Sanofi’s (SNY) experimental multiple sclerosis (MS) drug, tolebrutinib, has faced setbacks in its clinical trials. The drug failed to meet the primary endpoint in two Phase 3 studies (GEMINI 1 and 2) designed to assess its effectiveness in treating relapsing MS.
It is worth highlighting that Sanofi has another Phase 3 study, PERSEUS, evaluating tolebrutinib for primary progressive MS. The results of this trial are expected next year.
Sanofi is a healthcare company that provides pharmaceuticals, vaccines, and biotechnology products to improve patient health.
SNY’s New MS Drug Shows Mixed Trial Results
The GEMINI 1 and 2 trials, which tested a new treatment for relapsing multiple sclerosis, failed to outperform Sanofi’s existing MS drug, Aubagio. However, in a different late-stage trial called HERCULES, which targeted non-relapsing secondary progressive MS, the drug tolebrutinib successfully met its primary goal of slowing the progression of disability compared to a placebo.
Despite the mixed results, Sanofi plans to seek the U.S. Food and Drug Administration’s (FDA) approval for tolebrutinib for non-relapsing secondary progressive MS. Interestingly, the company believes there is a lack of effective treatments for this condition.
In this regard, SNY plans to discuss the results with regulators and file for approval by the end of 2024. The outcome of these discussions and the PERSEUS trial results will be crucial in determining the drug’s future.
Is SNY Stock a Good Buy?
SNY has a Strong Buy consensus rating on TipRanks. This is based on three Buy and one Hold recommendations. Analysts’ average price target on Sanofi stock of $59.33 implies an 5.46% upside potential from current levels. The stock gained about 23% in the past six months.
