Great overview of Sarepta continuing to be snake oil sales co, pushing sketchy data and corrupt lobbying. None of their drugs work!!
Eteplirsen (Exondys 51) was approved on super thin data- a TWELVE(!!) patient study, no placebo group and ambiguous results. The FDA’s own scientific staff said the data didn’t show it worked at all and later internal memos later showed internal drama and full on civil war over approving it.... Janet Woodcock overruling her own team to push it through for her buddies. (https://www.statnews.com/pharmalot/2016/09/19/sarepta-fda-du... and https://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/2064...)
Once the FDA bent over for them once it was all over and Serepta pushed through more of the same - tiny surrogate endpoints and spliced half-assed data.
Their gene therapy Elevidys (SRP-9001) was hyped up as a cure, raised billions then data readouts were so underwhelming. Pivotal trial EMBARK didn't even meet it's primary endpoint yet the FDA still expanded it's approval!! Biotech lobbyists framed this as a triumph of accelerated approval process but really just demonstrative of how the FDA no longer has staff or spine.
Their stock behavior also is sketchy as hell, with Sarepta execs getting rich selling shares right after hype events and before disappointing data drops.
randycupertino•3mo ago
Eteplirsen (Exondys 51) was approved on super thin data- a TWELVE(!!) patient study, no placebo group and ambiguous results. The FDA’s own scientific staff said the data didn’t show it worked at all and later internal memos later showed internal drama and full on civil war over approving it.... Janet Woodcock overruling her own team to push it through for her buddies. (https://www.statnews.com/pharmalot/2016/09/19/sarepta-fda-du... and https://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/2064...)
Once the FDA bent over for them once it was all over and Serepta pushed through more of the same - tiny surrogate endpoints and spliced half-assed data.
Their gene therapy Elevidys (SRP-9001) was hyped up as a cure, raised billions then data readouts were so underwhelming. Pivotal trial EMBARK didn't even meet it's primary endpoint yet the FDA still expanded it's approval!! Biotech lobbyists framed this as a triumph of accelerated approval process but really just demonstrative of how the FDA no longer has staff or spine.
Their stock behavior also is sketchy as hell, with Sarepta execs getting rich selling shares right after hype events and before disappointing data drops.
One of the worst biotechs out there.