Sarepta Therapeutics (NASDAQ:SRPT) stock is taking a beating on Tuesday after the biopharmaceutical company announced results from a Phase 3 clinical trial.
That clinical trial covers the use of ELEVIDYS as a treatment for patients ages four to seven suffering from Duchenne muscular dystrophy. Unfortunately for SRPT stockholders, the clinical trial failed to reach statistical significance.
That’s due to the patients taking ELEVIDYS only seeing a 2.6-point improvement on the North Star Ambulatory Assessment after 52 weeks. For comparison, patients taking the placebo saw a 1.9-point improvement over that same period of time.
What’s Next for SRPT Stock?
Even though the Phase 3 study didn’t meet its primary endpoint, Sarepta Therapeutics isn’t giving up on ELEVIDYS just yet. The company is seeking Food and Drug Administration (FDA) approval to expand the label to include all patients.
Sarepta Therapeutics is going this route following the results of secondary endpoints in the study. These showed improvements in timed functional endpoints.
Craig McDonald, M.D., an investigator in the study, said the following about this news:
“The strong prognostic power of time to rise, and the particular importance of the 5 second milestone in predicting functional decline and future loss of ambulation, is clearly demonstrated in natural history. In EMBARK, the reduction in patients progressing past this milestone when treated with ELEVIDYS is highly clinically relevant.”
SRPT stock is down 47.2% as of Tuesday morning, with some 4.6 million shares traded. The company’s daily average trading volume is around 916,000 shares.
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On the date of publication, William White did not have (either directly or indirectly) any positions in the securities mentioned in this article. The opinions expressed in this article are those of the writer, subject to the InvestorPlace.com Publishing Guidelines.
