Insmed Surges after Clinical Hold Lifted by FDA
Shares of Insmed (NASDAQ: INSM) are seeing much strength on Friday after the company announced that the hold on its ARIKACE drug has been lifted by the FDA. Shares were halted before the announcement.
The U.S. Food and Drug Administration lifted the clinical hold previously placed on ARIKACE (liposomal amikacin for inhalation) in patients with non-tuberculous mycobacteria lung disease. Insmed will continue to engage in discussions with FDA regarding the clinical hold placed on ARIKACE in Cystic Fibrosis patients with Pseudomonas lung infections.
The FDA previously requested that Insmed conduct a phase 2 clinical trial of ARIKACE in adult patients with NTM to provide proof-of-concept efficacy and safety data before proceeding with a phase 3 clinical trial.
Insmed also announced that it will move ahead with the 9-month dog inhalation toxicity study of ARIKACE as previously requested by FDA to determine if the findings of the rat inhalation carcinogenicity study are observed in a non-rodent model.
Adam Feurstein, notable biotech analyst, stated that this lift of the clinical hold is an "OK" development for the company, but that there are still large risking overhead.
Currently, shares of Insmed are trading about 22% higher in the pre-market session at $4.65.
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