Shares of Ironwood Pharmaceuticals (IRWD) jumped nearly 20%, to $16.75, in premarket trading on Monday after Astellas Pharma and Ironwood on Sunday revealed positive top-line results from a phase III clinical trial of linaclotide conducted in Japan in adults with chronic constipation.
"Today's positive phase III results for linaclotide in chronic constipation mark the ninth phase III/IIIb clinical trial in which linaclotide has met its primary endpoints, once again demonstrating consistent results in clinical trials across two indications, evaluating multiple doses and conducted in multiple countries," said Mark Currie, chief scientific officer and president of research and development at Cambridge, Mass.-based Ironwood, in a statement.
Meanwhile, Rigel Pharmaceuticals (RIGL) shares were up 11%, to $2.20, after the South San Francisco, Calif., company on Monday provided updates to the clinical program of fostamatinib in patients that have chronic immune thrombocytopenic purpura, or ITP.
"We now have over 16 months of FIT phase III data to analyze and we're very encouraged that chronic ITP patients who respond to fostamatinib are able to maintain a median platelet count of over 100,000 platelets/uL," said Rigel president and CEO Raul Rodriguez in a statement. "These data continue to support our plan to submit a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for fostamatinib in chronic ITP in the first quarter of this year."
Among the other stock movers ahead of the opening bell Monday is FibroGen (FGEN) , whose shares were trading at $25, up 7%. The San Francisco company and its subsidiary FibroGen China Medical Technology Development on Monday announced positive top-line results from the two phase III clinical studies of roxadustat in China. Roxadustat is an orally administered small molecule for treatment of anemia in dialysis-dependent chronic kidney disease, or DD-CKD, and non-dialysis-dependent CKD, or NDD-CKD, patients.
"We are very encouraged by the top line results of these two pivotal phase III studies for roxadustat, which bring us closer to the first oral anemia therapy that does not require injectable administration or IV iron supplementation," said FibroGen CEO Tom Neff in a statement. "In addition, use of roxadustat is free of the burden of cold-chain storage and maintaining sterility, and costly distribution infrastructure. Data from these two studies will be used to complete our new drug application submission in China later this year."