Form 3 Celcuity Inc. For: Oct 01 Filed by: GRYSKA DAVID W
This article reports on a Form 3 filing by David W. Gryska for Celcuity Inc. The filing indicates Gryska's initial statement of beneficial ownership of securities as a Director, with the event date being October 1, 2026. The document details the reporting person's address, their relationship to the issuer, and confirms the filing is for one reporting person.
Celcuity to present gedatolisib trial data at ESMO congress By Investing.com
Celcuity Inc. (NASDAQ:CELC) is set to present clinical trial data for its drug gedatolisib at the European Society for Medical Oncology Congress 2026 in Madrid. The presentations will include a late-breaking rapid oral presentation and three poster presentations, focusing on gedatolisib's efficacy in hormone receptor positive, HER2 negative breast cancer and metastatic castration-resistant prostate cancer. Abstracts for these presentations will be published on the ESMO website on October 19, 2026.
Celcuity appoints David W. Gryska as director and Audit & Compensation committee member
Celcuity has appointed David W. Gryska as a new director, effective October 1, 2026. He will also serve on the Audit Committee and Compensation Committee. This appointment expands the board from eight to nine members, filling the resulting vacancy.
Celcuity appoints David Gryska to board of directors By Investing.com
Celcuity Inc. has appointed David W. Gryska to its board of directors, leveraging his 35 years of financial and strategic leadership in the life sciences industry. This appointment comes as Celcuity transitions into a commercial-stage company following FDA approval for REVTORPYK, its therapy for advanced breast cancer. Gryska's extensive board experience with several public biotechnology companies is expected to be a significant asset.
Celcuity Inc (CELC-Q) Stock Price and News
This article provides a comprehensive overview of Celcuity Inc. (CELC-Q) stock, including its real-time price data, analyst ratings, and recent news. It highlights the company's profile as a cellular analysis company focused on discovering new cancer sub-types and commercializing diagnostic tests. The news section features multiple "Buy" ratings from various financial institutions and announces the FDA approval of REVTORPYK™ for breast cancer treatment.
A ninth director joins Celcuity (CELC) with over 35 years of life sciences leadership experience.
Celcuity Inc. has appointed David W. Gryska to its Board of Directors, increasing the board size to nine members. Gryska brings over 35 years of strategic and financial leadership experience in the life sciences industry and will serve on the Audit and Compensation Committees. His appointment comes as Celcuity transitions into a commercial-stage company following the FDA approval of REVTORPYK™.
Celcuity Inc. Announces Appointment of David W. Gryska to Board of Directors and Member of the Audit Committee and Compensation Committee, Effective October 1, 2026
Celcuity Inc. has appointed David W. Gryska to its Board of Directors, effective October 1, 2026, to fill a vacancy. Mr. Gryska will also serve on the Audit Committee and Compensation Committee. He brings over 35 years of strategic and financial leadership experience in the life sciences industry, having previously served in executive financial roles at Incyte Corporation, Celgene Corporation, and Scios Inc., and on the boards of several public biotechnology companies.
H.C. Wainwright Maintains Celcuity(CELC.US) With Buy Rating, Maintains Target Price $155
H.C. Wainwright has reiterated its Buy rating for Celcuity (CELC.US) and maintained its target price at $155. This indicates a continued positive outlook from the firm regarding Celcuity's stock performance and potential.
Celcuity appoints David Gryska to board of directors
Celcuity Inc. has appointed David W. Gryska to its board of directors, leveraging his 35 years of strategic and financial leadership in the life sciences industry. This appointment comes as Celcuity transitions into a commercial-stage company following the FDA approval of REVTORPYK for advanced breast cancer. Gryska's extensive experience, including CFO roles at Incyte and Celgene, and board memberships at several biotechnology companies, is expected to be valuable as Celcuity advances its targeted therapies.
Celcuity Appoints David Gryska To Its Board Of Directors
Celcuity Inc. (Nasdaq: CELC), a biotechnology company, has announced the appointment of David W. Gryska to its Board of Directors. Mr. Gryska brings over 35 years of strategic and financial leadership experience in the life sciences industry, which will be valuable as Celcuity transitions into a commercial-stage company following the FDA approval of REVTORPYK™. His expertise will support the launch of REVTORPYK, advance clinical development programs, and contribute to long-term growth.
Celcuity Appoints David Gryska To Its Board Of Directors
Celcuity Inc., a biotechnology company, has appointed David W. Gryska to its Board of Directors. Gryska brings over 35 years of strategic and financial leadership experience in the life sciences industry, including advising early-stage biotechnology companies. His appointment comes as Celcuity transitions into a commercial-stage company following the FDA approval of REVTORPYK for advanced breast cancer.
Celcuity launches Revtorpyk for advanced breast cancer in US
Celcuity Inc. has commercially launched Revtorpyk (gedatolisib) in the U.S. for advanced hormone receptor-positive, HER2-negative breast cancer patients without a PIK3CA mutation who have progressed after at least one line of endocrine therapy. The drug, approved by the FDA on July 14, 2026, is available in combination with palbociclib and fulvestrant, or with fulvestrant alone. Celcuity has also introduced Revtorpyk Support Services to assist patients with financial and treatment enrollment resources.
Celcuity Announces That REVTORPYK™ (gedatolisib) Is Now Commercially Available In The United States
Celcuity Inc. has announced the commercial availability of REVTORPYK™ (gedatolisib) in the United States. This kinase inhibitor is approved for eligible patients with HR+/HER2- locally advanced or metastatic breast cancer without a PIK3CA mutation, following progression on or after endocrine therapy. REVTORPYK is the first FDA-approved therapy to inhibit all class I PI3K isoforms and mTOR complexes, and Celcuity has launched a patient support program to ensure access to this new treatment option.
Celcuity (CELC) Could Be 50% Below Fair Value As Gedatolisib Story Stays In Focus
Celcuity (CELC), a clinical-stage biotechnology company, is trading at $80.61, which is approximately 50% below its estimated fair value of $161, primarily due to the potential of its drug gedatolisib. The bullish valuation depends on gedatolisib successfully navigating regulatory hurdles and clinical trials, with management projecting peak revenues of $2.5 billion to $3 billion in its addressable market. While the stock has seen a recent pullback, its long-term momentum remains strong, with significant returns over the past three years.
Celcuity Inc. - Common Stock (NQ: CELC)
This page provides the latest news and financial updates for Celcuity Inc. (Nasdaq: CELC), including scheduled earnings reports, past earnings beats, and corporate announcements. It highlights upcoming earnings dates and links to various financial news articles covering the company's performance and market movements.
JPMorgan initiates Celcuity stock coverage with overweight rating By Investing.com
JPMorgan has initiated coverage of Celcuity Inc (NASDAQ:CELC) with an Overweight rating and a $157.00 price target, anticipating the launch of its drug Revtorpyk in late Q3 2026 for breast cancer treatment. While Celcuity's shares have risen, InvestingPro suggests they might be overvalued, and JPMorgan's estimates are more conservative than current consensus. Analysts are optimistic about Revtorpyk's long-term potential, including its efficacy in prostate cancer, despite not expecting the company to be profitable this year.
JPMorgan initiates Celcuity stock coverage with overweight rating By Investing.com
JPMorgan has initiated coverage on Celcuity Inc. (NASDAQ:CELC) with an Overweight rating and a $157.00 price target, citing the long-term potential of its drug Revtorpyk. The drug is expected to launch in late Q3 2026 for breast cancer, with potential for further indication expansion. Despite current overvaluation suggested by InvestingPro, JPMorgan's estimates for peak sales align with consensus, though analysts do not expect profitability this year.
Trading Systems Reacting to (CELC) Volatility
This article analyzes Celcuity Inc. (NASDAQ: CELC) volatility, presenting neutral near and mid-term readings but a positive long-term bias. It outlines institutional trading strategies, including position, momentum breakout, and risk hedging, based on AI models, with specific entry, target, and stop-loss levels. The analysis also provides multi-timeframe signal insights and emphasizes risk management for optimal trading.
Celcuity at Wells Fargo healthcare conference: launch, data in focus
Celcuity presented at the Wells Fargo 21st Annual Healthcare Conference, detailing the launch plans for its newly approved breast cancer therapy, REVTORPYK. The company discussed manufacturing approvals, reimbursement strategies, and physician adoption challenges for the intravenous therapy, while also highlighting strong efficacy data and future development plans for PIK3CA-mutant patients and in prostate cancer. Despite an anticipated temporary J-code causing potential reimbursement delays, Celcuity expects to address these with extended payment terms and a robust sales force.
Celcuity Stock Price Forecast. Should You Buy CELC?
StockInvest.us rates Celcuity Inc (CELC) as a Sell Candidate with a technical score of -1.37, unchanged from its previous evaluation. The stock gained 0.701% on the last trading day, but a 3-month trend forecast predicts a 5.25% fall. Multiple negative signals, including sell signals from both short and long-term Moving Averages and MACD, indicate that the stock is likely to perform weakly in the near future.
Celcuity Submits sNDA to FDA for REVTORPYK™ (gedatolisib) for HR+/HER2-, PIK3CA Mutant Locally Advanced or Metastatic Breast Cancer
Celcuity Inc. has submitted a supplemental New Drug Application (sNDA) to the FDA for REVTORPYK™ (gedatolisib) to treat HR+/HER2-, PIK3CA mutant locally advanced or metastatic breast cancer. This application is supported by positive Phase 3 VIKTORIA-1 clinical trial results, where REVTORPYK significantly reduced the risk of disease progression or death. If approved, REVTORPYK would be the first therapy for advanced breast cancer with a PIK3CA mutation that inhibits all class I PI3K isoforms and mTOR complexes mTORC1 and mTORC2.
How Investors May Respond To Celcuity (CELC) Deepening Losses As Gedatolisib Commercial Plans Advance
Celcuity Inc. reported significant net losses in Q2 2026, driven by increased spending for the clinical development and potential commercialization of gedatolisib, particularly REVTORPYK. While the FDA approval of REVTORPYK is a positive catalyst, the widening losses highlight a critical risk: whether future revenue can offset the growing cash burn. The article suggests investors need to assess if REVTORPYK's launch and future trial results will outpace the company's financial commitments.
E Fund Management Co. Ltd. Purchases New Holdings in Celcuity, Inc. $CELC
E Fund Management Co. Ltd. has acquired 45,895 shares of Celcuity, Inc. (NASDAQ:CELC), valued at approximately $4.8 million, representing a 0.09% stake in the company. Institutional investors collectively own 63.33% of Celcuity, with several firms adjusting their positions. Despite a recent earnings miss and a stock price below its 52-week high, analysts maintain a "Moderate Buy" consensus rating with an average price target of $154.55.
Celcuity (CELC) insider logs stock transactions with SEC
Celcuity Inc.'s CEO, Brian F. Sullivan, reported recent stock transactions to the SEC via a Form 4 filing. The filing indicates that Sullivan acquired 80,000 shares of common stock and 120,000 performance stock units, with details on vesting schedules and beneficial ownership. The report provides a neutral impact and sentiment analysis from Rhea-AI.
Celcuity (NASDAQ: CELC) insider updates stock holdings
Celcuity Inc. Chief Science Officer, Lance G. Laing, reported insider transactions via a Form 4 filing, indicating a net purchase of 20,000 shares. These transactions involved the grant of 20,000 common stock shares and 10,000 performance stock units. The common stock vests over four years, while performance units vest upon achieving specific share price thresholds.
Celcuity (NasdaqCM:CELC) Stock Forecast & Analyst Predictions
Celcuity (CELC) is forecast to achieve significant earnings and revenue growth, with EPS expected to increase by 68.1% annually. Recent updates include FDA approval for REVTORPYK for breast cancer, targeting a late Q3 2026 commercial launch, and revised breakeven date forecasts. The company faces risks such as negative shareholder equity and past share dilution but shows potential with its lead therapeutic candidate, gedatolisib, in ongoing clinical trials.
Celcuity keeps cool amid questions about Revtorpyk launch timing
Celcuity is addressing investor concerns regarding the slower-than-expected launch of its breast cancer drug, Revtorpyk, which led to a significant stock drop. The delay is primarily due to awaiting FDA approval for a second manufacturing facility. Despite this, the company remains confident in the drug's potential, anticipating annual sales exceeding $6 billion, and expects shipments to begin by the end of the third quarter.
Citizens reiterates Celcuity stock rating ahead of drug launch
Citizens has reiterated its Market Outperform rating and $177.00 price target for Celcuity Inc (NASDAQ:CELC) following the company's second-quarter 2026 financial results and updates on its drug REVTORPYK. The drug is anticipated to launch in late third-quarter 2026, with regulatory aspects expected to be complete prior to launch. Despite a wider-than-expected loss in Q2 2026 due to pre-launch spending, Celcuity maintains strong clinical data and sufficient cash reserves through 2029, with Wall Street analysts remaining bullish on the stock.
Celcuity's (CELC) "Market Outperform" Rating Reiterated at Citizens Jmp
Citizens Jmp has reiterated its "Market Outperform" rating for Celcuity (NASDAQ:CELC), setting a price target of $177, which suggests a 92% potential upside. Despite missing quarterly adjusted earnings estimates, analyst sentiment remains positive with a "Moderate Buy" consensus and an average price target of $153.64, as institutional investors hold a significant stake in the company. Celcuity, a clinical-stage biotechnology company, specializes in precision oncology diagnostics to optimize cancer treatment selection.
Guggenheim raises Celcuity stock price target on drug pricing data
Guggenheim raised its price target on Celcuity Inc (NASDAQ:CELC) to $175 from $165, maintaining a Buy rating, citing the higher-than-expected disclosed price of Revtorpyk. Celcuity plans to begin commercial shipments of Revtorpyk in late Q3 and submit a supplemental new drug application for PIK3CAm in Q3 2026. Despite a wider-than-expected loss in Q2 2026, the company holds a strong cash balance and positive analyst outlooks, although some price targets have been adjusted.
H.C. Wainwright reiterates Celcuity stock rating on pricing update
H.C. Wainwright has reiterated its Buy rating and $155 price target for Celcuity Inc (NASDAQ:CELC) following the company's Q2 results and corporate update, despite the stock being considered overvalued by InvestingPro data. Analysts maintain a Strong Buy consensus, with price targets ranging from $140 to $178. Celcuity has set a wholesale acquisition cost of $10,000 per vial for its REVTORPYK regimen, which has been named a preferred Category 1 option by the National Comprehensive Cancer Network, and commercial shipments are on track for late Q3 2026.
Bronstein, Gewirtz & Grossman, LLC Encourages Celcuity Inc. (CELC) Investors to Inquire about Securities Investigation
Bronstein, Gewirtz & Grossman, LLC is investigating potential claims on behalf of purchasers of Celcuity Inc. (NASDAQ:CELC) following a significant drop in its stock price. The investigation stems from Celcuity's announcement of FDA approval for its breast cancer therapy, Revtorpyk, with an anticipated commercial launch in late Q3 2026, which analysts deemed a delayed timeline. Investors who purchased Celcuity securities are encouraged to contact the firm to assist in the investigation.
The Bull Case For Celcuity (CELC) Could Change Following Revtopik’s FDA Approval And NCCN Category 1 Status
Celcuity Inc. (CELC) reported a wider Q2 net loss of US$78.86 million, but its investment outlook has been reshaped by the FDA approval and NCCN Category 1 status for its drug Revtopik in HR-positive, HER2-negative advanced breast cancer. This approval shifts the focus from binary trial events to commercialization execution, with potential initial revenue generation in late Q3 2026. Despite accelerating cash burn and reliance on financing, the market's previous cautious revenue forecasts for Celcuity may need to be revised upwards due to Revtopik's strong efficacy data and rapid guideline endorsement.
The Bull Case For Celcuity (CELC) Could Change Following Revtopik’s FDA Approval And NCCN Category 1 Status
Celcuity Inc. (CELC) reported a wider Q2 net loss of US$78.86 million but secured FDA approval and NCCN Category 1 status for Revtopik, its breast cancer drug. This development significantly alters the company's investment narrative, shifting focus from gedatolisib's potential to Revtopik's commercialization and its ability to offset increasing losses. The rapid guideline endorsement is expected to lead to initial revenue generation by late Q3 2026, though investors are cautioned to consider the company's accelerating cash burn and reliance on financing.
Celcuity (NASDAQ:CELC) Stock Rating Lowered by Wall Street Zen
Wall Street Zen downgraded Celcuity (NASDAQ:CELC) from a "sell" to a "strong sell," despite a "Moderate Buy" consensus from other analysts with an average price target of $153.64. The company's shares opened at $92, below its 52-week high, and reported a larger-than-expected quarterly loss of $1.44 per share, missing consensus estimates. Institutional investors currently hold 63.33% of the stock.
Celcuity (NASDAQ:CELC) Releases Quarterly Earnings Results, Misses Estimates By $0.28 EPS
Celcuity (NASDAQ:CELC) recently reported its quarterly earnings, missing analyst estimates with a loss of $1.44 per share against a consensus of $1.16, and revenue of $0.09 million, significantly below the $4.42 million forecast. Despite the financial miss, the company highlighted the FDA approval of REVTORPYK and its strong performance in clinical trials for advanced breast cancer, with commercial shipments expected to begin in late Q3 2026. Celcuity's net loss widened to $78.9 million due to launch expenses, but it ended June with $754 million in cash, providing funding through 2029.
Celcuity remains a Buy as FDA approval and strong trial data boost confidence in its cancer drug launch.
Celcuity Inc. has received a "Buy" rating following the FDA approval of its cancer drug REVTORPYK/gedatolisib and its quick inclusion in NCCN Category 1 guidelines, which is expected to aid adoption. Despite high upfront commercial investments and a significant valuation, the company's strong cash position and positive clinical trial results suggest a promising market launch and potential for label expansion and earnings growth.
Stifel cuts Celcuity stock price target on refined market model
Stifel lowered its price target for Celcuity Inc. (NASDAQ:CELC) to $150 from $175, while maintaining a Buy rating, citing refined market model inputs for Revtorpyk and higher future administrative expenses. Despite the stock's strong performance, InvestingPro analysis suggests it might be overvalued, and analysts do not anticipate profitability this year. The company is preparing for the commercial launch of Revtorpyk in late Q3 2026, supported by strong liquidity and an ongoing Expanded Access Program.
Celcuity Inc. Stock 12‑Month Price Target Cut to $160.64, Implies 85% Upside
Analysts have adjusted Celcuity Inc.'s average 12-month price target from $163.55 to $160.64, with individual forecasts ranging from $140 to $178 per share. This new target suggests an 85% potential upside from the Aug. 13 closing price. The consensus rating for Celcuity Inc. remains a "Buy" among 12 analysts.
Needham cuts Celcuity stock price target on updated revenue model
Needham has reduced its price target for Celcuity Inc (NASDAQ:CELC) shares to $140 from $157, while maintaining a Buy rating. This adjustment follows the approval and upcoming launch of Revtorpyk, with Needham updating its revenue models to an incidence-based approach and incorporating new pricing and treatment-duration information. Despite the stock trading below its 52-week high, it has seen significant returns, though InvestingPro analysis suggests it is overvalued and the company is not expected to be profitable this year.
Celcuity Inc. Reports Release of Second Quarter 2026 Financial Results and Provides Corporate Update
Celcuity Inc. announced its Q2 2026 financial results, highlighted by the FDA approval of REVTORPYK (gedatolisib) for HR+/HER2- PIK3CA Wild-Type breast cancer and its inclusion in NCCN guidelines. The company plans a commercial launch for REVTORPYK in late Q3 2026 and intends to submit an sNDA for the PIK3CA mutant cohort of the VIKTORIA-1 trial. Financially, Celcuity reported a net loss of $78.9 million for the quarter, with cash and equivalents totaling $754.0 million, projected to fund operations until at least 2029.
Celcuity (CELC) Wins FDA Approval As Investors Weigh Whether The Pullback Is A Buying Opportunity
Celcuity (CELC) has received FDA approval for REVTORPYK for certain metastatic breast cancer patients and its inclusion in NCCN guidelines. Despite this positive news, the stock has experienced a significant pullback, falling 22% over 30 days and 37.1% over 90 days. Analysts currently value CELC at $161.09, which is considerably higher than its current trading price of $86.60, suggesting it may be undervalued despite being a pre-revenue company.
CELC: FDA approval, strong trial data, and robust cash position set stage for late Q3 launch
Celcuity Inc. (CELC) received FDA approval for REVTORPYK for HR-positive, HER2-negative advanced breast cancer, supported by strong trial data and NCCN guideline inclusion. Despite a Q2 net loss of $78.9M, the company has a robust cash position due to a $575M convertible note, setting the stage for a commercial launch in late Q3 2026. This summary is AI-generated and requires verification with the original source.
CELCUITY ($CELC) Releases Q2 2026 Earnings
CELCUITY ($CELC) reported Q2 2026 earnings, missing analyst estimates with -$1.44 per share, compared to an expected -$1.19, and revenue of $0, matching estimates. Insider trading activity for CELC in the last six months shows nine sales and no purchases. Institutional investors have had mixed activity, with 144 adding shares and 140 decreasing positions, while analysts have set a median price target of $160.0 for the stock.
Celcuity beats second quarter loss estimates
Celcuity Inc. reported an adjusted loss of $1.07 per share for the second quarter of 2026, surpassing analyst estimates. The company's shares rose 1% after the announcement, driven by the recent FDA approval of its breast cancer treatment, REVTORPYK. Celcuity expects to begin shipments of REVTORPYK late in the third quarter of 2026 and plans to submit a supplemental New Drug Application for a different patient population.
Earnings Flash (CELC) Celcuity Inc. Posts Q2 Adjusted Loss $1.07 per Share, vs. FactSet Est of $-1.12
Celcuity Inc. (CELC) reported a Q2 adjusted loss of $1.07 per share, which was better than the FactSet estimate of $-1.12 per share. The article, published on August 13, 2026, also noted that Celcuity's Q2 adjusted loss widened. This news follows several recent developments for the company, including FDA approval for its REVTORPYK drug.
Celcuity (CELC) Wins FDA Approval As Investors Weigh Whether The Pullback Is A Buying Opportunity
Celcuity (CELC) received FDA approval for REVTORPYK and inclusion in National Comprehensive Cancer Network guidelines, yet its share price has fallen significantly in recent months, trading at a discount to analyst targets. Analysts forecast substantial revenue by 2029 for the pre-revenue company, suggesting a strong upside despite current market skepticism. Investors are now evaluating whether the recent pullback represents a buying opportunity or signals potential risks related to future data and regulatory processes.
Celcuity, Inc. (NASDAQ:CELC) Receives Average Recommendation of "Moderate Buy" from Brokerages
Celcuity, Inc. (NASDAQ:CELC) has received an average "Moderate Buy" rating from eleven brokerages, with ten assigning a buy rating and one a sell rating. The average 12-month price target is $155.18, significantly higher than its current price of $92.08. The company recently reported quarterly EPS of -$0.97, surpassing analyst estimates, and institutional investors hold 63.33% of its stock.
Bank of America Corp DE Sells 262,789 Shares of Celcuity, Inc. $CELC
Bank of America Corp DE reduced its stake in Celcuity, Inc. (NASDAQ:CELC) by 26.9% during the first quarter, selling 262,789 shares but still holding 714,329 shares valued at $81.5 million. Despite the share reduction, analyst sentiment remains largely positive, with a "Moderate Buy" consensus rating and an average price target of $155.18, following the company's better-than-expected quarterly earnings report. Celcuity, a clinical-stage biotechnology company focused on precision oncology diagnostics, opened at $92.79, below its 200-day moving average.
California State Teachers Retirement System Acquires 12,201 Shares of Celcuity, Inc. $CELC
The California State Teachers Retirement System has significantly increased its stake in Celcuity, Inc. (NASDAQ:CELC) by 91.2%, purchasing an additional 12,201 shares, bringing its total holdings to 25,580 shares valued at $2.92 million. Despite this institutional interest, the company's shares opened at $92.79, below their 52-week high, following a reported quarterly loss of $0.97 per share, which nonetheless beat analyst expectations. Analysts maintain a "Moderate Buy" consensus rating with an average price target of $155.18, reflecting optimism about the clinical-stage biotechnology firm specializing in precision oncology diagnostics.
