• Why Insmed Could Still Double
post by levonchiko:
The driver for Insmed is a simple U.S. Securities and Exchange Commission (SEC) filing of less than 100 words that said that the U.S. Food and Drug Administration (FDA) granted Arikace, its liposomal amikacin for inhalation, a breakthrough therapy designation for the treatment of adult patients with nontuberculous mycobacterial lung disease who are treatment refractory. This was based on findings from Insmed’s Phase 2 clinical trial of Arikace, and the company has plans to meet with the FDA to discuss the regulatory pathway ahead.
As far as the analysts calling for a double, there were two very positive reports. Leerink expected an announcement regarding breakthrough status for the drug with huge upside, especially if no Phase 3 study is required. They had a $30 price target on the stock as of last weekend. Piper Jaffray had an astronomical $51 price target as of last weekend, which was so high that we had to confirm it with the firm.
Over the weekend we noted that the company had provided a spring interim update from the CLEAR-110 study, an ongoing, two-year, open-label extension study of once-daily Arikace. We said:
These data are from 98 patients who have completed the first 12 months of the CLEAR-110 extension study. The data were collected as part of a scheduled data safety monitoring board review of the CLEAR-110 extension study. The data showed that Arikace was well tolerated, and there was a sustained improvement from baseline level in Forced Expiratory Volume in One Second. Less