Related coverage linked through entity extraction aliases.
Aug 07, 2026
Biotech companies posted Q2 2026 results: REGENXBIO's Duchenne trial met its primary endpoint, Compass Pathways' COMP360 NDA submission is on track for Q4, Puma raised full-year guidance on NERLYNX demand, and Evotec cut its 2026 outlook.
May 15, 2026
EyePoint's DSMC recommended continuing its Phase 3 wet AMD trials without protocol changes after a third review. Topline data for LUGANO are expected mid-2026, with LUCIA shortly after. The company ended 2025 with $300 million in cash and a runway into Q4 2027.
Jul 18, 2026
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.
Jun 18, 2026
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.
May 17, 2026
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.
Mar 24, 2026
Ocular Therapeutix's experimental drug Axpaxli showed superior vision maintenance compared to Regeneron's Eylea in a late-stage wet AMD trial. Meanwhile, Ocugen reported 12-month data showing its gene therapy OCU410 reduced geographic atrophy lesions by 31%, though less than earlier interim results. Both companies are advancing toward regulatory submissions and further clinical development.
Mar 06, 2026
Outlook Therapeutics conducted a Type A meeting with the FDA to discuss the December 30, 2025 Complete Response Letter for ONS-5010/LYTENAVA™, focusing on substantial evidence of effectiveness and potential regulatory paths forward.
Feb 26, 2026
Zydus Lifesciences plans to launch Semaglutide injection in India after patent expiry and introduced ANYRA, India's first indigenous Aflibercept biosimilar. The USFDA cleared the company's Ahmedabad injectable facility with zero observations.
Feb 23, 2026
Ocular Therapeutix announced positive topline results from the SOL-1 Phase 3 superiority trial of AXPAXLI for wet age-related macular degeneration, meeting its primary endpoint with statistically significant improvements in vision outcomes compared to aflibercept.
Feb 17, 2026
Ocular Therapeutix's Axpaxli met its primary endpoint in the SOL-1 Phase 3 trial, showing superior vision maintenance compared to aflibercept in wet AMD patients. The company plans to pursue FDA approval based on the results.
Feb 14, 2026
Ocular Therapeutix announced positive topline results from SOL-1, its Phase 3 superiority trial of AXPAXLI for wet age-related macular degeneration, meeting primary and durability endpoints with high statistical significance.
