Celcuity Shares Rise 6% After Fast-Track Designation for Gedatolisib
Celcuity Inc. shares were up 6% to $12.18 after the company said the U.S. Food and Drug Administration has granted Fast Track designation to the Company's lead drug candidate, gedatolisib, for the treatment of patients with HR+/HER2- metastatic breast cancer after progression on CDK4/6 therapy.
Fast Track designation is granted by the FDA for products that are intended for the treatment of serious or life-threatening disease or conditions and which demonstrate the potential to address an unmet medical need. The designation offers the opportunity for frequent interactions with the FDA to discuss the drug's development plan and to ensure collection of appropriate data needed to support drug approval, as well as eligibility for rolling submission of a New Drug Application.
Celcuity said it remains on track to obtain feedback from the FDA and to finalize the design and protocol of its Phase 3 clinical trial in the first quarter of 2022. Site identification and feasibility activities for the Phase 3 clinical trial are on-going.
Celcuity also said it plans to initiate two Phase 2 clinical trials to evaluate gedatolisib in HR+/HER2- breast cancer patients selected with a CELsignia PI3K Pathway Test.
One trial will evaluate gedatolisib in combination with fulvestrant in up to 25 patients with metastatic breast cancer. The second trial will evaluate up to 15 patients with early-stage breast cancer with gedatolisib in combination with palbociclib and letrozole. Patient enrollment is expected to begin for the two trials in late 2022.
January 19, 2022
