We plan to complete a new drug application (NDA) submission in the second half of 2026 to support a potential U.S. approval.
SEC timing context:
nd deeply personalized with the goal of altering the course of disease and improving clinical outcomes for patients with cancer. Our current clinical pipeline of potential first-in-class product candidates spans four focus areas, as described below. Darovasertib for Uveal Melanoma Darovasertib is an oral, potent and selective small molecule inhibitor of protein kinase C and our most advanced clinical program. We are developing darovasertib for uveal melanoma (UM), a rare, aggressive form of ocular cancer, in both the metastatic and pre-metastatic settings of UM, as described below. • Metastatic UM (mUM). We are evaluating darovasertib in combination with crizotinib, Pfizer’s oral c-MET inhibitor, in a potentially registration-enabling, Phase 2/3 trial (OptimUM-02) for human leukocyte antigen-A*02:01 negative (HLA*A2(-)), patients with first line mUM. In April 2026, we reported positive topline data from the OptimUM-02, which met its primary endpoint demonstrating as statistically significant improvement in median progression free survival as assessed by blinded independent central review. We presented complete data from the primary analysis of the OptimUM-02 trial in a late-breaking oral presentation at the 2026 American Society of Clinical Oncology meeting in Chicago, Illinois. We plan to complete a new drug application (NDA) submission in the second half of 2026 to support a potential U.S. approval.
We are currently conducting a Phase 1 dose escalation trial and are targeting to provide a clinical data update by the end of 2026 or early 2027.
SEC timing context:
and NEC and plan to provide our first clinical data from this trial in the second half of the year. We are also having discussions with the FDA to align on the design of a Phase 3 registrational trial of IDE849 in refractory SCLC and/or NEC, and plan to provide more detail on the proposed trial design with our data update in the second half of the year, with the goal of initiating the registrational trial by the end of 2026. • IDE034 is a potential first-in-class, B7H3/PTK7 bispecific TOP1 ADC. We are currently conducting a Phase 1 dose escalation trial and are targeting to provide a clinical data update by the end of 2026 or early 2027.
We are also conducting a global Phase 1/2 trial of IDE849 in SCLC and NEC and plan to provide our first clinical data from this trial in the second half of the year.
“Registrational OptimUM-02 trial of the darovasertib combination in metastatic uveal melanoma (mUM) met its primary endpoint; new drug application (NDA) filing is underway under the real-time oncology review program (RTOR) with completion expected in H2 2026”
ORION has no confirmed start and end dates for this wording, so it is not compared with filings.
IDE034Clinical results
by the end of 2026 or early 2027
“IDE034 (B7H3/PTK7 bispecific TOP1 ADC): IDEAYA plans to provide initial clinical data from its ongoing Phase 1 dose escalation trial by the end of 2026 or early 2027, which is expected to include preliminary safety and efficacy data.”
ORION has no confirmed start and end dates for this wording, so it is not compared with filings.
IDE849Clinical results
in the second half of the year
“We are also conducting a global Phase 1/2 trial of IDE849 in SCLC and NEC and plan to provide our first clinical data from this trial in the second half of the year.”
“Not compared” means ORION has not matched this wording against a complete set of SEC filings for its period. It says nothing either way about whether a matching filing exists. Wording without exact dates is not given calendar dates.
Related companies
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First or second half, or first to fourth quarter, of the year named, as the company wrote it. Equivalent notations are compared together; the original wording stays visible.
SEC original
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Status
One of seven labels set by founder review of the original filings. Definitions: Methodology.
A New Drug Application (NDA) or Biologics License Application (BLA) asks the FDA to approve a drug or biologic for sale.Topline results are the main summary results of a clinical trial, released before the full data.