The U.S. Food and Drug Administration (FDA) has accepted a new drug application for gedatolisib in hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-), PIK3CA ...
The FDA has accepted a New Drug Application (NDA) for Celcuity’s gedatolisib in hormone receptor positive (HR+), human ...
Editor’s note: This is an automatically generated transcript. Please notify editor@healio.com if there are concerns regarding accuracy of the transcription. The current PI3K 3C inhibitors in use in ...
FDA grants Priority Review and assigns a PDUFA goal date of July 17, 2026MINNEAPOLIS, (GLOBE NEWSWIRE) -- Celcuity Inc. (Nasdaq: ...
Gedatolisib's NDA for advanced breast cancer treatment has been accepted by the FDA, with a priority review and a PDUFA date ...
Editor’s note: This is an automatically generated transcript. Please notify editor@healio.com if there are concerns regarding accuracy of the transcription. There are several clinical trials that are ...
Celcuity's gedatolisib, a pan-PI3K/mTOR inhibitor for advanced breast cancer, shows strong early efficacy and is in pivotal Phase 3 trials, yet remains undervalued. The company has a healthy cash ...
Monday, Relay Therapeutics Inc. (NASDAQ:RLAY) shared interim data for RLY-2608 from the ReDiscover study of RLY-2608 alone, in combination with fulvestrant, and in combination with fulvestrant and ...
HOUSTON -- Two-thirds of patients with PI3K-mutant brain metastases responded to the maximum tolerated dose (MTD) of the small-molecule inhibitor paxalisib plus radiation therapy (RT), a small phase I ...
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