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Call them the "Gnarly Nine."
The nine biotech and drug companies below are each developing different medicines, but have a common mission: to convince the U.S. Food and Drug Administration to grant approval of their respective drugs based on clinical data requiring the agency to bend, tweak or even maybe lower current standards. Two companies, PTC Therapeutics (PTCT) and CytRx (CYTR) , even believe they can secure FDA approvals with a submission consisting entirely of negative data from failed clinical trials.
That would be a nifty trick, but then, President Trump called the FDA drug approval process "slow and burdensome" in his speech to Congress last week. Trump hasn't offered up specific FDA reforms or even appointed a commissioner, but his comments and tweets parrot a desire by some to lower or even remove the efficacy thresholds the agency currently uses to approve new drugs. So, what happens to The Gnarly Nine will be an interesting test case for the FDA in the age of Trump.
Let's meet the members of the Gnarly Nine:
Alkermes (ALKS) is going to the FDA with a clinical data package consisting of three phase III clinical trials of ALKS-5461 in treatment-resistant depression. Two of the three studies failed to hit their primary endpoints. Alkermes argues the "totality" of the depression data shows ALKS-5461 is effective. The company plans to share those pooled study data with the FDA at a meeting in the second quarter, followed by a planned submission in the second half of the year.