Epoch 49: Cheat Sheet to Biotech Impacts of Trump’s Healthcare Appointees

HHS, FDA, CMS, NIH

Hello Avatar! Welcome back for another week of biotech analysis. Today is Sunday, which means this is our Building Biotech newsletter that is focused on discussing biopharma strategy topics. Today, we begin by examining the “RFK Effect” and its immediate impact on the biotech and healthcare markets. The announcement of Robert F. Kennedy Jr. as Secretary of HHS sparked a knee-jerk market reaction, with consumer health, generics, and biosimilars rallying while biotech, CROs, and vaccine-focused big pharma stumbled. Much of this initial volatility stems from uncertainty around RFK’s commitment to transparency, affordability, and domestic manufacturing. However, as his policies take shape, there is reason to believe that the market’s response will stabilize, offering clarity and opportunities for those prepared to adapt. We’ll also explore how RFK’s leadership, alongside Mehmet Oz at CMS and Martin Makary at FDA, signals a broader shift toward reform. From the push for localized production and accelerated approvals in oncology to the challenges facing high-cost blockbuster drugs like GLP-1 agonists, understanding these changes is critical for anyone navigating the evolving biotech landscape.

If you're not subbed yet click the link below.  Every Thursday we are out with our FREE public/private biotech market update. Sundays are the days we focus on forward looking strategy.  Monday’s are for public equity research.  Tomorrow we will focus on Neumora Therapeutics (NMRA) which is approaching a critical inflection point. The anticipated topline data from the Phase 3 KOASTAL-1 study of navacaprant for major depressive disorder (MDD) is expected in Q4 2024. With investor anticipation running high and market volatility expected (potential swings of +/- 100%), all eyes are on NMRA.

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Enough shilling for the day, lots to cover this week, let's get started!

INTRODUCTION

Recent appointments made under President-elect Donald Trump’s administration represent a significant shift for the healthcare and biotech industries. With unconventional choices like Robert F. Kennedy Jr. for HHS, Mehmet Oz for CMS, and, Martin Makary for the FDA, this administration has signaled its intention to challenge norms and implement bold reforms. While these appointments bring opportunities for innovation they also potentially create new hurdles for companies in the biopharma space. We will take you through it all today and give you our 2 cents.