Nuvectis Pharma Inc

Nuvectis Pharma Inc(NVCT)資訊與事件

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NVCT 資訊

NVCT 事件

10/26 09:30

Nuvectis Reports Positive Data for NXP200 with 40% Objective Response Rate in Brain Tumor Patients

Nuvectis announced positive, expanded data from the Phase 1b study for NXP200, a second-generation, paradox-breaker BRAF inhibitor, in patients with recurrent or progressive BRAF V600-mutated gliomas, presented at the 2026 European Society for Medical Oncology Congress in Madrid. As of the May 4 cutoff, 27 efficacy-evaluable patients were treated with NXP200 monotherapy, including 20 with high-grade glioma and 7 with low-grade glioma. Treatment with NXP200 resulted in an objective response rate of 40.0% in the high-grade glioma cohort, including 3 complete responses, and 42.9%, including one confirmed complete response, in the low-grade glioma cohort. Deep responses, greater than 80% tumor burden reduction, were achieved in 87.5% of responders with high-grade glioma and 66.7% of responders with low-grade glioma. Among the three patients previously treated with a BRAF inhibitor, two achieved a partial response and one had stable disease. In high-grade glioma, the median duration of response was 6.97 months and the median overall survival was 17.15 months. Among 28 safety-evaluable patients, 14.3% experienced a Grade 3 or higher treatment-related adverse event, and no treatment-related adverse event resulted in treatment discontinuation or death. The study is being conducted by Haisco Pharmaceutical Group in China, and in June, Nuvectis in-licensed exclusive worldwide, ex-Greater China rights to NXP200 from Haisco. "The rate and durability of the responses reported with single-agent NXP200 in patients with recurrent or progressive gliomas are very encouraging," said Ron Bentsur, chairman and CEO.

9/24 08:30

Nuvectis Pharma's NXP200 Granted Breakthrough Therapy Designation

Nuvectis Pharma announced that NXP200 has been granted Breakthrough Therapy Designation, BTD, for the treatment of patients with BRAF V600-mutant, recurrent or progressive high-grade glioma by China's Center for Drug Evaluation, CDE. Ron Bentsur, Chairman and Chief Executive Officer of Nuvectis, commented, "We congratulate our partner Haisco for achieving this significant regulatory milestone, which is further testament to its tremendous strategic and operational capabilities. The CDE's granting of Breakthrough Therapy Designation underscores the compelling clinical activity observed to date with NXP200 in patients with recurrent or progressive BRAF V600-mutant high-grade glioma. In parallel, we continue to advance NXP200 toward a U.S. IND submission in the fourth quarter of 2026."

8/21 17:00

Nuvectis Pharma Files $200M Mixed Securities Shelf

Nuvectis Pharma files $200M mixed securities shelf

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