SRPT - Sarepta Therapeutics: Navigating Elevidys Upside Potential

2024-06-17 13:29:18 ET

Summary

• Sarepta Therapeutics submitted a request to the FDA for label expansion of Elevidys, with a response expected by June 21st.
• Roche initiated the process for Elevidys marketing authorization application in Europe, expected to be completed by H1 2024.
• If successful, Elevidys label and geographic expansion is likely to unlock Sarepta’s capacity to maintain a strong revenue growth pattern. Thus, supporting a “buy” rating for SRPT.

Thesis

Sarepta Therapeutics, Inc. (SRPT), submitted a request to the FDA aiming to erase the ambulation and age restrictions for Elevidys, as well as a switch in the designation from accelerated to standard approval. The company reported, in its Q1 2024 conference call , that the FDA will be issuing a response by June 21st or earlier.

SRPT’s management seems very certain about their chances to obtain the label expansion. However, I believe the FDA has enough grounds to support or deny the request given that the 52-weeks top line results missed its primary endpoint, but showed statistically significant improvements in the secondary endpoints....

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