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January 14, 2013
05:55 EDTCBSH, CBSH, FRX, FRX, IRWD, IRWD, LEN, LEN, MBWM, MBWMCompanies reporting Before the Market Open on Tuesday
Notable companies reporting before the opening bell on Tuesday include Commerce Bancshares (CBSH), Forest Laboratories (FRX), Ironwood Pharmaceuticals (IRWD), Lennar Corp (LEN), and Mercantile Bank (MBWM).
News For CBSH;FRX;IRWD;LEN;MBWM From The Last 14 Days
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November 30, 2015
16:09 EDTIRWDIronwood, Astellas say Phase 3 linaclotide trial in Japan met primary endpoints
Astellas Pharma (ALPMY) and Ironwood Pharmaceuticals (IRWD) announced that the Phase 3 clinical trial of linaclotide conducted in Japan in adults with irritable bowel syndrome with constipation met its primary endpoints. Astellas expects to submit a new drug application to the Ministry of Health, Labor and Welfare in Japan in 2016, the company noted. Top-line data from the trial indicate linaclotide-treated patients showed "statistically significant" improvement compared to placebo-treated patients for both of the two co-primary endpoints. Regarding the first primary endpoint, 34% of linaclotide-treated patients were so-called Global Assessment of Relief of IBS Symptoms Responders, compared to 18% of placebo-treated patients. Regarding the second primary endpoint, 35% of linaclotide-treated patients were Complete Spontaneous Bowel Movement Overall Responders, compared to 19% of placebo-treated patients. Additionally, improvements were achieved in pre-specified secondary endpoints in the trial covering abdominal and constipation symptoms, including bloating and abdominal pain. Diarrhea rates in the trial were 9.6% for linaclotide versus 0.4% for placebo.
08:02 EDTIRWDIronwood says Phase II Linaclotide trial data 'positive'
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