Pharma BD Deal Intelligence
In March 2022 Sanofi and Blackstone Life Sciences (BXLS) announced a strategic, risk-sharing collaboration under which funds managed by BXLS contribute up to EUR 300M (~$331M) to accelerate the global pivotal program for a subcutaneous formulation of the anti-CD38 antibody Sarclisa (isatuximab) in multiple myeloma, delivered via Enable Injections' enFuse on-body delivery system. Sanofi retains full rights and control; BXLS is eligible for royalties on future subcutaneous sales. The bet has since largely de-risked: the pivotal Phase 3 IRAKLIA study (NCT05405166) met its co-primary endpoints in January 2025, showing non-inferiority of subQ on-body administration versus IV on objective response rate (71.1% vs 70.5%) and steady-state C-trough, with markedly fewer infusion reactions (1.5% vs 25%). In March 2026 the EU CHMP adopted a positive opinion recommending approval of Sarclisa SC via on-body injector across all approved MM indications. US approval remains pending: in April 2026 the FDA extended its review by up to three months to a revised action date of July 23, 2026. If approved, Sarclisa would be the first anticancer therapy administered via on-body injector.