Shares of Mallinckrodt (MNK) are under pressure after Andrew Left’s Citron Research tweeted that the company failed its “only real clinical trial of Acthar” and also failed to disclose the outcome. Additionally, the short-focused research firm pointed out that the “failed clinical studies comes weeks after OIG publishes that Acthar is a drug based on a history of fraud and abuse”.
CITRON ACCUSES MALLINCKRODT OF NOT DISCLOSING FAILED TRIAL: Using its Twitter account, Andrew Left’s Citron Research said that, “[Mallinckrodt] has just FAILED its only real clinical trial of Acthar. Mallinckrodt has failed to disclose. Citron will follow with the full story on why the OIG and MEDPAC are finally about to put an end to this charade.” The short-focused research firm linked its tweet to an article from the Clinical Journal of the American Society of Nephrology that discusses the ATLANTIS Randomized Trial. The conclusions section states that, “ACTH at 80 U/1.73 m2 administered twice weekly was ineffective at preventing disease relapses in pediatric nephrotic syndrome.” The publication also stated: “The ATLANTIS trial was the first randomized trial of ACTH in childhood nephrotic syndrome. The trial was stopped early because of the lack of discernible efficacy. ACTH monotherapy at 80 U/1.73 m2, administered twice weekly, given during disease remission failed to maintain disease remission, with similar relapse rate and time to relapse when compared with no relapse-preventing treatment. The negative trial findings contrast with recent case series that have suggested that ACTH is effective in reducing proteinuria in adults with nephrotic syndrome”. In a follow-up tweet, Citron also added that “[Mallinckrodt] failed clinical studies comes weeks after OIG publishes that Acthar is a drug based on a history of fraud and abuse. Citron believes that $MNK could be first pharma to go BK if Medicare opens its eyes”.