Insmed (INSM) Slammed as FDA Puts Clinical Hold on ARIKACE
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Insmed Inc. (Nasdaq: INSM) is getting slammed pre-market today, following news that the U.S. FDA "has notified the Company that the agency has placed a clinical hold on Insmed's phase 3 clinical trials for ARIKACE (liposomal amikacin for inhalation) in Cystic Fibrosis (CF) patients with Pseudomonas lung infections and patients with non-tuberculous mycobacterial (NTM) lung disease."
Shares are down over 40 percent ahead of the bell Tuesday.
A clinical hold is a notification issued by FDA to the sponsor to delay a proposed clinical trial or suspend an ongoing clinical trial.
Shares are down over 40 percent ahead of the bell Tuesday.
A clinical hold is a notification issued by FDA to the sponsor to delay a proposed clinical trial or suspend an ongoing clinical trial.
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