14,02 US$-5,5 %cierre 13 nov
Cifras hasta el 30 de septiembre de 2026, del 10-Q presentado el 12 de noviembre de 2026
Del propio 8-K de la empresa.
BlossomHill Therapeutics, Inc. reported on 12 de noviembre de 2026. We are fetching the call transcript; its summary follows once the transcript is in.
“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,”
Citado literalmente de la publicación, y mostrado solo cuando el informe lo atribuye a una persona con nombre.
Las publicaciones salen antes de la apertura o tras el cierre, así que la ventana va del cierre previo al día del informe al cierre de la sesión siguiente: la reacción queda dentro en ambos casos.
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 ).
La propia descripción de la empresa, tal como aparece al pie de la publicación.
La cita y la descripción de la empresa proceden del 8-K del punto 2.02 que BlossomHill Therapeutics, Inc. presentó el 12 de noviembre de 2026; la tabla se elabora a partir de sus informes trimestrales. Leer la publicación en EDGAR Las cotizaciones están ajustadas por splits y dividendos.