Upcoming FDA and clinical catalysts as of April 10 2012

Apr 10, 2012 No Comments by

Some short and long term potential catalysts as of April 9, 2012 (share prices as at the close of trading Monday, April 9, 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.

Achillion Pharmaceuticals, Inc(Nasdaq:ACHN) $10.57 – Phase 2a cEVR results for the fully enrolled trial of ACH-1625 in combination with P/R will be presented at The International Liver Congress (EASL 2012), April 18-22, in Barcelona, Spain.

Alexza Pharmaceuticals, Inc. (NASDAQ: ALXA) $0.55 – PDUFA date May 4, 2012 for AZ-004 (Staccato Loxapine) for agitation in schizophrenic or bipolar disorder patients.

Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY) $10.29 – Phase 2b data of ALN-RSV01 for the treatment of respiratory syncytial virus (RSV) infection, due mid-2012.

Anthera Pharmaceuticals, Inc. (Nasdaq: ANTH) $2.09 – Phase 2b topline data of its PEARL-SC trial of blisibimod in subjects with systemic lupus erythematosus, due 2Q 2012.

Amarin Corporation (NASDAQ: AMRN) $9.92 – PDUFA date July 26, 2012 for AMR101 in patients with very high triglycerides.

Arena Pharmaceuticals, Inc. (NASDAQ: ARNA) $3.12  –  PDUFA target date of June 27, 2012 for lorcaserin in patients with obesity. The Endocrinologic and Metabolic Drugs Advisory Committee will meet on May 10, 2012 to give their opinion on the drug.

Celldex Therapeutics, Inc. (NASDAQ: CLDX) $4.55 – will present topline results from the EMERGE randomized Phase 2b study of CDX-011 at the American Society of Clinical Oncology (ASCO) meeting in June 2012.

Furiex Pharmaceuticals, Inc (NASDAQ:FURX) $21.75 –  PDUFA date April 25, 2012 for its type 2 diabetes therapy alogliptin, and fixed-dose combination therapy alogliptin/pioglitazone.

GTx, Inc. (Nasdaq: GTXI) $3.59 – FDA has stated that it will provide a decision whether to lift the clinical hold on further Capesaris development by approximately May 4, 2012.

Human Genome Sciences, Inc. (Nasdaq: HGSI) $7.82 – Initial Phase 3 data of albiglutide for type 2 diabetes due mid-2012.

Horizon Pharma, Inc. (NASDAQ: HZNP) $3.84 – PDUFA date July 26, 2012 for LODOTRA for the treatment of rheumatoid arthritis (RA) in adults.

Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX) $1.69 – 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.

MediciNova, Inc. (Nasdaq:MNOV) $2.67 – Phase 2 preliminary data of MN-221 for treatment of acute exacerbations of asthma due 2Q 2012.

Pharmacyclics, Inc. (Nasdaq: PCYC) $27.68 –  Phase 1/2 interim analysis of PCI-27483 in patients with locally advanced or metastatic pancreatic cancer due 1H 2012. Phase 1/2  interim data of PCI-32765 in combination with ofatumumab in subjects with relapsed or refractory CLL or SLL, due mid-year 2012. Phase 1b/2 interim analysis of PCI-32765 in patients with relapsed/ refractory or with treatment-naïve (65 years of age or older) chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL), due mid-year 2012.

Protalix BioTherapeutics, Inc. (NYSE-AMEX: PLX, TASE: PLX) $6.32 – PDUFA date May 1, 2012, for taliglucerase alfa in patients with Gaucher disease.

Repligen Corporation (NASDAQ:RGEN) $6.22 – PDUFA date June 21, 2012 for SecreFlo for the improved detection of pancreatic duct abnormalities in patients with pancreatitis. The Gastrointestinal Drugs Advisory Committee will meet on May 31, 2012 to discuss the New Drug Application (NDA).

Sunesis Pharmaceuticals, Inc. (Nasdaq:SNSS) $2.66 – 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) $4.00 – Phase 2b interim data of ganetespib in combination with docetaxel in non-small cell lung cancer (NSCLC) due 2Q 2012. Final PFS data and preliminary OS data from Phase 2b portion due  in 2H 2012.

Talon Therapeutics, Inc. (OTCBB:TLON) – PDUFA date May 13, 2011 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) $10.51 – Phase 3  topline data of Diltiazem (VEN 307) in patients with anal fissures due mid-May 2012. Data from first Phase 3 trial of Iferanserin (VEN 309) for the topical treatment of hemorrhoids due June 2012.

VIVUS, Inc. (NASDAQ: VVUS) $22.92 – QNEXA for obesity. PDUFA date July 17, 2012.  PDUFA April 29 2012, for Avanafil in men with Erectile Dysfunction.

XenoPort, Inc. (Nasdaq: XNPT) $4.48 – 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) $5.11 – 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, 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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