1️⃣ Aardvark’s hold turns PWS into a regulator file Aardvark said FDA placed a full clinical hold on ARD-101, covering the Phase III HERO and extension studies in Prader-Willi syndrome, and will unblind available data to decide the path forward.
💡 Why it matters The regulatory risk moved from trial delay to program reset. For rare disease bets, cash runway now depends on what FDA needs to see next.
☕ Coffee talk Does unblinding help the file, or just tell investors how much program is left?
2️⃣ Biogen takes a messy tau win into Phase III Biogen said diranersen missed the Phase II dose-response endpoint, but tau reductions and cognitive signals, strongest at the lowest dose, are enough for registrational development.
💡 Why it matters Alzheimer’s investing still wants clean biology. This gives tau a path, but also a dose puzzle regulators will not ignore.
☕ Coffee talk How much can tau enthusiasm carry when the lowest dose does the awkward bit?
3️⃣ Isomorphic makes AI drug discovery expensive to ignore Isomorphic Labs raised a $2.1B Series B led by Thrive, with Alphabet, GV, MGX, Temasek, CapitalG and the UK Sovereign AI Fund also in the round.
💡 Why it matters This is platform capital at clinical-scale ambition. The burden shifts from model quality to whether AI-designed assets can survive humans.
☕ Coffee talk At $2.1B, how long before partners ask for drugs instead of better demos?