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    Thomas J. Smith • Leerink Partners

    Thomas J. Smith's questions to argenx SE (ARGX) leadership

    Thomas J. Smith's questions to argenx SE (ARGX) leadership • Q2 2025

    Question

    Thomas J. Smith from Leerink Partners asked for an update on the FDA FAERS safety signal regarding CIDP from June, including any visibility on resolution timelines and feedback from prescribers on the matter.

    Answer

    CMO Luc Truyen contextualized the FAERS signal, noting its limitations (e.g., lack of denominators) and classifying it as a 'potential' signal requiring a 12-month monitoring period. He stated that argenx's internal data shows a low event rate (<2%) and the benefit-risk profile remains unchanged. COO Karen Massey added that prescriber feedback is very positive, with a high grant rate for patient requests for Vyvgart, indicating continued physician confidence.

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    Thomas J. Smith's questions to Roivant Sciences Ltd (ROIV) leadership

    Thomas J. Smith's questions to Roivant Sciences Ltd (ROIV) leadership • Q4 2025

    Question

    Thomas J. Smith of Leerink Partners asked for the rationale behind the IMVT-1402 trial design in CIDP, which omits a washout period and doesn't measure response rates. He also inquired about patient selection optimization and how the resulting data will position the drug commercially.

    Answer

    CEO & Director Matt Gline explained the design was driven by three factors: FDA preference for direct placebo-controlled trials, investigator and patient aversion to washouts, and improved ability to select the right patients. He noted that data from their previous batoclimab study showed they can effectively identify patients who flare upon withdrawal, making a patient-friendly "no washout" design feasible and competitive.

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