Episode 195 - September 11, 2026

<p>On this week&#39;s episode, Tess Cameron, Brian Skorney, Paul Matteis, and Yaron Werber open with a look at markets, noting the XBI slipped just over 3% amid concerns about energy prices, inflation, and long-term U.S. fiscal health weighing on the rate-sensitive sector. The conversation then turns to policy, discussing new FDA leadership appointments including Karim Mikhail as CBER director, with hosts noting the industry&#39;s hope for a calmer, less chaotic regulatory tone. They highlight the FDA&#39;s apparent openness to psychedelics, pointing to stock reactions across the space. On the data front, Novartis&#39;s pelacarsen missed expectations reducing Lp(a) relative to rival programs from Amgen and Eli Lilly, while its DM1 program also fell short, shifting attention to Dyne Therapeutics&#39; upcoming expansion cohort data. The hosts debate whether Novartis&#39;s setbacks make early-commercial, post-Phase 3 companies more attractive acquisition targets given looming loss-of-exclusivity pressure across large pharma. In other data news, Roivant&#39;s mosliciguat hit its Phase 2 primary endpoints in interstitial lung disease, with the company already advancing to Phase 3. The episode closes with Biohaven&#39;s epilepsy trial hold pending further metabolite data, and questions over whether the hold could affect its recent SK Pharma deal. This episode aired on September 11, 2026.</p>