IDEAYA Gets FDA Breakthrough Therapy Designation For Darovasertib In Neoadjuvant UM; Stock Up

(RTTNews) - 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 from an ongoing Phase 2 open-label trial (NCT05907954) evaluating darovasertib monotherapy in the neoadjuvant setting for localized UM.

Updated clinical data in neoadjuvant UM, including efficacy, safety, radiation reduction, eye preservation, and vision preservation / improvement on treatment, were submitted as part of the BTD application that the company plan to present at medical conferences in 2025.

Further, multiple clinical data updates in neoadjuvant UM and MUM, including median overall survival (mOS) from the Phase 2 study (IDE196-001), are targeted to be presented at medical conferences in mid-year 2025 and the second half of 2025.

The company added that it intends to initiate a Phase 3 randomized registrational trial in neoadjuvant UM in the first half of 2025.

The BTD designation follows the Fast Track designation granted by the U.S. FDA for evaluation of darovasertib in combination with crizotinib in adult patients being treated for metastatic uveal melanoma (MUM), where a Phase 2/3 registration-enabling trial of the darovasertib and crizotinib combination in 1L HLA-A2-negative MUM is ongoing.

Darovasertib has also been designated as an Orphan Drug by the regulator in UM, including in MUM, entitling IDEAYA to certain potential tax credits, exemptions from user fees, and statutory marketing exclusivity.

Darrin Beaupre, Chief Medical Officer of IDEAYA, said, "We are pleased to receive FDA Breakthrough Therapy designation as we prepare to advance neoadjuvant darovasertib into a potential Phase 3 registrational trial in patients with primary UM. This designation highlights the potential of monotherapy darovasertib in a patient population with significant unmet medical need where there are currently no FDA-approved systemic therapies."

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