Thursday, September 15, 2016

Update on Lexicon

Since Seeking Alpha no longer allows meaningful updates to articles, I'll just post this here.

Lexicon announced on Sept 14 that the FDA was pushing back the PDUFA date on telotristat etiprate by 90 days (to the end of February). This was apparently triggered by a request for additional data analyses from the company and the agency's need for more time to review that.

This is not a positive development, but it's difficult to gauge its materiality. Obviously it takes away a "nice to have" positive news item, but it really doesn't impact the sales potential. The company had very little to say about this at today's BAML conference presentation, but it didn't sound like this was an especially material request.

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