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ADC Therapeutics flags FDA concerns over ZYNLONTA LOTIS-5 data at ASH and financial webcast

🇺🇸 ADC Therapeutics SA (ADCT) · Wed 04 Nov 2026

The company's 4 November webcast covered ASH abstracts and preliminary Q3 2026 figures, while its forward-looking statements cite serious FDA concerns raised at a pre-sBLA meeting.

ADC Therapeutics SA held a corporate webcast on 4 November 2026 to present highlights from its abstracts for the American Society of Hematology (ASH) meeting and to give a financial update, including preliminary third-quarter 2026 figures.

The most notable disclosure sits in the forward-looking statements. They refer to serious concerns raised by the US Food and Drug Administration about results from the LOTIS-5 trial of ZYNLONTA. According to the information available, the concerns were voiced at a pre-sBLA meeting, the type of discussion sponsors hold with the agency before submitting a supplemental biologics licence application. The material on file does not set out the nature of the concerns or say how the company plans to respond.

The statements also mention a pending marketing authorisation application in Japan for ZYNLONTA, filed by Tanabe. No decision timeline is given in the information available.

On the corporate side, the company referred to an expected cash runway into 2029 and a possible redomiciliation from Switzerland to Delaware. Details of the preliminary financial figures and the full webcast content were not available for this report.

What it means for your team

  • Regulatory teams should note that the FDA's concerns over LOTIS-5 emerged at the pre-sBLA stage, which may affect the path and timing of any US submission; specifics have not been disclosed.
  • Market-access and HTA teams tracking ZYNLONTA may want to await further company detail before revising assumptions about a potential expanded US indication.
  • The pending Japanese application, filed by Tanabe, remains a separate regulatory track to monitor.
  • Any move of the company's domicile from Switzerland to Delaware is described only as possible, so no change in regulatory responsibilities can be assumed.

Company's press release (SEC filing): ADC Therapeutics SA ↗

Article written by VigiEye from the official source (ADC Therapeutics SA). Claims are the company's own. AI-assisted; check the source before acting.

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