RHHBY Roche Holdings AG ADR

$RHHBY Swiss drugmaker Roche (ROPC.S), opens new tab will pay up to $1.27 billion to license Alector's (ALEC.O), opens new tab experimental treatment for ​Parkinson's disease, the US biotech said ‌on Monday, sending its shares surging 72% in premarket trading. Genentech, a unit of Roche, will ​pay Alector $100 million upfront and up ​to $1.17 billion more if the treatment reaches development, regulatory ⁠and sales targets. Alector is also ​eligible for royalties.

$RHHBY FDA accepted Roche's fenebrutinib NDA under priority review on Sept 30 (Genentech release), covering both relapsing MS and primary progressive MS. First BTK inhibitor with FDA filing acceptance in both. FENhance 1 and 2: the annualized relapse rate fell 51.1% and 58.5% vs teriflunomide over 96 weeks. The progressive data is the more interesting read. In FENtrepid, fenebrutinib met non-inferiority to Ocrevus on 12-week composite confirmed disability progression, with a numerical 12% risk reduction (HR 0.88). First investigational medicine in over a decade to slow disability progression in a Phase III PPMS trial. The wrinkle is the comparator. Ocrevus is Roche's own blockbuster and the only FDA-approved therapy specifically for PPMS. This is Roche lining up an oral successor to its own franchise. The race behind it: Novartis reported positive Phase III for remibrutinib in September and plans global submissions. Sanofi's tolebrutinib won EU approval in June.

Running a little experiment to see how well our AI overlords can predict biotech approvals based on clinical outcomes benchmarked to SoC sprinkled with regulatory precedent. Posting the calls ahead of time so we can spank the model if it's wrong. $RHHBY — FDA action date: Oct. 9 Tecentriq Hybreza (subcutaneous atezolizumab) for adjuvant dMMR/MSI-H colon cancer. Priority review granted in June. AI model call: • Approval probability: 95% • Estimated move on approval: +10% • Estimated move on miss: -15% Let's see what happens

$RHHBY you’re entering what is becoming a crowded market for IgAN and you can’t even show your data? Not a good look, Roche.