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    Alexander Thompson • Stifel

    Alexander Thompson's questions to Crinetics Pharmaceuticals Inc (CRNX) leadership

    Alexander Thompson's questions to Crinetics Pharmaceuticals Inc (CRNX) leadership • Q1 2025

    Question

    Alexander Thompson asked about the CAH Phase III trial design, specifically regarding investigator discretion in glucocorticoid reduction and whether guidelines are in place to manage potential variability.

    Answer

    Dr. R. Struthers, CEO, explained that the trial is designed to reflect real-world clinical practice. He clarified that while investigators have discretion in the pace of glucocorticoid tapering for individual patients, the protocol provides general guidance on reduction increments to ensure a careful and judicious process.

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    Alexander Thompson's questions to argenx SE (ARGX) leadership

    Alexander Thompson's questions to argenx SE (ARGX) leadership • Q1 2025

    Question

    Alexander Thompson asked how the net price of VYVGART should be expected to evolve over time, given the introduction of the pre-filled syringe (PFS) and three available formulations.

    Answer

    Chief Operating Officer Karen Massey highlighted the positive reception and optimal label for the PFS, positioning it as a growth driver. Chief Financial Officer Karl Gubitz explained that the PFS, as a pharmacy benefit product, will have a lower net price per patient due to manufacturer payments in the catastrophic phase. He reiterated the annual net price guidance of $225,000 for gMG and $450,000 for CIDP, noting it will evolve over time.

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    Alexander Thompson's questions to argenx SE (ARGX) leadership • Q4 2024

    Question

    Alexander Thompson asked for more detail on the potential magnitude and rate of the net price impact from the prefilled syringe (PFS) launch.

    Answer

    Chief Financial Officer Karl Gubitz explained that the shift to self-administration will move patients to the pharmacy benefit (Medicare Part D), which will increase the gross-to-net percentage due to higher rebates and the IRA redesign. However, he expects this impact to be offset by increased patient volumes. He also noted that value-based agreements (VBAs) would likely phase out over time.

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    Alexander Thompson's questions to argenx SE (ARGX) leadership • Q1 2024

    Question

    Alexander Thompson asked about the expectation for self-administration for CIDP at launch and whether the prefilled syringe (PFS) is the primary route to achieving that on the label.

    Answer

    COO Karen Massey clarified that the initial VYVGART Hytrulo label for CIDP, if approved, would be for healthcare provider (HCP) administration. She confirmed that the PFS is the intended path forward to seek a self-administration label for both gMG and CIDP, subject to FDA review and approval.

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    Alexander Thompson's questions to Travere Therapeutics Inc (TVTX) leadership

    Alexander Thompson's questions to Travere Therapeutics Inc (TVTX) leadership • Q4 2024

    Question

    Alexander Thompson asked for an update on the progress toward restarting the Phase III HARMONY study for pegtibatinase and when more specific timelines might be provided.

    Answer

    SVP of R&D, Dr. Bill Rote, reported that the company is making good progress with its CDMO partners on the necessary process improvements for manufacturing scale-up. He reiterated the expectation to restart enrollment for the HARMONY study in 2026, noting that a more precise timeline is data-driven and depends on the outcomes of the ongoing scale-up experiments.

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    Alexander Thompson's questions to Ascendis Pharma A/S (ASND) leadership

    Alexander Thompson's questions to Ascendis Pharma A/S (ASND) leadership • Q3 2024

    Question

    Alexander Thompson inquired about the commercial supply readiness for YORVIPATH's U.S. launch and whether the company still plans to run a broader basket study for TransCon CNP.

    Answer

    Jan Mikkelsen, President and CEO, asserted that Ascendis has 'unlimited supply' for YORVIPATH, with a robust manufacturing and supply chain in place. He also confirmed the company is planning a basket trial for CNP-related diseases, in addition to a trial in hypochondroplasia, as part of its broader strategy to be a leader in treating various growth disorders.

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    Alexander Thompson's questions to Ascendis Pharma A/S (ASND) leadership • Q2 2024

    Question

    Alexander Thompson asked what specific data the FDA needs to see to approve the use of current YORVIPATH material for a potential Q4 U.S. launch.

    Answer

    President and CEO Jan Mikkelsen stated his belief that the FDA already has all the necessary data to make a decision. He clarified that current discussions are focused less on data and more on logistical aspects, such as ensuring sufficient supply to manage the expected high demand upon launch, rather than on any outstanding data requests from the agency.

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    Alexander Thompson's questions to Immunovant Inc (IMVT) leadership

    Alexander Thompson's questions to Immunovant Inc (IMVT) leadership • Q3 2024

    Question

    Alexander Thompson asked what Immunovant needs to see in the upcoming Myasthenia Gravis (MG) and CIDP data to validate the best-in-class profile for IMVT-1402, and if there was any scenario for batoclimab to move forward.

    Answer

    Executive Peter Salzmann responded that the key goal is to demonstrate a strong correlation between deeper IgG reduction and clinical improvement across multiple endpoints, reinforcing the company's core thesis. He emphasized that seeing this correlation over time in MG and CIDP, similar to the Graves' data, would provide high confidence in the asset's profile. The response focused exclusively on the path forward for IMVT-1402.

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    Alexander Thompson's questions to Immunovant Inc (IMVT) leadership • Q3 2024

    Question

    Alexander Thompson of Stifel asked what Immunovant needs to see in the upcoming CIDP and MG readouts to validate the best-in-class profile for IMVT-1402, and if there was any scenario for batoclimab to move forward.

    Answer

    Executive Peter Salzmann responded that the key is to demonstrate a strong correlation between deeper IgG reduction and better clinical improvement across multiple parameters, reinforcing the company's core thesis. He emphasized that this was observed in the Graves' data and is what they expect to see in MG and CIDP. The response focused exclusively on IMVT-1402, implying batoclimab is not being advanced.

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    Alexander Thompson's questions to Viridian Therapeutics Inc (VRDN) leadership

    Alexander Thompson's questions to Viridian Therapeutics Inc (VRDN) leadership • Q1 2024

    Question

    Alexander Thompson of Stifel Financial Corp. asked for perspective on TEPEZZA's safety profile, questioning if more recent studies represent a better benchmark for hearing issues. He also inquired if the top-line data for VRDN-001's Phase III trial would include results beyond the 15-week primary endpoint.

    Answer

    President and CEO Stephen Mahoney confirmed the top-line data would be limited to the 15-week endpoint. Chief Medical Officer Thomas Ciulla added that the company is recording adverse events using standard MedDRA terms and assessing audiometry at baseline and prespecified points, consistent with evolving clinical practice and FDA guidance.

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    Alexander Thompson's questions to Aclaris Therapeutics Inc (ACRS) leadership

    Alexander Thompson's questions to Aclaris Therapeutics Inc (ACRS) leadership • Q1 2024

    Question

    Alexander Thompson asked how ATI-2138 differs from Pfizer's ritlecitinib and whether the drug could potentially differentiate itself regarding the class-wide black box warning.

    Answer

    Interim CEO Neal Walker noted that while a black box warning should be anticipated for any JAK-targeting drug, the final label is data-driven and can vary. Chief Scientific Officer Joseph Monahan detailed the key differentiation: while both are covalent inhibitors, ATI-2138 has similar high potency on both ITK and JAK3, whereas ritlecitinib is a JAK3-biased drug with little impact on ITK at its clinical dose. This allows ATI-2138 to meaningfully block both pathways.

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