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.
Jun 09, 2026
Biotech stocks Ocugen, Kodiak Sciences, and CytoDyn are experiencing market movements driven by clinical data and regulatory milestones, particularly Biologics License Application (BLA) filings. Ocugen saw a surge in short interest, Kodiak reached a 52-week high on positive trial results, and CytoDyn's stock remains volatile as it advances its monoclonal antibody pipeline.
Mar 26, 2026
Kodiak Sciences' experimental drug Zenkuda achieved 62.5% response rate in diabetic retinopathy trial with 85% reduction in sight-threatening complications. The company plans to accelerate FDA submission while preparing for wet AMD study readout in Q3 2026. Shares surged 68.6% following the positive late-stage results.
Mar 24, 2026
Ocugen reported Phase 2 data for its geographic atrophy gene therapy OCU410 showing 31% lesion growth reduction versus control. The company plans Phase 3 initiation in Q3 2026 and maintains its goal of three BLA filings in three years. Shares fell 11.48% following the data release which trailed earlier interim results.
Mar 03, 2026
Xbrane Biopharma reported full year 2025 revenue of SEK 152.4 million and a profit of SEK 127.2 million, driven by a SEK 168.9 million gain from the Alvotech transaction. The FDA issued a Complete Response Letter for the company's ranibizumab biosimilar application in October.
Feb 18, 2026
The FDA has approved an expanded label for Sandoz's aflibercept biosimilar Enzeevu to include multiple retinal indications beyond its original approval for neovascular age-related macular degeneration. The product is expected to launch in the US in Q4 2026.
Feb 13, 2026
Samsung Bioepis and Regeneron reached a settlement allowing U.S. launch of Opuviz, an aflibercept biosimilar, in January 2027. The agreement resolves a patent dispute that began in late 2023.