A Merry Xmas to all readers of BioPharmCatalyst. Thank you all for your support over the past year and wish you all a relaxing break with friends and family!
See individual posts made in the last week for more detail.
PDUFA/FDA RELATED EVENTS
Santarus, Inc. (NASDAQ: SNTS) submitted its NDA for UCERIS for mild to moderate active ulcerative colitis.
Repligen Corporation (NASDAQ: RGEN) submitted its NDA for SecreFlo (RG1068) for pancreatic imaging in patients with pancreatitis. A 6-month priority review was requested.
Impax Pharmaceuticals (NASDAQ: IPXL) filed its NDA for IPX066 for the treatment of idiopathic Parkinson’s disease.
Chelsea Therapeutics International, Ltd. (Nasdaq:CHTP) – Cardiovascular and Renal Drugs Advisory Committee is likely to review Northera NDA on February 23. TBC.
VIVUS, Inc. (NASDAQ: VVUS) – announced the Endocrinologic and Metabolic Drugs Advisory Committee will discuss the Qnexa NDA for obesity on February 22, 2012.
Zogenix, Inc. (Nasdaq:ZGNX) is set to submit NDA for Zohydro for patients having moderate to severe chronic pain requiring continuous around-the-clock opioid therapy in early 2Q 2012.
Raptor Pharmaceutical Corp. (Nasdaq:RPTP) said that it expects to file its NDA and MAA for RP103 in patients with nephropathic cystinosis, during 1Q 2012, seeking a 6-month priority review.
CLINICAL TRIAL DATA ( or notice of upcoming data)
VIVUS, Inc. (NASDAQ: VVUS) announced topline preliminary results from its FORTRESS study as part of the Qnexa NDA for obesity.Women who had taken topiramate during pregnancy had a prevalence rate of 0.29% (5/1,740) while those who had taken topiramate prior to pregnancy had a rate of 0.16% (21/13,512).
Trius Therapeutics, Inc. (Nasdaq:TSRX) announced that tedizolid phosphate just met the primary objective of non-inferiority for the efficacy outcome of early clinical response compared with linezolid (Zyvox) 79.5% vs $79.4%.
Salix Pharmaceuticals, Ltd. (NASDAQ:SLXP) and Progenics Pharmaceuticals, Inc. (NASDAQ:PGNX) announced positive data from their Phase 3 trial of oral methylnaltrexone for the treatment of opioid-induced constipation (OIC) in subjects with chronic, non-cancer pain. They plan to file their NDA during mid 2012.
Chelsea Therapeutics International, Ltd. (Nasdaq:CHTP) announced results of its Phase 2 trial of droxidopa for the treatment of fibromyalgia. The 600 mg TID arm showed a 6.2-point average improvement from a baseline score of 23.00 on the Short Form McGill Questionnaire (SF-MPQ), the trial’s primary endpoint, a 3.2 unit improvement over placebo on the SF-MPQ total pain score.
Amicus Therapeutics (Nasdaq:FOLD) completed enrollment of its Phase 3 (Study 011) of migalastat HCl for Fabry disease. Results are due during 3Q 2012.
Celldex Therapeutics, Inc. (Nasdaq: CLDX) noted that data from its Phase 2b EMERGE study, evaluating CDX-011 (glembatumumab vedotin) in patients with previously treated metastatic or locally advanced breast cancer will be presented at a scientific conference in 1H 2012.
CLINICAL TRIAL INITIATIONS
Geron Corporation (Nasdaq: GERN) initiated a Phase 2 trail of GRN1005 in patients with brain metastases arising from NSCLC.
Alkermes plc (NASDAQ: ALKS) initiated its Phase 3 trial of ALKS 9070 for the treatment of schizophrenia. Data due mid-2013.
Raptor Pharmaceutical Corp. (Nasdaq:RPTP) is set to initiate Phase 2b RP104 for non-alcoholic steatohepatitis (NASH) in 1Q 2012.
XOMA Ltd. (Nasdaq:XOMA) initiated its Phase 2 trial of gevokizumab (XOMA 052) for the treatment of the inflammatory lesions seen in moderate to severe acne vulgaris.
CytRx Corporation (Nasdaq: CYTR) initiated its Phase 2b clinical trial of INNO-206 in patients with late-stage soft tissue sarcoma.
AVEO Pharmaceuticals, Inc.(NASDAQ: AVEO) initiated its open-label, multicenter, randomized Phase 2 clinical trial, called BATON-CRC, evaluating tivozanib in combination with modified FOLFOX6 compared to bevacizumab in combination with mFOLFOX6 as first-line therapy in patients with advanced metastatic colorectal cancer.
STOCK OFFERINGS/SHELF FILINGS
Marina Biotech, Inc. (NASDAQ: MRNA) effected a 1:10 reverse split and also entered into a $5 million private placement.
ARCA biopharma, Inc.(Nasdaq: ABIO) raised net proceeds of approximately $1.5m through the issuance of stock and warrants.
ONCOTHYREON INC (Nasdaq: ONTY) filed a $150m shelf allowing it to issue shares and warrants from time to time.
Adeona Pharmaceuticals, Inc. (NYSE Amex: AEN) intends to change the name of its company to Synthetic Biologics, Inc.
Zogenix, Inc.(Nasdaq:ZGNX) co-promotion of SUMAVEL DosePro Needle-free Delivery System with Astellas will end on March 31, 2012.
Poniard Pharmaceuticals, Inc. (NASDAQ: PARDD) today announced that its planned merger with Allozyne has been terminated.
Curis, Inc. (NASDAQ: CRIS) today announced that its partner Roche submitted a MAA for vismodegib to the EMA for the treatment of adults with advanced basal cell carcinoma (BCC).