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    Heidi Jacobson •

    Heidi Jacobson's questions to Rhythm Pharmaceuticals Inc (RYTM) leadership

    Heidi Jacobson's questions to Rhythm Pharmaceuticals Inc (RYTM) leadership • Q2 2025

    Question

    Heidi Jacobson of Leerink Partners asked for an update on the planned Phase 3 study design for Bivomelagon in acquired hypothalamic obesity (HO), including dose, size, and the remaining steps before the trial can begin.

    Answer

    David Meeker, Chairman, President & CEO, outlined that the next step is to submit meeting requests and a proposed trial design to the FDA and EMA. His 'wish list' for the design includes using the existing Phase 3 data as a historical control to avoid a double-blinded study and potentially having an earlier readout, though he acknowledged regulators may require a design similar to the previous HO trial.

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    Heidi Jacobson's questions to MannKind Corp (MNKD) leadership

    Heidi Jacobson's questions to MannKind Corp (MNKD) leadership • Q1 2025

    Question

    Heidi Jacobson inquired about the potential Phase II/III trial design for MNKD-201 in IPF, including any feedback received from the FDA on a seamless study approach.

    Answer

    Michael Castagna, an executive, stated that guidance on FDA feedback is limited but clarified the design is for a global trial. He mentioned the trial is planned to have several dose arms against a placebo and that the company is finalizing whether to test on top of existing therapies or in naive/intolerant patients.

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