Celcuity reports Phase III VIKTORIA-1 trial results for breast cancer
Celcuity has reported the results of its Phase III VIKTORIA-1 trial for breast cancer. The trial focused on an unnamed drug and its efficacy in treating breast cancer, with the company announcing the outcomes. Further details on the specific results were not provided in this brief snippet.
Celcuity Inc. Files Amendment No. 1 to Form 8-K/A with SEC for February 2026 Event
Celcuity Inc. has filed Amendment No. 1 to its Form 8-K/A with the SEC, updating its previously filed report from February 2026. The key disclosure in the amendment is the expansion of the Board of Directors, which may signal future strategic changes within the company. The filing also confirms Celcuity is not an emerging growth company and has no current price-sensitive communications related to M&A or tender offers.
H.C. Wainwright Maintains Celcuity(CELC.US) With Buy Rating, Raises Target Price to $185
H.C. Wainwright analyst Swayampakula Ramakanth has maintained a Buy rating for Celcuity (CELC.US) and increased the target price from $165 to $185. Ramakanth boasts a 41.3% success rate and a 16.1% average return over the past year, according to TipRanks data. The analyst's performance is ranked using a star system based on success rate and average return.
Celcuity Shareholders Approve New 2026 Equity Incentive Plans
Celcuity shareholders approved a new 2026 Stock Incentive Plan, authorizing 3,000,000 shares for equity awards, and an amended 2017 Employee Stock Purchase Plan extending it for ten years with additional shares. They also re-elected directors, ratified the auditor, and endorsed executive compensation, signaling strong support for the company's governance and incentive frameworks. An analyst rating indicates a Buy with a $185.00 price target, while TipRanks' AI Analyst views CELC as Neutral due to weak financial performance despite positive technical signals and clinical data.
Why Celcuity (CELC) Is Up 5.1% After VIKTORIA-1 Success And Pipeline Expansion - And What's Next
Celcuity (CELC) saw its stock rise by 5.1% following the successful primary progression-free survival endpoint of its Phase 3 VIKTORIA-1 trial for gedatolisib in breast cancer. Despite a wider net loss in Q1 2026, the company is strategically expanding its VIKTORIA-2 trial to include a broader patient population and developing a subcutaneous formulation of gedatolisib to improve long-term treatment convenience. This move aims to solidify gedatolisib as a platform therapy, although investors remain cautious about continued pre-revenue losses and heavily financed operations.
Celcuity Shareholders Approve New 2026 Equity Incentive Plans
Celcuity shareholders have approved a new 2026 Stock Incentive Plan, authorizing three million shares for equity awards, and an expanded employee stock purchase plan extending for ten more years. These approvals, alongside the re-election of directors and ratification of auditors, demonstrate continued support for the company's governance and long-term equity-based incentives. An analyst rating shows a Buy with a $185.00 price target, while TipRanks' AI Analyst, Spark, rates CELC as "Neutral" due to weak financial performance often offset by technical uptrend signals and positive Phase 3 data.
Citizens reiterates Celcuity stock rating ahead of July approval
Citizens has maintained its Market Outperform rating and $160.00 price target for Celcuity Inc. shares, ahead of a potential July regulatory approval and an upcoming ASCO presentation. The company recently reported better-than-expected Q1 2026 earnings, leading other firms like H.C. Wainwright and Stifel to also raise their price targets, signaling growing confidence in Celcuity's clinical progress and financial stability, despite not yet being profitable. The firm’s price target is derived from a discounted cash flow analysis.
Why Celcuity (CELC) Is Up 5.1% After VIKTORIA-1 Success And Pipeline Expansion - And What's Next
Celcuity Inc. (CELC) saw its stock rise by 5.1% following successful Phase 3 VIKTORIA-1 trial results for gedatolisib in breast cancer and plans to expand its VIKTORIA-2 trial. Despite a wider net loss in Q1 2026, the company is developing a subcutaneous formulation of gedatolisib and expanding trials to include both endocrine-resistant and endocrine-sensitive patients, aiming to broaden its market and establish gedatolisib as a platform therapy. The article highlights both the compelling upside potential of gedatolisib and the risks associated with ongoing pre-revenue losses and financing needs.
Celcuity's Cancer Drug Expansion Could Ignite Massive New Market Opportunity: Analyst
Celcuity Inc. has expanded its Phase 3 VIKTORIA-2 clinical trial for gedatolisib to include endocrine-sensitive breast cancer patients, following positive results from its VIKTORIA-1 trial. The company also filed a patent for a subcutaneous formulation of gedatolisib, aiming to improve long-term treatment and reach a larger patient population. Needham analysts maintain a Buy rating with a $157 price target, viewing these developments as significant for the drug's commercial potential.
Celcuity Inc. (NASDAQ:CELC) Q1 2026 Earnings Call Transcript
Celcuity Inc. reported its Q1 2026 financial results, with EPS of $-0.97, beating expectations. The company highlighted significant progress in preparing for the potential FDA approval and commercial launch of gedatolisib for advanced breast cancer in Q3 2026, citing positive data from the VIKTORIA-1 study for both wild-type and PIK3CA mutant cohorts. Celcuity also announced an expansion of its VIKTORIA-2 trial to include first-line treatment for endocrine-sensitive HR-positive, HER2-negative advanced breast cancer patients and the development of a subcutaneous formulation for gedatolisib.
A Look At Celcuity (CELC) Valuation As Shares Extend Recent Momentum
Celcuity (CELC) has seen significant recent share price momentum, leading to a review of its valuation. While one narrative suggests the stock is 15.4% overvalued with a fair value of $116.70, a Discounted Cash Flow (DCF) model indicates it may be trading at a large discount, implying a potential future cash flow value of $760.43. Investors are encouraged to assess these contrasting views and consider potential risks and rewards.
Analysts Are Bullish on Top Healthcare Stocks: Celcuity (CELC), Rubicon Organics (ROMJF)
Analysts are expressing bullish sentiments on two healthcare stocks, Celcuity (CELC) and Rubicon Organics (ROMJF). LifeSci Capital maintained a Buy rating on Celcuity with a $165.00 price target, while Haywood analyst Neal Gilmer gave Rubicon Organics a Buy rating and a C$1.30 price target. Both companies received positive analyst consensus, with Celcuity holding a Strong Buy and Rubicon Organics a Moderate Buy.
A subcutaneous solution to Celcuity’s patent woes? | ApexOnco - Clinical Trials news and analysis
Celcuity has addressed concerns regarding the limited patent life of its cancer drug, gedatolisib, by filing a U.S. patent for a subcutaneous (SC) formulation of the drug. This new SC form could extend the treatment duration and establish a new patent life, requiring only bioequivalence demonstration with the existing intravenous (IV) form. Additionally, Celcuity announced an overhaul of its Viktoria-2 gedatolisib study, changing the patient stratification method.
Celcuity Inc. Stock 12‑Month Price Target Raised to $167.18, Implies 24% Upside
Celcuity Inc.'s average 12-month stock price target has increased to $167.18 from $159.91, according to estimates from 11 analysts. This new target suggests a potential upside of approximately 24% based on the May 14 closing price. The consensus rating from 12 analysts remains a "Buy," with no "Hold" or "Sell" recommendations.
Transcript: Celcuity Q1 2026 Earnings Conference Call
Celcuity reported a Q1 2026 net loss of $52.8 million, attributed to increased R&D and administrative expenses for commercial launch preparations of gatalisib. The company is advancing gatalisib for HR-positive HER2-negative advanced breast cancer, with positive Phase 3 trial results and plans to expand clinical trials and develop a subcutaneous formulation. Celcuity anticipates potential FDA approval for gatalisib by July 17th and projects an annual addressable market of $5 billion, with peak revenues up to $2.5 billion.
Celcuity Inc reports results for the quarter ended December 31 - Earnings Summary
Celcuity Inc has released its financial results for the quarter that ended on December 31. This brief report, sourced from Reuters, provides an earnings summary for the company (CELC).
Earnings Flash (CELC) Celcuity Inc. Posts Q1 Adjusted Loss $0.86 per Share, vs. FactSet Est of $-0.95
Celcuity Inc. (CELC) reported an adjusted loss of $0.86 per share for the first quarter of 2026, which is better than the FactSet estimated loss of $0.95 per share. The company's Q1 adjusted loss widened compared to the previous year. This earnings flash was published on May 14, 2026.
Celcuity Inc. Reports Release of First Quarter 2026 Financial Results and Provides Corporate Update
Celcuity Inc. announced its Q1 2026 financial results, reporting a net loss of $52.8 million. The company highlighted positive topline results from its Phase 3 VIKTORIA-1 trial for gedatolisib in HR+/HER2- advanced breast cancer, showing significant improvement in progression-free survival for PIK3CA mutant patients. Celcuity also expanded its VIKTORIA-2 study and is developing a subcutaneous formulation of gedatolisib, anticipating potential FDA approval in Q3 2026.
Celcuity Stock Surges As Gedatolisib Data Ignites Wall Street
Celcuity Inc. (CELC) stock surged by 8.23% following positive Phase 3 VIKTORIA-1 clinical trial results for its drug gedatolisib in metastatic breast cancer. The data showed statistically significant progression-free survival, leading Celcuity to plan a supplemental NDA filing and prompting multiple analysts to raise price targets, with some seeing a 50% expansion in the eligible patient population. The stock's performance reflects its potential as a biotech momentum play driven by these strong trial outcomes and imminent regulatory milestones.
Celcuity’s Phase 3 VIKTORIA-2 Trial of Gedatolisib as a First-Line Treatment for HR+/HER2- Advanced Breast Cancer Expanding to Include Endocrine-Sensitive Patients
Celcuity announced updates to its Phase 3 VIKTORIA-2 trial for gedatolisib, expanding it to include endocrine-sensitive HR+/HER2- advanced breast cancer patients and amending the protocol to evaluate both endocrine-resistant and endocrine-sensitive groups with independent statistical analyses. The company also filed a patent for a subcutaneous formulation of gedatolisib to support long-term treatment durations. These changes aim to advance the standard of care for a broader population of HR+/HER2- ABC patients.
Breast cancer trial widens as Celcuity develops injection option
Celcuity (Nasdaq: CELC) is expanding its Phase 3 VIKTORIA-2 trial for gedatolisib, a first-line treatment for HR+/HER2- advanced breast cancer, to include separate studies for endocrine-resistant and endocrine-sensitive patients. The company also announced the submission of its first patent application for a subcutaneous formulation of gedatolisib, aiming for clinical equivalence to the current intravenous form to offer an injection alternative. This expansion and formulation development are based on promising prior Phase 1b data and seek to improve treatment accessibility and duration for a wider range of patients.
Celcuity expands phase 3 breast cancer trial design By Investing.com
Celcuity Inc. has announced expanded designs for its Phase 3 VIKTORIA-2 clinical trial of gedatolisib for HR+/HER2- breast cancer, splitting it into two studies focusing on endocrine-resistant and endocrine-sensitive patients. This development follows a period of significant stock growth for Celcuity and positive results from its VIKTORIA-1 trial, leading to increased price targets from several analyst firms, despite the company currently being unprofitable. The company also submitted a patent for a subcutaneous formulation of gedatolisib and has a Prescription Drug User Fee Act goal date of July 17, 2026, for its New Drug Application.
Celcuity Inc expected to post a loss of $1.05 a share - Earnings Preview
Celcuity Inc (CELC) is projected to report a loss of $1.05 per share in its upcoming earnings announcement. This information is provided as an earnings preview by Refinitiv. The article is a brief report on this financial forecast.
Celcuity (CELC) Stock Forum and Discussion
This document appears to be a placeholder for a stock forum and discussion page for Celcuity (CELC). It likely aims to provide a platform for investors and interested parties to share insights, analysis, and opinions regarding the company's stock performance. However, the provided content is empty, suggesting the actual discussion or forum content was not captured.
A Quick Look at Today's Ratings for Celcuity(CELC.US), With a Forecast Between $150 to $165
This article provides a summary of recent analyst ratings for Celcuity (CELC.US), noting a consensus among analysts that the stock is poised for growth. The price target range for Celcuity has been set between $150 and $165, suggesting a significant upside potential from its last closing price. This information could be valuable for investors tracking analyst sentiment and potential stock performance.
Celcuity’s Gedatolisib Data Sharpen Focus On Breast Cancer Commercial Path
Celcuity's lead drug candidate, gedatolisib, has shown positive Phase 3 results in the VIKTORIA-1 trial for PIK3CA-mutant HR+/HER2- metastatic breast cancer, meeting its primary endpoint with significant improvement in progression-free survival. The company plans to submit a supplemental NDA to the FDA, with full data presentation at ASCO 2026. This development provides a clearer commercial path for gedatolisib, alongside an existing Priority Review for the wild-type population, positioning Celcuity to address a significant market segment despite being pre-revenue.
LifeSci Capital Maintains Celcuity(CELC.US) With Buy Rating, Maintains Target Price $165
LifeSci Capital has reiterated its Buy rating for Celcuity (CELC.US) and maintained its target price at $165. This indicates a continued positive outlook on the company's stock performance by the investment firm.
Celcuity reports Phase III VIKTORIA-1 trial results for breast cancer
The article reports that Celcuity has released Phase III VIKTORIA-1 trial results for its breast cancer treatment. There are no further details provided in this very brief article about the trial results or the specific drug.
Why is Avoro Capital Advisors Making a Big Bet on Celcuity (CELC)
Avoro Capital Advisors has made a significant investment in Celcuity (CELC), a clinical-stage biotechnology company, signaling strong conviction in its lead drug candidate, gedatolisib. Gedatolisib, a dual PI3K/mTOR inhibitor for advanced breast cancer, has a PDUFA date of July 17, 2026, with an estimated addressable market of $5-6 billion in the U.S. While the stock has seen dramatic appreciation, its future success hinges on FDA approval and successful commercialization, presenting both substantial upside and inherent clinical-stage risks.
CELC Stock Price and Chart — NASDAQ:CELC
This article provides a detailed overview of Celcuity Inc. (CELC) stock, including its current price, performance statistics, key financial data, and analyst ratings. It covers the company's profile, information on its advanced cellular analysis technology for cancer treatment, and lists ETFs holding the stock. The article also addresses frequently asked questions about CELC's stock performance and financial outlook.
Celcuity Schedules Release of First Quarter 2026 Financial Results and Webcast/Conference Call
Celcuity Inc. (Nasdaq: CELC), a clinical-stage biotechnology company, announced it will release its first-quarter 2026 financial results after market close on Thursday, May 14, 2026. Management will host a webcast/teleconference at 4:30 p.m. Eastern Time on the same day to discuss the results and provide a corporate update. Details for accessing the teleconference and live webcast are provided.
Celcuity Schedules Release of First Quarter 2026 Financial Results and Webcast/Conference Call
Celcuity Inc. (Nasdaq: CELC) announced that it will release its first quarter 2026 financial results after the market closes on Thursday, May 14, 2026. Management will host a webcast/teleconference on the same day at 4:30 p.m. Eastern Time to discuss the results and provide a corporate update. Details for accessing the teleconference and live webcast are provided.
Celcuity (Nasdaq:CELC) - Stock Analysis
Celcuity (CELC) is a clinical-stage biotechnology company focused on developing targeted therapies for solid tumors. The company's stock has seen significant performance, including a 1,141.3% increase over the past year, driven by positive Phase 3 data for its lead drug candidate, gedatolisib, in advanced breast cancer. Analysts are in good agreement that the stock price will rise, anticipating breakeven by 2027 and annual earnings growth of 61%.
ASCO 2026 preview – Celcuity gets a mutant coup | ApexOnco - Clinical Trials news and analysis
Celcuity announced a significant win for its PI3K/mTOR inhibitor, gedatolisib, in PIK3CA-mutant breast cancer from the Viktoria-1 trial, securing a late-breaker slot at ASCO 2026. This positive outcome, alongside promising results in PIK3CA wild-type disease, positions Celcuity for a potential FDA approval and strengthens its market position, especially after acquiring the asset for a modest sum from Pfizer. The full data for the mutant cohort will be presented at the conference.
Guggenheim Keeps Their Buy Rating on Celcuity (CELC)
Guggenheim analyst Bradley Canino has maintained a Buy rating on Celcuity (CELC), setting a price target of $165.00. Canino, a 4-star analyst, has an average return of 9.4% and covers the Healthcare sector. Celcuity has a Strong Buy consensus among analysts, with a price target consensus of $158.86. The company recently reported a quarterly GAAP net loss of $50.97 million.
Celcuity Stock Jumps 16% as Gedatolisib Breast-Cancer Data Raise FDA Stakes
Celcuity Inc. shares surged nearly 16% after announcing that its lead drug candidate, gedatolisib, met the primary endpoint in a late-stage breast cancer trial for patients with PIK3CA-mutant tumors. This positive data positions the company to seek an expanded label for the drug through a supplemental FDA application, adding to the anticipation of a July FDA decision for its initial New Drug Application. The company's market cap rose to $6.9 billion, and analysts have adjusted their price targets upwards, despite the company still being in the clinical stage with no commercial drugs or revenue.
Celcuity strengthens case for ASCO-spotlighted breast cancer drug
Celcuity's experimental breast cancer drug, gedatolisib, has shown promising results in a Phase 3 trial, delaying disease progression in patients with PIK3CA gene mutations. This new data strengthens the case for broader approval of the drug, which is already under regulatory review and will be featured at the upcoming ASCO meeting. The positive findings, especially in the PIK3CA-mutated cohort, could significantly expand the drug's market opportunity.
Celcuity upgraded by H.C. Wainwright with a new price target
Celcuity Inc. (CELC) has received an upgrade from H.C. Wainwright, accompanied by a new price target of $165.00. This analyst rating update follows other recent coverage from Citizens, Wells Fargo, and Wolfe Research. The article also highlights recent related news, including SEC filings and a press release about Celcuity's Phase 3 VIKTORIA-1 trial achieving its primary endpoint.
Celcuity CELC Soars On Strong Phase 3 Cancer Data
Celcuity Inc. (CELC) stock surged due to positive Phase 3 VIKTORIA-1 trial results for its drug gedatolisib in metastatic breast cancer. The drug met its primary endpoint, leading to plans for a supplemental NDA filing and an Outperform rating from Citizens with a $150 price target. This success in both PIK3CA-mutant and wild-type settings positions gedatolisib for broad second-line use, creating significant catalysts for the stock despite the company's current negative earnings.
Celcuity reports Phase III VIKTORIA-1 trial results for breast cancer
Celcuity announced positive topline results from the PIK3CA mutant cohort of its Phase III VIKTORIA-1 trial for breast cancer, showing a statistically significant improvement in progression-free survival with gedatolisib combinations. The gedatolisib triplet (gedatolisib, fulvestrant, palbociclib) and doublet (gedatolisib, fulvestrant) demonstrated superior efficacy and a manageable safety profile compared to alpelisib and fulvestrant. The company plans to submit these data to the FDA for a new drug application, highlighting the potential for gedatolisib to become a new treatment standard for HR+/HER2- advanced breast cancer regardless of PIK3CA status.
Celcuity reports Phase III VIKTORIA-1 trial results for breast cancer
Celcuity announced positive topline results from the PIK3CA mutant cohort of its Phase III VIKTORIA-1 clinical trial, evaluating gedatolisib combined with fulvestrant, with or without palbociclib, for HR+/HER2- PIK3CA mutant breast cancer. The gedatolisib triplet showed statistically significant and clinically meaningful improvement in progression-free survival compared to alpelisib and fulvestrant. The treatments were well-tolerated, and Celcuity plans to seek regulatory approval from the FDA and other authorities, highlighting the drug's potential to improve care for this patient population.
Celcuity’s gedatolisib beats Novartis’ Piqray in phase 3 breast cancer study
Celcuity's pan-PI3K/mTOR inhibitor, gedatolisib, achieved its primary endpoint in a phase 3 breast cancer study, clearing the path for a second FDA submission. The drug, in combination with Faslodex and Ibrance, showed significantly longer progression-free survival compared to Novartis’ Piqray with Faslodex. Celcuity's shares rose following the news, and the company plans further FDA and European submissions, with analysts forecasting significant sales potential.
Why Celcuity’s Hot Cancer Drug Stock Is Sinking
Celcuity's stock (CELC) is experiencing a downturn despite recent positive clinical news from its Phase 3 VIKTORIA-1 breast cancer trial. Investors appear to be taking profits after an earlier rally, suggesting a reassessment of how much positive sentiment was already factored into the stock price. The market is now questioning the speed at which clinical successes will translate into commercial profits and long-term valuation gains.
CELC stock jumps after hours on positive breast cancer trial data
The article reports that CELC stock experienced a significant jump in after-hours trading. This increase was driven by positive data from a breast cancer trial.
Jennison Associates LLC Purchases Shares of 229,704 Celcuity, Inc. $CELC
Jennison Associates LLC has acquired 229,704 shares of Celcuity, Inc. (NASDAQ:CELC) in the fourth quarter, a stake valued at approximately $22.9 million, representing about 0.50% of the company. Institutional investors collectively own 63.33% of Celcuity. Analysts maintain a "Moderate Buy" rating for CELC with a consensus target price of $114.33, while the company recently reported stronger-than-expected quarterly earnings per share.
LifeSci Capital Maintains Celcuity(CELC.US) With Buy Rating, Raises Target Price to $165
LifeSci Capital has reiterated its 'Buy' rating for Celcuity (CELC.US) and increased its price target to $165. This indicates a strong positive outlook from the firm regarding Celcuity's future performance and valuation. The raised target suggests confidence in the company's prospects.
CELC Stock Jumps After Hours On Positive Breast Cancer Trial Data
Celcuity Inc. (CELC) shares surged 14% after hours following positive data from a trial of its experimental cancer drug, gedatolisib. The drug showed a statistically significant and clinically meaningful improvement in progression-free survival for patients with certain advanced breast cancers. Celcuity plans to submit these results to the FDA for a supplemental New Drug Application.
Celcuity announced that its Phase III Viktoria-1 clinical trial has successfully achieved the primary endpoint in the Pik3CA mutant patient cohort.
Celcuity's Phase III Viktoria-1 clinical trial has met its primary endpoint in the Pik3CA mutant patient cohort. The trial demonstrated a clinically significant improvement in progression-free survival for these patients. This announcement highlights a positive development in Celcuity's therapeutic research.
Celcuity's Phase 3 VIKTORIA-1 Trial Achieves Primary Endpoint With Clinically Meaningful Improvement in Progression-Free Survival in PIK3CA Mutant Cohort
Celcuity Inc. announced positive topline results from the PIK3CA mutant cohort of its Phase 3 VIKTORIA-1 clinical trial, demonstrating a statistically significant and clinically meaningful improvement in progression-free survival with gedatolisib regimens for HR+/HER2- advanced breast cancer. These results will be presented at the 2026 ASCO Annual Meeting and Celcuity plans to submit the data to the FDA for a supplemental New Drug Application. The company highlights the potential for gedatolisib, a pan-PI3K and mTORC1/2 inhibitor, to become a transformative new medicine for patients with PIK3CA mutant HR+/HER2- advanced breast cancer.
Celcuity (CELC) Is Up 6.9% After FDA Grants Priority Review For Gedatolisib And Debt Financing - Has The Bull Case Changed?
Celcuity (CELC) has seen a 6.9% increase after the FDA granted Priority Review for its breast cancer drug candidate, gedatolisib, with a PDUFA goal date in July 2026. The company also secured $30 million in debt financing to expand commercial operations. This marks a significant shift from a research-focused biotech to a potential commercial oncology drug developer, though the increased debt and risk of regulatory delays remain factors.
