David Nierengarten • Wedbush Securities

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CEO David Hung clarified that the decision to add a maintenance evaluation for sacrocitinib was made by Nuvation Bio, not at the FDA's recommendation. He stated that discussions with the FDA regarding the design of a pivotal study are ongoing, and details will be disclosed publicly on clinicaltrials.gov once finalized.

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CEO David Hallal stated that a potential delay would have "no impact" on the PRV. President of R&D Akshay Vaishnaw confirmed that labeling was part of the constructive late-cycle meeting, but could not share specifics, only reiterating that the FDA is working towards the September 22 PDUFA date.

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President of R&D Akshay Vaishnaw confirmed a significant opportunity exists beyond SMA in disorders like DMD and FSHD, referencing strong preclinical data. He also mentioned ALS as a potential area of interest and stated that the company is working through details for new studies, with more information to be shared later in the year.

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EVP & CCO Ross Moat stated it was too early to define a precise efficacy expectation for KPL-387 but noted the study is designed to optimize and demonstrate the drug's strength. On competition, he reinforced KNSA's leadership position, emphasizing their understanding that complete disease control requires inhibiting both IL-1 alpha and IL-1 beta, a key differentiator from other potential mechanisms.

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Chief Medical Officer Dr. John Paolini stated that while the Phase II/III study for KPL-387 will start mid-year, specific details of the trial design are not being shared at this time. He noted the plan is based on regulatory interactions and directed investors to clinicaltrials.gov for future updates.

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Chief Commercial Officer Ross Moat responded that prescribing for first-recurrence patients appears to be scattered across the board, with no specific correlation to prescriber experience or repeat status observed yet. He emphasized that the company's strategic initiatives, like the partnership with the American Heart Association, are focused on shortening the overall patient journey to an accurate diagnosis for all patient types.

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CEO Michael Rossi clarified that the primary goal of the initial studies (1001 and 1201) is to establish the safety of the SADA protein itself, which remains constant. By using the existing linker, they minimize variables. Once the protein's safety is confirmed, the new, improved linker-chelator can be introduced via a bridging study or amendment for the treatment phase of development.

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President and CEO Michael Rossi clarified the decision was driven purely by PK data, not tumor type or burden. The human PK profile at 0.3, 1, and 3 mg/kg closely matched preclinical models, which had pointed to 1 mg/kg as the optimal dose to 'paint the tumor' without prolonging clearance time. The adjustment back to 1 mg/kg was a logical step to fine-tune the dosing window based on this data, and was not related to any toxicity concerns.

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Chief Executive Officer Tim Van Hauwermeiren described ocular MG as a debilitating condition with high unmet need and a very limited treatment toolbox, typically consisting of mestinon and high-dose corticosteroids. He positioned VYVGART as a disruptive alternative with a strong benefit-risk profile, highlighting the opportunity to offer these patients a real alternative to chronic high-dose steroids.

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