ADC Therapeutics' ZYNLONTA Phase 3 Trial Hits Primary Endpoint; sBLA Submission Planned for Q4 2026
ADCT is trading near its 52-week low of $2.55 (25% below the low).
Summary
ADC Therapeutics announced positive Phase 3 LOTIS-5 trial results for ZYNLONTA, meeting the primary endpoint of progression-free survival (PFS) with a median PFS of 6.1 months versus 4.7 months for the control arm. This follows an 8-K filed earlier today disclosing the topline results. Positive Phase 3 results are a critical step towards expanding ZYNLONTA's label, which could significantly boost revenue for this ~$391M market cap biotech. While the safety profile showed higher serious adverse events, the efficacy data is strong. A pre-sBLA meeting with the FDA is planned for August, with a supplemental Biologics License Application (sBLA) submission targeted for Q4 2026.
At the time of this announcement, ADCT was trading at $1.90 on NYSE in the Life Sciences sector, with a market capitalization of approximately $391.7M. The 52-week trading range was $2.55 to $4.98. This news item was assessed with positive market sentiment and an importance score of 8 out of 10. Source: Wiseek News.