After Insmed revealed in March that its inhaled antibiotic failed to meet the primary endpoint in a Phase II trial, more than a few analysts and market watchers looked askance at the company's plans to ask the FDA to give it a breakthrough therapy designation. But, three months later, the New Jersey biotech has prevailed upon regulators, picking up the agency's coveted guarantee of a speedy review for its well-traveled treatment.
Insmed's Phase II trial of Arikayce, or inhaled liposomal amikacin for the treatment of nontuberculous mycobacterial lung infections, did not meet its primary endpoint, but new data released May 20 from the 84-day open-label extension show that patients receiving the compound showed significant improvement, the company said.
Insmed is once again hustling to put the best spin possible on a clinical study of its only therapy. But faced with a row of skeptical analysts, it's not likely to make much headway.
Welcome to this week's roundup of hirings and firings throughout the industry. Please send the good word (or the bad) from your shop to Michael Gibney (email | Twitter) or Emily Mullin (email |...
Bright and early this morning Insmed ($INSM) announced that its inhaled antibiotic Arikace hit its primary endpoint in a Phase III study and was awarded fast-track status at the FDA.
Welcome to this week's roundup of hirings and firings throughout the industry. Please send the good word (or the bad) from your shop to Alison Bryant (email | Twitter) and Nesa Nourmohammadi (...
The company's stock price skyrocketed nearly 63% to $4.40 per share as of 12:07 p.m. ET after the announcement.
Shares of Insmed ($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
Insmed's regulatory woes with the cystic fibrosis drug Arikace are continuing this morning with the news that the FDA will not release its hold on the late-stage trial for the treatment and is now
Just seven months after completing its takeover of Transave, Insmed is reporting that the FDA has put a clinical hold on the Phase III trial of Arikace, a late-stage cystic fibrosis drug that had