BlossomHill Therapeutics, Inc.

BlossomHill Therapeutics, Inc.이(가) 2026년 11월 12일에 보고한 내용

기업이 직접 제출한 8-K에서 가져왔습니다.

경영진의 발언

“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,”

발표 자료에서 그대로 인용했으며, 공시가 발언자를 실명으로 밝힌 경우에만 표시합니다.

주가는 어떻게 반응했나

실적 발표는 개장 전이나 장 마감 후에 나오므로, 기간은 발표일 전 종가부터 발표일 다음 거래일 종가까지입니다. 어느 경우든 반응은 이 기간에 들어 있습니다.

BlossomHill Therapeutics, Inc.은(는) 무엇을 하는 기업인가

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 ).