Celcuity Shares Surge 38% After Completing Enrollment For Phase 3 Breast Cancer Trial Using Gedatolisib

• Celcuity said it has completed enrolment for the phase 3 trial of its breast cancer trial treating PIK3CA mutant.
• The company said that the gedatolisib triplet therapy demonstrated clinically meaningful improvement by reducing the risk of disease progression or death by 76%.
• Needham said it considers the updated results from the PIK3CA wild-type cohort of the pivotal VIKTORIA-1 study as further de-risking for gedatolisib and potentially practice changing.

Celcuity (CELC) shares jumped 38% in afternoon trading on Monday after the biotechnology company said that it has completed enrolment for the phase 3 trial of its breast cancer trial treating PIK3CA mutant.

The trial by Celcuity is called VIKTORIA-1 and focuses on patients with advanced breast cancer. The company is using Gedatolisib, which is an investigational drug that blocks multiple cancer-driving pathways.

Retail sentiment on Celcuity jumped to ‘extremely bullish’ from ‘bullish’ territory compared to a day ago, with message volumes at ‘extremely high’ levels, according to data from Stocktwits.

Results From PIK3CA Wild-Type Cohort Of Phase 3 VIKTORIA-1

Celcuity announced the results from the PIK3CA wild-type cohort of the Phase 3 VIKTORIA-1 clinical trial of gedatolisib. The company said that the gedatolisib triplet therapy demonstrated clinically meaningful improvement compared to fulvestrant (a standard treatment for breast cancer), reducing the risk of disease progression or death by 76%.

The company noted that gedatolisib doublet therapy reduced the risk of progression or death by 67% versus fulvestrant.

Celcuity said that the median progression-free survival benefit of the gedatolisib triplet and doublet compared to fulvestrant was consistent across subgroups. The firm noted that the gedatolisib triplet showed higher clinical benefit in nearly all subgroups compared to the gedatolisib doublet, particularly for patients who were pre or perimenopausal, endocrine therapy resistant, or had visceral metastases.

Analyst’s Take On The Trial

Needham raised its price target on Celcuity to $95 from $70 and maintained a ‘Buy,’ according to TheFly. The firm said it considers updated results from the PIK3CA wild-type cohort of the pivotal VIKTORIA-1 study as further de-risking for gedatolisib and potentially practice changing.

The firm said that it furthermore thinks a lack of progression-free survival benefit observed for Roche's (RHHBY) oral selective estrogen receptor degrader giredestrant in Estrogen Receptor 1 wild-type patients removes an overhang on Celcuity.

Shares of the company have gained nearly 450% this year.

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