Insmed stock soars after FDA ends hold on key lung drug

Posted under Arikace, Blog, Companies, cystic fibrosis, Diagnostics, FDA, Funding, Insmed, Medical Devices, Medical Supply, Pharmaceuticals, Pipeline, Regulatory, Startups, Universities, Videos by rmcbride

Drug developer Insmed has rallied on news that U.S. regulators have lifted the clinical hold on its experimental lung-disease treatment Arikace. The company's stock price skyrocketed nearly 63% to $4.40 per share as of 12:07 p.m. ET after the announcement. 

This ends the clinical hold the FDA had put on the inhaled antibiotic for treating cystic fibrosis patients with Pseudomonas lung infections, the Monmouth Junction, NJ-based developer reported. Early this year, regulators withdrew a hold on the developmental treatment in patients with non-tuberculous mycobacteria, Reuters reported.

Lifting the holds is a big deal for Insmed. The company has scrapped programs in cancer and other diseases, deciding to gamble most of its resources on Arikace, an inhaled liposomal formulation of amikacin. With the clinical holds removed, the company met eye-to-eye with regulators on a revised CF trial population involving certain adults with chronic Pseudomonas infections, and the company is in talks to hammer out other details of a Phase III study.

Cystic fibrosis, which affects about 30,000 people in the U.S., is a chronic genetic disease that clogs the lungs with sticky mucus and often leads to frequent respiratory infections.

"We are pleased that FDA has lifted the clinical hold on the Arikace studies in both CF and, as previously disclosed, in patients with [non-tuberculosis mycobacteria] lung disease," Timothy Whitten, Insmed's president and CEO, stated. "We believe that Arikace has the potential to be an important treatment option for" those patients.

- here's the company's release
- check out Reuters' article

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Posted under Arikace, Blog, Companies, cystic fibrosis, Diagnostics, Funding, Insmed, Medical Devices, Medical Supply, Pharmaceuticals, Startups, Universities, Videos by John Carroll

Now that the FDA has lifted its hold on Insmed's ($INSM) lung study for Arikace, the biotech says it will be ready to start enrolling patients with non-tuberculous mycobacteria lung disease for a mid-stage study mid-year.

Regulators hit the brakes on the clinical work after voicing concerns about safety issues. A hold remains on Insmed's planned cystic fibrosis trial, although the Monmouth Junction, NJ-based company says it plans to launch a late-stage European study for CF in a few months. Investigators plan to recruit about 300 patients for that study.

"I am pleased to announce that we are moving forward with the Arikace clinical development program in NTM in the U.S., and with the European CF program," says Insmed CEO Timothy Whitten in a statement. "We look forward to continuing our dialogue with FDA regarding the CF clinical program in the U.S., and continue to believe that Arikace has the potential to be an important treatment option for CF and NTM patients."

- here's Insmed's press release
- get the report from Reuters

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Insmed shares spike after FDA lifts hold

Posted under antibiotic, Blog, Companies, Diagnostics, FDA, Funding, Insmed, Medical Devices, Medical Supply, Pharmaceuticals, Startups, Universities, Videos by John Carroll

Shares of Insmed ($INSM) shot up on Friday after the company reported that the FDA has lifted a clinical hold on its trial of Arikace, an inhalable antibiotic for lung disease. Regulators had stepped in after concluding that they didn't have sufficient information to assess the risk involved in the study. Report