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    Susan

    Managing Director and Senior Equity Research Analyst at Bank of America Securities

    Susan Roth Katzke is a Managing Director and Senior Equity Research Analyst at Bank of America Securities, specializing in U.S. large-cap banks and financial institutions. She is known for her in-depth coverage of key industry players including JPMorgan Chase, Citigroup, Bank of America, Goldman Sachs, and Wells Fargo, with a consistently strong track record evidenced by her ranking among the top financial sector analysts on platforms such as TipRanks and Institutional Investor. Susan began her Wall Street career in the early 1990s and previously held senior research roles at Credit Suisse and Bear Stearns before joining Bank of America in 2009. She holds a CFA charter, maintains several FINRA securities licenses, and has been regularly recognized in Institutional Investor’s All-America Research Team polls for her exceptional analytical insight.

    Susan's questions to Amylyx Pharmaceuticals (AMLX) leadership

    Susan's questions to Amylyx Pharmaceuticals (AMLX) leadership • Q1 2025

    Question

    An analyst from Bank of America Securities, on behalf of Tim Anderson, asked about the ongoing discussions with the FDA regarding the Phase III trial design for AMX0035 in Wolfram syndrome. She also inquired what specific insights the upcoming 48-week HELIOS data would provide to inform these regulatory discussions.

    Answer

    Chief Medical Officer Dr. Camille Bedrosian stated that Amylyx does not disclose details of its FDA interactions but confirmed the 48-week data is crucial for informing the Phase III design. She guided listeners to expect updates on endpoints similar to the 24-week data, including C-peptide response, glycemic measures, and visual acuity, noting that stabilization in this progressive disease is significant. She emphasized this is the first-ever trial in Wolfram, so there is no existing template.

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