,400,600 on January 27, reducing his stake by 18.18%. The stock traded down to $112.12, with a market capitalization of $5.19 billion, and analysts have a "Moderate Buy" consensus rating with a target price of $105.25. Institutional investors own 63.33% of the company, with notable increases in holdings from Vanguard, Soleus Capital, and UBS Group AG.

Celcuity (CELC) Is Up 11.3% After FDA Grants Priority Review To Gedatolisib NDA - What's Changed

https://simplywall.st/stocks/us/pharmaceuticals-biotech/nasdaq-celc/celcuity/news/celcuity-celc-is-up-113-after-fda-grants-priority-review-to
Celcuity (CELC) shares rose 11.3% after the FDA granted Priority Review to its New Drug Application for gedatolisib, a multi-target PAM pathway inhibitor, for HR+/HER2-, PIK3CA wild-type advanced breast cancer. This decision sets a PDUFA goal date of July 17, 2026, and significantly impacts the company's investment narrative by crystallizing regulatory risk and timing. While this development reinforces the potential of Celcuity's approach and has driven share price increases, it also raises expectations and highlights ongoing financial risks and future execution challenges.

Celcuity (CELC) Is Up 11.3% After FDA Grants Priority Review To Gedatolisib NDA - What's Changed

https://simplywall.st/stocks/us/pharmaceuticals-biotech/nasdaq-celc/celcuity/news/celcuity-celc-is-up-113-after-fda-grants-priority-review-to/amp
Celcuity Inc. has seen its stock rise 11.3% after the FDA granted Priority Review to its New Drug Application for gedatolisib, a multi-target PAM pathway inhibitor, for HR+/HER2- breast cancer. This move solidifies a PDUFA goal date of July 17, 2026, and elevates the investment narrative around regulatory timing. While bringing higher expectations and potential for growth, it also introduces increased binary risk for investors.

Celcuity stock hits all-time high at 116.65 USD

https://www.investing.com/news/company-news/celcuity-stock-hits-alltime-high-at-11665-usd-93CH-4467804
Celcuity LLC's stock reached an all-time high of $116.65, with a market capitalization of approximately $5.3 billion, reflecting a significant 904.49% one-year increase. This surge is likely driven by investor confidence and advancements in the company's R&D, including the FDA's Priority Review acceptance for its New Drug Application for gedatolisib for advanced breast cancer, and positive Phase 3 trial results. Despite potential overvaluation according to InvestingPro data, analysts maintain a Strong Buy consensus, and firms like Leerink Partners and Jefferies have raised price targets.
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Celcuity, Inc. (NASDAQ:CELC) Given Average Recommendation of "Moderate Buy" by Analysts

https://www.marketbeat.com/instant-alerts/celcuity-inc-nasdaqcelc-given-average-recommendation-of-moderate-buy-by-analysts-2026-01-25/
Celcuity, Inc. (NASDAQ:CELC) has received an average "Moderate Buy" rating from analysts, with a consensus 12-month price target of $105.25. Several firms recently raised their price targets, indicating a positive outlook. Key institutional investors have also increased their holdings, although a director recently sold a significant portion of shares.

Celcuity Inc. (CELC) Stock Analysis: Exploring the Biotechnology Innovator’s Growth Potential

https://www.directorstalkinterviews.com/celcuity-inc-celc-stock-analysis-exploring-the-biotechnology-innovators-growth-potential/4121236413
Celcuity Inc. (CELC) is a clinical-stage biotechnology company focused on developing targeted therapies for solid tumors, particularly hormone receptor-positive and HER2-negative advanced breast cancer, and metastatic castration-resistant prostate cancer, with its lead drug candidate, Gedatolisib. Despite operating at a loss due to heavy R&D investments, the company holds a favorable view from analysts, indicating a bullish trend. Celcuity's strategic collaborations, like the one with Pfizer, and its proprietary CELsignia diagnostic platform suggest significant growth potential for risk-tolerant, long-term investors.

(CELC) Movement Within Algorithmic Entry Frameworks

https://news.stocktradersdaily.com/news_release/98/CELC_Movement_Within_Algorithmic_Entry_Frameworks_012126040802_1769029682.html
Celcuity Inc. (NASDAQ: CELC) is showing strong sentiment across all horizons, leading to an overweight bias. Algorithmic entry frameworks indicate a mid-channel oscillation pattern and an exceptional 59.1:1 risk-reward short setup. The article details three distinct AI-generated trading strategies—Position Trading, Momentum Breakout, and Risk Hedging—along with multi-timeframe signal analysis and support/resistance levels.

FDA to review Celcuity breast cancer drug gedatolisib by July 2026

https://www.stocktitan.net/news/CELC/celcuity-announces-fda-acceptance-of-new-drug-application-for-hemfddvn25du.html
The FDA has accepted Celcuity's New Drug Application (NDA) for gedatolisib for HR+/HER2-/PIK3CA wild-type advanced breast cancer, granting it Priority Review with a PDUFA goal date of July 17, 2026. The NDA was submitted under the Real-Time Oncology Review (RTOR) program and is based on data from the Phase 3 VIKTORIA-1 clinical trial. Gedatolisib, which previously received Breakthrough Therapy and Fast Track designations, is a multi-target PI3K/AKT/mTOR inhibitor.

Celcuity Announces FDA Acceptance of New Drug Application

https://www.globenewswire.com/news-release/2026/01/20/3221601/0/en/Celcuity-Announces-FDA-Acceptance-of-New-Drug-Application-for-Gedatolisib-in-HR-HER2-PIK3CA-Wild-Type-Advanced-Breast-Cancer.html
Celcuity Inc. announced that the FDA has accepted its New Drug Application (NDA) for gedatolisib, a treatment for HR+/HER2-/PIK3CA wild-type advanced breast cancer. The FDA granted Priority Review, setting a PDUFA goal date of July 17, 2026, and the NDA was submitted under the Real-Time Oncology Review program. This milestone follows gedatolisib receiving both Breakthrough Therapy and Fast Track designations based on promising clinical data from the Phase 3 VIKTORIA-1 trial.
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FDA accepts Celcuity’s NDA for gedatolisib with priority review

https://www.investing.com/news/company-news/fda-accepts-celcuitys-nda-for-gedatolisib-with-priority-review-93CH-4454992
The FDA has accepted Celcuity Inc.'s New Drug Application for gedatolisib and granted it Priority Review, with a decision expected by July 17, 2026. This application seeks approval for gedatolisib to treat hormone receptor positive, HER2-negative, PIK3CA wild-type advanced breast cancer, building on breakthrough and fast-track designations. The news has significantly boosted investor confidence, with Celcuity's shares soaring 878% over the past year.

Short Interest in Celcuity, Inc. (NASDAQ:CELC) Expands By 20.9%

https://www.marketbeat.com/instant-alerts/short-interest-in-celcuity-inc-nasdaqcelc-expands-by-209-2026-01-19/
Celcuity, Inc. (NASDAQ:CELC) experienced a significant 20.9% increase in short interest during December, reaching 8,853,129 shares as of December 31st. This represents approximately 22.7% of the company's shares outstanding and a short-interest ratio of 10.5 days. The stock recently traded at $106.96, with a market capitalization of $4.95 billion, and analysts have a "Moderate Buy" consensus rating with a target price of $105.25.

CELC Stock Price, Forecast & Analysis | CELCUITY INC (NASDAQ:CELC)

https://www.chartmill.com/stock/quote/CELC/profile
This article provides a detailed analysis of Celcuity Inc. (NASDAQ: CELC) stock, including its current price, technical and fundamental ratings, financial highlights, and analyst forecasts. While the stock has shown significant year-over-year price performance, its fundamental rating is low due to profitability concerns. The company operates as a cellular analysis firm with a focus on therapeutic candidates for breast and prostate cancer treatment.

Nisa Investment Advisors LLC Buys 14,930 Shares of Celcuity, Inc. $CELC

https://www.marketbeat.com/instant-alerts/filing-nisa-investment-advisors-llc-buys-14930-shares-of-celcuity-inc-celc-2026-01-16/
Nisa Investment Advisors LLC significantly increased its stake in Celcuity, Inc. (NASDAQ:CELC) by 2,142.0% in Q3, purchasing 14,930 shares to bring their total holdings to 15,627 shares valued at $772,000. This move aligns with a broader "Moderate Buy" consensus from Wall Street analysts, who have an average price target of $105.25 for the precision oncology diagnostics company. Insider activity includes a director selling shares, while institutional investors collectively own 63.33% of the stock.

Celcuity stock reaches all-time high at 112.78 USD By Investing.com

https://ng.investing.com/news/company-news/celcuity-stock-reaches-alltime-high-at-11278-usd-93CH-2290250
Celcuity LLC (CELC) stock reached an all-time high of $112.78 USD, marking an 899.47% surge over the past year. This growth is attributed to investor confidence in the biotechnology company's innovative cellular analysis approach and promising Phase 3 trial results for its cancer drug, gedatolisib. Despite strong market performance and analyst "strong buy" consensus, the company is not yet profitable, though it maintains a healthy liquidity position.
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Celcuity stock reaches all-time high at 112.78 USD By Investing.com

https://ca.investing.com/news/company-news/celcuity-stock-reaches-alltime-high-at-11278-usd-93CH-4402583
Celcuity's stock has hit an all-time high of $112.78, marking an 899.47% surge over the past year. This growth is driven by investor confidence in its cellular analysis approach and promising Phase 3 trial results for its cancer drug, gedatolisib. Despite strong performance and analyst confidence, the company is not yet profitable, with net income expected to drop this year, though it maintains strong liquidity.

The Bull Case For Celcuity (CELC) Could Change Following Shelf Registration And FDA Review Progress - Learn Why

https://simplywall.st/stocks/us/pharmaceuticals-biotech/nasdaq-celc/celcuity/news/the-bull-case-for-celcuity-celc-could-change-following-shelf
Celcuity Inc. recently filed a shelf registration and had its NDA accepted by the FDA for its PIK3CA asset, signaling both financing flexibility and a significant regulatory milestone. While these events sharpen investor focus on the company's development and funding plans, they also introduce risks regarding potential dilution and the high expectations reflected in the company's stock price. The article highlights that despite a recent retreat, Celcuity's shares might still be overvalued, implying further downside potential.

The Bull Case For Celcuity (CELC) Could Change Following Shelf Registration And FDA Review Progress - Learn Why

https://simplywall.st/stocks/us/pharmaceuticals-biotech/nasdaq-celc/celcuity/news/the-bull-case-for-celcuity-celc-could-change-following-shelf/amp
Celcuity Inc. has filed an omnibus shelf registration and its NDA for a PIK3CA asset was accepted by the FDA under the real-time oncology review program. This increases financing flexibility and marks a significant regulatory milestone. The company's investment narrative now centers on the success of gedatolisib in breast cancer and its ability to transition to commercial stage without significant shareholder dilution.

Wells Fargo initiates coverage on Celcuity Inc. (CELC)

https://www.msn.com/en-us/health/other/wells-fargo-initiates-coverage-on-celcuity-inc-celc/ar-AA1TYVh9
Wells Fargo has initiated coverage on Celcuity Inc. (CELC). This news suggests potential increased investor interest and analysis for the biotechnology company. The initiation of coverage by a major financial institution like Wells Fargo is often seen as a positive development for a company.

Assessing Celcuity (CELC) Valuation After Wells Fargo Coverage And Key FDA NDA Review Progress

https://simplywall.st/stocks/us/pharmaceuticals-biotech/nasdaq-celc/celcuity/news/assessing-celcuity-celc-valuation-after-wells-fargo-coverage
Celcuity (CELC) is gaining investor attention following Wells Fargo's initiation of coverage and a recent omnibus shelf registration filing. Despite a high Price-to-Book ratio of 42.5x, suggesting overvaluation compared to peers, a Discounted Cash Flow (DCF) model indicates the stock may be significantly undervalued. The article highlights that while strong momentum exists, the lack of revenue and ongoing losses for a clinical-stage biotech mean any setbacks could challenge current optimism.
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