JAZZ 最新10-Q变化

相对上期新增的文字 · 来源:10-Q · 2026-08-03

• Given SCLC is an aggressive cancer and patients rapidly progress after induction chemotherapy, we conducted the Phase 3 IMforte trial to evaluate Zepzelca and atezolizumab in combination in the first-line maintenance setting.

• In October 2024, we announced positive top-line results from the Phase 3 IMforte trial showing a statistically significant and clinically meaningful progression-free survival and overall survival benefit. In October 2025, FDA approved Zepzelca in combination with atezolizumab as a maintenance treatm…

• Based on the results from the LAGOON trial of Zepzelca in second-line metastatic SCLC, which were reported in June 2026, and in alignment with FDA, in the third quarter of 2026, we will submit for FDA's review and subsequent action a labeling supplement to remove the second-line indication. The firs…

• Rylaze was approved by FDA in June 2021, and was launched in the U.S. in July 2021, for use as a component of a multi-agent chemotherapeutic regimen for the treatment of patients with ALL and LBL, in pediatric and adult patients one month and older who have developed hypersensitivity to E. coli-deri…

• Our R&D activities encompass all stages of development and currently include clinical testing of new product candidates and activities related to clinical improvements of, or additional indications or new clinical data for, our existing marketed products. We also have active preclinical and early-st…

相对上期删除的文字 · 来源:10-Q · 2026-05-05

• seizures associated with LGS or DS, in conjunction with clobazam, for patients two years of age and older. The clobazam restriction is limited to the EU and U.K. Epidyolex was also approved for adjunctive therapy of seizures associated with TSC for patients 2 years of age and older in the EU in Apri…

• academic and community cancer centers. In October 2024, we announced positive top-line results from the Phase 3 IMforte trial showing a statistically significant and clinically meaningful progression-free survival and overall survival benefit for Zepzelca and atezolizumab in combination in the first…

• Rylaze was approved by FDA in June 2021, and was launched in the U.S. in July 2021, for use as a component of a multi-agent chemotherapeutic regimen for the treatment of patients with ALL and LBL, in pediatric and adult patients one month and older who have developed hypersensitivity to E. coli-deri…

• Our R&D activities encompass all stages of development and currently include clinical testing of new product candidates and activities related to clinical improvements of, or additional indications or new clinical data for, our existing marketed products. We also have active preclinical and early-st…

• trastuzumab plus chemotherapy in patients with HER2-positive breast cancer whose disease has progressed on previous T-DXd treatment, and a Phase 3 confirmatory trial examining zanidatamab in first-line patients with HER2-positive BTC.

相对上期新增的文字 · 来源:10-Q · 2026-08-03

• (Executive Vice President, Global Head of Research and Development, Chief Medical Officer)

• 5/28/2027, or such earlier date upon which all transactions are completed or expire without execution

• 8/5/2027, or such earlier date upon which all transactions are completed

• (1) Dr. Iannone's Rule 10b5-1 Trading Plan provides for the (i) same-day exercise and sale of up to 53,700 stock options, (ii) sale of up to 16,038 ordinary shares, (iii) sale of an indeterminable number of ordinary shares sufficient to cover stock option exercise costs and estimated tax withholding…