BlossomHill Therapeutics, Inc.

Ce a raportat BlossomHill Therapeutics, Inc. la 12 noiembrie 2026

Din raportul 8-K al companiei.

Ce a spus conducerea

“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,”

Citat cuvânt cu cuvânt din comunicat și afișat doar atunci când raportarea îl atribuie unei persoane numite.

Cum a reacționat prețul

Comunicatele apar înainte de deschidere sau după închidere, așa că intervalul merge de la închiderea dinaintea zilei raportului până la închiderea ședinței de după — reacția intră în el în ambele cazuri.

Cu ce se ocupă BlossomHill Therapeutics, Inc.

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 ).