NeuroMarket Pulse — June 24, 2026
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The FDA’s acceptance of Regeneron’s cemdisiran under Priority Review, with a November 2026 target action date, sets up the first siRNA challenge to a gMG market long ruled by complement inhibitors and FcRn blockers — while Sanofi’s tolebrutinib clears the EU as Cenrifki for nonrelapsing SPMS even as its US application sits under a December 2025 CRL.
Today’s top developments:
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What to Watch
- EAN Congress, Geneva (June 27–30) — the week’s highest-stakes catalyst, with Lundbeck’s further Phase 2b PROCEED readout for bocunebart (anti-PACAP ligand mAb) the most-watched migraine event of Q2; the responder analysis in CGRP non-responders is the key commercial subgroup to track. See Catalyst Calendar for full timing.
- Cemdisiran PDUFA, November 2026 — a pivotal H2 2026 event for gMG; with roughly six months until the FDA decision, Regeneron and Alnylam must build neurologist familiarity with RNA interference as a therapeutic modality, while the concurrent EMA review (EU decision H2 2027) adds operational complexity.
- Tavapadon FDA decision, expected around mid-2026 — AbbVie’s NDA (filed September 26, 2025) for the first-in-class D1/D5 partial agonist approaches its standard 10-month review window; an approval would be the most mechanistically novel Parkinson’s motor therapy in over a decade. See Catalyst Calendar for full timing.
- NICE reconsideration of lecanemab and donanemab — the appeal anchored on under-weighted unpaid carer costs could unlock NHS access to Leqembi and Kisunla and set a carer-cost precedent influencing future neurodegeneration, progressive MS, and gMG assessments through H2 2026.
This brief highlights the edition’s top stories. Read the full June 24, 2026 edition → for all stories and analysis — or browse the NeuroMarket Pulse archive.
