2024-04-11 02:27:54 ET
Summary
- Sarepta Therapeutics reported strong Q4/2023 performance, with $365.1M in net product revenue, up 55% from the previous year.
- ELEVIDYS, despite not meeting its primary endpoint in the Phase III trial, showed significant improvements in motor function and secondary endpoints, keeping the potential for label expansion alive.
- SRPT's growth prospects, including potential label expansion for ELEVIDYS, have led to an updated strategy and bullish outlook for the company.
In my last Sarepta Therapeutics ( SRPT ) article , I discussed Sarepta's Q3 performance and their clinical progress in Duchenne muscular dystrophy (DMD) and other rare diseases. At that time, Sarepta had recently revealed their Q3 product revenue was up 49% year-over-year, aided by ELEVIDYS, which pulled in $69.1M in its first quarter on the market. Unfortunately, ELEVIDYS' Phase III EMBARK trial failed to hit its primary endpoint, generating an abrupt sell-off for SRPT. However, the market's reaction was a bit overblown considering ELEVIDYS was able to hit its secondary endpoints, thus, keeping the potential label expansion and full approval in play. It appeared as if investors were overlooking the FDA's track record of using surrogate endpoints for gene therapies due to the inability of standard endpoints to showcase a therapy's true benefit. Well, it turns out the FDA accepted ELEVIDYS' supplemental Biologics License Application (sBLA) for eliminating age and ambulation restrictions from the label. If approved, Sarepta's growth in the DMD population would be nearly unbridled, as nearly all DMD patients would qualify for the treatment. The hay is not in the barn for ELEVIDYS, but Sarepta's growth prospects have forced me to dramatically alter my SRPT strategy moving forward....
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Sarepta Therapeutics: Growth Trajectory Alters Trading Strategy