India, March 31 -- IDEAYA Biosciences, Inc. (IDYA), a precision medicine oncology company, announced Monday that the U.S. Food and Drug Administration has granted Breakthrough Therapy designation or BTD for darovasertib monotherapy in neoadjuvant uveal melanoma.
In pre-market activity on the Nasdaq, IDEAYA shares were gaining around 2.6 percent to trade at $17.50.
darovasertib, a potential first-in-class protein kinase C (PKC) inhibitor, gets the BTD designation for neoadjuvant treatment of adult patients with primary uveal melanoma (UM) for whom enucleation has been recommended. The designation enables expedited development and priority regulatory review of darovasertib.
The BTD application was supported by updated interim clinical data...