BlossomHill Therapeutics, Inc.

BlossomHill Therapeutics, Inc. ने 12 नवंबर 2026 को क्या बताया

कंपनी की अपनी 8-K रिपोर्ट से।

प्रबंधन ने क्या कहा

“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,”

विज्ञप्ति से हूबहू उद्धृत, और तभी दिखाया गया जब रिपोर्ट उसे किसी नामित व्यक्ति से जोड़ती है।

शेयर भाव ने कैसी प्रतिक्रिया दी

विज्ञप्तियाँ बाज़ार खुलने से पहले या बंद होने के बाद आती हैं, इसलिए यह अवधि रिपोर्ट के दिन से पहले के बंद भाव से उसके बाद वाले सत्र के बंद भाव तक है — प्रतिक्रिया दोनों ही स्थितियों में इसमें आ जाती है।

BlossomHill Therapeutics, Inc. क्या करती है

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 ).