Is Sarepta’s latest failure tied to its earlier success?

We still don’t know the full list of reasons the FDA rejected Sarepta Therapeutics’ latest treatment for Duchenne muscular dystrophy, but history may offer some clues.

As STAT’s Adam Feuerstein points out, Sarepta’s last tangle with the FDA involved scant evidence, agency unrest, and a unilateral decision based at least in part on the company’s financial solvency. The result was a controversial approval for Exondys 51, a drug that now brings in about $300 million a year for Sarepta.

Cut to this week, and the FDA’s consideration of the company’s follow-on drug could well have been motivated by its prior experience. Sarepta is now worth more than $8 billion, and it by all means had the financial wherewithal to run a longer clinical trial before asking for the FDA’s blessing. And thus that rejection could be regulatory payback.

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