SchaeffersResearch.com

Biotech Stock Blasting Off After Late-Stage Trial Results

CELC is trading at record highs today after the company's big breakthrough Biotech stock Celcuity Inc (NASDAQ:CELC) is skyrocketing today, up 221% at $43.76 at last glance, after upbeat phase 3 trial ...
Cure Today

FDA Accepts Gedatolisib Application for Some With Breast Cancer

Gedatolisib targets HR+/HER2-, PIK3CA wild-type advanced breast cancer, with a PDUFA goal date of July 17, 2026. The drug's multi-target approach inhibits all four class 1 PI3K isoforms, mTORC1, and ...
Yahoo Finance

Celcuity to Initiate NDA Submission of Gedatolisib in PIK3CA Wild-Type Cohort in HR+/HER2- Advanced Breast Cancer Under FDA’s Real-Time Oncology Review Program

The above button links to Coinbase. Yahoo Finance is not a broker-dealer or investment adviser and does not offer securities or cryptocurrencies for sale or facilitate trading. Coinbase pays us for ...
Nasdaq

Celcuity Stock Hits All-Time High On Gedatolisib Progress

(RTTNews) - Shares of Celcuity Inc. (CELC) touched an all-time high of $53.85 in early trading today, building on several eventful months driven by developments surrounding its lead drug candidate, ...
MSN on MSN

Experimental drug gedatolisib shows promise for patients with advanced breast cancer after treatment stops working

A new investigational drug called gedatolisib can help keep cancer from returning for longer for certain patients with HR+, ...
Yahoo Finance

Celcuity Announces Completion of Submission of Its New Drug Application to the U.S. FDA for Gedatolisib in HR+/HER2-/PIK3CA Wild-Type Advanced Breast Cancer

The above button links to Coinbase. Yahoo Finance is not a broker-dealer or investment adviser and does not offer securities or cryptocurrencies for sale or facilitate trading. Coinbase pays us for ...
Cure Today

Gedatolisib Plus Faslodex Shows Efficacy in Advanced HR+ Breast Cancer

Gedatolisib plus Faslodex, with or without Ibrance, improved PFS in hormone receptor-positive, HER2-negative, PIK3CA wild-type advanced breast cancer. The VIKTORIA-1 trial demonstrated significant PFS ...
Nasdaq

Celcuity presents overall survival data from Phase 1b trial with gedatolisib

Celcuity (CELC) announced overall survival, OS, data from two patient cohorts evaluated in a Phase 1b trial with gedatolisib, a pan-PI3K/mTORC1/2 inhibitor, in combination with palbociclib and either ...
manilatimes

Celcuity’s Phase 3 VIKTORIA-2 Trial of Gedatolisib as a First-Line Treatment for HR+/HER2- Advanced Breast Cancer Expanding to Include Endocrine-Sensitive Patients

Development of a gedatolisib formulation for subcutaneous injection is underway; first patent application submitted to the U.S. Patent and Trademark Office MINNEAPOLIS, May 14, 2026 (GLOBE NEWSWIRE) - ...
Business Insider

Celcuity to Hold Conference Call to Discuss Results for the PIK3CA Mutant Cohort of the Phase 3 VIKTORIA-1 Clinical Trial of Gedatolisib Regimens in HR+/HER- Advanced Breast ...

MINNEAPOLIS, June 01, 2026 (GLOBE NEWSWIRE) -- Celcuity Inc. (Nasdaq: CELC), a clinical-stage biotechnology company focused on the development of targeted therapies for the treatment of multiple solid ...
Medscape

Gedatolisib Prolongs PFS in Advanced Breast Cancer

BERLIN — The investigational drug gedatolisib substantially extends progression-free survival (PFS) among patients with advanced hormone receptor (HR)-positive, HER2-negative breast cancer that has ...