BioCentury
ARTICLE | Product Development

Nov. 17 Quick Takes: Phase III miss for BrainStorm’s ALS program; plus Novo, BioMarin-Deep Genomics, Lexicon, Seed-Lilly and RhoVac 

November 18, 2020 2:32 AM UTC
Updated on Nov 18, 2020 at 3:03 AM UTC

BrainStorm sees path forward for ALS therapy despite Phase III miss
BrainStorm Cell Therapeutics Inc. (NASDAQ:BCLI) shed $7.92 (66%) to $4.02 on Tuesday after its mesenchymal stem cell therapy NurOwn missed the primary endpoint in a Phase III trial to treat amyotrophic lateral sclerosis (ALS), with 34.7% of treated patients achieving 1.25 points per month improvement in the Revised Amyotrophic Lateral Sclerosis Functional Rating Scale versus 27.7% of patients in the placebo group (p=0.453). But BrainStorm sees a possible path forward based on results in a prespecified subgroup with early disease in which the company said NurOwn demonstrated a clinically meaningful treatment response across the primary and some secondary endpoints. It plans to discuss those data with FDA to determine next steps.

High dose Ozempic beats approved dose on HbA1c, weight loss
Novo Nordisk A/S (CSE:NOVO B; NYSE:NVO) announced Tuesday that a 2 mg dose of Ozempic semaglutide met the primary endpoint of a statistically significant reduction in HbA1c vs. the approved 1 mg dose of Ozempic in the Phase IIIb SUSTAIN FORTE trial. The higher dose of the once-weekly GLP-1 agonist also led to significantly greater weight loss vs. the approved dose without any increases in the frequency of known adverse events for the class...