Topics:

Insmed stock soars after FDA ends hold on key lung drug

Tools

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

Related Articles:
Insmed shares spike after FDA lifts hold
Insmed shares crater as FDA puts a clamp on Ph3 CF study