Boston, MA 06/20/2014 (wallstreetpr) – Insmed Incorporated (NASDAQ:INSM) has received the breakthrough designation to Arikayce. It is a form of treatment for the people suffering from nontuberculous mycobacterial lung disease. It is specifically meant for the adults who are treatment refractory. The biopharmaceutical company, Insmed, is into the development and commercializing of inhaled therapies aimed to cure serious lung diseases.
The Initial Reaction
The breakthrough designation was given by the FDA. It was received by the Insmed Incorporated (NASDAQ:INSM) as it reported the positive data from the phase 2 clinical trial. There is a great need for the nontuberculous mycobacterium lung disease. Arikayce will undergo a clinical trial for the treatment for pseudomonas lung infections. The stock price posted gain of more than 40% after the news. There was high volume trading in the stock after the news that suggests that the higher prices are bound to stay.
The Great News
Getting the designation from FDA is a great news as the company’s lead product Is Arikayce. It is an inhaled antibiotic treatment product. The patient gets the anti-infective directly to the place serious lung infections. Now with the designation, Insmed Incorporated (NASDAQ:INSM) can move ahead with the further development and review of Arikayce. It will also meet the FDA for the further regulatory proceedings. It will work out to find a pathway to acquire regulatory approval for Arikayce. The company has the right of potentially filing new drug applications on the basis of the early and mid-stage data. It will work as a base to get the approval.
As of now, things are looking quite bright for the Insmed Incorporated (NASDAQ:INSM). It is not the time to sell the stock. Arikayce will be pushing for a new drug application soon. And if it happens, the chances of stock moving higher are quite high. Investors should wait for some consolidation before jumping to buy the stock.
