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Celcuity Heads Toward A Major Regulatory Catalyst Next Month

By TajSabreen Ahamed   ✉  | Published:  | Google News Follow Us  | Join Us
breastcancer 22062026 lt

Celcuity Inc. (CELC) recently reported new clinical and regulatory progress for Gedatolisib, its PI3K/mTOR inhibitor being evaluated across multiple late-stage programs for HR-positive, HER2-negative advanced breast cancer.

Data from the VIKTORIA-1 Phase 3 trial showed that Gedatolisib combination regimens doubled the likelihood of patients remaining alive without disease progression or death compared to alpelisib plus fulvestrant in PIK3CA-mutant cohort. In this cohort, the Gedatolisib triplet regimen with fulvestrant and palbociclib achieved a median progression-free survival of 11.1 months, while Gedatolisib doublet regimen with fulvestrant achieved 11.3 months, compared to 5.6 months for the control arm. The company noted that both Gedatolisib regimens demonstrated favorable tolerability profiles with lower rates of high-grade adverse events and fewer treatment discontinuations than the comparator regimen.

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Global Economics Weekly Update -June 15 - June 19, 2026

June 19, 2026 16:46 ET
Major central banks continued to dominate the economic news flow this week too, led by the Federal Reserve, as they announced their latest policy decisions. The Federal Reserve policy session was in focus as it was the first to be led by the new chief Kevin Warsh. In Europe, central banks of the U.K. and Switzerland announced their rate decisions. In Asia, the Bank of Japan drew attention for its policy moves, while data out of China threw some light on the state of the economy.