Celcuity Inc. (CELC)

MINNEAPOLIS, Sept. 22, 2025 (GLOBE NEWSWIRE) -- Celcuity Inc. (Nasdaq: CELC), a clinical-stage biotechnology company pursuing development of targeted therapies for oncology, today announced that a late breaking abstract reporting clinical data from the Phase 3 VIKTORIA-1 trial has been selected for an oral presentation at the upcoming European Society of Medical Oncology (ESMO) Congress, being held October 17-21, 2025. The presentation will provide detailed efficacy and safety data from the PIK3CA wild-type cohort of the VIKTORIA-1 trial.

MINNEAPOLIS, Sept. 09, 2025 (GLOBE NEWSWIRE) -- Celcuity Inc. (“Celcuity”), a clinical-stage biotechnology company pursuing development of targeted therapies for oncology, today announced that it has entered into an amendment to its existing senior secured credit facility with an affiliate of Innovatus Capital Partners, LLC (“Innovatus”) and Oxford Finance LLC, and its affiliates (together, “Oxford”). The amendment increases the total term loan facility size to $500 million, including $350 million in committed capital and up to $150 million at the mutual discretion of Celcuity and its lenders. At the closing of the Amendment, the initial funding under the amended credit facility was in a principal amount of $30 million, bringing the total term loan outstanding to $130 million.

MINNEAPOLIS, Aug. 27, 2025 (GLOBE NEWSWIRE) -- Celcuity Inc. (Nasdaq: CELC), a clinical-stage biotechnology company pursuing development of targeted therapies for oncology, today announced the U.S. Food and Drug Administration (“FDA”) agreed to accept its New Drug Application (“NDA”) for gedatolisib in HR+/HER2- advanced breast cancer (“ABC”) for review under the Real-Time Oncology Review (“RTOR”) program, which facilitates earlier submission of topline efficacy and safety results, prior to the submission of the complete application, to support an earlier start to the FDA's evaluation of the application. Celcuity is expected to initiate in September a rolling submission to the FDA of its NDA for gedatolisib, based on topline data from the PIK3CA wild-type cohort of the Phase 3 VIKTORIA-1 clinical trial. Completion of the NDA submission is targeted for the fourth quarter of 2025.

Celcuity Inc. (NASDAQ:CELC ) Q2 2025 Earnings Conference Call August 14, 2025 4:30 PM ET Company Participants Brian F. Sullivan - Co-Founder, Chairman & CEO Vicky Hahne - Chief Financial Officer Conference Call Participants Chase Richard Knickerbocker - Craig-Hallum Capital Group LLC, Research Division Eason Lee - Leerink Partners LLC, Research Division Frances Dovell - TD Cowen, Research Division Gil Joseph Blum - Needham & Company, LLC, Research Division Mohamad Amin Makarem - Jefferies LLC, Research Division Stephen Douglas Willey - Stifel, Nicolaus & Company, Incorporated, Research Division Apoorva Chaloori - Unidentified Company Operator Good afternoon, ladies and gentlemen, and welcome to the Celcuity Second Quarter 2025 Financial Results Webcast and Conference Call.

MINNEAPOLIS, Aug. 14, 2025 (GLOBE NEWSWIRE) -- Celcuity Inc. (Nasdaq: CELC), a clinical-stage biotechnology company pursuing development of targeted therapies for oncology, today announced financial results for the second quarter ended June 30, 2025 and other recent business developments.

MINNEAPOLIS, Aug. 07, 2025 (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 2025 after the market closes on Thursday, August 14, 2025. Management will host a webcast/teleconference the same day at 4:30 p.m. Eastern Time to discuss the results and provide a corporate update.

Celcuity's phase 3 VIKTORIA-1 trial showed gedatolisib significantly improved progression-free survival in PIK3CA wild-type HR+/HER2- advanced breast cancer patients. NDA submission for gedatolisib in 2nd-line PIK3CA wild-type HR+/HER2- ABC patients is planned for Q4 2025, with expansion to mutant and 1st-line cohorts underway as well. Strong market opportunity exists as HR+/HER2- breast cancer represents 70% of all breast cancers; Data from PIK3CA-mutant cohort expected by end of 2025.

MINNEAPOLIS, July 30, 2025 (GLOBE NEWSWIRE) -- Celcuity Inc. (Nasdaq: CELC) (the “Company”), a clinical-stage biotechnology company pursuing development of targeted therapies for oncology, today announced the pricing of its underwritten public offering of $175,000,000 aggregate principal amount of its 2.750% convertible senior notes due 2031 (the “Convertible Notes” and such offering, the “Convertible Notes Offering”), and its underwritten public offering of 1,836,842 of shares of its common stock (the “Common Stock”) at a public offering price of $38.00 per share and, in lieu of Common Stock to investors who so choose, pre-funded warrants to purchase up to 400,000 shares of Common Stock (the “Pre-Funded Warrants”) at a public offering price of $37.999 per Pre-Funded Warrant, which represents the per share public offering price of each share of Common Stock less the $0.001 per share exercise price of each Pre-Funded Warrant (such offering, the “Common Stock Offering”).

Celcuity stock (NASDAQ: CELC), a clinical-stage biotechnology company, experienced an extraordinary 3x surge in a single trading session, with shares rocketing from approximately $14 to a peak of $46 before stabilizing around $37. This dramatic price movement was triggered by positive topline results from the PIK3CA wild-type cohort of the company's Phase 3 VIKTORIA-1 clinical trial for gedatolisib, a targeted therapy for HR+/HER2- breast cancer.

MINNEAPOLIS, July 28, 2025 (GLOBE NEWSWIRE) -- Celcuity Inc. (Nasdaq: CELC) (the “Company”), a clinical-stage biotechnology company pursuing development of targeted therapies for oncology, today announced proposed underwritten public offerings of $150,000,000 aggregate principal amount of its convertible senior notes due 2031 (the “Convertible Notes” and such offering, the “Convertible Notes Offering”) and $75,000,000 of shares of its common stock (the “Common Stock” and, such offering, the “Common Stock Offering”).

Shares of Celcuity surged more than 186% on Monday after the biotechnology company reported highly positive topline results from a Phase 3 clinical trial of its investigational breast cancer treatment. The stock was set for its best day on record if it held the gains.

Biotech stock Celcuity Inc (NASDAQ:CELC) is skyrocketing today, up 221% at $43.76 at last glance, after upbeat phase 3 trial results for its advanced breast cancer therapy, gedatolisib, which it hopes will have Food & Drug Administration (FDA) approval by the end of the year.

Celcuity said on Monday its experimental combination treatment delayed the progression of a type of advanced breast cancer, sending the biotech firm's shares surging more than twofold in premarket trading.

Hazard Ratios and Improvements in Median PFS are Unprecedented in HR+/HER2- Advanced Breast Cancer (“ABC”)

MINNEAPOLIS, July 25, 2025 (GLOBE NEWSWIRE) -- Celcuity Inc. (Nasdaq: CELC), a clinical-stage biotechnology company pursuing development of targeted therapies for oncology, today announced the Company will hold a conference call and webcast on Monday, July 28, 2025 at 8:00 AM ET to disclose the topline results of the PIK3CA Wild-Type Cohort from the Phase 3 VIKTORIA-1 trial.

MINNEAPOLIS, July 24, 2025 (GLOBE NEWSWIRE) -- Celcuity Inc. (Nasdaq: CELC), a clinical-stage biotechnology company pursuing development of targeted therapies for oncology, today announced that the first patient has been dosed in VIKTORIA-2, its Phase 3 clinical trial evaluating gedatolisib plus a CDK4/6 inhibitor and fulvestrant as first-line treatment for patients with HR+/HER2- advanced breast cancer (“ABC”) who are endocrine therapy resistant. Gedatolisib is an investigational, multi-target PI3K/AKT/mTOR (“PAM”) inhibitor that potently targets all four class I PI3K isoforms, mTORC1, and mTORC2 to induce comprehensive blockade of the PAM pathway.