Celcuity Shares Rise 6% After Fast-Track Designation for Gedatolisib
January 18 2022 - 12:49PM
Dow Jones News
By Chris Wack
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.
Write to Chris Wack at chris.wack@wsj.com
(END) Dow Jones Newswires
January 18, 2022 12:34 ET (17:34 GMT)
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