The FDA granted breakthrough therapy designation to subcutaneous amivantamab for recurrent or metastatic HPV-unrelated HNSCC after progression on platinum-based chemotherapy and a PD-1/PD-L1 inhibitor. The decision was supported by OrigAMI-4 cohort 1 data showing a 45% ORR and 76% clinical benefit rate.
AstraZeneca is expanding in China with a $200m upfront COPD drug license from Sino Biopharmaceutical, a $1.5bn licensing deal for Dizal's Zegfrovy, and a $15bn manufacturing and R&D investment. The deals add revenue-generating assets to its respiratory and oncology portfolios.
Cocrystal Pharma advanced CDI-988 in a Phase 1b norovirus study and received FDA Fast Track designation. Nuvation Bio reported $18.5 million in IBTROZI net product revenues and presented updated TRUST trial data. Nautilus Biotechnology progressed its proteomics platform toward commercialization, maintaining a cash runway through 2027.
AstraZeneca reported strong Q1 2026 results with 8% revenue growth and 12% operating profit growth, driven by its oncology portfolio and pipeline progress. The company also saw unusual options activity and maintained full-year guidance. Key oncology brands including Imfinzi and Enhertu showed double-digit growth.
Relay Therapeutics reported Q4/FY 2025 results, outlined 2026 milestones for zovegalisib, and held ~$555M in cash. Initial vascular anomaly data and breast cancer triplet data are expected in 2026.
A phase 3 trial of azacitidine and chidamide plus CHOP in untreated PTCL showed a significant overall survival improvement but no significant gains in response rate or progression-free survival. The study suggests molecular profiling could guide future therapies.
A large clinical trial found that adding apalutamide to hormone therapy before and after prostate cancer surgery improves outcomes for high-risk patients. NHS England will roll out SABR radiotherapy requiring only five sessions, and new ctDNA and robotic biopsy technologies are advancing prostate cancer care.
Nuvation Bio reported updated Phase 2 data for safusidenib in IDH1-mutant glioma with a 52% ORR and 79% 36-month PFS rate. The company is expanding its clinical program with two new studies and expanding the SIGMA trial to a pivotal Phase 3, aiming to address broader patient populations.
The FDA has cleared Telomir Pharmaceuticals' IND for Telomir-Zn in advanced or metastatic triple-negative breast cancer. The company plans to initiate a first-in-human Phase 1/2 trial in the first half of 2026.
Six-year SEQUOIA trial data show zanubrutinib sustains a progression-free survival advantage (74% vs 32%) over bendamustine-rituximab in CLL without del(17p). Benefit extends to high-risk del(17p) patients.