ADC THERAP. CL.C SF-,064

ADC Therapeutics presented Zynlonta as its core business at the Cantor conference, targeting annual sales of roughly $75–80 million and about a 10% market share in third‑line-and-beyond DLBCL. After the phase III LOTIS‑5 study the FDA flagged concerns about an increased incidence of treatment‑related fatal infections; management attributes this to the study design and lack of prophylaxis. Early data from LOTIS‑7 (Zynlonta plus glofitamab) show a complete response rate of 78% and are seen as a near‑term catalyst; the company plans new study designs, potential Breakthrough Therapy designation applications, and is targeting peak sales above $600 million. ADC Therapeutics has liquidity runway into 2028, but broader approval depends on regulatory assessment and further study results. » Más en de.investing.com

ADC Therapeutics reported adjusted Q2 EPS of -$0.11 (forecast -$0.22) and revenue of $19.25 million (expectation $18.89 million), with net product revenue for ZYNLONTA at $18.6 million (+2.8% y/y). Despite the stronger results, the stock fell in pre-market trading after the FDA raised significant benefit‑risk concerns about the LOTIS‑5 combination study (ZYNLONTA plus Rituximab). Management emphasized that ZYNLONTA monotherapy remains unaffected, that accelerated approval is still expected, and that liquidity of $219.1 million should last at least until 2028. The company has cut costs, reduced the workforce by about 17% and expects annual savings of roughly $10 million, but is evaluating further measures to resolve the regulatory concerns and the next steps for its clinical programs. » Más en de.investing.com

ADC Therapeutics' stock fell about 45.9% in after‑hours trading following publication of the topline results from the Phase‑3 LOTIS‑5 study. ZYNLONTA plus rituximab met the primary endpoint with a median progression‑free survival of 6.1 vs. 4.7 months and showed higher overall and complete response rates, but demonstrated significant safety issues. The combination arm experienced more serious adverse events (49.0% vs. 34.5%), higher treatment‑related deaths (Grade 5: 13.2% vs. 4.6%, predominantly ≥75‑year‑olds) and more treatment discontinuations (25.5% vs. 9.1%). ADC Therapeutics plans to discuss the benefit‑risk profile with the FDA, has a preparatory meeting scheduled for August and is targeting an sBLA submission in Q4 2026. » Más en de.investing.com