Ocular Therapeutix stock surged 30% in premarket trading as the company prepared to release topline Phase 3 data for AXPAXLI in wet AMD. The SOL-1 trial results will be presented at the Macula Society meeting later in February. The company plans to file for FDA approval using one-year data if results are favorable.
Akeso reported overall survival benefit for ivonescimab plus chemotherapy in Phase III lung cancer study. The company enrolled first patient in Phase Ib/II trial of next-generation HER3 ADC AK138D1 for advanced breast cancer. Akeso also received China approval to start Phase II trials for AK139 bispecific antibody.
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.
BioNTech faces mixed analyst views as Bernstein initiates with a cautious Market Perform rating, while the company secures FDA Fast Track designation for BNT113 and prepares for a shareholder vote on capital restructuring and leadership transition.
4D Molecular Therapeutics said 4D-150 is in Phase 3 for wet AMD and nearing Phase 3 in diabetic macular edema. The company reported rapid enrollment, 18-month treatment burden reductions and favorable safety data.
Crescent Biopharma dosed the first patient in its ASCEND Phase 1/2 trial of CR-001, a PD-1 x VEGF bispecific antibody for solid tumors. The company also reported Q1 2026 results and outlined pipeline milestones including ADC combination trials expected in the second half of 2026.
Compass Therapeutics reported mixed Phase 2/3 data for tovecimig in biliary tract cancer and plans to meet with the FDA for a BLA discussion. The study met its primary ORR endpoint (17% vs 5%), while PFS and OS data are due late this quarter.
The FDA approved updated labeling for Vabysmo to allow extended treatment of macular edema following retinal vein occlusion beyond six months. The label update removes the prior 6-month restriction and retains monthly 6 mg intravitreal dosing.
China’s cross-border biotech outlicensing hit US$60 billion in the first quarter of 2026. AbbVie’s up to $745 million Haisco pain deal highlights multinationals’ rising interest in Chinese drug assets.
Bio-Thera Solutions expands its partnership with Intas Pharmaceuticals for BAT2506, a golimumab biosimilar, through an exclusive commercialization agreement for India. The India biosimilars market is projected to grow from $184 million to $1.02 billion by 2035, driven by patent expirations and strategic partnerships.
