Insmed Skyrockets 70% after FDA Lifts Clinical Hold

Shares of Insmed

are seeing much strength during Monday's trading session after the FDA announced it lifted a clinical hold of one of its drugs. The U.S. Food and Drug Administration has lifted the clinical hold previously placed on ARIKACE (liposomal amikacin for inhalation) in Cystic Fibrosis patients with Pseudomonas lung infections. Insmed has reached agreement with FDA on a revised CF clinical trial population consisting of adult patients who have chronic Pseudomonas lung infections and FEV-1 % predicted between 25% and 75%. The Company is continuing discussions with the Agency in an effort to finalize additional details of the phase 3 study protocol for the potential clinical trial. At the same time, the Company is evaluating possible next steps for the ARIKACE U.S. CF clinical program given the current progress and anticipated resource requirements of the ongoing ARIKACE CF (CLEAR-108) and U.S. non-tuberculous mycobacteria (NTM) clinical programs. Currently, shares of Insmed are trading up about 69% at $4.56 per share.