MAPP receives CRL. ISTA buyout. RPTP NDA filing this week. APPA NDA mid-2012 + ASTX VVUS ARNA CLVS NBIX news
MAP Pharmaceuticals, Inc. (Nasdaq: MAPP) today announced it received a Complete Response letter for LEVADEX. The FDA noted that the company will need to address issues relating to chemistry, manufacturing and controls (CMC) and observations from a recent facility inspection of a third party manufacturer. The FDA also noted that it had requested the company to provide information of inhaler usability, but the company said the FDA had apparently not completed a review of the information.
Astex Pharmaceuticals, Inc. (NASDAQ:ASTX) filed a mixed shelf allowing it from time to time to issue common stock, preferred stock, depositary shares, warrants, debt securities, up to $200m.
ISTA Pharmaceuticals, Inc. (NASDAQ: ISTA), today announced that it will be acquired by Bausch + Lomb for $9.10 per share in cash, or a total of approximately $500 million, with the transaction expected to close in 2Q 2012.
VIVUS,Inc. (Nasdaq:VVUS) today announced that a Marketing Authorization Application (MAA) has been accepted by the European Medicines Agency (EMA) for the review of avanafil, for the treatment of erectile dysfunction (ED).
Raptor Pharmaceutical Corp. (Nasdaq:RPTP) reiterated that it intends to file its NDA for RP103 for the treatment of nephropathic cystinosis by the end of this month (March 2012). It also noted that the European Medicines Agency has accepted its MAA.
Arena Pharmaceuticals, Inc. (NASDAQ: ARNA) also announced today that its MAA has been accepted by the EMA for the review of lorcaserin, for the treatment of obesity.
A.P. Pharma, Inc. (OTCBB: APPA) today said that a New Drug Application for APF530, for the the prevention of both acute- and delayed-onset chemotherapy-induced nausea and vomiting (CINV), is due to be filed in mid-2012. It intends to complete a human factors validation study during 2Q 2012 prior to the NDA filing. It also noted that a QT study showed that granisetron, the active drug used in APF530, does not have an effect on cardiac re-polarisation as measured by the QT-interval.
Clovis Oncology, Inc. (Nasdaq: CLVS) announced today that it has reached the target enrollment in its pivotal LEAP (Low hENT1 and Adenocarcinoma of the Pancreas) study of CO-101 in metastatic pancreatic cancer, with top-line overall survival data expected in 4Q 2012.
Neurocrine Biosciences, Inc. (NASDAQ: NBIX) today released Phase 2 data from its trial of NBI-98854 in 37 tardive dyskinesia patients. The company intends to initiate a twelve week Phase 2b study against placebo, followed by six weeks of active treatment with NBI-98854 in mid-2012, with top-line data anticipated by the end of 2012.