KURA 最新10-Q变化

相对上期新增的文字 · 来源:10-Q · 2026-08-12

• For the six months ended June 30, 2026, we achieved $14.9 million in KOMZIFTI net product revenue.

• We anticipate presenting updated long-term data from the KOMET-007 Phase 1b trial, including durability, survival, and MRD outcomes, in the second half of 2026.

• On June 14, 2026, we shared long-term results from our evaluation of ziftomenib with 7+3 in newly diagnosed NPM1-mutated or KMT2A-rearranged AML from the KOMET-007 trial in an oral presentation at the European Hematology Association Congress. The presentation featured results from 99 patients treate…

• We are evaluating ziftomenib in combination with venetoclax and azacitidine in patients with relapsed or refractory NPM1-mutated or KMT2A-rearranged AML in our Phase 1 KOMET-007 trial.

• We have completed enrollment of patients with relapsed or refractory NPM1-mutated AML in the dose expansion cohort evaluating the combination of ziftomenib with venetoclax and azacitidine. On June 2, 2026, we announced the publication in Blood of updated results from our evaluation of this combinati…

相对上期删除的文字 · 来源:10-Q · 2026-05-12

• We have begun generating product revenue from sales of KOMZIFTI. In the first quarter of 2026 – the first full quarter of commercialization – we achieved $5.8 million in KOMZIFTI net product revenue.

• We previously evaluated ziftomenib in combination with 7+3 in patients with newly diagnosed NPM1-mutated or KMT2A-rearranged adverse risk AML in the KOMET-007 trial. In June 2025, we presented positive data at the European Hematology Association Congress from the KOMET-007 Phase 1b cohort evaluating…

• KMT2A-rearranged AML with a median time to MRD negativity of 4.4 weeks were observed. 96% of patients with NPM1-mutated AML and 88% of patients with KMT2A-rearranged AML remained alive and on study as of the data cutoff.

• Updated data from our evaluation of ziftomenib with 7+3 in newly diagnosed NPM1-mutated or KMT2A-rearranged AML from the KOMET-007 trial have been accepted for an oral presentation at the European Hematology Association Congress on June 14, 2026. The presentation will feature results from the 99 pat…

• We are evaluating ziftomenib in combination with venetoclax and azacitidine in patients with relapsed or refractory NPM1-mutated or KMT2A-rearranged AML in our Phase 1 KOMET-007 trial. At ASH in December 2025, we delivered an oral presentation of safety and clinical activity results from Phases 1a a…

相对上期新增的文字 · 来源:10-Q · 2026-08-12

• some state and local laws require certain regulatory licenses to manufacture or distribute our products commercially and/or the registration of pharmaceutical sales representatives; and

• analogous state and foreign laws and regulations, such as state anti-kickback and false claims laws, which may apply to sales or marketing arrangements and claims involving healthcare items or services reimbursed by non-governmental third-party payors, including private insurers. Further, some state…

• If there is no lawful manner for us to transfer personal data from the EEA, the UK, or other jurisdictions to the United States, or if the requirements for a legally-compliant transfer are too onerous, we could face significant adverse consequences, including the interruption or degradation of our o…

• At the state level, legislatures have increasingly passed legislation and implemented regulations designed to control pharmaceutical and biological product pricing, including price or patient reimbursement constraints, discounts, restrictions on certain product access and marketing cost disclosure a…

• Our future success further depends on the successful development and commercialization of darlifarnib and other product candidates. Our product candidates will require additional clinical development, evaluation of clinical, preclinical and manufacturing activities, regulatory approval in one or mor…

相对上期删除的文字 · 来源:10-Q · 2026-05-12

• analogous state and foreign laws and regulations, such as state anti-kickback and false claims laws, which may apply to sales or marketing arrangements and claims involving healthcare items or services reimbursed by non-governmental third-party payors, including private insurers.

• law, such as the EEA standard contractual clauses, the UK’s International Data Transfer Agreement / Addendum, and the EU-U.S. Data Privacy Framework and the UK extension thereto (which allows for transfers to relevant U.S.-based organizations who self-certify compliance and participate in the Framew…

• If there is no lawful manner for us to transfer personal data from the EEA, the UK, or other jurisdictions to the United States, or if the requirements for a legally-compliant transfer are too onerous, we could face significant adverse consequences, including the interruption or degradation of our o…

• strategies and profitability, while increasing their operational costs and compliance risks. In June 2024, in Loper Bright Enterprises v. Raimondo, the U.S. Supreme Court greatly reduced judicial deference to regulatory agencies, which could result in additional legal challenges to federal regulatio…

• At the state level, legislatures have increasingly passed legislation and implemented regulations designed to control pharmaceutical and biological product pricing, including price or patient reimbursement constraints, discounts, restrictions on certain product access and marketing cost disclosure a…

相对上期新增的文字 · 来源:10-Q · 2026-08-12

• 219,434 shares, options net shares unsold, RSUs net shares to be received, and ESPP net shares to be purchased

• 226,332 shares, options net shares unsold, RSUs net shares to be received, and ESPP net shares to be purchased

• 30,000 shares, options net shares unsold, PSUs and RSUs net shares to be received, and ESPP net shares to be purchased

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

• (2) 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 · 2026-05-12

• 184,460, RSUs net shares to be received, and PSUs net shares to be received

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

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

• *** Represents the modification, as described in Rule 10b5-1(c)(1)(iv) under the Exchange Act, of a written plan adopted on September 9, 2025 that was intended to satisfy the affirmative defense conditions of Rule 10b5-1(c) under the Exchange Act.