FDA Approves First SMA Drug That Targets Muscle Loss, Not Just Nerves
The FDA approved Scholar Rock’s Isembyld, the first SMA therapy aimed at muscle wasting in patients already on nerve-targeted treatment.
The FDA approved Scholar Rock’s Isembyld, the first SMA therapy aimed at muscle wasting in patients already on nerve-targeted treatment.
Artisan Partners wants Novartis board changes after Avidity’s del-desiran and pelacarsen failed late-stage trials and wiped out $30B in value.
Novartis’ DM1 trial miss hit Dyne. JPMorgan cut DYN to Underweight with a $10 target; Stifel and Jefferies stay Buy.
Novartis del-desiran missed its Phase 3 HARBOR goal in DM1. Shares fell ~9–10% a day after a cholesterol-drug miss. Sarepta and Dyne also dropped.
BMO cut Amgen to Market Perform on valuation after a 34% YTD rally. A Novartis Lp(a) trial miss also raises questions for Amgen’s olpasiran.
Novartis and Ionis said pelacarsen lowered Lp(a) but failed to cut heart attacks, strokes or deaths in a Phase 3 trial of 8,323 patients.