Celcuity Inc.
Celcuity is a clinical-stage biotechnology company developing targeted therapies for multiple solid tumor indications. Its lead drug candidate, gedatolisib, is an intravenous kinase inhibitor designed to target all class I PI3K isoforms and the mTORC1 and mTORC2 complexes in the PI3K/AKT/mTOR pathway. The company’s clinical programs focus on advanced breast cancer and metastatic castration-resistant prostate cancer. Celcuity is evaluating gedatolisib with fulvestrant, with or without palbociclib, in the Phase 3 VIKTORIA-1 trial for hormone receptor-positive, HER2-negative advanced breast cancer, and with a CDK4/6 inhibitor and fulvestrant in the Phase 3 VIKTORIA-2 trial. Its Phase 1b/2 CELC-G-201 trial evaluates gedatolisib with darolutamide in prostate cancer. The company is headquartered in Minneapolis, Minnesota.
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See all $CELC insider activity →Celcuity Inc. [CELC] reported strong early launch access metrics. Positive phase III results and first-line data indicate broad opportunities. Key milestones include an sNDA review, prostate phase II completion in 2027, and expanded manufacturing capacity, according to a Stifel conference transcript.
Celcuity Inc. (CELC) announced the FDA accepted its supplemental New Drug Application (sNDA) for REVTORPYK, aiming to treat a specific type of breast cancer. The FDA set a goal date of June 25, 2027, for review. This follows the drug's expected approval in July 2026 for patients without a detected PIK3CA mutation.
HC Wainwright & Co. maintained its Buy rating on Celcuity but reduced its price target from $155 to $150, a 3.2% decrease. The new target suggests a 124.6% upside from the Nov 6 closing price of $66.79. Recent analyst price targets for Celcuity range from $140 to $169.
Over the past 7 days, AlphAI's AI scored 5 news stories mentioning CELC (Celcuity Inc.). Coverage has skewed bullish: 4 bullish, 1 neutral, and 0 bearish.
Recent CELC coverage spans financial news, earnings and regulation.
Positive trial data and expanded capacity may boost investor sentiment.
The acceptance signals continued regulatory review but delays the potential market approval, likely keeping the stock under pressure.
HC Wainwright & Co. maintained its Buy rating on Celcuity but reduced its price target from $155 to $150, a 3.2% decrease. The new target suggests a 124.6% upside from the Nov 6 closing price of $66.79. Recent analyst price targets for Celcuity range from $140 to $169.
Analyst upgrade and better-than-expected loss guidance may drive buying interest.
Analyst downgrade may weigh on the stock in the short term.
AlphAI scores every news story that mentions CELC with an AI model for sentiment and relevance, and aggregates insider trades from Celcuity Inc.'s SEC EDGAR Form 4 filings. Figures refresh continuously.
Celcuity Inc. [CELC] reported strong early launch access metrics. Positive phase III results and first-line data indicate broad opportunities. Key milestones include an sNDA review, prostate phase II completion in 2027, and expanded manufacturing capacity, according to a Stifel conference transcript.
Celcuity Inc. (CELC) announced the FDA accepted its supplemental New Drug Application (sNDA) for REVTORPYK, aiming to treat a specific type of breast cancer. The FDA set a goal date of June 25, 2027, for review. This follows the drug's expected approval in July 2026 for patients without a detected PIK3CA mutation.
HC Wainwright & Co. maintained its Buy rating on Celcuity but reduced its price target from $155 to $150, a 3.2% decrease. The new target suggests a 124.6% upside from the Nov 6 closing price of $66.79. Recent analyst price targets for Celcuity range from $140 to $169.
Citizens maintained a Market Outperform rating on Celcuity (NASDAQ:CELC) with a $177.00 price target, citing competitive positioning. The stock is currently at $66.79, below its 52-week high of $151.02. Celcuity reported a smaller-than-expected adjusted loss of $1.21 per share for Q3 2026, but revenue fell short of forecasts. The company's expenses rose due to the launch of its breast cancer drug, REVTORPYK.
Guggenheim kept its Buy rating on Celcuity but reduced its price target to $169 from $171, a 1.2% decrease. This implies a 163.9% upside from the Nov 5 close of $64.04, according to the firm.
Celcuity (CELC) reported Q3 earnings, highlighting sufficient production capacity and regulatory updates. The company submitted a supplemental new drug application to the FDA and expects to provide further data to global regulators. Operating expenses rose to $77.3M, driven by commercial spending. Celcuity ended the quarter with $642.7M in cash and expects it to fund operations through 2029.
Celcuity Inc. (CELC) filed an SEC Form 8-K — Results of Operations and Financial Condition. Exhibit 99.1 Celcuity Inc. Reports Third Quarter 2026 Financial Results and Provides Corporate Update REVTORPYK became commercially available on September 30th for the treatment of patients with HR+/HER2- PIK3CA wild-type locally advanced or metastatic breast cancer 91% of U.S. c
Celcuity reported that Revtorpyk, combined with fulvestrant and Pfizer's Ibrance, improved median progression-free survival in a phase 3 trial for breast cancer compared to Novartis' Vijoice.
Celcuity reported VIKTORIA-1 subgroup data showing median PFS of 21.5 months for triplet therapy, 11.5 months for doublet, vs 9.1 months for alpelisib+fulvestrant in PIK3CA MT HR+/HER2- ABC without liver mets. TEAE discontinuations were lower for Celcuity's treatments.
Celcuity Inc. (CELC) announced new data from the VIKTORIA-1 study showing that its drug gedatolisib, combined with other treatments, improved progression-free survival in patients with HR+/HER2- breast cancer. The study found median PFS of 21.5 months for the triplet therapy in patients without liver metastases, compared to 9.1 months for the control group. The data was presented at the ESMO Congress 2026.
