BlossomHill Therapeutics (Nasdaq: BLSM) will present preclinical and clinical data for BH-30236 at the American Society of Hematology meeting on December 14, 2026.
The poster presentation is scheduled for 7:00–9:00 p.m. ET in New Orleans. BH-30236 is an investigational oral CDC-like kinase inhibitor being evaluated in a Phase 1/1b trial in adults with relapsed or refractory acute myeloid leukemia and higher-risk myelodysplastic syndrome. BlossomHill says the clinical data demonstrate target engagement and support the drug's potential to address treatment resistance; no numerical clinical results were disclosed.
BlossomHill Therapeutics (Nasdaq: BLSM) will participate in Guggenheim’s 3rd Annual Healthcare Innovations Conference on November 10, 2026, in Boston. Management’s fireside chat is scheduled for 3:00 pm Eastern Time at the Intercontinental Boston, alongside one-on-one investor meetings. An audio webcast will be accessible through the company’s investor website, with an archived replay available for 90 days.
BlossomHill Therapeutics (Nasdaq: BLSM) announced a collaboration with Foundation Medicine to develop a companion diagnostic for BH-30643 in EGFR C797S-mutated lung cancer.
The collaboration will use the ongoing Phase 1/2 SOLARA trial to validate a test detecting the resistance mutation and guide BH-30643 development in EGFR-mutant non-small cell lung cancer. EGFR C797S is the most common EGFR mutation driving resistance to osimertinib treatment in this population.
BH-30643 has received Fast Track designation for the C797S resistance population after third-generation EGFR inhibitor treatment. SOLARA spans more than 40 sites in 10 countries. Dose-expansion cohorts are enrolling patients with and without prior treatment with tyrosine kinase inhibitors, including a C797S resistance cohort. BlossomHill identifies patients whose disease progressed after prior EGFR-targeted therapy as its near-term development priority.
BlossomHill Therapeutics (BLSM) presented preclinical data for its investigational pan-KRAS inhibitor BH-501284 at an AACR pancreatic cancer conference.
A protein-binding study found a target residence time of more than 54 hours using GDP-state KRAS G12D protein. In KRAS-mutant cell lines, BH-501284 prolonged KRAS signaling inhibition and showed activity across multiple KRAS mutations while sparing HRAS and NRAS. It produced tumor regression at relatively low doses in pancreatic, lung and colorectal cancer models with KRAS G12V, D or C mutations.
In a KRAS G12C lung cancer model, regression was comparable to that achieved with covalent, irreversible KRAS G12C inhibitors. In a KRAS G12D pancreatic model, regression was deeper and more durable than with tricomplex RAS inhibitors at similar doses. Combined with anti-PD-1 treatment, BH-501284 prolonged survival versus either treatment alone in a KRAS G12D colorectal model. The company is advancing the drug toward an investigational new drug (IND) submission in Q1 2027.
BlossomHill Therapeutics (BLSM) reported second quarter 2026 results and pipeline progress on September 18, 2026.
The company strengthened its balance sheet with approximately $168.3 million in gross proceeds from its upsized August 2026 IPO, after ending June 30, 2026 with $95.4 million in cash and cash equivalents. BlossomHill expects existing cash plus IPO proceeds to fund operations into the second quarter of 2028. The FDA granted Fast Track designation to lead asset BH-30643 for advanced EGFR C797S-positive NSCLC. Phase 1 SOLARA data showed a 45% objective response rate and 88% disease control rate in patients with C797S resistance to prior TKIs.
R&D expenses rose to $21.4 million and G&A to $3.3 million, driving a quarterly net loss of $23.8 million, or $(8.75) per share.
BlossomHill Therapeutics (BLSM) reported updated Phase 1/2 SOLARA trial data showing encouraging anti-tumor activity and favorable safety for OMNI-EGFR™ inhibitor BH-30643 in EGFR C797S-positive non-small cell lung cancer (NSCLC).
Among 40 patients with EGFR C797S-positive resistance to prior EGFR inhibitors, with or without concurrent T790M, BH-30643 achieved a 45% objective response rate (18/40; 95% CI: 29%-62%) and an 88% disease control rate (35/40). At a median efficacy follow-up of 6.9 months, 63% (25/40) of patients remained on treatment. In 174 patients treated at 40–60 mg twice daily, treatment-related dose reductions and discontinuations occurred in 9% and 3% of patients, respectively, with mainly Grade 1 EGFR wild-type-associated adverse events.
BH-30643 has FDA Fast Track designation, ongoing expansion cohorts across multiple EGFR-mutant settings, and a global Phase 2 trial in C797S-positive NSCLC is planned for Q1 2027.
BlossomHill Therapeutics (BLSM) will present at two September 2026 industry and investor conferences focused on oncology and drug development.
Chief Medical Officer Geoff Oxnard, M.D., will speak at the 8th Annual RAS-Targeted Drug Development Summit at The Colonnade Hotel in Boston on Thursday, September 10, at 10:00 a.m. PT / 1:00 p.m. ET. Founder, President and CEO J. Jean Cui, Ph.D., will present at the H.C. Wainwright 28th Annual Global Investment Conference at the Lotte New York Palace Hotel in New York City on Tuesday, September 15, at 7:30 a.m. PT / 10:30 a.m. ET, with webcast access and a 90-day replay available via the company’s Investor Relations website.
BlossomHill Therapeutics (Nasdaq: BLSM) will present updated data from the ongoing Phase 1/2 SOLARA trial of its investigational macrocyclic OMNI-EGFR™ inhibitor BH-30643 in EGFR‑mutant non-small cell lung cancer (NSCLC) at the 2026 World Conference on Lung Cancer in Seoul.
The mini-oral presentation, scheduled for September 15, 2026, will highlight anti-tumor activity in patients with secondary EGFR resistance mutations, including EGFR C797S, a setting where, according to BlossomHill Therapeutics, no oral targeted therapies are currently approved. BH-30643 is an orally bioavailable, non-covalent, macrocyclic, brain-active, mutant-selective EGFR inhibitor designed to address multiple EGFR mutation categories while sparing wild-type EGFR and has received FDA Fast Track designation for C797S-positive resistance after third-generation EGFR TKI treatment. SOLARA is a global, open-label Phase 1/2 study across more than 40 sites in 10 countries, evaluating safety, pharmacokinetics, pharmacodynamics and preliminary anti-tumor activity.
BlossomHill Therapeutics (Nasdaq: BLSM) announced that the U.S. FDA has granted Fast Track designation to BH-30643 for treating adult patients with advanced or metastatic EGFR C797S-positive non-small cell lung cancer (NSCLC) after prior third-generation EGFR TKI therapy. BH-30643, a novel, orally bioavailable, non-covalent, macrocyclic, brain-active, mutant-selective OMNI-EGFR inhibitor, is being studied in SOLARA, a global Phase 1/2 first-in-human trial at more than 40 sites in 10 countries, including C797S resistance cohorts in TKI-pretreated and TKI-naïve settings.
According to BlossomHill Therapeutics, Fast Track status enables more frequent FDA interactions and potential eligibility for rolling review, Accelerated Approval, and Priority Review if criteria are met. The company’s pipeline also includes BH-30236 for R/R AML or HR-MDS and BH-501284, a preclinical pan-KRAS Switch II inhibitor.
BlossomHill Therapeutics (Nasdaq: BLSM), a clinical-stage biopharmaceutical company focused on small molecule cancer therapies, priced its upsized initial public offering of 9,375,000 common shares at $16.00 per share, for expected gross proceeds of $150.0 million before costs and any underwriter option exercise.
BlossomHill granted underwriters a 30-day option for up to 1,406,250 additional shares at the public price, less discounts and commissions. All shares are offered by the company. Trading on the Nasdaq Global Select Market is expected to begin on August 7, 2026 under the ticker BLSM, with closing expected on August 10, 2026, subject to customary conditions.
BlossomHill’s pipeline includes lead clinical candidates BH-30643 for EGFR-mutant NSCLC and BH-30236 for R/R AML or HR-MDS, plus preclinical KRAS program BH-501284.