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    Jack Padovano • Stifel

    Jack Padovano's questions to Regenxbio Inc (RGNX) leadership

    Jack Padovano's questions to Regenxbio Inc (RGNX) leadership • Q2 2025

    Question

    Jack Padovano, on for Annabel, questioned the rationale for adding a fourth dose level to the Suravec trial, asking if the one-year efficacy data from dose level three was already considered sufficient for approval or if further improvement was needed to convince the FDA.

    Answer

    President & CEO Curran Simpson confirmed the latter, stating that while dose level three results are considered sufficient and meet the target product profile, dose level four presents an opportunity to achieve even better efficacy. CMO Dr. Steve Pakola added that the one-year effect size is acceptable from a benefit-risk standpoint, and the key is that it translates into preventing vision-threatening events, which has been observed.

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    Jack Padovano's questions to Regenxbio Inc (RGNX) leadership • Q3 2024

    Question

    Jack Padovano, on for Annabel Samimy at Stifel, questioned REGENXBIO's plans for the RGX-202 pivotal trial, asking if a minimum microdystrophin expression threshold is still being considered and how meaningful the functional data from a small patient sample will be.

    Answer

    Dr. Steve Pakola, CMO, noted that while a 10% expression threshold is a concept in the field, RGX-202 is showing much higher levels, providing flexibility in trial design. CEO Curran Simpson stated that even with a limited data set, the goal is to build conviction for pivotal success, emphasizing that the differentiated product with high expression levels should drive strong patient interest and enrollment.

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    Jack Padovano's questions to Supernus Pharmaceuticals Inc (SUPN) leadership

    Jack Padovano's questions to Supernus Pharmaceuticals Inc (SUPN) leadership • Q2 2025

    Question

    Jack Padovano from Stifel asked how Supernus plans to balance its commercial efforts for ZERZUVEY between OB/GYNs and its traditional strength in psychiatry. He also inquired about the dynamics of KELBRE's combination use with stimulants in adults.

    Answer

    CEO Jack Khattar explained that while OB/GYNs generate 70-80% of ZERZUVEY prescriptions, the company will explore leveraging its psychiatry relationships in partnership with Biogen. Regarding KELBRE, he noted that combination use with stimulants remains common (~40% in adults) as physicians prefer to taper patients off stimulants gradually while initiating KELBRE therapy.

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    Jack Padovano's questions to Supernus Pharmaceuticals Inc (SUPN) leadership • Q1 2025

    Question

    Jack Padovano, on behalf of Annabel Samimy at Stifel, asked for details on ONAPGO's reimbursement, launch trajectory, and key differentiators versus competitors like AbbVie's pump. He also questioned if the previous SPN-820 trial in treatment-resistant depression (TRD) offered any insights that could revive that program or add confidence for the new trial in major depressive disorder (MDD).

    Answer

    Executive Jack Khattar stated that ONAPGO's key differentiators include its apomorphine molecule and its ability to be used as an add-on therapy, unlike competitors that replace oral levodopa/carbidopa. For SPN-820, he clarified the previous trial's outcome was likely due to the dosing regimen, not the indication. Consequently, the company is not abandoning TRD but is prioritizing MDD for the follow-on study, as it may allow for faster patient enrollment.

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    Jack Padovano's questions to Supernus Pharmaceuticals Inc (SUPN) leadership • Q4 2024

    Question

    Jack Padovano, on for Annabel Samimy, asked about the addressable market for ONAPGO given its label, the potential for cannibalizing APOKYN, and how the company's full portfolio of Parkinson's disease products fit together strategically.

    Answer

    CEO Jack Khattar explained that ONAPGO is for advanced Parkinson's and is positioned for all-day continuous control, which is distinct from APOKYN's use for acute episodes. While acknowledging a possibility of minor cannibalization for patients on multiple daily APOKYN injections, he emphasized the products are largely separate. He highlighted apomorphine's strong clinical profile, acting directly on dopamine receptors, as a key differentiator from other treatments.

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