Brainstorm Cell Therapeutics (NASDAQ:BCLI) news for Tuesday has BCLI stock taking a beating following results from its Amyotrophic lateral sclerosis (ALS) study.
Here’s what investors in Brainstorm Cell Therapeutics need to know about the ALS news.
- The company revealed topline results from its Phase 3 trial of NurOwn to treat ALS.
- Unfortunately for BCLI stock, the study didn’t produce statistically significant results.
- This has it missing its primary endpoint, which was determining NurOwn’s effectiveness compared to a placebo.
- Brainstorm Cell Therapeutics was expecting to see response rates of 35% for its drug compared to 15% for the placebo.
- However, that wasn’t the case.
- Instead, its response rate came in at 34.7%, which is close to the 35% it was aiming for.
- The problem comes from the placebo response rate, which was 27.7%.
- That’s an unusually high placebo rate compared to other ALS studies and Brainstorm Cell Therapeutics’ own Phase 2 results.
Chaim Lebovits, CEO of Brainstorm Cell Therapeutics, said this about the news.
“This clinical trial included a more severely affected ALS population compared to other recent ALS clinical trials. We identified a superior treatment response in a pre-specified subgroup of patients with less advanced disease. We are in active discussions with the FDA who have expressed their eagerness to review the data and have committed to prioritize review of this data. The FDA will review the data to see if there is a path forward to support approval.”
BCLI stock was down 66.4% as of noon Tuesday.
On the date of publication, William White did not have (either directly or indirectly) any positions in the securities mentioned in this article.