ADCT 最新10-Q变化

相对上期新增的文字 · 来源:10-Q · 2026-08-13

• On June 24, 2026, we announced a strategic reorganization to focus resources behind key value-driving initiatives in support of ZYNLONTA. As part of the reorganization, we are reducing our global workforce by approximately 17%, which is expected to be substantially completed by September 30, 2026 (“…

• In June 2026 we announced topline data from our Phase 3 LOTIS-5 confirmatory trial evaluating ZYNLONTA in combination with rituximab in patients with relapsed or refractory diffuse large B-cell lymphoma (“r/r DLBCL”). ZYNLONTA plus rituximab achieved statistical significance on the trial’s primary e…

• The LOTIS-5 trial is a randomized, open‐label, two‐arm, multicenter study evaluating ZYNLONTA plus rituximab versus the standard immunochemotherapy rituximab gemcitabine‐oxaliplatin (R‐GemOx), for the treatment of r/r DLBCL after one or more lines of systemic therapy. The study met the primary endpo…

• Overall, TEAE rates were similar between arms (98.5% vs. 97.5%). Higher rates of SAEs were seen in the test arm (49.0% vs. 34.5%). Grade ≥3 TEAEs observed in > 5% of patients were hematologic (40.7% vs. 59.4%), followed by infection/

• infestations (24.5% vs. 15.7%), then hepatotoxicity (primarily increased GGT) (17.2% vs. 8.1%) and oedema/effusion (7.4% vs. 0.5%) when comparing ZYNLONTA plus rituximab to R-GemOx. A higher rate of Grade 5 TEAEs was observed in the ZYNLONTA plus rituximab arm (27 pts/13.2%) vs. R-GemOx (9 pts/4.6%)…

相对上期删除的文字 · 来源:10-Q · 2026-05-04

• Three Months Ended March 31, 2026 Compared to Three Months Ended March 31, 2025

• The following table summarizes our results of operations for the three months ended March 31, 2026 and 2025:

• We generate product revenue through the sale of ZYNLONTA in the United States. Revenue is recognized when control is transferred to the customer at the net selling price, which includes reductions for gross-to-net (“GTN”) sales adjustments

• such as government rebates, chargebacks, distributor service fees, other rebates and administrative fees, sales returns and allowances and sales discounts. Our product revenue may fluctuate from period to period based on a number of factors, including patient demand, as well as the timing, dose and …

• Product revenues, net, were $20.0 million for the three months ended March 31, 2026 as compared to $17.4 million for the three months ended March 31, 2025, an increase of $2.6 million, or 15.1%. The increase is primarily attributable to higher sales volume and a higher price.

相对上期新增的文字 · 来源:10-Q · 2026-08-13

• Below we are providing, in supplemental form, an addition to our risk factors as previously disclosed in our Annual Report on Form 10-K for the year ended December 31, 2025.

• The FDA expressed substantial concerns that the results from the LOTIS-5 trial are not supportive of a favorable benefit-risk assessment or verification of clinical benefit.

• Following the publication of topline results from the LOTIS-5, we discussed the results with the FDA. The FDA noted that the increased Grade 5 adverse events in the treatment arm, compared to the control arm, when assessed in the context of a marginal treatment benefit, processes, substantial concer…