IDYA 最新10-Q变化

相对上期新增的文字 · 来源:10-Q · 2026-08-04

• 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,…

• IDE849 is a potential first-in-class, DLL3 TOP1 ADC being evaluated by our partner, Hengrui Pharma, in a multi-site, open label Phase 1 clinical trial in China in patients with small-cell lung cancer (SCLC) and neuroendocrine carcinomas (NEC). Hengrui plans to provide a clinical data update from thi…

• 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. Dosing of the first patient with IDE034 in the first quarter of 2026 triggered a $5.0…

相对上期删除的文字 · 来源:10-Q · 2026-05-05

• 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 have completed enrollment of approximately 100 patients in this trial and plan to present updated clinical data at a medical c…

• Adjuvant UM. In collaboration with our partner, Servier, we plan to initiate a global Phase 3 registrational trial (OptimUM-11) of darovasertib and crizotinib in the adjuvant setting of primary UM in the first half of 2026.

• We have successfully completed a Type C meeting with the U.S. FDA to align on the Phase 3 registrational design of the OptimUM-11 trial. The trial will enroll approximately 450 primary uveal melanoma patients with increased risk of metastasis, irrespective of HLA status, randomized 1:1 to treatment …

• In August 2025, we entered into an exclusive license agreement with Servier, for the development and commercialization of darovasertib outside of the United States. We received an upfront payment of $210.0 million and are eligible to receive up to $320.0 million in milestone payments, clinical trial…

• Neoadjuvant UM. We are also evaluating darovasertib as a monotherapy 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 metastat…

相对上期新增的文字 · 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.

相对上期删除的文字 · 来源:10-Q · 2026-05-05

• During the three months ended March 31, 2026, no Section 16 officers or directors adopted or terminated contracts, instructions or written plans for the purchase or sale of our securities.