Latest Headlines

Latest Headlines

Insmed shares shrivel as PhIII Arikayce plan chills hopes for quick OK

The news at Insmed tends to run hot and cold for investors. When their experimental antibiotic Arikayce hits trouble, its stock price goes cold and shrivels. Good news runs hot on the market. On Monday, though, the share price plunged after the biotech laid out plans for a lengthy pair of late-stage studies, squashing hopes for a quick dash to the FDA for an early approval.

Insmed snags a surprise 'breakthrough' tag for its up-and-down antibiotic

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.

New data boost Insmed's inhaled liposomal delivery mechanism for lung infections

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.

UPDATED: Insmed faces another setback as lead therapy flunks PhII lung study

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.

Siemens CEO Peter Löscher ousted amid revenue struggle

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 |...

Insmed shares routed on head-to-head antibiotic Phase III results

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.

Bayer exec takes reins at J&J's troubled consumer products biz

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 (...

Insmed stock soars after FDA ends hold on key lung drug

The company's stock price skyrocketed nearly 63% to $4.40 per share as of 12:07 p.m. ET after the announcement.

Insmed shares spike after FDA lifts hold

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 shares nosedive as regulators demand tox study on PhIII drug

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