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was back on August 22, 2005 when Preliminary Phase II Results for Exenatide Once Weekly was announced and the stock went from a 8/21/05 closing price of $8.53 to close on 8/22/05 @ $12.06, a 45% increase. Here is that press release:
Once Weekly Exenatide LAR Well Tolerated and Improved Glucose Control - Preliminary Results From Phase 2 Study Announced - SAN DIEGO, INDIANAPOLIS and CAMBRIDGE, Mass., Aug. 22 /PRNewswire-FirstCall/ -- Amylin Pharmaceuticals, Inc., (Nasdaq: AMLN), Eli Lilly and Company (NYSE: LLY) and Alkermes, Inc. (Nasdaq: ALKS) today announced results from the ongoing Phase 2 multi-dose study of a long-acting release (LAR) formulation of BYETTA(TM) (exenatide) injection in patients with type 2 diabetes. The study was designed to assess the safety, tolerability and pharmacokinetics of exenatide LAR given once a week. After 15 weeks, both doses of exenatide LAR were well tolerated and expected therapeutic blood levels of exenatide were achieved. Dose-dependent improvements in hemoglobin A1C (A1C) and weight were observed. A1C, a measure of glucose control, improved approximately 2 percent for subjects receiving the high dose of exenatide LAR, compared to placebo. At the beginning of the study, the average A1C of study participants was approximately 8.5 percent. The decrease in A1C was progressive with no evidence of a plateau at week 15. Twelve of the 14 high-dose subjects who entered the study with an A1C greater than 7 percent achieved an A1C of 7 percent or less at 15 weeks. None of the 14 subjects receiving placebo achieved that target. The American Diabetes Association recommends a target A1C of less than 7 percent. Fasting blood glucose concentrations were reduced by approximately 50 mg/dL for subjects in the high dose group compared to those receiving placebo. Subjects in this group experienced an average weight reduction of approximately 9 pounds compared to those receiving placebo. The most common adverse event was mild nausea, which occurred in approximately 20 percent of subjects in the high dose group compared to approximately 7 percent in the placebo group. No severe gastrointestinal side effects were reported. No severe hypoglycemia was reported, and no subjects receiving exenatide LAR withdrew because of adverse events. This Phase 2, randomized, placebo-controlled, double-blind study includes 45 subjects with type 2 diabetes who were not achieving adequate glucose control using diet and exercise with or without metformin. Subjects were randomized to receive 15 once-weekly subcutaneous injections of exenatide LAR at one of two doses or placebo. At this time, study participants have completed the active dosing period. Subjects will be observed for an additional 12 weeks with follow-up observations and data analyses ongoing. The companies anticipate that the full study results will be presented in a future scientific forum. Sentiment : Strong Buy Rating :
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Last Big Phase II Announcement
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kevinmik |
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4-Nov-09 09:33 pm | ||
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I just hope the next press annoucement is a little...
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wizkidtoo |
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4-Nov-09 10:22 pm | ||
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Kev, I think the gain was a bit different - from $...
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BrianDTurne... | (2 Ratings) | 5-Nov-09 07:22 am | ||
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My apology...your are correct I I picked up t...
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kevinmik | (1 Rating) | 5-Nov-09 08:36 am | ||
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The jump was on Aug. 23rd. But that was the b...
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posterposte... | (2 Ratings) | 5-Nov-09 08:46 am | ||
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Bull market or not, the following press ...
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kevinmik | (1 Rating) | 5-Nov-09 09:14 am |
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