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Mar 02, 2026
Genmab is moving GEN1106, a SLITRK6-targeting ADC acquired through its $1.8bn ProfoundBio takeover, into phase 1 trials despite several recent discontinuations and the 2017 failure of the only other similar project.
Mar 02, 2026
Phase 3 BREAKWATER trial shows encorafenib plus cetuximab and chemotherapy achieved 30.3 months median overall survival versus 15.1 months with standard therapy in previously untreated BRAF V600E-mutant metastatic colorectal cancer.
Feb 27, 2026
ALX Oncology reported fourth quarter and full year 2025 financial results, highlighting validation of CD47 as a predictive biomarker for evorpacept in HER2-positive cancers and progress in its ALX2004 EGFR-targeted ADC program.
Feb 27, 2026
Summit Therapeutics will participate in three investor conferences in March 2026, following FDA acceptance of its BLA for ivonescimab in lung cancer with a PDUFA date of November 14, 2026.
Feb 27, 2026
Izalontamab brengitecan demonstrated statistically significant improvements in progression-free survival and overall survival compared to chemotherapy in patients with previously treated metastatic triple-negative breast cancer, marking the third Phase III success for the bispecific ADC.
Feb 27, 2026
Phase 2 trial of amivantamab in recurrent/metastatic adenoid cystic carcinoma achieved 72.2% clinical benefit rate with good tolerability. Combination therapy with pembrolizumab is being evaluated in head and neck squamous cell cancer.
Feb 21, 2026
The FDA approved acalabrutinib plus venetoclax as the first all-oral, fixed-duration BTK inhibitor regimen for CLL/SLL and cleared monthly dosing for amivantamab in EGFR-mutated NSCLC. Additional regulatory reviews are underway for PCNSL and breast cancer treatments.
Feb 21, 2026
The FDA has approved a once-monthly dosing schedule for subcutaneous amivantamab and hyaluronidase-lpuj (Rybrevant Faspro) combined with lazertinib for first-line treatment of EGFR-mutated advanced NSCLC, based on PALOMA-2 trial data showing comparable efficacy to biweekly dosing.
Feb 25, 2026
The FDA has approved a new monthly dosing schedule for Johnson & Johnson's Rybrevant Faspro combined with Lazcluze for first-line treatment of advanced EGFR-mutated non-small cell lung cancer, allowing patients to transition to monthly dosing as early as week five.
Feb 25, 2026
Phase 3 trials demonstrate atrasentan slows kidney function decline in IgA nephropathy patients, while obinutuzumab achieves superior remission rates in primary membranous nephropathy compared to standard treatment.
Feb 24, 2026
Vir Biotechnology reported Q4 EPS of ($0.31), beating estimates by $0.23, with revenue of $64.07 million. The company announced a global strategic collaboration with Astellas for VIR-5500 and reported $781.6 million in cash and investments.
Feb 24, 2026
Vir Biotechnology announced a global strategic collaboration with Astellas for VIR-5500, a PSMA-targeted dual-masked T-cell engager for prostate cancer, and reported $781.6 million in cash and investments as of December 31, 2025.
Feb 19, 2026
Novartis commits $23 billion to U.S. manufacturing expansion with new facilities in North Carolina, California, and Florida, while advancing its immunoglobulin A nephropathy drug portfolio with positive Phase III results for Vanrafia.
Feb 18, 2026
The U.S. FDA granted Breakthrough Therapy Designation for subcutaneous Rybrevant Faspro as monotherapy for adults with advanced head and neck squamous cell carcinoma, based on Phase 1b/2 study data showing rapid and durable responses.
Feb 19, 2026
Hansa Biopharma announced on February 18, 2026 that the FDA has accepted its Biologics License Application for imlifidase, supported by positive Phase 3 ConfIdeS trial results in highly sensitized kidney transplant patients.
Feb 17, 2026
The FDA has approved a monthly dosing schedule for Rybrevant Faspro in EGFR-mutated NSCLC and granted breakthrough therapy designation for the drug as monotherapy in HPV-unrelated recurrent or metastatic head and neck squamous cell carcinoma after prior therapy.
Feb 16, 2026
Eli Lilly's Retevmo (selpercatinib) demonstrated statistically significant event-free survival improvement in the Phase III LIBRETTO-432 trial for early-stage RET fusion-positive non-small cell lung cancer.
Feb 16, 2026
Eli Lilly announced positive Phase 3 LIBRETTO-432 trial results showing Retevmo (selpercatinib) significantly improved event-free survival in patients with early-stage RET fusion-positive non-small cell lung cancer as adjuvant therapy.
Feb 16, 2026
Novartis announced final Phase III ALIGN trial results showing Vanrafia (atrasentan) slowed kidney function decline in adults with IgA nephropathy, with a 2.39ml/min/1.73m² eGFR difference versus placebo at week 136.
Feb 14, 2026
A newly published study in Int. J. Mol. Sci. confirms that deuterium concentration directly influences gene expression in lung adenocarcinoma cells, validating HYD LLC's three-decade research on deuterium-depleted water as a complementary cancer therapy.
