IDYA 最新10-Q变化

相对上期新增的文字 · 来源:10-Q · 2026-11-03

• Metastatic UM (mUM). We are evaluating darovasertib in combination with crizotinib, Pfizer’s oral c-MET inhibitor (the darovasertib combination), in a potentially registration-enabling, Phase 2/3 trial (OptimUM-02) in patients with first line, human leukocyte antigen-A*02:01 negative (HLA*A2(-)) mUM…

• During the third quarter, we successfully submitted a new drug application (NDA) to the U.S. Food and Drug Administration (FDA) under the Oncology Center of Excellence Real-Time Oncology Review (RTOR) program to support a potential U.S. approval of the darovasertib combination in mUM. The RTOR progr…

• Neoadjuvant UM. We are evaluating single-agent darovasertib in the neoadjuvant setting of primary UM, where the goal of treatment is to prevent enucleation (surgical eye removal), preserve vision prior to and post-plaque brachytherapy and potentially delay or prevent progression to metastatic diseas…

• Due to ongoing site activation and enrollment challenges, we have decided to stop enrollment and close the Phase 3 OptimUM-010 trial. We remain committed to enabling patient access to neoadjuvant darovasertib, and

• plan to submit published data from OptimUM-09 to support potential inclusion in clinical practice guidelines. If successful, guideline inclusion is intended to provide evidence to support the potential clinical benefit of neoadjuvant darovasertib and may allow payor coverage for eligible patients in…

相对上期删除的文字 · 来源:10-Q · 2026-08-04

• 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 p…

• We plan to complete a new drug application (NDA) submission in the second half of 2026 to support a potential U.S. approval. Pursuant to Food and Drug Administration's (FDA) authorization, we have begun pre-submitting components of the NDA under the Oncology Center of Excellence Real-Time Oncology R…

• We are also evaluating the combination of darovasertib and crizotinib in HLA*A2:01 positive (HLA*A2(+)), mUM patients in our ongoing, single-arm Phase 2 OptimUM-01 trial. We plan to present updated clinical data from this trial at the 2026 European Society for Medical Oncology (ESMO) Congress being …

• Neoadjuvant UM. We are evaluating single-agent darovasertib in the neoadjuvant setting of primary UM, where the goal of treatment is to prevent enucleation (surgical eye removal), preserve vision prior to and post-plaque brachytherapy and potentially delay or prevent progression to metastatic diseas…

• Adjuvant UM. In collaboration with our partner, Servier, we have initiated a global Phase 3 registrational trial (OptimUM-11) of darovasertib and crizotinib in the adjuvant setting of primary UM. The trial is expected to enroll approximately 450 primary UM patients with increased risk of metastasis,…

相对上期新增的文字 · 来源:10-Q · 2026-11-03

• During the three months ended September 30, 2026, our Section 16 officers and directors adopted or terminated contracts, instructions or written plans for the purchase or sale of our securities as noted below:

• * Intended to satisfy the affirmative defense of Rule 10b5-1(c)

• ** Not intended to satisfy the affirmative defense of Rule 10b5-1(c)

相对上期删除的文字 · 来源:10-Q · 2026-08-04

• During the quarter ended June 30, 2026, no director or “officer” of the Company (as defined in Rule 16a-1(f) of the Exchange Act) adopted or terminated a “Rule 10b5-1 trading arrangement” or a “non-Rule 10b5-1 trading arrangement,” as each term is defined in Item 408 of Regulation S-K.