Some short and long term potential catalysts (share prices as at the close of trading Friday, April 15, 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.
Acura Pharmaceuticals, Inc. (ACUR) $4.19 – PDUFA date July 17, 2011 for Acurox without niacin for the relief of moderate to severe pain. FDA raised concerns relating to an intranasal abuse liability study included in the NDA and requested additional information relating to this study and other issues.
Affymax, Inc. (Nasdaq: AFFY) $6.39 – submit NDA for Hematide (peginesatide) during 2Q for the treatment of anemia associated with chronic renal failure.
Alimera Sciences, Inc. (ALIM) $7.88 – resumbit NDA for Iluvien for the treatment of Diabetic Macular Edema, early this quarter.
Anadys Pharmaceuticals, Inc. (ANDS) $1.16 – ANA598 for Hepatitis C. Week 8 antiviral response data due by end of 2Q 2011.
Celsion Corporation (CLSN) $2.20 – Pivotal Phase 3 ThermoDo clinical study (HEAT Study) for primary liver cancer. Interim analysis due 2Q.
Corcept Therapeutics Incorporated (CORT) $4.32 – seeking 6-month priority review for Corlux for Cushings Syndrome. PDUFA mid-October assuming 6-month review.
Cyclacel Pharmaceuticals, Inc. (CYCC) $1.27 – waiting on interim Phase 2 data of sapacitabine in patients with NSCLC.
Depomed, Inc. (Nasdaq:DEPO) 8.54 – Phase 3 data BREEZE trial data evaluating Serada for menopausal hot flashes due 4Q.
DURECT Corporation (DRRX) $3.25 and Pain Therapeutics, Inc. (PTIE) $8.79 – PDUFA date of June 23, 2011 for REMOXY by King Pharmaceuticals, Inc. (KG) for moderate-to-severe chronic pain.
Exelixis, Inc. (EXEL) $11.96 – Top-line data from Phase 3 trial of XL184 for medullary thyroid cancer (MTC) during 1H 2011 and potentially file NDA during 2H 2011.
Amicus Therapeutics (FOLD) $7.20 – expect to release Phase 3 data of Amigal for Fabry Disease and Phase 2 data for Pompe Disease during 2H, 2011.
Keryx Biopharmaceuticals (Nasdaq: KERX) $5.13 – will present final from their Phase 3 trial of Zerenex for the treatment of hyperphosphatemia in end-stage renal disease patients on dialysis, at a session on April 28, 2011.
Lexicon Pharmaceuticals, Inc. (LXRX) $1.68 – Phase 2a data of LX 1032 for Carcinoid Syndrome due 2Q 2011.
Myrexis, Inc. (MYRX) $4.16 – Report Phase 2 monotherapy results in recurrent glioblastoma multiforme (GBM) patients naive to treatment with Avastin, 2Q 2011.
NuPathe Inc. (PATH) $6.70 – PDUFA date of August 29, 2011 for Zelrix, a transdermal patch for the treatment of migraine.
Optimer Pharmaceuticals, Inc. (OPTR) $12.58 – Fidaxomicin for the treatment of Clostridium difficile infection (CDI). PDUFA date May 30, 2011.
Pacira Pharmaceuticals, Inc (PCRX) $7.15 – PDUFA date of July 28, 2011 for EXPAREL, a long-acting bupivacaine for postsurgical pain management.
Peregrine Pharmaceuticals, Inc. (PPHM) $2.50 – top-line survival data of Phase 2 dose confirmation trial of Cotara in patients with recurrent glioblastoma multiforme (GBM) during mid-2011.
QLT Inc. (QLTI) $7.80 – Phase 2 data of latanoprost punctal plug drug delivery system (L-PPDS) in glaucoma. Data due 2Q or 3Q 2011.
Raptor Pharmaceutical Corp (RPTP) $3.35 – Phase 3 data of cysteamine bitartrate in patients with nephropathic cystinosis 2Q 2011.
Spectrum Pharmaceuticals (SPPI) $8.96 – PDUFA date April 29, 2011 for sNDA of Fusilev, for the treatment of patients with advanced metastatic colorectal cancer. It has already approved for the rescue after high-dose methotrexate therapy in osteosarcoma.
Transcept Pharmaceuticals, Inc. (TSPT) $8.89 – PDUFA date of July 14, 2011 following its Class 2 resubmission.
XOMA Ltd. (XOMA) $3.05 – Phase 2a top line results from the full six months treatment of XOMA 052 for diabetes.
Vical Incorporated (Nasdaq:VICL) – Phase 3 data of Allovectin-7 for melanoma due 2H 2011.
Zogenix, Inc. (ZGNX) $5.08 – Phase 3 data of ZX002 (Hydrocodone) for moderate to severe chronic pain in patients requiring around-the-clock opioid therapy due 3Q 2011.