CELC

4 - Celcuity Inc. (0001603454) (Issuer)

DEFA14A - Celcuity Inc. (0001603454) (Filer)

DEF 14A - Celcuity Inc. (0001603454) (Filer)

4 - Celcuity Inc. (0001603454) (Issuer)

10-K - Celcuity Inc. (0001603454) (Filer)

8-K - Celcuity Inc. (0001603454) (Filer)

The U.S. Food and Drug Administration ("FDA") accepted Celcuity's New Drug Application ("NDA") and granted Priority Review with a Prescription Drug User Fee Act ("PDUFA") goal date of July 17, 2026, for gedatolisib in HR+/HER2-/PIK3CA wild-type ("WT") advanced breast cancer ("ABC")Results from PIK3CA WT cohort of Phase 3 VIKTORIA-1 study of gedatolisib regimens in HR+/HER2- ABC published in Journal of Clinical OncologyTopline results from the PIK3CA mutant cohort of the Phase 3 VIKTORIA-1 study are expected to be released in the second quarter of 2026Management to host webcast and conference call today, March 25, 2026, at 4:30 p.m. EDT MINNEAPOLIS, March 25, 2026 (GLOBE NEWSWIRE) -- Celcu

SCHEDULE 13D/A - Celcuity Inc. (0001603454) (Subject)

MINNEAPOLIS, March 18, 2026 (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 2025 after the market closes on Wednesday, March 25, 2026. 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. Webcast and Conference Call Information To participate in the teleconference, domestic callers should dial 1-800-717-1738 and international callers should dial 1-646-307-1865. A live webcast presentation can also be accessed usi

As previously presented, gedatolisib + palbociclib + fulvestrant ("gedatolisib triplet") and gedatolisib + fulvestrant ("gedatolisib doublet") reduced the risk of disease progression or death versus fulvestrant by 76% and 67%, respectively MINNEAPOLIS, March 09, 2026 (GLOBE NEWSWIRE) -- Celcuity Inc. (NASDAQ:CELC), a clinical-stage biotechnology company pursuing development of targeted therapies for oncology, today announced publication of efficacy and safety results from the PIK3CA wild-type ("WT") cohort of the Phase 3 VIKTORIA-1 clinical trial of gedatolisib, an investigational pan-PI3K/mTORC1/2 inhibitor, in the Journal of Clinical Oncology. The cohort consists of patients with hormon

MINNEAPOLIS, Feb. 25, 2026 (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 TD Cowen 46th Annual Healthcare Conference at 10:30 a.m. ET on Wednesday, March 4, 2026. A live webcast will be available using this weblink: https://event.summitcast.com/view/9z5g2VrV6e6rbCqQgDRoHA/NYER3h287L9qyxak8BZiq2A fireside chat at the Leerink Global Healthcare Conference at 2:20 p.m. ET on Tuesday, M

SCHEDULE 13G/A - Celcuity Inc. (0001603454) (Subject)

4 - Celcuity Inc. (0001603454) (Issuer)

3 - Celcuity Inc. (0001603454) (Issuer)

8-K - Celcuity Inc. (0001603454) (Filer)

MINNEAPOLIS, Feb. 12, 2026 (GLOBE NEWSWIRE) -- Celcuity Inc. (NASDAQ:CELC), a clinical-stage biotechnology company pursuing development of targeted therapies for oncology, today announced the appointment of Charles (Chip) R. Romp to its Board of Directors. Mr. Romp brings over 25 years of experience in the pharmaceutical industry to Celcuity, including leadership of sales teams and commercial organizations in the oncology setting. "Chip brings a wealth of oncology-related commercial expertise to our Board," said Brian Sullivan, Chief Executive Officer and co-founder of Celcuity. "Chip's deep experience commercializing significant oncology drugs will provide valuable insight to Celcuity as

MINNEAPOLIS, Feb. 04, 2026 (GLOBE NEWSWIRE) -- Celcuity Inc. (NASDAQ:CELC), a clinical-stage biotechnology company pursuing development of targeted therapies for oncology, today announced its participation in the Guggenheim Emerging Outlook: Biotech Summit 2026 to be held in New York, New York on February 11-12, 2026. Brian Sullivan, Chief Executive Officer and Co-founder of Celcuity, is scheduled for a fireside chat at 9:30 a.m. ET on Wednesday, February 11, 2026. A live webcast of the event will be available using this weblink https://event.summitcast.com/view/kbtj9ZAiVkB78KPZiu5dZ9/2Q8oLmGM98qWAwr5LXWSr8. Alternatively, the live webcast will be accessible from the Investors section of

4 - Celcuity Inc. (0001603454) (Issuer)

144 - Celcuity Inc. (0001603454) (Subject)

FDA grants Priority Review and assigns a PDUFA goal date of July 17, 2026 MINNEAPOLIS, Jan. 20, 2026 (GLOBE NEWSWIRE) -- Celcuity Inc. (NASDAQ:CELC), a clinical-stage biotechnology company pursuing development of targeted therapies for oncology, today announced that the U.S. Food and Drug Administration ("FDA") has accepted for filing its New Drug Application ("NDA") for gedatolisib in hormone receptor positive ("HR+"), human epidermal growth factor receptor 2 negative ("HER2-"), PIK3CA wild-type advanced breast cancer ("ABC"). The FDA granted Priority Review and assigned a Prescription Drug User Fee Act ("PDUFA") goal date of July 17, 2026. The NDA was submitted under the FDA's Real-Tim

4 - Celcuity Inc. (0001603454) (Issuer)

S-3ASR - Celcuity Inc. (0001603454) (Filer)

Issued on behalf of Oncolytics Biotech Inc. VANCOUVER, British Columbia, Jan. 08, 2026 (GLOBE NEWSWIRE) -- Equity-Insider.com News Commentary – Biopharma M&A is entering a fever pitch, with precision oncology investments alone exploding to $138 billion as major players scramble to secure proven cancer therapies before their most profitable drugs lose protection[1]. This looming $170 billion "patent cliff" has triggered a massive capital rotation into de-risked platforms that can reach patients and the market within the next 18 to 24 months[2]. This urgent race for registration-ready assets is driving the 2026 investment case for Oncolytics Biotech Inc. (NASDAQ:ONCY), OS Therapies Inc. (NY

Wells Fargo initiated coverage of Celcuity with a rating of Overweight and set a new price target of $126.00

For patients whose time to progression on immediate prior therapy was >18 months, median progression-free survival ("PFS") was 12.4 months with gedatolisib + palbociclib + fulvestrant ("gedatolisib triplet") and 10.0 months with gedatolisib + fulvestrant ("gedatolisib doublet") versus 1.9 months for fulvestrantFor patients enrolled in the U.S., Canada, Western Europe, and Asia Pacific, median PFS was 16.6 months with the gedatolisib triplet and 7.1 months with the gedatolisib doublet versus 1.9 months for fulvestrantMeasures to mitigate stomatitis were generally effective; most patients experienced resolution to a lower grade of stomatitis within 2 weeks MINNEAPOLIS, Dec. 11, 2025 (GLOBE