(Reuters) - Shares of Insmed Inc more than doubled on Tuesday after the company said its drug to treat adults with a rare lung disorder met the main goal in a key study, leading it to apply for accelerated approval.
Insmed’s shares jumped 140 percent in early trade - their record intraday percentage gain. The U.S. Food and Drug Administration had previously granted the drug breakthrough therapy designation and fast-track status.
“I feel highly confident that the drug will be approved by the FDA in the next 12 months,” Stifel analyst Adam Walsh told Reuters.
“In our model, we see gross price of $60,000 and net price of $48,000 in the U.S. for the drug if it gets approved,” Walsh added.
The inhaled once-daily drug, Alis, was used for the treatment of resistant nontuberculous mycobacterial (NTM) lung infections in a late-stage study that involved 336 adult patients.
The company said the addition of the drug to standard treatment showed statistical significance in reducing bacterial density, a measure of change in infection, by the sixth month in 29 percent of patients, compared with 9 percent in patients on standard treatment alone.
NTM lung infections are caused by a type of bacteria found in soil as well as water and are characterized by cough, fever and blood in the mucus. There is no approved treatment for the infections.
The company, which expects Japan as one of its key markets for Alis, said it plans to hold discussions with Japanese regulators in the first half of 2018 for the drug’s approval.
Insmed is developing several other lung disease treatments. Its drug, Arikayce, is being tested in late stage, while others are in their early stages.
The company’s stock, which touched a more than 11-year high of $29.52, was the third-most actively traded on the Nasdaq.
Reporting by Akankshita Mukhopadhyay in Bengaluru; Editing by Maju Samuel