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FDA Calendar Updates: POZN, AZN, SNY, CEPH, APPY, CYTR
POZN
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-13.70%
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145 days
<> Below is a summary of updates to the <font> BioMedReports.com FDA Calendar </font> , which includes a database of over 200 entries. The calendar was originally created by Mike Havrilla to track companies with pending new drug, biological agent, or medical device new product decisions at the FDA. With the launch of <font> BioMedReports.com </font> , the FDA Calendar has expanded to include the following categories: pending new submissions to the FDA (e.g. NDA, BLA, 510k, PMA, sNDA, sBLA filings), pending complete response letter (CRL) re-submissions to the FDA, and pending late-st...
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The FDA's approval of Treximet should lead to profitability in the second quarter.
POZN
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-50.07%
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583 days
Pozen and partner GlaxoSmithKline announced late this
evening that the U.S. Food and Drug Administration (FDA)
has approved Treximet for the acute treatment of migraine
attacks with or without aura in adults.
The news was as expected and results in a $20 million
milestone from Glaxo ($10 million for approval and $10
million for the launch) to be recorded by Pozen in the second
quarter of 2008. This should lead to profitability in the
second quarter.
We are maintaining our Buy rating and $18 near-term price
target on the shares. We are buyers on this positive ne...
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From the Blogosphere
Pozen Initiates New Phase III – Analyst Blog
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This morning, Pozen (POZN) initiated phase III studies on PA-325/40, a fixed-dose combination of 325mg enteric coated aspirin and 40mg of immediate release omeprazole. The phase III program will consist of two pivotal trials conducted under a Special Protocol Assessment (SPA) agreed upon with the U.S. FDA, and one long-term safety study.
The two pivotal programs will enroll approximately 500 patients per study at over 100 sites around the U.S. The primary endpoint of the pivotal studies is the cumulative incidence of gastric ulcers over the six-month treatment period for PA32540 versus 325 m...
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Pozen Files For Approval of Vimovo
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By 2013 Pozen (POZN) should be posting revenues near $200 million, with high profitability.
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Pozen Files For Approval of Vimovo
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By 2013 Pozen (POZN) should be posting revenues near $200 million, with high profitability.
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Morning Movers 1/29: Allstate (ALL) Lower Following Results, Credit Downgrade; Sepracor (SEPR) Up On Results/Guidance
StreetInsider.com Morning Movers:
<>POZEN Inc. (NASDAQ: POZN) 30% HIGHER; Informed by FDA That Endoscopic Gastric Ulcer Incidence Continues to Be an Acceptable Primary Endpoint
Lloyds Banking Group plc (NYSE: LYG) 25% LOWER; UK banks continue to see extreme volitility.
DryShips, Inc. (Nasdaq: DRYS) 23% LOWER; filed to offer up to $500 million in common shares.
Innovative Solutions and Support, Inc. (Nasdaq: ISSC) 24% LOWER; reports Q1 EPS of $0.11, 8 cents better than the analyst estimate of $0.03. Revenue for the quarter was $10.6 million, versus the consensus of $9.47 million. Innovative Sol...
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Unusual 11 Mid-Day Movers 10/17: CIT, ICUI, MPEL, UAUA Higher; LBY, POZN, ING, PPC Lower
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CIT Group (NYSE: CIT) 39.9% HIGHER; after reporting a Q3 loss of $1.13, shares of CIT fell about 36% yesterday. The stock appears to be correcting after yesterday's large slide.
Libbey Inc. (NYSE: LBY) 37% LOWER; reports preliminary Q3 sales of $211.5 million, versus the consensus of $220.14 million. Sees FY08 sales in the range of $833-$843 million, versus the consensus of $876.25 million.
POZEN Inc. (NASDAQ: POZN) 28.7% LOWER; today announced that the U.S. FDA has informed the Company that, as part of the FDA's on-going discussions with the Company and their review of both the Special
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