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Home  /   Forum   /   BioPharma   /   INSM - Insmed - 2009 draadje

BioPharma« Terug naar discussie overzicht

INSM - Insmed - 2009 draadje

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3.044 Posts
Pagina: «« 1 ... 146 147 148 149 150 ... 153 »» | Laatste | Omlaag ↓
  2. [verwijderd] 11 februari 2014 14:21
    Form 8-K

    On February 10, 2014, Insmed Incorporated (the “Company”) entered into a Contract Manufacturing Agreement (the “Agreement”) with Therapure Biopharma Inc. (“Therapure”) for the manufacture of the Company’s product ARIKACE TM , liposomal amikacin for inhalation, (“Arikace”). Pursuant to the Agreement, the Company and Therapure will collaborate to construct a production and quality control area for the manufacture and testing of Arikace in Therapure’s existing manufacturing facility in Mississauga, Ontario, Canada. Therapure will manufacture Arikace for the Company on a non-exclusive basis.

    investor.insmed.com/secfiling.cfm?fil...

    En tegelijkertijd een downgrade van 18 naar 7 (!!) door Wedbush... premarket een flinke klap...

    RT
  5. ludwig mack 11 februari 2014 15:29
    hoe langer ik in bio zit, hoe smeriger ik de handel er in vindt; wij zijn speelballen van een paar krachten die we niet kennen, uit ongecontroleerde hoeken vallen ze je aan, je krijgt er geen greep op; omhoog stuwen en weer laten klappen, en dat door huichelende zich indekkende voor het geval dat marketing makers....
  9. ludwig mack 12 februari 2014 17:46
    ik pas even, ik ben er uit gestapt;
    je zit er zo lang in en wellicht zijn prognoses te hoog gestemd op deze koers, dat je je moet afvragen wat de toekomst brengt, vandaar ook die down gisteren;
    neem bedenktijd en laat het even rusten, maar de bovenstaande vraag staat er nog ...
    zwaar verlies door in- en uitstappen, dat wel.
  12. [verwijderd] 18 februari 2014 20:29
    Ugrade van Piper Jaffray van $34 naar $45.. zij hebben er dus wèl vertrouwen in...

    •Piper's Josh Schimmer says that a key opinion leader will soon publish data that will get Insmed's (INSM +6.2%) Arikace lung-infection treatment approved based on a primary end-point.
    •Piper is as confident of Arikace's speedy approval as it was with the prospect of Vanda receiving FDA authorization for its Hetlioz sleep-wake disorder drug - the therapy was approved at the end of January

    RT
    (die er gewoon nog in zit.. enjoying the rollercoaster)
  13. [verwijderd] 19 februari 2014 13:06
    CF UPDATE !

    Insmed Provides Interim Update from Two-Year, Open-Label Extension Study of ARIKACE to Treat Pseudomonas aeruginosa in Cystic Fibrosis Patients

    Initial 12-Month Data Demonstrate Long-Term Safety and Durability of Effect

    MONMOUTH JUNCTION, N.J.--(BUSINESS WIRE)-- Insmed Incorporated (Nasdaq GS:INSM), a biopharmaceutical company focused on developing an inhaled anti-infective to treat patients battling serious lung diseases in orphan indications that are often life-threatening, provides an interim update from the Company's CLEAR-110 study, an ongoing, two-year, open-label extension study of once-daily ARIKACE®, or liposomal amikacin for inhalation, to treat Pseudomonas aeruginosa (Pa) in cystic fibrosis (CF) patients. These data are from 98 patients who have completed the first 12 months (six cycles) of the CLEAR-110 extension study. The data were collected as part of a scheduled data safety monitoring board (DSMB) 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 (FEV1). These patients also experienced a sustained reduction in density of Pa sputum while on treatment.

    investor.insmed.com/releaseDetail.cfm...

    RT
  15. [verwijderd] 25 maart 2014 21:49
    Spannend...

    Insmed to Announce Results From U.S. Phase 2 Clinical Trial for Treatment Resistant Nontuberculous Mycobacteria Lung Infections
    Conference Call Scheduled for Wednesday, March 26, 2014 at 8:00 a.m. Eastern Time
    MONMOUTH JUNCTION, NJ -- (Marketwired) -- 03/25/14 -- Insmed Incorporated (NASDAQ: INSM) will announce results from its U.S. phase 2 clinical trial of ARIKAYCE™, or liposomal amikacin for inhalation, to treat nontuberculous mycobacteria (NTM) lung infections on Wednesday, March 26, 2014 at approximately 7:00 a.m. Eastern time.

    RT
  17. spyfly 26 maart 2014 12:48
    The primary efficacy endpoint of the study was a semi-quantitative measurement of the change in mycobacterial density on a seven-point scale from baseline (day one) to the end of the randomized portion of the trial (day 84). ARIKAYCE did not meet the pre-specified level for statistical significance although there was a positive trend (p=0.148) in favor of ARIKAYCE. However, ARIKAYCE did achieve statistical significance with regard to the clinically relevant key secondary endpoint of culture conversion, with 11 out of 44 patients treated with ARIKAYCE (added to standard of care treatment) demonstrating negative cultures by day 84 of the study as compared to 3 out of 45 patients treated with placebo (added to standard of care treatment) (p=0.01).

    Bron: investor.insmed.com/releaseDetail.cfm...

    Ben benieuwd naar de verdere toelichting via conference call/call transcript.
  18. [verwijderd] 26 maart 2014 12:51
    Eerste analist die de betekenis van de uitkomst beter leest dan de kudde..

    Insmed met 'much more meaningful' secondary endpoint, says Piper Jaffray
    Piper Jaffray says Insmed's Phase 2 Study of Arikayce for nontuberculous mycobacteria met the "much more meaningful and clinically relevant" secondary endpoint of culture conversion while missing the less clinically relevant primary endpoint of sputum density. Piper says the drug works and thinks the stock could end up staying close to where it is currently given the split decision on endpoints. The firm reiterates an Overweight rating on Insmed.

    RT
3.044 Posts
Pagina: «« 1 ... 146 147 148 149 150 ... 153 »» | Laatste |Omhoog ↑

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