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Insmed Incorporated Message Board

insm_info_repost 7 posts  |  Last Activity: Jun 18, 2014 12:47 PM Member since: Apr 5, 2014
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  • insm_info_repost by insm_info_repost Jun 18, 2014 12:47 PM Flag

    • 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

  • Reply to

    why Insmed only did an SEC filing and not a PR?

    by kvnmcdd Jun 18, 2014 11:08 AM
    insm_info_repost insm_info_repost Jun 18, 2014 12:43 PM Flag

    bump

  • Reply to

    Why Insmed Could Still Double

    by levonchiko Jun 18, 2014 11:04 AM
    insm_info_repost insm_info_repost Jun 18, 2014 11:22 AM Flag

    thanks! on top

  • posted by justarook04

    Insmed breakthrough designation a 'game changer,' says Piper Jaffray
    Piper Jaffray views the breakthrough designation for Arikayce for the treatment of nontuberculous mycobacterial as a "game changer" for Insmed. Piper expects shares to move sharply higher today and says the news brings the company "another important step closer toward approval." It reiterates an Overweight rating on Insmed with a $51 price target. The stock is up 27% in pre-open trading to $15.82

  • Reply to

    Piper Jaffray!

    by justarook04 Jun 18, 2014 9:10 AM
    insm_info_repost insm_info_repost Jun 18, 2014 9:51 AM Flag

    Yes! on top

  • Reply to

    Piper Jaffray!

    by justarook04 Jun 18, 2014 9:10 AM
    insm_info_repost insm_info_repost Jun 18, 2014 9:23 AM Flag

    great news! on top

  • insm_info_repost by insm_info_repost Jun 18, 2014 9:13 AM Flag

    posted on March 27 by Fudfighter3

    25% cure allows filing as Breakthrough Therapy
    "What today's news does is eliminate any debate about the clinical meaningfulness of the data," said Andrew Fein, an analyst with HC Wainwright & Co.

    Andrew was right on point.

    We were hoping for confirmation that more patients on Arikace than in the placebo arm generated culture results evidencing a significant reduction in bacterial density.

    But whereas satisfactory evidence on the culture results MAY (Wedbush?) have been accepted by the FDA as predictive of a clinical benefit, the 25% conversion to culture-negative was an actual clinical benefit - opening the door to Breakthrough Therapy designation.

    It's worth revisiting a Bloomberg News article from February last year -

    [ One of the most tantalizing new programs now being rolled out at the FDA is its brand new category for "breakthrough" drugs, offering a select number of companies a chance at a shortcut to the market based on early-stage data for transformational new therapies.

    So when Janet Woodcock, the influential director of the FDA's Center for Drug Evaluation and Research, started outlining how the program will work--indicating that a company can move from an expanded Phase I directly to commercialization, Bloomberg reporters were paying close attention.

    According to the business news wire, Woodcock says that companies which earn breakthrough status will have the ear of the agency.

    "We expect many of these would come available very quickly with Phase I data," she said. ]

    [ Biotechs have been paying particularly close attention to this new, infinitely shorter path to the marketplace.

    A breakthrough designation would revolutionize their commercial prospects, upending some well known methods for building value through long-term partnerships with Big Pharma--which can easily take years to complete.

INSM
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