Alvotech Q4 Earnings Call Highlights

McClellan said the company implemented most corrective actions by the end of 2025 and is now focused on demonstrating that improvements are “effective and sustainable over time” before resubmission. Based on current progress, he said the company remains on track to resubmit in the second quarter of 2026, which “would position us for FDA decisions before the end of the year.” In the Q&A, he added the company is working to submit by the end of the first quarter but is prepared that it could slip into the seco ...