The PIK3CA wild-type cohort of the Phase 3 VIKTORIA-1 trial is 100% enrolled; expect to report topline data for this cohort in late Q1 2025 or Q2 2025 Approximately $264 million in cash, cash equivalents and investments at end of Q3 2024 expected to fund current clinical development program activities through 2026 Management to host webcast and conference call today, November 14, 2024, at 4:30 p.m. ET MINNEAPOLIS, Nov. 14,... Read More

MINNEAPOLIS, Nov. 12, 2024 (GLOBE NEWSWIRE) -- Celcuity Inc. (Nasdaq: CELC), a clinical-stage biotechnology company pursuing development of targeted therapies for oncology, today announced that Brian Sullivan, Chief Executive Officer, and Co-founder of Celcuity, will present and be available for one-on-one investor meetings at the following investor conferences: A fireside chat at the Stifel 2024 Healthcare Conference at... Read More

MINNEAPOLIS, Nov. 07, 2024 (GLOBE NEWSWIRE) -- Celcuity Inc. (Nasdaq: CELC), a clinical-stage biotechnology company pursuing development of targeted therapies for oncology, today announced that it will release its financial results for the third quarter 2024 after the market closes on Thursday, November 14, 2024. Management will host a webcast/teleconference the same day at 4:30 p.m. Eastern Time to discuss the results and... Read More

Announced plan to initiate Phase 3 VIKTORIA-2 trial evaluating gedatolisib combined with fulvestrant plus a CDK4/6 inhibitor as first-line treatment for patients with HR+, HER2- advanced breast cancer; expect to enroll first patient in Q2 2025 Expect to reach enrollment target for VIKTORIA-1 PIK3CA WT cohort in Q4 2024 and report topline data for this cohort in late Q4 2024 or Q1 2025 Raised $129 million in gross proceeds... Read More

MINNEAPOLIS, Aug. 07, 2024 (GLOBE NEWSWIRE) -- Celcuity Inc. (Nasdaq: CELC), a clinical-stage biotechnology company pursuing development of targeted therapies for oncology, today announced that it will release its financial results for the second quarter 2024 after the market closes on Wednesday, August 14, 2024. Management will host a webcast/teleconference the same day at 4:30 p.m. Eastern Time to discuss the results and... Read More

MINNEAPOLIS, June 03, 2024 (GLOBE NEWSWIRE) -- Celcuity Inc. (Nasdaq: CELC), a clinical-stage biotechnology company pursuing development of targeted therapies for oncology, today announced its participation in the Jefferies Global Healthcare Conference to be held in New York on June 4-6, 2024. Brian Sullivan, Chief Executive Officer, and Co-founder of Celcuity, is scheduled for a fireside chat at 10:00 a.m. ET on Thursday,... Read More

MINNEAPOLIS, May 30, 2024 (GLOBE NEWSWIRE) -- Celcuity Inc. (Nasdaq: CELC), a clinical-stage biotechnology company pursuing development of targeted therapies for oncology, today announced the pricing of an underwritten offering of 3,871,000 shares of its common stock at an offering price of $15.50 per share. All of the securities are to be sold by Celcuity. Investors who have agreed to purchase shares in the offering include... Read More

The Phase 3 clinical trial will evaluate gedatolisib plus a CDK4/6 inhibitor and fulvestrant as first-line treatment for patients with HR+/HER2- advanced breast cancer who are endocrine therapy resistant Received an additional term loan of approximately $62 million in conjunction with an amendment to an existing debt facility agreement MINNEAPOLIS, May 30, 2024 (GLOBE NEWSWIRE) -- Celcuity Inc. (Nasdaq: CELC), a... Read More

The Phase 3 VIKTORIA-1 trial remains on track to report topline data from PIK3CA wild type patient sub-group in the second half of 2024 First patient dosed in a Phase 1b/2 clinical trial evaluating gedatolisib in combination with darolutamide in patients with metastatic castration resistant prostate cancer $177.7 million in cash, cash equivalents and short-term investments expected to provide runway into the first half of... Read More

MINNEAPOLIS, May 08, 2024 (GLOBE NEWSWIRE) -- Celcuity Inc. (Nasdaq: CELC), a clinical-stage biotechnology company pursuing development of targeted therapies for oncology, today announced that it will release its financial results for the first quarter 2024 after the market closes on Wednesday, May 15, 2024. Management will host a webcast/teleconference the same day at 4:30 p.m. Eastern Time to discuss the results and... Read More

MINNEAPOLIS, April 04, 2024 (GLOBE NEWSWIRE) -- Celcuity Inc. (Nasdaq: CELC), a clinical-stage biotechnology company pursuing development of targeted therapies for oncology, today announced that Brian Sullivan, Chief Executive Officer, and Co-founder of Celcuity, will present and be available for one-on-one investor meetings at the following investor conferences: A fireside chat at the 23 rd Annual Needham Virtual Healthcare... Read More

Dosed the first patient in a Phase 1b/2 trial evaluating gedatolisib in combination with darolutamide for the treatment of metastatic castration resistant prostate cancer Presented nonclinical data demonstrating the superior therapeutic effects of gedatolisib compared to other PI3K/AKT/mTOR inhibitors at the 2023 SABCS Raised $65 million from the sale of equity; expect cash, cash equivalents, investments and available funds... Read More

MINNEAPOLIS, March 20, 2024 (GLOBE NEWSWIRE) -- Celcuity Inc. (Nasdaq: CELC), a clinical-stage biotechnology company pursuing development of targeted therapies for oncology, today announced that it will release its financial results for the fourth quarter and full year 2023 after the market closes on Wednesday, March 27, 2024. Management will host a webcast/teleconference the same day at 4:30 p.m. Eastern Time to discuss the... Read More

MINNEAPOLIS, March 06, 2024 (GLOBE NEWSWIRE) -- Celcuity Inc . (Nasdaq: CELC), a clinical-stage biotechnology company pursuing development of targeted therapies for oncology, today announced its participation in the Leerink Partners Global Biopharma Conference 2024 to be held in Miami on March 11-13, 2024. Brian Sullivan, Chief Executive Officer, and Co-founder of Celcuity, is scheduled for a podium presentation at 8:40 a.m.... Read More

MINNEAPOLIS, Feb. 28, 2024 (GLOBE NEWSWIRE) -- Celcuity Inc. (Nasdaq: CELC), a clinical-stage biotechnology company pursuing development of targeted therapies for oncology, today announced its participation in Cowen’s 44 th Annual Health Care Conference to be held in Boston on March 4-6, 2024. Brian Sullivan, Chief Executive Officer, and Co-founder of Celcuity, is scheduled for a fireside chat at 2:10 p.m. ET on Wednesday,... Read More

MINNEAPOLIS, Feb. 22, 2024 (GLOBE NEWSWIRE) -- Celcuity Inc. (Nasdaq: CELC), a clinical-stage biotechnology company developing targeted therapies for oncology, today announced that the first patient has been dosed in its Phase 1b/2 study (CELC-G-201) evaluating gedatolisib in combination with Nubeqa ® (darolutamide), an approved androgen receptor inhibitor, for the treatment of patients with metastatic castration resistant... Read More

MINNEAPOLIS, Feb. 20, 2024 (GLOBE NEWSWIRE) -- Celcuity Inc. (Nasdaq: CELC), a clinical-stage biotechnology company pursuing development of targeted therapies for oncology, today announced the appointment of Eldon Mayer as Chief Commercial Officer. Mr. Mayer joins Celcuity with over 30 years of biopharmaceutical commercial experience in companies ranging from early-stage biotechs to full scale pharmaceutical companies across... Read More

MINNEAPOLIS, Dec. 06, 2023 (GLOBE NEWSWIRE) -- Celcuity Inc. (Nasdaq: CELC), a clinical-stage biotechnology company pursuing development of targeted therapies for oncology, today presented data from preclinical studies evaluating gedatolisib and other PI3K/AKT/mTOR (PAM) inhibitors in breast cancer cell lines during a poster session at the 2023 San Antonio Breast Cancer Symposium (SABCS). The preclinical studies evaluated... Read More

MINNEAPOLIS, Dec. 01, 2023 (GLOBE NEWSWIRE) -- Celcuity Inc. (Nasdaq: CELC), a clinical-stage biotechnology company pursuing development of targeted therapies for oncology, today announced that an abstract accepted for a poster presentation at the 2023 San Antonio Breast Cancer Symposium (SABCS) is now available on the SABCS website. The 2023 San Antonio Breast Cancer Symposium (SABCS) is being held virtually and in-person... Read More

MINNEAPOLIS, Nov. 22, 2023 (GLOBE NEWSWIRE) -- Celcuity Inc. (Nasdaq: CELC), a clinical-stage biotechnology company pursuing development of targeted therapies for oncology, today announced its participation in the 6 th Annual Evercore ISI HealthCONx Conference held in Miami. Brian Sullivan, Chairman, Chief Executive Officer, and Co-founder of Celcuity, is scheduled for a fireside chat at 12:30 p.m. ET on Wednesday, November... Read More

Received FDA clearance of IND to evaluate gedatolisib in combination with darolutamide in patients with metastatic castration resistant prostate cancer (mCRPC) Entered into a clinical trial collaboration and supply agreement with Bayer AG to provide Nubeqa ® (darolutamide) for planned Phase 1b/2 clinical trial Raised $50 million in private placement sale of equity Management to host webcast and conference call today,... Read More

MINNEAPOLIS, Nov. 06, 2023 (GLOBE NEWSWIRE) -- Celcuity Inc. (Nasdaq: CELC), a clinical-stage biotechnology company pursuing development of targeted therapies for oncology, today announced that it will release its financial results for the third quarter 2023 before the market opens on Monday, November 13, 2023. Management will host a webcast/teleconference the same day at 8:00 a.m. Eastern Time to discuss the results and... Read More

MINNEAPOLIS, Nov. 01, 2023 (GLOBE NEWSWIRE) -- Celcuity Inc. (Nasdaq: CELC), a clinical-stage biotechnology company pursuing development of targeted therapies for oncology, today announced that Brian Sullivan, Chairman, Chief Executive Officer, and Co-founder of Celcuity, will present and be available for one-on-one investor meetings at the following investor conferences: A formal presentation at the Stifel 2023 Healthcare... Read More

MINNEAPOLIS, MN / ACCESSWIRE / October 18, 2023 / Celcuity Inc. (NASDAQ:CELC), a clinical-stage biotechnology company pursuing development of targeted therapies for oncology, announced today that it has entered into a securities purchase agreement to sell securities in a private placement that is expected to result in gross proceeds of approximately $50 million. In the private placement, an institutional investor has agreed... Read More

Leading key opinion leaders to review the treatment landscape in breast and prostate cancer and the importance of targeting the PI3K/mTOR pathway in hormonally driven tumor types Discussion of the planned Phase 1b/2 trial for gedatolisib in combination with Nubeqa ® (darolutamide) in patients with mCRPC Event to be webcast from 10:00 a.m. – 12:00 p.m. ET on September 21, 2023 MINNEAPOLIS, Sept. 07, 2023 (GLOBE NEWSWIRE) --... Read More

MINNEAPOLIS, Aug. 22, 2023 (GLOBE NEWSWIRE) -- Celcuity Inc. (Nasdaq: CELC), a clinical-stage biotechnology company pursuing development of targeted therapies for oncology, today announced that it has entered into a clinical trial collaboration and supply agreement with Bayer AG for Celcuity’s Phase 1b/2 clinical trial of gedatolisib and Nubeqa® (darolutamide) in patients with metastatic castration resistant prostate cancer... Read More

Received FDA clearance of IND for gedatolisib in combination with darolutamide Virtual Science Day to be held on September 21, 2023 from 10:00 a.m. – 12:00 p.m. ET MINNEAPOLIS, Aug. 22, 2023 (GLOBE NEWSWIRE) -- Celcuity Inc. (Nasdaq: CELC), a clinical-stage biotechnology company pursuing development of targeted therapies for oncology, has been notified by the U.S. Food and Drug Administration (FDA) that its Investigational... Read More

Phase 3 VIKTORIA-1 clinical trial is now recruiting patients at nearly 200 sites in 20 countries Presented updated results from Phase 1b study of gedatolisib in treatment-naïve advanced breast cancer at the ESMO Breast Cancer Annual Congress Median progression free survival (PFS) was 48.6 months in treatment-naïve patients with HR+/HER2- advanced breast cancer who were treated with gedatolisib in combination with palbociclib... Read More

MINNEAPOLIS, Aug. 03, 2023 (GLOBE NEWSWIRE) -- Celcuity Inc. (Nasdaq: CELC), a clinical-stage biotechnology company focused on development of targeted therapies for oncology, today announced that it will release its financial results for the second quarter 2023 after the stock market close on Thursday, August 10, 2023. Management will host a webcast/teleconference the same day at 4:30 p.m. Eastern Time to discuss the results... Read More

MINNEAPOLIS, July 31, 2023 (GLOBE NEWSWIRE) -- Celcuity Inc. (Nasdaq: CELC), a clinical-stage biotechnology company focused on development of targeted therapies for oncology, today announced that Brian Sullivan, Chairman, Chief Executive Officer, and Co-founder of Celcuity, will participate in one-on-one meetings at the BTIG Virtual Biotechnology Conference being held on August 7-8, 2023. About Celcuity Celcuity is a... Read More

MINNEAPOLIS, MN / ACCESSWIRE / June 20, 2023 / Celcuity Inc. (NASDAQ:CELC), a clinical-stage biotechnology company focused on development of targeted therapies for oncology, is set to join the Russell 2000 ® and 3000 ® Indexes at the conclusion of the 2023 Russell indexes annual reconstitution, effective after the U.S. market opens on June 26, according to the most recent list of additions posted June 16. Annual Russell... Read More

MINNEAPOLIS, MN / ACCESSWIRE / May 24, 2023 / Celcuity Inc. (NASDAQ:CELC), a clinical-stage biotechnology company focused on development of targeted therapies for oncology, today announced that Brian Sullivan, Chairman, Chief Executive Officer, and Co-founder of Celcuity, will participate in the following investor conferences: One-on-one and small group meetings at the 20th Annual Craig-Hallum Institutional Investor... Read More

Presented updated results for treatment-naïve patients from Phase 1b study of gedatolisib at the ESMO Breast Cancer Annual Congress - median progression free survival (PFS) was 48.6 months Presented nonclinical prostate cancer data at ASCO GU Cancers Symposium demonstrating the superior therapeutic effect of gedatolisib compared to other PI3K, AKT, and mTOR inhibitors regardless of PTEN or P13K mutational status Presented... Read More

Median progression free survival (PFS) was 48.6 months in treatment-naïve patients with HR+/HER2- advanced breast cancer who were treated with gedatolisib in combination with palbociclib and letrozole Median duration of response (DOR) was 46.9 months MINNEAPOLIS, MN / ACCESSWIRE / May 12, 2023 / Celcuity Inc. (NASDAQ:CELC), a clinical-stage biotechnology company focused on development of targeted therapies for oncology,... Read More

MINNEAPOLIS, MN / ACCESSWIRE / May 8, 2023 / Celcuity Inc. (NASDAQ:CELC), a clinical-stage biotechnology company focused on development of targeted therapies for oncology, today announced that it will release its financial results for the first quarter 2023 after the stock market close on Monday, May 15, 2023. Management will host a webcast/teleconference the same day at 4:30 p.m. Eastern Time to discuss the results and... Read More

MINNEAPOLIS, MN / ACCESSWIRE / May 8, 2023 / Celcuity Inc. (NASDAQ:CELC), a clinical-stage biotechnology company focused on development of targeted therapies for oncology, today announced publication of an abstract reporting updated results for treatment-naïve patients from the Phase 1b study of gedatolisib, a pan-PI3K/mTOR inhibitor, in combination with palbociclib and letrozole in women with HR+/HER2- advanced breast... Read More

Gedatolisib demonstrated superior anti-proliferative potency and efficacy in endometrial, ovarian and cervical cancer cell lines compared to other PAM inhibitors evaluated regardless of PTEN, P13K, or AKT mutational status MINNEAPOLIS, MN / ACCESSWIRE / April 18, 2023 / Celcuity Inc. (Nasdaq:CELC), a clinical-stage biotechnology company focused on development of targeted therapies for oncology, today presented data from... Read More

MINNEAPOLIS, MN / ACCESSWIRE / April 12, 2023 / Celcuity Inc. (NASDAQ:CELC), a clinical-stage biotechnology company focused on development of targeted therapies for oncology, today announced its participation in the 22nd Annual Needham Virtual Healthcare Conference. Brian Sullivan, Chairman, Chief Executive Officer, and Co-founder of Celcuity, is scheduled to present at 1:30 p.m. ET on Wednesday, April 19, 2023. A live... Read More

Dosing of first patient in VIKTORIA-1 in the fourth quarter triggered closing of $100 million PIPE financing and drawdown of $20 million term loan tranche, which extends cash runway through 2025 Updated clinical data from the Phase 1b advanced breast cancer trial with gedatolisib was presented at SABCS in December - median PFS was 42.3 months in treatment naïve advanced breast cancer patients Preclinical data reporting... Read More

MINNEAPOLIS, MN / ACCESSWIRE / March 16, 2023 / Celcuity Inc. (NASDAQ:CELC), a clinical-stage biotechnology company focused on development of targeted therapies for oncology, today announced that it will release its financial results for the fourth quarter and full year 2022 after the stock market close on Thursday, March 23, 2023. Management will host a webcast/teleconference the same day at 4:30 p.m. Eastern Time to... Read More

MINNEAPOLIS, MN / ACCESSWIRE / March 15, 2023 / Celcuity Inc. (NASDAQ:CELC), a clinical-stage biotechnology company focused on development of targeted therapies for oncology, today announced publication of an abstract reporting data from preclinical studies evaluating gedatolisib and other PI3K/AKT/mTOR inhibitors in endometrial, ovarian, and cervical cancer cell lines. A poster will be presented at the 2023 Annual Meeting... Read More

MINNEAPOLIS, MN / ACCESSWIRE / March 1, 2023 / Celcuity Inc. (NASDAQ:CELC), a clinical-stage biotechnology company focused on development of targeted therapies for oncology, today announced its participation in Cowen's 43rd Annual Health Care Conference to be held in Boston on March 6-8, 2023. Brian Sullivan, Chief Executive Officer and co-founder of Celcuity, is scheduled to present at 11:10 a.m. ET on Wednesday, March 8,... Read More

Gedatolisib demonstrated superior potency and efficacy in prostate cancer cell lines compared to other PI3K/AKT/mTOR inhibitors evaluated regardless of PI3K or PTEN status MINNEAPOLIS, MN / ACCESSWIRE / February 16, 2023 / Celcuity Inc. (NASDAQ:CELC), a clinical-stage biotechnology company focused on development of targeted therapies for oncology, today presented data from preclinical studies evaluating gedatolisib and other... Read More

MINNEAPOLIS, MN / ACCESSWIRE / December 12, 2022 / Celcuity Inc. (NASDAQ:CELC), a clinical-stage biotechnology company, today announced the closing of its private placement, resulting in gross proceeds of approximately $100 million, before deducting placement agent fees and other expenses. The closing follows dosage of the first patient in Celcuity's Phase 3 clinical trial, VIKTORIA-1, evaluating gedatolisib, Celcuity's lead... Read More

High response rates and encouraging median progression free survival rates were observed in patients regardless of PIK3CA mutation status Median progression free survival (PFS) of 42.3 months was reported for patients who were treatment naïve in the advanced setting MINNEAPOLIS, MN / ACCESSWIRE / December 9, 2022 / Celcuity Inc. (Nasdaq:CELC), a clinical-stage biotechnology company focused on development of targeted... Read More

First patient dosing enables closing of $100 million PIPE financing and drawdown of $20 million term loan tranche MINNEAPOLIS, MN / ACCESSWIRE / December 7, 2022 / Celcuity Inc. (Nasdaq:CELC), a clinical-stage biotechnology company developing targeted therapies for oncology, today announced that the first patient has been dosed in its Phase 3 clinical trial, VIKTORIA-1, evaluating gedatolisib plus fulvestrant with and... Read More

MINNEAPOLIS, MN / ACCESSWIRE / November 22, 2022 / Celcuity Inc. (NASDAQ:CELC), a clinical-stage biotechnology company focused on development of targeted therapies for cancer treatment, today announced that an abstract accepted for a Spotlight Poster presentation at the 2022 San Antonio Breast Cancer Symposium (SABCS) is now available on the SABCS website. The 2022 San Antonio Breast Cancer Symposium (SABCS) is being held... Read More