Celcuity stock shot to a record high Monday, up almost 60% at one point, after the company said its experimental drug delayed progression for over a year in some patients with breast cancer.
The company tested two- and three-drug regimens containing its drug, gedatolisib, in patients whose breast cancer is driven by a mutation in the ESR1 gene. Patients can have a mutant ESR1 gene, where the changes are permanently "on," or wild-type, which requires estrogen to activate it.
Patients with mutant-type disease lived for a median of 19.7 months, with intermittent dosing, before their cancer worsened. In the wild-type group, the triple-drug regimen staved off cancer progression for a median of 9.1 months.
Importantly, Celcuity's regimen looked more powerful than a two-drug cocktail from Roche. Roche presented its own data at the same conference. Roche's regimen failed to show a benefit in wild-type patients.
This positions Celcuity favorably in the battle for market share, Leerink Partners analyst Andrew Berens said in a report. Of patients with previously treated HR+ breast cancer — meaning their cancer has estrogen and progesterone receptors — 70% to 80% have wild-type ESR1 mutations.
Celcuity stock surged 35.8%, closing at 70.58. Shares have a perfect Relative Strength Rating of 99, according to IBD Digital. This means Celcuity stocks outranks 99% of all stocks in terms of 12-month performance.
'Practice Changing'
Needham analyst Gil Blum said Celcuity's results are "potentially practice-changing." He hiked his price target on Celcuity stock to 95 from 70, and reiterated his buy rating.
Celcuity's gedatolisib works differently from Roche's rival treatment, giredestrant. Gedatolisib targets the PI3K pathway, which is involved in cell growth and survival. Giredestrant blocks estrogen from binding to its receptor, thus triggering its breakdown.
The fact giredestrant failed to show a progression-free survival benefit for patients with ESR1 wild-type breast cancer removes an overhang on Celcuity stock, Blum said in a report.
An upcoming readout for gedatolisib in patients with mutant-type breast cancer could be the next big catalyst for Celcuity, he said. He noted gedatolisib appears to perform better in patients with the mutant form of cancer vs. those with wild-type.
"We view the upcoming mutant readout as a key clearing event for CELC, providing Pharma the full dataset it would require for potential consolidation," he said.
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