Trader consensus reflects near-certainty at 99.7% for "No" following the FDA's April 22, 2026, announcement extending review of Sanofi's biologics license application for subcutaneous Sarclisa (isatuximab-irfc), an anti-CD38 monoclonal antibody for multiple myeloma. The Prescription Drug User Fee Act target date shifted from April 23 to July 23, 2026, to allow additional evaluation time, despite positive phase 3 data showing pharmacokinetic non-inferiority and similar efficacy to the approved intravenous formulation via on-body injector. No approval has been posted on official FDA channels, solidifying the outcome as the market's resolution criteria—tied to the original timeline—remain unmet. Realistic shifts would require an unforeseen expedited approval before close, though routine extensions signal low likelihood amid standard regulatory caution.