TLDR
- IDEAYA Biosciences reported positive Phase 2/3 trial results for darovasertib combined with crizotinib in metastatic uveal melanoma
- The drug combo delivered median progression-free survival of 6.9 months vs. 3.1 months for standard care
- Patients on the combination saw a 58% reduction in risk of disease progression
- Overall response rate hit 37.1% for the combo vs. just 5.8% for standard treatment — with 5 complete responses in the combo arm, none in the control
- IDEAYA plans to file a New Drug Application (NDA) with the FDA in the second half of 2026
IDEAYA Biosciences (IDYA) stock surged in premarket trading Monday after the company released positive results from its Phase 2/3 trial of a two-drug combination targeting metastatic uveal melanoma — a rare and difficult-to-treat form of eye cancer.
IDEAYA Biosciences, Inc., IDYA
The trial tested darovasertib alongside crizotinib. Results showed the combo more than doubled median progression-free survival compared to standard-of-care therapy.
Patients in the combination arm reached a median PFS of 6.9 months. Those receiving standard treatment hit just 3.1 months. That difference met the trial’s primary endpoint.
The combination also cut the risk of disease progression by 58%. That’s a number that will get any oncology investor’s attention.
Strong Secondary Endpoint Numbers
The secondary endpoints were equally strong. The overall response rate came in at 37.1% for the darovasertib combo, compared to just 5.8% for standard care.
Five patients in the combination arm achieved complete responses. The standard-care arm recorded zero.
Median duration of response in the combo arm was 6.8 months. The drug was described as well-tolerated with a manageable safety profile.
There was also an early trend suggesting overall survival benefit for the combination versus standard treatment, though full data on that front is not yet mature.
Metastatic uveal melanoma has historically had very few effective treatment options. These results position darovasertib as a potential first-in-class therapy for the condition.
FDA Filing Planned for Late 2026
IDEAYA said it plans to submit a New Drug Application to the FDA in the second half of 2026, based on these trial results.
That timeline puts a potential approval decision sometime in 2027, depending on FDA review speed.
IDYA stock was up as much as 26.36% in premarket trading, reaching $38.60, according to Benzinga Pro data. Earlier reports placed the gain at around 15%, with the stock trading near $35.
The stock had already been trading near its 52-week high of $41.02 before Monday’s announcement. Over the past 12 months, IDYA is up roughly 78%.
The broader market was softer on Monday, with S&P 500 futures down about 0.6% at the time of the premarket move.
IDEAYA plans to present full trial data at an upcoming medical conference, with further details expected later in 2026.
🚨 Our April Stock Picks Are Live!
A new month means new opportunities. Our analysts have just released their top stock picks for April, highlighting companies with strong momentum that rank highly on our KO Score algorithm. We’re also now sharing trade ideas for both long-term and short-term investors, giving you more ways to spot potential opportunities in the market.
Sign up to Knockout Stocks today and get 50% off to unlock the full list and see which stocks made the cut.
Use coupon code Special50 for your exclusive discount!
Get 3 Free Stock Ebooks
Discover top-performing stocks in AI, Crypto, and Technology with expert analysis.
- Top 10 AI Stocks - Leading AI companies
- Top 10 Crypto Stocks - Blockchain leaders
- Top 10 Tech Stocks - Tech giants
