BlossomHill Therapeutics, Inc.

BlossomHill Therapeutics, Inc. 在 2026年11月12日 公布了什么

取自公司自己的 8-K 文件。

管理层说了什么

“We are pleased to have aligned with the FDA on a recommended Phase 2 dose of 50 mg BID based on favorable PK, safety and efficacy data in the Phase 1 portion of the SOLARA trial. We are now preparing to initiate SOLARA-2, a single arm, pivotal Phase 2 trial designed to evaluate BH-30643 in both chemotherapy-naive and chemotherapy-pretreated patients with C797S-positive NSCLC after progression on a third-generation EGFR TKI,”

逐字引自公告，且只在文件将其归于具名人士时才展示。

股价作何反应

公告在开盘前或收盘后发布，因此区间从公告日前一个交易日的收盘价到公告日之后那个交易日的收盘价——无论哪种情况，反应都包含在内。

BlossomHill Therapeutics, Inc. 做什么

BH-30643 is an investigational, novel, orally bioavailable, non-covalent, macrocyclic, brain active, mutant-selective, OMNI-EGFR ™ inhibitor for the treatment of EGFR -mutant NSCLC. BH-30643 was designed to overcome the limitations of currently approved EGFR inhibitors, which were discovered over a decade ago without the current, modern understanding of the structure and protein dynamics of mutant EGFRs. In preclinical studies, BH-30643 demonstrated potent inhibitory activity across diverse EGFR mutation categories — classical mutations, on-target resistance mutations such as C797S with or without T790M, atypical mutations and exon 20 insertions — while maintaining marked selectivity over wild-type EGFR. BH-30643 has received Fast Track designation and is being evaluated in SOLARA, a global Phase 1/2, first-in-human clinical trial with ongoing Phase 1 dose expansion cohorts enrolling in both TKI-pretreated and TKI-naive settings, including a C797S resistance cohort. SOLARA-2, a global Phase 2 pivotal study in C797S-Positive NSCLC is scheduled to dose the first patient in the first quarter of 2027. For additional information on SOLARA, including a list of study sites and how to enroll, please visit clinicaltrials.gov ( NCT06706076 ).

公司自己的描述，取自公告末尾。