Ideaya falls as analysts cautious despite eye cancer drug receiving FDA's 'breakthrough' tag

Shares of California-based drug developer Ideaya BiosciencesIDYA.O down 4.5% at $16.28

IDYA receives breakthrough therapy designation for company's experimental drug, darovasertib, to treat a type of eye cancer called neoadjuvant uveal melanoma, before surgery

Brokerage Leerink Partners says the majority of the neoadjuvant opportunity lies in the ~80% of patients scheduled for radiotherapy (both plaque and beam), which does not appear to be included in this designation

"The drug will likely need to show an improvement over placebo in time" - Leerink Partners

IDYA says the drug is currently being tested in a mid-stage trial and co plans to begin a late-stage study in H1 2025

Neoadjuvant Uveal Melanoma affects 12,000 patients annually and is a high unmet medical need with no FDA-approved systemic therapies - IDYA

Stock had fallen 35.8% YTD