Word abonnee en neem Beursduivel Premium
Rode planeet als pijlen grid met hoorntjes Beursduivel
Uitgebreid zoeken

BioPharma Terug naar discussie overzicht

INSM - Insmed - 2009 draadje

3.044 Posts
Pagina: «« 1 ... 78 79 80 81 82 ... 153 »» | Laatste | Omlaag ↓
  2. ludwig mack 21 maart 2011 14:14

    • ludwig mack

      Lid sinds: 30 jan 2004

      Laatste bezoek: 10 feb 2025

    • Aanbevelingen

      Ontvangen: 412

      Gegeven: 29

    •    Aantal posts: 8.675


    Insmed Announces FDA Clearance of IND for Pivotal Phase 3 Trial of ARIKACE™ in Nontuberculous Mycobacteria Indication
    -- Company Continues to Expect to Begin Accruing Patients to Phase 3 Study in Second Half of 2011 --

    RICHMOND, Va., March 21, 2011 /PRNewswire/ -- Insmed Incorporated (Nasdaq: INSMD), a biopharmaceutical company, announced today that the Company's Investigational New Drug Application (IND) to conduct a pivotal Phase 3 clinical trial of ARIKACE™ (liposomal amikacin for inhalation) in nontuberculous mycobacteria (NTM) lung infections has been cleared by the U.S. Food and Drug Administration (FDA).

    In 2010, Insmed initially submitted a regulatory filing to FDA requesting clearance to proceed with a Phase 2 clinical trial for ARIKACE in NTM. FDA responded by suggesting that the Company could change the proposed Phase 2 trial to a primary efficacy study. Based on this feedback, Insmed submitted its IND seeking FDA clearance to initiate a Phase 3 clinical trial of ARIKACE in NTM earlier in the first quarter of this year.

    Development of the clinical program aimed at NTM infections was done in partnership with the National Institute of Allergy and Infectious Diseases (NIAID) at the National Institutes of Health. According to Kenneth Oliver, M.D., M.P.H., staff pulmonologist in the NIAID Laboratory of Clinical Infectious Diseases, current NTM treatment requires lengthy multi-drug regimens that can be poorly tolerated and are often not very effective, especially in patients with severe disease or in those who have failed prior treatment attempts.

    No new drugs have been assessed for NTM in a significant number of years. The sustained-release formulation of ARIKACE allows for targeting of the drug to the lungs and the site of disease.

    "FDA clearance of our IND to conduct a pivotal Phase 3 clinical trial for ARIKACE in NTM is a critical step in continuing to advance our development plan for this compound," said Renu Gupta, M.D., Executive Vice President Development & Chief Medical Officer of Insmed. "We continue to expect that patient accrual will begin in our Phase 3 clinical trials of ARIKACE in NTM, as well as in the cystic fibrosis P
  3. ludwig mack 21 maart 2011 17:08

    • ludwig mack

      Lid sinds: 30 jan 2004

      Laatste bezoek: 10 feb 2025

    • Aanbevelingen

      Ontvangen: 412

      Gegeven: 29

    •    Aantal posts: 8.675



    INFORMATION TO BE INCLUDED IN THE REPORT

    Section 8—Other Events

    Item 8.01

    Other Events

    On March 17, 2011 Insmed Incorporated received a letter from The NASDAQ Stock Market informing Insmed that the Company has regained compliance with the bid price rule and is currently in compliance with all continued listing standards of The NASDAQ Capital Markets.

    Insmed issued a press release on March 21, 2011 to announce that the Company had regained compliance, a copy of which is attached hereto as Exhibit 99.1.

    Also, on March 21, 2011, Insmed Incorporated issued a press release announcing FDA clearance of IND for pivotal Phase 3 trial of ARIKACE™ in nontuberculous mycobacteria indication. A copy of the press release is attached hereto as Exhibit 99.2.

    The information contained herein, including the Exhibit attached hereto shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as shall be expressly set forth by specific reference in such a filing.
  11. ludwig mack 25 maart 2011 19:06

    • ludwig mack

      Lid sinds: 30 jan 2004

      Laatste bezoek: 10 feb 2025

    • Aanbevelingen

      Ontvangen: 412

      Gegeven: 29

    •    Aantal posts: 8.675

    Last Trade: 6.27
    Trade Time: 1:49PM EDT
    Change: Up 0.98 (18.53%)
    Prev Close: 5.29
    Open: 5.39
    Bid: 6.26 x 900
    Ask: 6.29 x 700
    1y Target Est: 10.00
    Day's Range: 5.36 - 6.27
    52wk Range: 4.69 - 12.10
    Volume: 167,767
    Avg Vol (3m): 43,502
    Market Cap: 98.14M
    P/E (ttm): N/A
    EPS (ttm): -0.49
    Div & Yield: N/A (N/A)
  12. ludwig mack 25 maart 2011 19:07

    • ludwig mack

      Lid sinds: 30 jan 2004

      Laatste bezoek: 10 feb 2025

    • Aanbevelingen

      Ontvangen: 412

      Gegeven: 29

    •    Aantal posts: 8.675

    On Friday March 25, 2011, 1:20 pm

    NEW YORK (AP) --

    A look at the 10 biggest percentage gainers on Nasdaq at 1 p.m.:
    Astea International Inc. rose 53.5 percent to $6.14.
    Body Central Corp. rose 23.9 percent to $22.93.
    Zagg Inc. rose 17.7 percent to $7.50.
    Insmed Inc. rose 15.1 percent to $6.09.
    Canterbury Park rose 11.5 percent to $13.20.
    Pervasive Software Inc. rose 10.6 percent to $6.90.
    Funtalk China Holdings Ltd. rose 10.1 percent to $6.77.
    First Bankshares Inc. rose 9.5 percent to $6.47.
    Warren Resources Inc. rose 8.9 percent to $5.02.
    Omeros Corp. rose 8.3 percent to $7.27.

    finance.yahoo.com/news/Nasdaq-stocks-...
  19. ludwig mack 25 maart 2011 19:40

    • ludwig mack

      Lid sinds: 30 jan 2004

      Laatste bezoek: 10 feb 2025

    • Aanbevelingen

      Ontvangen: 412

      Gegeven: 29

    •    Aantal posts: 8.675

    ik koop bij als ik meer weet; risico is niet meer of minder geworden; met de flow meegaan zonder wat is ook zo wat;
    sta op zwaar verlies dus laat maar komen ;-)
3.044 Posts
Pagina: «« 1 ... 78 79 80 81 82 ... 153 »» | Laatste |Omhoog ↑

Neem deel aan de discussie

Word nu gratis lid van Beursduivel.be

Al abonnee? Log in

Direct naar Forum

Zoek alfabetisch op forum

  1. A
  2. B
  3. C
  4. D
  5. E
  6. F
  7. G
  8. H
  9. I
  10. J
  11. K
  12. L
  13. M
  14. N
  15. O
  16. P
  17. Q
  18. R
  19. S
  20. T
  21. U
  22. V
  23. W
  24. X
  25. Y
  26. Z
Forum # Topics # Posts
Aalberts 466 7.106
AB InBev 2 5.531
Abionyx Pharma 2 29
Ablynx 43 13.356
ABN AMRO 1.582 52.078
ABO-Group 1 23
Acacia Pharma 9 24.692
Accell Group 151 4.132
Accentis 2 267
Accsys Technologies 23 10.829
ACCSYS TECHNOLOGIES PLC 218 11.686
Ackermans & van Haaren 1 192
Adecco 1 1
ADMA Biologics 1 34
Adomos 1 126
AdUX 2 457
Adyen 14 17.804
Aedifica 3 925
Aegon 3.258 323.045
AFC Ajax 538 7.088
Affimed NV 2 6.305
ageas 5.844 109.901
Agfa-Gevaert 14 2.062
Ahold 3.538 74.349
Air France - KLM 1.025 35.265
AIRBUS 1 12
Airspray 511 1.258
Akka Technologies 1 18
AkzoNobel 467 13.049
Alfen 16 25.180
Allfunds Group 4 1.516
Almunda Professionals (vh Novisource) 651 4.251
Alpha Pro Tech 1 17
Alphabet Inc. 1 418
Altice 106 51.198
Alumexx ((Voorheen Phelix (voorheen Inverko)) 8.486 114.826
AM 228 684
Amarin Corporation 1 133
Amerikaanse aandelen 3.837 243.748
AMG 971 134.235
AMS 3 73
Amsterdam Commodities 305 6.744
AMT Holding 199 7.047
Anavex Life Sciences Corp 2 495
Antonov 22.632 153.605
Aperam 92 15.047
Apollo Alternative Assets 1 17
Apple 5 384
Arcadis 252 8.798
Arcelor Mittal 2.034 320.943
Archos 1 1
Arcona Property Fund 1 286
arGEN-X 17 10.350
Aroundtown SA 1 221
Arrowhead Research 5 9.750
Ascencio 1 28
ASIT biotech 2 697
ASMI 4.108 39.597
ASML 1.766 109.813
ASR Nederland 21 4.507
ATAI Life Sciences 1 7
Atenor Group 1 522
Athlon Group 121 176
Atrium European Real Estate 2 199
Auplata 1 55
Avantium 32 13.834
Axsome Therapeutics 1 177
Azelis Group 1 66
Azerion 7 3.447

Macro & Bedrijfsagenda

  1. 24 maart

    1. Samengestelde inkoopmanagersindex maart (Jap)
    2. Samengestelde inkoopmanagersindex maart (Fra)
    3. Samengestelde inkoopmanagersindex maart (Dld)
    4. Samengestelde inkoopmanagersindex maart (eur)
    5. Samengestelde inkoopmanagersindex maart (VK)
    6. Chicago Fed index februari (VS)
    7. Samengestelde inkoopmanagersindex maart (VS)

  2. 25 maart

    1. Ifo ondernemersvertrouwen maart (Dld)
    2. Case Shiller huizenprijzen januari (VS)
    3. Shell beleggersdag
de volitaliteit verwacht indicator betekend: Market moving event/hoge(re) volatiliteit verwacht
Naar de hele agenda