Protocols: Snubbed at the FDA, again, Chiasma chops staff, again; J&J lands second BTD for depression drug esketamine
A few days after acknowledging that it was slapped down, again, by regulators, Chiasma is chopping nearly half its workforce in a second restructuring. Chiasma CEO Mark Leuchtenberger says the move to ax 44% of its remaining staff was needed so the company can conserve its cash while talking to the FDA about its requirements on proving the efficacy of Mycapssa (octreotide) for acromegaly. The FDA rejected Mycapssa and recently repeated a demand that the biotech design and execute a much better late-stage study. Regulators were unhappy with Chiasma’s single arm study for a drug that is seeking to replace the injectables now in use.
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