Insmed Inc. (NASDAQ: INSM) shares were screaming higher on Wednesday. This is just days after we featured it this last weekend as one of three stocks that could double. While no one can take really credit for a three-day turnaround in timing, the reality is that the same analysts who said this could double or more will be featuring the report very positively.
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.
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The consensus figure still screens as $33.40, and that is after a 36% gain to $17.03 in Wednesday trading. Insmed shares were at $12.12 late on Friday, and its 52-week range is $9.00 to $22.29. Even after a 36% gain, the expectation is that Insmed could still double – or more!
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