The Latest Breaking News from Celcuity

FDA Approves First Drug Specifically for 60 Percent of Metastatic Breast Cancer Patients Who Had No Prior Options

The FDA approved gedatolisib (Revtorpyk) on July 14, 2026, for HR+/HER2- advanced breast cancer patients without a PIK3CA mutation. Here is who qualifies and what the trial showed.

Medical Daily · Jul 24

A Breast Cancer Drug Decision Due July 17 Could Open a New Treatment Path for 37,000 Women a Year Who Have No Good Options Now

FDA decides on gedatolisib July 17, 2026, for HR+/HER2-/PIK3CA wild-type advanced breast cancer. A Phase 3 trial showed 76% risk reduction in progression. 37,000 patients per year.

Medical Daily · Jul 13

Celcuity Q1 Earnings Call Highlights

Celcuity (NASDAQ:CELC) reported a wider first-quarter loss as the biotechnology company increased spending tied to commercial launch preparations and continued development of gedatolisib, its investigational therapy for hormone receptor-positive, HER2-negative advanced breast cancer. On the company

MarketBeat · May 14

Recap: Celcuity Q1 Earnings

Celcuity (NASDAQ:CELC) reported its Q1 earnings results on Monday, May 16, 2022 at 04:00 PM. Here's what investors need to know about the announcement. Earnings Celcuity beat estimated earnings by 7.84%, reporting an EPS of $-0.47 versus an estimate of $-0.51.

Benzinga · May 16, 2022

Earnings Preview For Celcuity

Celcuity (NASDAQ:CELC) is set to give its latest quarterly earnings report on Monday, 2022-05-16. Here's what investors need to know before the announcement. Analysts estimate that Celcuity will report an earnings per share (EPS) of $-0.51.

Benzinga · May 13, 2022

Celcuity Plans To Start Pivotal Gedatolisib Trial In Breast Cancer In 1H 2022

Celcuity Inc (NASDAQ:CELC) concluded two formal meetings with the FDA to obtain their feedback on the gedatolisib Phase 3 trial in the breast cancer setting. The study dubbed VIKTORIA-1 will evaluate gedatolisib combined with fulvestrant with or without palbociclib in HR+/HER2- advanced breast cancer. The trial will include adult patients whose disease has…

Benzinga · Mar 24, 2022

Recap: Celcuity Q4 Earnings

Celcuity (NASDAQ:CELC) reported its Q4 earnings results on Wednesday, March 23, 2022 at 04:00 PM. Here's what investors need to know about the announcement. Earnings Celcuity beat estimated earnings by 2.63%, reporting an EPS of $-0.37 versus an estimate of $-0.38.

Benzinga · Mar 23, 2022

Preview: Celcuity's Earnings

Celcuity (NASDAQ:CELC) is set to give its latest quarterly earnings report on Wednesday, 2022-03-23. Here's what investors need to know before the announcement. Analysts estimate that Celcuity will report an earnings per share (EPS) of $-0.38.

Benzinga · Mar 22, 2022

FDA Grants Fast Track Tags To Drug Candidates For Antares Pharma, Celcuity, Celularity

The 

Benzinga · Jan 18, 2022