Upcoming Catalysts as of December 9 2011

Dec 11, 2011 No Comments by

Some short and long term potential catalysts as of December 9 2011 (share prices as at the close of trading Friday, December 9, 2011). See the links in the FDA Calendar for more details about each catalyst.

The possible catalysts listed below represent both short and long opportunities. It is NOT a recommendation to take SHORT or LONG positions in certain stock.

Affymax, Inc. (Nasdaq:AFFY) $7.64 – PDUFA date of March 27, 2012 for peginesatide for anemia associated with chronic kidney disease (CKD) in adult patients on dialysis on December 7, 2011.

Alexza Pharmaceuticals, Inc. (NASDAQ: ALXA) $0.63 – PDUFA date February 4, 2012 for AZ-004 (Staccato Loxapine) for agitation in schizophrenic or bipolar disorder patients. Psychopharmacologic Drugs Advisory Committee (PDAC) meeting on December 12, 2011.

ArQule, Inc. (NASDAQ: ARQL) $5.71 - Phase 2 data of Tivantinib (ARQ 197) for hepatocellular carcinoma (HCC) due early 2012.

Astex Pharmaceuticals, Inc. (NASDAQ: ASTX) $1.69 – PDUFA date March 6, 2012 for sNDA of Dacogen in the elderly Acute Myeloid Leukemia indication despite average trial data.

AVEO Pharmaceuticals, Inc. (NASDAQ: AVEO) $16.96 - Phase 3 Topline data of tivozanib in patients with advanced renal cell carcinoma due 1Q 2012.

BioSante Pharmaceuticals, Inc. (NASDAQ: BPAX) $2.45 - Phase 3 efficacy data of Libigel for Female sexual dysfunction due December 2011. PDUFA February 14, 2012 for Bio-T-Gel for male hypogonadism.

Chelsea Therapeutics International, Ltd. (Nasdaq:CHTP) $5.15 - Cardiovascular and Renal Drugs Advisory Committee meeting due February (exact date TBA)  for NORTHERA for the treatment of Symptomatic NOH. PDUFA date March 28, 2012.

Columbia Laboratories, Inc. (NASDAQ: CBRX) $2.19 – PDUFA date of February 26, 2012 for PROCHIEVE for the reduction of risk of preterm birth in women with short uterine cervical length in the mid-trimester of pregnancy. Advisory Committee meeting scheduled for January 20, 2012.

Corcept Therapeutics Incorporated (NASDAQ: CORT) $3.28 – PDUFA date February 17, 2012 for CORLUX for Cushings Syndrome.

Discovery Laboratories, Inc. (NASDAQ: DSCO) $1.70 – PDUFA date March 6, 2012 for SURFAXIN (lucinactant) for the prevention of Respiratory Distress Syndrome (RDS) in premature infants.

DURECT Corporation (Nasdaq: DRRX) $1.29 – Phase 3 topline data of POSIDUR for Post-Operative Pain Relief Depot due 4Q 2011. NDA filing due 1H 2012 pending positive Phase 3 data.

Idenix Pharmaceuticals, Inc. (NASDAQ: IDIX) $8.13 – Phase 2b interim data for the first 30 patients from the Phase 2b trial of IDX184 for  HCV due early1Q 2012. 100 patients were enrolled in total.

MediciNova, Inc (Nasdaq:MNOV) $1.99 – Phase 2 MN-221 data for the treatment of acute exacerbations of asthma and chronic obstructive pulmonary disease exacerbations trial due 4Q 2011.

NeurogesX, Inc. (Nasdaq:NGSX) $1.07 -PDUFA action date of March 7, 2012 for sNDA of Qutenza for the management of neuropathic pain associated with HIV-associated peripheral neuropathy (HIV-PN). Granted a priority six month review classification.

NewLink Genetics Corp (NASDAQ: NLNK) $7.00 - Phase 2 HyperAcute Melanoma data due by end of 2011.

Omeros Corporation (NASDAQ: OMER) $4.04 - Phase 3 data of OMS302 for intra-ocular lens replacement surgery due 1Q 2012.

Sucampo Pharmaceuticals, Inc. (NASDAQ: SCMP) $4.07 – Third Phase 3 trial data of lubiprostone for opioid-induced bowel dysfunction, due mid-late December, 2011.

Synta Pharmaceuticals Corp. (NASDAQ: SNTA) $4.83 - Phase 2b data of ganetespib in combination with docetaxel in non-small cell lung cancer (NSCLC) due early 2012.

Threshold Pharmaceuticals, Inc. (NASDAQ: THLD) $1.35 – TH-302 Phase 2 topline data for pancreatic cancer due end of 2011. Also interim Phase 3 data for soft tissue sarcoma due late 2012EDIT: SINCE THIS POST THLD GAVE UPDATED GUIDANCE OF A RELEASE DATE IN MID-LATE FEBRUARY 2012.

Trius Therapeutics, Inc. (Nasdaq:TSRX) $7.23 – Phase 3 data of tedizolid phosphate for acute bacterial skin and skin structure infections (ABSSSI) due early 2012. First of two Phase 3 trials.

VIVUS, Inc. (NASDAQ: VVUS) $10.68 – QNEXA for obesity. PDUFA date April 17, 2012. FORTRESS birth defect data due December 2011. Advisory Committee meeting to be held 1Q 2012.

YM BioSciences Inc (AMEX: YMI) $1.56 – Phase 1-2 data of CYT387 for myelofibrosis due at ASH December 12, 2011.

Catalysts

About the author

Currently residing in New Zealand and employed in the education industry, Mr. A. Burden holds a M.Com in International Business from the University of Sydney and used these skills together with his passion for investing to establish BioPharmCatalyst in June 2010 as a tool for investing decisions in the US pharmaceutical market. He spends much of his free time mountain biking, playing squash and hiking.
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