Shares of Celcuity surged more than 186% on Monday after the biotechnology company reported highly positive topline results from a Phase 3 clinical trial of its investigational breast cancer treatment.
The stock was set for its best day on record if it held the gains.
The trial tested gedatolisib, a PAM inhibitor developed by Celcuity, in combination with Pfizer’s Ibrance and AstraZeneca’s Faslodex, in patients with previously treated HR+/HER2- advanced breast cancer.
The triple combination therapy significantly delayed disease progression compared to standard treatment.
According to the company, patients receiving the combination lived 9.3 months without progression of the disease versus just two months for those on Faslodex alone.
This marks a more than seven-month improvement, a striking advancement in the treatment landscape for this breast cancer subtype, which accounts for about 70% of all breast cancer cases.
The study also found that the risk of disease progression or death was reduced by 76% when the triple therapy was used, compared to Faslodex monotherapy.
A secondary analysis revealed that a double combination of gedatolisib and Ibrance alone reduced the risk of progression or death by 67%, extending progression-free survival to an average of 7.4 months.
Sara Hurvitz, co-principal investigator for the trial, said that the data for both combination treatments in the trials are “potentially practice-changing.”
Analysts call results ‘unprecedented’
“The study showed “unprecedented results,” Leerink Partners analyst Andrew Berens said.
Gedatolisib could become a new standard of care as a second-line treatment in breast cancer, especially in the community settings, Berens said.
The optimism was reflected in investor response, with Celcuity’s stock more than doubling during premarket trading and maintaining gains throughout the day.
Gedatolisib belongs to the same class of drugs as Novartis’s Afinitor and AstraZeneca’s Truqap, both known as PI3K/mTOR inhibitors.
Celcuity noted that its combination therapy showed improved tolerability compared to earlier-stage trials, with lower rates of high blood sugar and inflammation of the mouth lining—side effects that often limit treatment adherence.
Regulatory plans and financial outlook
Celcuity said it plans to submit a New Drug Application for gedatolisib in the fourth quarter of 2025.
The company also expects to share full Phase 3 results and additional data from a separate trial later this year.
Despite being a pre-revenue company with negative earnings per share of -$3.05, Celcuity has a strong cash position of $205.69 million.
This provides sufficient runway to support ongoing clinical development.
Analysts remain bullish, with price targets ranging up to $33.00 and recent sentiment tilting toward Buy and Strong Buy ratings.
Needham maintained a price target of $29 per share for Celcuity, a downside of 26.24%.
In a further boost to its long-term prospects, Celcuity recently secured a patent extension for gedatolisib through 2042, strengthening its intellectual property position ahead of potential commercialization.
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