Negative Adcom votes for DCTH and AVEO. ARNA withdraws MAA + pipeline updates for ACOR RPRX DCTH AGN INCY ECYT NBIX OGXI NBY CLDX
Arena Pharmaceuticals, Inc. (NASDAQ: ARNA) announced that it will be withdrawing the BELVIQ Marketing Authorization Application (MAA) for obesity in the European Union.
Acorda Therapeutics, Inc. (Nasdaq: ACOR) noted that it remains on track to submit its NDA for Diazepam Nasal Spray in 2013.
Repros Therapeutics Inc.(Nasdaq:RPRX) announced that it has completed enrolment in its second pivotal trial of (ZA-302) of Androxal for the treatment of secondary hypogonadism, one month ahead of schedule. Topline results are due 4Q 2013.
Delcath Systems, Inc. (NASDAQ: DCTH) announced that the FDA Oncologic Drugs Advisory Committee (ODAC) voted 16 to 0 AGAINST recommending approval of its Melblez Kit for the treatment of patients with unresectable ocular melanoma metastatic to the liverThe PDUFA date is September 13, 2013.
Allergan, Inc., (NYSE: AGN) announced that the FDA General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee voted unanimously in favour of JUVÉDERM VOLUMA XC, an injectable hyaluronic acid dermal filler for cheek augmentation to correct age-related volume deficit in the mid-face, outweigh the risks.
AVEO Oncology (NASDAQ: AVEO) and Astellas Pharma Inc announced that the FDA Oncologic Drugs Advisory Committee (ODAC) voted 13-1 AGAINST recommending approval of tivozanib for the treatment of advanced renal cell carcinoma (RCC).
Incyte Corporation (Nasdaq: INCY) provided an update noting that results of RESPONSE, evaluating ruxolitinib in patients with polycythemia vera (PV), are expected in early 2014, with a possible NDA filing in 1H 2014. The company also noted that data from its Phase 2 trial of ruxolitinib in combination with capecitabine in patients with recurrent or treatment refractory metastatic pancreatic cancer (the RECAP trial), are due in 2H 2013.
Endocyte, Inc. (NASDAQ: ECYT) announced that its expects the European Medicines Agency (EMA) to make a decision on both of its MAAs in 4Q 2013. Top-line data are expected from its Phase 2b TARGET trial in non-small cell lung cancer (NSCLC) in 1H 2014.
Neurocrine Biosciences, Inc. (NASDAQ:NBIX) noted that in its two Phase 2b studies of its VMAT2 inhibitor, NBI-98854, top-line data from both trials (Kinect and Kinect 2) are expected in 3Q 2013, with data from the latter study following the release of data from Kinect. It intends to hold a Phase 2 meeting for NBI-98854 in tardive dyskinesia with the FDA in 4Q 2013.
OncoGenex Pharmaceuticals, Inc. (NASDAQ: OGXI) provided an update of upcoming events. Its Borealis-1 Phase 2 trial of OGX-427 in combination with first-line gemcitabine and cisplatin in patients with metastatic bladder cancer, is expected to complete enrolment in 2H 2013. Enrolment of its Phase 2 Spruce trial of OGX-427 in combination with carboplatin and pemetrexed in patients with previously untreated, advanced, non-squamous, non-small cell lung cancer (NSCLC), is expected to commence in mid-2013. Enrollment is expected to begin in its Rainier Phase 2 trial evaluating OGX-427 in combination with ABRAXANE and gemcitabine, also in mid-2013. In regard to its Phase 3 SYNERGY trial, for custirsen in combination with first-line docetaxel chemotherapy in men with metastatic CRPC, data are expected to be announced in 1H 2014.
NovaBay Pharmaceuticals, Inc. (AMEX: NBY) noted in its pipeline update that data from its Phase 2b trial of an eye drop formulation of auriclosene for treating adenoviral conjunctivitis, are due in 2H 2013. Data from its Phase 2b trial of auriclosene for the treatment of highly contagious skin infection, impetigo, are also due 2H 2013, while its urinary catheter irrigation solution containing auriclosene is currently in a Phase 2 study, are due data mid-2013.
Celldex Therapeutics, Inc. (NASDAQ: CLDX) said in its update that data from the ReACT study of rindopepimut in combination with Avastin in patients with recurrent/refractory EGFRvIII-positive glioblastoma, are due towards the end of 2013. Data from a Phase 2 trial of CDX-1135 in dense deposit disease are expected in 2H 2013. The company also intends to initiate a Phase 2 study of CDX-1401 in combination with CDX-301 in 2013.