Rigel falsely claims FDA approval in ‘website error’

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Rigel Pharmaceuticals has falsely claimed its chronic immune thrombocytopenia drug Tavalisse is FDA approved. The erroneous claim was up on Rigel’s website for more than 24 hours before a spike in the company’s stock raised awareness of the mistake.

San Francisco-based Rigel corrected the website on Thursday afternoon, Eastern Time. Prior to that, the firm’s investor relations website described Tavalisse as its “first FDA approved product.” The FDA is due to rule on a filing for approval of the oral spleen tyrosine kinase inhibitor by Tuesday. Rigel has since said it is yet to receive notice from the FDA about the ruling.

A cached version of the website shows the erroneous claim was live from at least the early hours of Wednesday morning. Knowledge of it spread when Rigel’s stock jumped the following afternoon. The company then swung into action, distancing itself from the claim and blaming the error on the host of the website. Rigel’s stock closed up 17%, having been up as much as 40% earlier in the day.

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The snafu isn’t the first time a company has erroneously claimed an FDA approval through a website error—and the message from history is that these mistakes don’t necessarily precede a regulatory nod. In 2016, an AstraZeneca website claimed Lokelma was FDA approved. Days later, the FDA sent a CRL to AstraZeneca. The FDA still hasn’t approved Lokelma.

Rigel will be hoping for a better outcome for Tavalisse. The biotech has endured a rocky ride up to this point, with its stock seesawing back and forth as clinical data have alternately dialed hopes up and down. Rigel emerged from that period with the data to support a filing for approval in its lead indication. Now, it and the rest of the world have to wait a little longer to find out how the story ends.



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