Shots:
Novartis has reported topline data from P-III (REMODEL-1/-2) trials assessing remibrutinib (100mg) vs teriflunomide in ~2,000 adults with relapsing multiple sclerosis (RMS)
Remibrutinib met the 1EP, significantly reducing annualized relapse rate (ARR), plus trial showed clinically meaningful reductions in key 2EPs related to disability progression, with a positive trend in 3mCDP & nominally significant…
Shots:
The P-II trial of obexelimab (250mg, SC, QW) vs PBO in RMS, met its 1EP with a 95% relative reduction in cumulative new Gd-enhancing T1 lesions over wks. 8 & 12, with near-complete suppression by wk. 8 sustained through wk. 12.
Adjusted mean new lesions was 0.01 vs 0.23, only 2 vs 19 total…
Shots:
Zenas BioPharma has entered into an agreement with Royalty Pharma granting it royalty rights on the future sales of obexelimab
As per the deal, Zenas will receive ~$300M, consisting of a $75M upfront & 3 additional $75M each in milestones tied to P-III (INDIGO) trial achievement & FDA approvals in IgG4-RD & SLE, while Royalty Pharma…
Shots:
Genentech has reported 96wk. data from P-II (FENopta) trial assessing fenebrutinib vs PBO for 12wks. in 109 RMS pts (18-55yrs.); 99 pts then opted for a 192wk. OLE study, with 93 remaining after 96wks.
OLE study showed sustained efficacy over 96wks. with a low ARR of 0.06, no disability progression (per EDSS) & no…

