ADCT ADC Therapeutics

ADC Therapeutics: Tanabe Pharma files MAA for ZYNLONTA in Japan for r/r DLBCL

Tanabe Pharma submitted a marketing authorization application to Japan's MHLW for ZYNLONTA (loncastuximab tesirine) in relapsed/refractory DLBCL after >=2 lines of therapy, based on positive Japanese Phase 1/2 bridging study results consistent with LOTIS-2. Tanabe also sublicensed commercialization rights to Nippon Shinyaku. This filing triggers a near-term regulatory milestone payment to ADC Therapeutics under the 2022 license agreement.

ADC Therapeutics Announces Financial Restructuring and ASH 2026 Data Presentations for ZYNLONTA

ADC Therapeutics announced an $86.6M PIPE financing, HCR royalty agreement amendment eliminating change-of-control payment, and senior loan refinancing reducing principal to $50M due 2029. These changes extend cash runway into 2029 to fund ZYNLONTA pipeline studies including Phase 3 trials. The company will present LOTIS-7 and MZL data at the December 2026 ASH annual meeting.

ADCT: FDA flags benefit-risk concerns in LOTIS-5 pre-sBLA meeting

The FDA expressed substantial concerns over the benefit-risk profile and verification of clinical benefit in the LOTIS-5 Phase 3 trial due to an imbalance in Grade 5 events and only marginal treatment benefit. As a result, ADC Therapeutics is now reassessing the regulatory path forward for ZYNLONTA to obtain full approval and advance into earlier lines of DLBCL, rather than proceeding directly to an sBLA submission.

ADCT: LOTIS-5 Phase 3 topline met PFS endpoint for ZYNLONTA + rituximab

The Phase 3 LOTIS-5 trial met its primary PFS endpoint with statistical significance (HR 0.73, p=0.008). ADC Therapeutics plans a pre-sBLA meeting with FDA in August 2026 and an sBLA submission in Q4 2026 to seek full approval for ZYNLONTA plus rituximab in r/r DLBCL.