“We believe the results from the VIKTORIA-1 study validate our pioneering approach to targeting cancers involving the PI3K/AKT/mTOR pathway. Researchers have sought for nearly 20 years to develop a drug that blockades this pathway comprehensively without inducing unacceptable levels of toxicity,” commented Brian Sullivan, Chairman, CEO and co-founder of Celcuity.
“From the outset, our goal has been to build a discovery engine that systematically unlocks high-value, challenging targets and delivers first-in-class precision medicines,” said Adam Friedman, M.D., Ph.D., Chief Executive Officer of Antares. “This collaboration lets us scale that engine alongside Novartis’ world-class development capabilities and global reach, so we
“We are very pleased that the iDMC has recommended continuation of the landmark OVATION 3 clinical trial without modification, representing another important validation of the remarkable efficacy and safety data previously reported and further indicating the potential for IMNN-001 to represent a historic advance in the treatment of ovarian cancer,”
“VS-7375 has demonstrated anti-tumor activity across multiple dose levels and tumor types, encouraging signals from rational combination strategies, and a favorable safety profile that improves meaningfully beyond the first treatment cycle, underscoring its potential to be not only the best-in-class oral KRAS G12D inhibitor, but also the preferred treatment option
“We are pleased that the FDA has demonstrated urgency in reconsidering the RP1 BLA with an expeditious action date in recognition of the significant unmet need for advanced melanoma patients and support from the broader melanoma community,” said Sushil Patel, Ph.D., CEO of Replimune. “We look forward to a productive
