25 Upcoming Catalysts as of May 29, 2012

May 29, 2012 No Comments by

25 short and long term potential catalysts as of May 29, 2012. 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.

Alkermes plc (Nasdaq: ALKS) – Phase 2b data of ALKS 37 for the treatment of opioid-induced constipation, due mid-2012.

Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY)  – Phase 2b data of ALN-RSV01 for the treatment of respiratory syncytial virus (RSV) infection, due mid-2012.

Anthera Pharmaceuticals, Inc. (Nasdaq: ANTH) – Phase 2b topline data of its PEARL-SC trial of blisibimod in subjects with systemic lupus erythematosus, due 2Q 2012.

 Auxilium Pharmaceuticals, Inc. (Nasdaq: AUXL) – Phase 3 top-line data of XIAFLEX for the treatment of Peyronie’s expected late in 2Q 2012.

Amarin Corporation (NASDAQ: AMRN) – PDUFA date July 26, 2012 for AMR101 in patients with very high triglycerides.

Arena Pharmaceuticals, Inc. (NASDAQ: ARNA) – PDUFA target date of June 27, 2012 for lorcaserin in patients with obesity.

Chelsea Therapeutics International, Ltd. (Nasdaq:CHTP) – Phase 2 top-line data of CH-4051, in patients with rheumatoid arthritis (RA), due 2Q 2012.

Clovis Oncology, Inc. (NASDAQ:CLVS) – Phase 3 top-line overall survival results of the LEAP study in patients with pancreatic cancer are expected during 4Q 2012.

Amicus Therapeutics (Nasdaq:FOLD) – Phase 3 Migalastat HCl Monotherapy data for Fabry Disease to be released 3Q 2012.

Human Genome Sciences, Inc. (Nasdaq: HGSI) – Initial Phase 3 data of albiglutide for type 2 diabetes due mid-2012.

Horizon Pharma, Inc. (NASDAQ: HZNP) – PDUFA date July 26, 2012 for LODOTRA for the treatment of rheumatoid arthritis (RA) in adults.

Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX) – Phase 2b topline data of LX4211 in patients with Type 2 diabetes due by mid-2012. Data from its dose-ranging study of LX2931 in rheumatoid arthritis patients, due 2Q 2012.

MAP Pharmaceuticals, Inc. (Nasdaq: MAPP) – Meeting with FDA 2Q 2012 following receipt of the Complete Response letter for LEVADEX, for the treatment of migraine.

Navidea Biopharmaceuticals, Inc.(NYSE Amex: NAVB) – PDUFA date September 10, 2012 for Lymphoseek, a tracing agent of lymphatic mapping and lymphoscintigraphy.

NewLink Genetics Corporation (Nasdaq: NLNK) – Phase 2 HyperAcute Melanoma data for the treatment of advanced melanoma due 2Q 2012. Phase 3 interim data of HyperAcute Pancreas in pancreatic cancer patients due late 2012.

NPS Pharmaceuticals, Inc. (Nasdaq: NPSP) – PDUFA date of September 30, 2012, for Gattex, for the treatment of adult short bowel syndrome or SBS.

Onyx Pharmaceuticals, Inc. (Nasdaq: ONXX) – FDA Oncologic Drugs Advisory Committee (ODAC) will review the its new drug application (NDA) for carfilzomib for the treatment of patients with relapsed and refractory multiple myeloma who have received at least two prior therapies, on June 20, 2012. The PDUFA date is July 27, 2012.

Repligen Corporation (NASDAQ:RGEN) – PDUFA date June 21, 2012 for SecreFlo for the improved detection of pancreatic duct abnormalities in patients with pancreatitis. The company has previously noted that it expects to receive a Complete Response Letter (CRL).

Salix Pharmaceuticals, Ltd. (NASDAQ: SLXP) and Progenics Pharmaceuticals (NASDAQ: PGNX) – PDUFA goal date July 27, 2012 for their Supplemental New Drug Application (sNDA) for RELISTOR (methylnaltrexone bromide) injection for subcutaneous use for the treatment of opioid-induced constipation (OIC) in adult patients with chronic, non-cancer pain.

Sunesis Pharmaceuticals, Inc. (Nasdaq:SNSS) – Phase 3 interim analysis of  vosaroxin in patients with first relapsed or refractory acute myeloid leukemia (AML), due 3Q 2012.

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

Talon Therapeutics, Inc. (OTCBB:TLON) – PDUFA date August 12, 2012 of Marqibofor the treatment of adult Philadelphia chromosome-negative (Ph-) acute lymphoblastic leukemia (ALL) in second or greater relapse or that has progressed following two or more lines of anti-leukemia therapy.

Ventrus BioSciences, Inc. (Nasdaq:VTUS) – Phase 3 data from its first Phase 3 trial of Iferanserin (VEN 309) for the topical treatment of hemorrhoids due June/July 2012.

VIVUS, Inc. (NASDAQ: VVUS) – QNEXA for obesity. PDUFA date July 17, 2012.  The company has also guided that it expects the Committee for Medicinal Products for Human Use (CHMP) to make a response regarding its Marketing Authorization Application (MAA) for the European Union, in 2Q 2012. The only remaining meeting in 2Q will be held June 18-21, 2012.

XenoPort, Inc. (Nasdaq: XNPT) – PDUFA date June 9, 2012 for the supplemental new drug application (sNDA) of Horizant in the management of post-herpetic neuralgia (PHN).

ZIOPHARM Oncology, Inc. (Nasdaq: ZIOP) – Palifosfamide for metastatic soft tissue sarcoma in the front-line setting. The outcome in progression-free survival is anticipated during 2H 2012.

See the FDA Calendar and PDUFA Calendar for a list of other catalysts.

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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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