ARIA MRK receive CRL. VVUS Qnexa MAA decision delayed. ABT NBIX initiate Phase 3 endometriosis. DYAX analysis of ecallantide due within 3 months + SGYP
Merck (NYSE: MRK) announced that the FDA issued a complete response letter (CRL) regarding the New Drug Application (NDA) for ridaforolimus for patients with metastatic soft tissue or bone sarcoma. The letter stated that additional clinical trial would need to be conducted to further assess safety and efficacy. ARIAD Pharmaceuticals, Inc (Nasdaq: ARIA) has a license agreement with Merck where Merck is responsible for the development and worldwide commercialization of ridaforolimus in oncology.
Dyax Corp. (NASDAQ: DYAX) said in a filing that it expects to conduct an interim analysis of the first 40 percent of patients treated in its Phase 2 trial of ecallantide for the treatment of ACE-induced angioedema (ACEI-AE). The company expects that it will complete and announce its interim analysis of trial data within ninety days (by early September 2012).
VIVUS, Inc. (Nasdaq:VVUS) announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has rescheduled its oral hearing with the company regarding the Qnexa MAA for the treatment of obesity, to September 2012. The CHMP opinion on the Qnexa MAA is now expected following the September meeting.
Abbott (ABT) and Neurocrine Biosciences, Inc. (NASDAQ: NBIX) announced the initiation of a pivotal Phase 3 clinical trial of elagolix in female patients with endometriosis. A second pivotal Phase 3 study is planned with an NDA filing targeted in 2016.
Synergy Pharmaceuticals Inc. (Nasdaq:SGYP) announced the partial exercise of the over-allotment option granted to the underwriters in connection with its previously announced underwritten public offering of 10m shares of common stock, bringing total gross proceeds from the offering to $48,375,000.