25 Upcoming Catalysts as of November 4 2011

Nov 04, 2011 No Comments by

Some short and long term potential catalysts as of November 4 2011 (share prices as at the close of trading Friday, November 4, 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.

Antares Pharma, Inc. (AIS) $2.30 – PDUFA date December 8, 2011 for Anturol Gel in patients with overactive bladder (OAB).

Affymax, Inc. (Nasdaq:AFFY) $4.97 – Oncologic Drugs Advisory Committee (ODAC) review of peginesatide for anemia associated with chronic kidney disease (CKD) in adult patients on dialysis on December 7, 2011. PDUFA date of March 27, 2012.

Alexza Pharmaceuticals, Inc. (ALXA) $1.35 – 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.

Alimera Sciences, Inc. (ALIM) $7.31 – PDUFA date of November 12, 2011 for ILUVIEN in the treatment of diabetic macular edema.

Anthera Pharmaceuticals, Inc. (ANTH) $6.82 – Phase 2b interim efficacy analysis of PEARL-SC study for lupus 1Q 2012.

ARIAD Pharmaceuticals (ARIA) $12.01 – Pivotal Phase 2 interim data of ponatinib for chronic myeloid leukemia (CML) and Philadelphia-chromosome positive acute lymphoblastic leukemia (Ph ALL), due to be presented at ASH in December, 2011.

Columbia Laboratories, Inc. (CBRX) $2.41 – 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.

Corcept Therapeutics Incorporated (CORT) $3.16 – PDUFA date February 17, 2012 for CORLUX for Cushings Syndrome.

Discovery Laboratories, Inc. (Nasdaq: DSCO) $1.79 – PDUFA date March 6, 2012 for SURFAXIN (lucinactant) for the prevention of Respiratory Distress Syndrome (RDS) in premature infants.

DURECT Corporation (Nasdaq: DRRX) $1.55 – 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.

Incyte Corporation (Nasdaq:INCY) $13.32 – PDUFA date December 3, 2011 under priority review for Ruxolitinib as a treatment for Myelofibrosis.

IntelGenx Corp. (OTCBB:IGXT) $0.66 – PDUFA date of November 13 for its antidepressant CPI-300.

MediciNova, Inc (Nasdaq:MNOV) $2.22 – Phase 2 MN-221 data for the treatment of acute exacerbations of asthma and chronic obstructive pulmonary disease exacerbations trial due 4Q 2011.

Nabi Biopharmaceuticals (NABI) $1.86 – Phase 3 Data of NicVAX for Nicotine Addiction due late 4Q or early 1Q 2011 – second of two Phase 3 trials.

NeurogesX, Inc. (NGSX) $1.03 – Topline data of NGX-1998 for postherpetic neuralgia (PHN) due mid-November 2011.

NPS Pharmaceuticals, Inc. (NPSP) $5.61 – Phase 3 topline data of NPSP558 in hypoparathyroidism due 4Q 2011. GATTEX NDA for short bowel syndrome also due to be filed 4Q.

Peregrine Pharmaceuticals, Inc. (PPHM) $1.06 – Interim Phase 2 data of bavituximab for first line NSCLC due 4Q.

Protalix BioTherapeutics Inc. (PLX) $6.36 – PDUFA date February 1, 2012 for Taliglucerase Alfa for Gaucher disease.

Spectrum Pharmaceuticals (SPPI) $11.73 – ZEVALIN (already approved) – PDUFA date November 20, 2011 for Prior Approval Supplement for the Removal of the Bioscan Requirement.

Threshold Pharmaceuticals, Inc. (THLD) $1.55 – TH-302 Phase 2 topline data for pancreatic cancer due end of 2011. Also interim Phase 3 data for soft tissue sarcoma due late 2012.

Transcept Pharmaceuticals, Inc. (TSPT) $8.30 – Intermezzo NDA for insomnia. PDUFA date November 27, 2011.

Trius Therapeutics, Inc. (Nasdaq:TSRX) $6.80 – 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. (VVUS) $9.92 – QNEXA for obesity. PDUFA date April 17, 2012. FORTRESS birth defect data due December 2011. Advisory Committee meeting to be held 1Q 2012.

XenoPort, Inc. (XNPT) $5.75 – Phase 2b topline data of XP21279 for Parkinsons disease due by the end of 2011.

YM BioSciences Inc (YMI) $1.84 – Phase 1-2 data of CYT387 for myelofibrosis due at ASH Dec 2011.

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About the author

Currently residing in New Zealand, Mr. A.Burden holds a Master of Commerce 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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