NPSP PDUFA date confirmed with BLA filing due end of 2012. PLX offering. INCY update
NPS Pharmaceuticals, Inc.(NASDAQ: NPSP) confirmed that it has been assigned a PDUFA date of September 30, 2012 for Gattex for the treatment of adult short bowel syndrome or SBS. It also intends to submit to the FDA a Biologics License Application (BLA) for Natpara toward the end of 2012 as the first replacement therapy for hypoparathyroidism.
Protalix BioTherapeutics, Inc. (NYSE Amex:PLX) (TASE:PLX) announced today that it intends to offer and sell shares of its common stock in an underwritten public offering.
Incyte Corporation (Nasdaq: INCY) gave a pipeline update noting that its global Phase 3 trial evaluating ruxolitinib in patients with advanced polycythemia vera who are resistant to or intolerant of hydroxyurea (the RESPONSE trial) continues to enroll patients and is expected to complete recruitment of 200 patients in 2012. Results from the RESPONSE trial are expected in 2H 2013. Its Phase 2 trial of ruxolitinib in combination with capecitabine for patients with recurrent or treatment refractory metastatic pancreatic cancer (the RECAP trial) is also ongoing. Data is expected from its partner initiated Phase 2b trial of LY3009104 (formerly known as INCB28050) in patients with rheumatoid arthritis in 2012. Its Phase 2b trial of LY3009104 in patients with moderate to severe psoriasis was initiated in December 2011 with primary endpoint results expected in 2013. A Phase 2 trial of INCB24360 in patients with melanoma is expected to be initiated before mid-year and in patients with ovarian cancer later this year.
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