VIVUS,Inc. (Nasdaq:VVUS) announced it will offer 8.5m shares of its common stock in an underwritten public offering with an option to issue 1.275m additional shares of common stock to cover over-allotments, if any.
It also noted that it received the 180-Day list of outstanding issues (LOI) from the Committee for Medicinal Products for Human Use (CHMP) for the Qnexa Marketing Authorization Application (MAA) for the European Union. The 180-day LOI contained requests for additional information including risk minimization activities (the equivalent of REMS in the US) to address various issues relating to cardiovascular, neuropsychiatric and potential teratogenic effects of Qnexa. In addition, they were asked to discuss the benefit/risk of the different doses of Qnexa, its potential use in different patient populations, and the expected long-term benefit of treatment with Qnexa. In order to perform additional analyses to allow further insights into the data as previously presented, they have requested and have been granted a two-month extension to respond. As a result it anticipates responding to the 180-day LOI in 2Q of 2012. It had recently guided for an expected decision by CHMP during 1Q 2012.
POZEN Inc. (NASDAQ: POZN) gave a pipeline update today noting that its PA32540 Phase 3 pivotal studies have been fully enrolled. Top line data are anticipated in Q2 2012 and the New Drug Application (NDA) submission is targeted for Q3 2012.
BioDelivery Sciences International, Inc. (Nasdaq: BDSI) today announced that it has reached agreement with the FDA on the development program for BEMA Buprenorphine/Naloxone (BNX) that should result in a NDA filing for the treatment of opioid dependence in 1H 2013. It plans on initiating a pivotal pharmacokinetic study and safety study by mid-2012. Results of the pivotal pharmacokinetic study are anticipated to be available within three months of initiation and the safety study by early 2013. This will allow for an anticipated NDA filing in the first half of 2013.
ARIAD Pharmaceuticals, Inc.(NASDAQ: ARIA) gave a pipeline update today maintaining guidance that it intends to make both NDA and MAA filings of ponatinib, in patients with resistant or intolerant chronic myeloid leukemia (CML) and Philadelphia-chromosome positive acute lymphoblastic leukemia (Ph+ALL), during 3Q 2011. It also expects to initiate a Phase 3 trial of ponatinib in patients with newly diagnosed CML in 3Q of 2012. With regard to its Phase 1/2 clinical trial of AP26113 ALK-positive and EGFR-positive lung cancer, it expects to move into the Phase 2 portion of the Phase 1/2 trial at approximately mid-year 2012.