Also known as: TKI
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.
More than 80% of U.S. physicians use AI in their work. AI is revealing new cardiac biomarkers and speeding drug discovery, with the healthcare AI market projected to reach $505.6 billion by 2033—but studies warn of bias and eroding critical thinking.
Axpaxli (OTX-TKI) met its primary endpoint in the SOL-1 Phase 3 trial, demonstrating superiority over aflibercept in preserving visual acuity in wet AMD patients at week 36. A single injection of the intravitreal hydrogel led to higher rescue-free rates and better fluid control, supporting potential for reduced treatment burden. Ocular Therapeutix plans to submit a New Drug Application to the FDA.
Multiple recent studies evaluate different immunotherapy approaches for advanced NSCLC, including long-term benefits for nivolumab plus ipilimumab with chemotherapy in PD-L1-negative tumors, limited advantages from PD-(L)1 rechallenge strategies, and early positive signals from combining TIGIT and PD-1 inhibitors in PD-L1-high patients.
Hansoh received EU approval for Aumolertinib for EGFR-mutated NSCLC, while China's NMPA granted Breakthrough Therapy status to HS-10504 for EGFR C797S-mutated NSCLC.
The FDA has accepted for review a supplemental application for taletrectinib in advanced ROS1-positive NSCLC, with a PDUFA date of January 4, 2027. Updated TRUST-I and TRUST-2 data showed high response rates, durable responses and no new safety signals.
Sacituzumab tirumotecan demonstrated a median overall survival of 20.0 months versus 13.5 months with docetaxel in pretreated EGFR-mutated NSCLC patients. The phase 2 OptiTROP-Lung03 study showed a hazard ratio of 0.63 for overall survival benefit with the TROP2-directed antibody-drug conjugate.
Sanofi has submitted a revised acquisition bid for Ocular Therapeutix ahead of pivotal Phase 3 trial results for AXPAXLI, a sustained-release treatment for wet AMD. The deal could position Sanofi to re-enter the ophthalmology market it previously abandoned. The acquisition would give Sanofi access to innovative hydrogel delivery technology with potential applications beyond eye disease.
The FDA has approved a monthly subcutaneous dosing schedule for Johnson & Johnson's Rybrevant Faspro for EGFR-mutated NSCLC, based on PALOMA-2 trial data showing 82-87% response rates. The approval follows the drug's initial biweekly dosing approval in December 2025 and offers reduced administration time and reactions compared to intravenous delivery.
Ocular Therapeutix's Axpaxli outperformed low-dose Eylea in a Phase 3 trial for wet AMD, while Oculis Holding reported narrowed Q4 losses and expects Phase 3 trial readouts for OCS-01 in Q2 2026.
