IDEAYA's Darovasertib+Crizotinib Shows Significant PFS Benefit in Phase 2/3 Trial: 6.9 vs 3.1 Months
IDYA sits 49% above its 52-week low of $19.48.
Summary
IDEAYA Biosciences presented detailed positive Phase 2/3 OptimUM-02 results for its darovasertib plus crizotinib combination therapy, demonstrating a median Progression-Free Survival (mPFS) of 6.9 months versus 3.1 months for the control arm. This follows the company's earlier announcement of positive topline results in April and a same-day 8-K confirming the presentation of complete data at ASCO. The specific data points, including a highly significant hazard ratio of 0.42 and a 37.1% objective response rate, strongly validate the drug's efficacy in metastatic uveal melanoma. The FDA is currently conducting a real-time review, with a New Drug Application (NDA) submission anticipated in the second half of 2026.
At the time of this announcement, IDYA was trading at $28.94 on NASDAQ in the Life Sciences sector, with a market capitalization of approximately $2.5B. The 52-week trading range was $19.48 to $39.28. This news item was assessed with positive market sentiment and an importance score of 8 out of 10. Source: Wiseek News.