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INSM - Insmed - 2009 draadje

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  1. [verwijderd] 3 september 2014 14:19

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    Insmed Announces Multiple Clinical and Scientific Presentations at European Respiratory Society's International Congress 2014
    Introduces INS-1009 (Treprostinil) for the Treatment of Pulmonary Arterial Hypertension

    BRIDGEWATER, NJ -- (Marketwired) -- 09/03/14 -- Insmed Incorporated (NASDAQ: INSM) announces that the Company's novel inhalation technologies for the treatment of orphan pulmonary diseases will be highlighted in a variety of clinical and scientific presentations at the European Respiratory Society's (ERS) International Congress 2014, taking place September 6-10, 2014 at the Internationales Congress Center München in Munich, Germany.

    There will be several presentations regarding the Company's lead product ARIKAYCE™, or liposomal amikacin for inhalation delivered by an investigational eFlow® Nebulizer System (PARI Pharma GmbH), for the treatment of both nontuberculous mycobacteria lung infections (NTM) and Pseudomonas aeruginosa in cystic fibrosis patients. In addition, the Company will present several posters regarding INS-1009 (treprostinil), the Company's novel inhalation formulation of a proven prostacyclin for the treatment of pulmonary arterial hypertension (PAH), a chronic, life-threatening disorder characterized by abnormally high blood pressure in the arteries between the heart and lungs.

    Insmed has applied its product design, drug development and sustained-release formulation expertise to advance INS-1009 with the goal of addressing current limitations of inhaled prostacyclin therapies in the treatment of PAH. INS-1009 is expected to be delivered once-daily via inhalation. It is designed to provide consistent, effective drug levels and may also reduce the acute systemic effects of current treatment options.

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

    RT
  2. [verwijderd] 6 november 2014 13:37

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

    Insmed Reports Third Quarter 2014 Financial Results

    Reported its U.S. regulatory strategy to initiate one global phase 3 confirmatory study of ARIKAYCE™, or liposomal amikacin for inhalation, for patients with nontuberculous mycobacterial (NTM) lung infections who failed prior standard of care treatment;
    • Announced plans to file a Market Authorization Application (MAA) by year-end 2014 with the European Medicines Agency (EMA) for ARIKAYCE for the treatment of two orphan lung diseases: NTM lung infections and Pseudomonas aeruginosa lung infections in patients with cystic fibrosis (CF);
    • Strengthened the Company's balance sheet with an underwritten public offering, which provided net proceeds of approximately $108.0 million; and
    • Introduced INS-1009 (inhaled treprostinil), the Company's novel inhalation formulation of a proven prostacyclin for the treatment of pulmonary arterial hypertension (PAH), with the presentation of several pre-clinical studies at the European Respiratory Society meeting.

    RT
  3. [verwijderd] 15 december 2014 13:22

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    Insmed has submitted its Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) and is awaiting its validation.

    Insmed's phase 3 pivotal trial for patients with treatment resistant nontuberculous mycobacteria (NTM) lung infections (the "212" trial) is on track.

    Insmed has completed a pre-investigational new drug (IND) meeting with the FDA for INS-1009, its novel formulation of a proven prostacyclin therapy for the treatment of Pulmonary Arterial Hypertension (PAH) and has clarified that, subject to final review of the pre-clinical data, it would be eligible for a 505(b)(2) approval pathway.

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

    RT
  7. [verwijderd] 6 maart 2015 07:50

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    Buy-out geruchten, goed nieuws op komst (acceptance MAA voor NTM in Europa), iPlex borrelt nog steeds op de achtergrond en ondertussen een indrukwekkende pipeline (hoewel nog steeds in de phase 2-3 stadia). Ik hoop niet dat ze opgekocht worden, dit pareltje kan de komende 2-3 jaar verveelvoudigen.. Maja, ik zit er ook al heel veel jaren in..

    RT
    ps volg, door de rommel heen, het yahoo forum
  8. [verwijderd] 23 maart 2015 14:42

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    Insmed Appoints Dr. Eugene Sullivan as Chief Medical and Scientific Officer

    20 Year Industry Veteran Brings Industry, Clinical and Regulatory Experience in Pulmonary and Orphan Diseases

    BRIDGEWATER, N.J.--(BUSINESS WIRE)-- Insmed Incorporated (NASDAQ:INSM) today announced that Eugene Sullivan, M.D. has joined Insmed as its Chief Medical and Scientific Officer. Dr. Sullivan will report to Will Lewis, President and Chief Executive Officer. Several highlights from Dr. Sullivan's career include:
    • Former pulmonary physician at the Cleveland Clinic
    • Former Deputy Director at US Food and Drug Administration
    • Former Chief Medical Officer of United Therapeutics

    Dr. Sullivan joins Insmed with more than 20 years of experience with a focus on pulmonary and orphan diseases. He is a medical doctor trained in internal medicine, pulmonary medicine and critical care medicine and practiced at the Cleveland Clinic from 1995 to 1999. From 1999 through 2006, Dr. Sullivan held several positions at the U.S. Food and Drug Administration, including Deputy Director of the Division of Pulmonary and Allergy Products. From 2007 through 2012, Dr. Sullivan was the Chief Medical Officer of United Therapeutics. In recent years, Dr. Sullivan was a Vice President, Global Regulatory Affairs at Astra Zeneca and consulted to companies, including Insmed, on clinical drug development and strategic regulatory matters.

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

    RT
  12. [verwijderd] 2 april 2015 08:12

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    Helemaal niet verkeerd Junk: priced at $20,65 dus redelijk op de huidige koers. Alles is al verkocht en geeft ze weer genoeg geld in het laatje om b.v. de kosten voor het vermarkten van Arikayce te betalen, of zelfs een partij / medicijn te kopen (acquire at least one external asset).

    Daarnaast sterkt dit het verhaal van baasje Lewis dat hij van Insmed een 'patient-focused and sustainable biopharmaceutical' bedrijf wil maken. Dus geen buyout nu, terwijl de echte waarde nog moet komen in de komende 2 jaar.

    RT
  13. [verwijderd] 2 april 2015 09:38

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    quote:

    Rieltijm schreef op 2 april 2015 08:12:

    Helemaal niet verkeerd Junk: priced at $20,65 dus redelijk op de huidige koers. Alles is al verkocht en geeft ze weer genoeg geld in het laatje om b.v. de kosten voor het vermarkten van Arikayce te betalen, of zelfs een partij / medicijn te kopen (acquire at least one external asset).

    Daarnaast sterkt dit het verhaal van baasje Lewis dat hij van Insmed een 'patient-focused and sustainable biopharmaceutical' bedrijf wil maken. Dus geen buyout nu, terwijl de echte waarde nog moet komen in de komende 2 jaar.

    RT
    Ik heb geen insmed,dus het maakt mij niet uit hoor..Maar het is wel weer 20% verwatering .
  16. [verwijderd] 21 april 2015 11:46

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    Ondertussen gesloten op $23,08... hopelijk komt er nu snel wat nieuws over bv een partner of een upgrade van een analist, dan knallen we zo door de 25 heen.

    RT
  17. [verwijderd] 7 mei 2015 14:13

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    BRIDGEWATER, N.J.--(BUSINESS WIRE)-- Insmed Incorporated (Nasdaq:INSM), a global biopharmaceutical company focused on developing orphan treatments for rare pulmonary diseases, today reported financial results for the quarter ended March 31, 2015.

    First quarter and recent highlights include:
    • Validation of the company's Marketing Authorization Application (MAA) for ARIKAYCE™ by the European Medicines Agency (EMA).
    • Advancement of the company's phase 3 global 212 study of patients with treatment-resistant nontuberculous mycobacteria (NTM), lung infections with the opening of multiple clinical trial sites.
    • Acceptance of six abstracts for poster presentation at the American Thoracic Society (ATS) 2015 International Conference taking place in Denver from May 15 - 20.
    • Additions to the senior leadership team including the appointments of Eugene Sullivan, MD, chief medical and scientific officer and Don Nociolo, vice president of technical operations.
    • Completion of a public offering of 11.5 million shares of common stock that generated net proceeds of approximately $223 million.

    "2015 is a year of key deliverables for Insmed and we remain on track to deliver our five stated corporate objectives, which include the advancement of ARIKAYCE and the development of INS1009," said Will Lewis, president and chief executive officer of Insmed. "Our global registration program for ARIKAYCE is making important progress with an increasing number of sites actively recruiting patients in the 212 study. We are also advancing our newest program, INS1009, an inhaled prodrug formulation of treprostinil for pulmonary arterial hypertension, and we look forward to providing additional updates on this promising clinical candidate as the year progresses."

    First Quarter 2015 Financial Results

    For the first quarter of 2015, Insmed posted a net loss of $27.4 million, or ($0.55) per share, compared with a net loss of $14.3 million, or ($0.36) per share, for the first quarter of 2014. The company's financial results for the first quarter of 2014 were positively impacted by a $4.4 million income tax benefit that resulted from the sale of a portion of its New Jersey Net Operating Losses under New Jersey's Technology Business Tax Certificate Transfer Program.

    Research and development expenses were $17.2 million for the first quarter of 2015 as compared with $11.4 million in the first quarter of 2014. The increase in research and development expenses was primarily due to the advancement of the company's clinical development program for ARIKAYCE, the build-out of additional third-party manufacturing capacity, and an increase in internal expenses.

    General and administrative expenses for the first quarter of 2015 were $9.5 million as compared with $6.7 million in the first quarter of 2014. The increase in general and administrative expenses was primarily related to an increase in personnel-related expenses, which included a $1.5 million increase in non-cash stock-based compensation expense related to performance-based stock options that vested upon EMA's validation of the ARIKAYCE MAA, as well as pre-commercial activities related to Europe.
  18. [verwijderd] 11 mei 2015 14:47

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    Insmed to Participate at the UBS Global Healthcare Conference

    BRIDGEWATER, N.J.--(BUSINESS WIRE)-- Insmed Incorporated (Nasdaq:INSM), a global biopharmaceutical company focused on developing orphan treatments for rare pulmonary diseases, today announced that company management will participate at the 2015 UBS Global Healthcare conference taking place at the Sheraton New York Times Square Hotel from May 18 to May 20. Will Lewis, president and chief executive officer of Insmed, will participate in an analyst-led fireside chat on Monday, May 18 at 4:00 PM ET.
  19. [verwijderd] 13 mei 2015 14:06

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    Insmed Announces Upcoming Data Presentations at the American Thoracic Society 2015 International Meeting

    BRIDGEWATER, N.J.--(BUSINESS WIRE)-- Insmed Incorporated (Nasdaq:INSM), a global biopharmaceutical company focused on developing orphan treatments for rare pulmonary diseases, today reported that three ARIKAYCE™ abstracts and three INS1009 abstracts will be presented at the American Thoracic Society (ATS) 2015 International Conference taking place in Denver from May 15 - 20. ARIKAYCE, or liposomal amikacin for inhalation, is in late-stage development for the treatment of adult patients with nontuberculous mycobacterial (NTM) lung infections caused by Mycobacterium avium complex (MAC). INS1009, an inhaled prodrug formulation of treprostinil, is the company's clinical candidate for pulmonary arterial hypertension.

    RT
  20. [verwijderd] 17 juni 2015 14:33

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    Insmed to Participate at the JMP Securities Life Sciences Conference

    BRIDGEWATER, N.J.--(BUSINESS WIRE)-- Insmed Incorporated (Nasdaq:INSM), a global biopharmaceutical company focused on the needs of patients with rare diseases, today announced that company management will participate at the 2015 JMP Securities Life Sciences Conference 2015 taking place at The St. Regis New York from June 23 to June 24. Andy Drechsler, chief financial officer of Insmed, will present a corporate overview on Wednesday, June 24 at 11:30 AM ET.


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

    RT
  21. [verwijderd] 29 juli 2015 06:25

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    Insmed to Host Second Quarter 2015 Financial Results Conference Call on Thursday, August 6, 2015

    BRIDGEWATER, N.J., July 28, 2015 (GLOBE NEWSWIRE) -- Insmed Incorporated (Nasdaq:INSM), a global biopharmaceutical company focused on the needs of patients with rare diseases, today announced that it will release its financial results for the three months ended June 30, 2015, before the opening of the stock market on Thursday, August 6, 2015.

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

    RT
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