Episode 195 - September 11, 2026

On this week'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's hope for a calmer, less chaotic regulatory tone. They highlight the FDA's apparent openness to psychedelics, pointing to stock reactions across the space. On the data front, Novartis'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' upcoming expansion cohort data. The hosts debate whether Novartis'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'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'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.