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Breakthrough Designation Rescissions: Who Might US FDA Drop Next?

 
• By Bridget Silverman

Our chart details the pipeline candidates who might lose the coveted status as treatment paradigms change and trial results come in.

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Even if a development-stage product loses Breakthrough designation from the US FDA, it's regulatory progress isn't necessarily going in reverse.

Being told you aren't special isn't particularly fun, but it's not the end of the world either, as anyone who has gone through a bad breakup can attest. Still, no one likes getting dumped, and given that Tonix Pharmaceuticals Holding Corp.’s PTSD therapy Tonyma and Trevena Inc.’s novel pain drug Olinvo just had to break up with their Breakthrough Therapy Designations (BTDs), the Pink Sheet is thinking about some other pipeline candidates that the US FDA might soon be telling, "It's not you, it's me."

It's actually trial results and changes to existing treatment paradigms, rather than FDA's shifting sentiments, that cause a candidate to lose a breakthrough designation. But even without a BTD, FDA...

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