Some short and long term potential catalysts (share prices as at the close of trading Friday, February 25, 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) $3.27 – 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.
Amarin Corporation (AMRN) $8.09 – top-line results from ANCHOR trial Q2 2011 of AMR101 in patients with high triglyceride levels.
Achillion Pharmaceuticals, Inc. (ACHN) $5.85 – Phase 2 ACH-1625 for Hepatitis C. 28-day segment rapid viral response (RVR) data due early 2011.
Anadys Pharmaceuticals, Inc. (ANDS) $1.25 – ANA598 for Hepatitis C. Week 8 antiviral response data due by end of 2Q 2011.
Celsion Corporation (CLSN) $2.51 – Pivotal Phase 3 ThermoDo clinical study (HEAT Study) for primary liver cancer. Interim analysis due 2Q.
Corcept Therapeutics Incorporated (CORT) $3.79 – seeking 6-month priority review for Corlux for Cushings Syndrome. NDA filing late 1Q.
Curis, Inc. (CRIS) $3.00 – Pivotal Phase 2 data for GDC-0449 in advanced BCC expected 1Q, 2011. A pivotal Phase 2 trial means that no Phase 3 trial is required assuming appropriate results are realised. Their Phase 2 trial of GDC-0449 for ovarian cancer failed last year.
Cyclacel Pharmaceuticals, Inc. (CYCC) $1.34 – waiting on interim Phase 2 data of sapacitabine in patients with NSCLC.
DURECT Corporation (DRRX) $3.29 and Pain Therapeutics, Inc. (PTIE) $6.71 – PDUFA date of June 23, 2011 for REMOXY by King Pharmaceuticals, Inc. (KG) for moderate-to-severe chronic pain. DRRX is also expecting Phase 2b data of ELADUR for lower back pain 1H 2011.
EntreMed, Inc. (ENMD) $5.05 – Phase 2 ENMD2076 ovarian cancer data due early 2011.
Exelixis, Inc. (EXEL) $11.82 – Top-line data from Phase 3 trial of XL184 for medullary thyroid cancer (MTC) during 1H 2011 and potentially file NDA during 2H 2011. Exelixis also is evaluating XL184 in Phase 2 in solid tumors including metastatic castration-resistant prostate cancer, ovarian cancer, melanoma, breast cancer, non-small cell lung cancer, and hepatocellular cancer.
Myrexis, Inc. (MYRX) $3.84 – Report Phase 2 monotherapy results in recurrent glioblastoma multiforme (GBM) patients naive to treatment with Avastin, 2Q 2011.
NuPathe Inc. (PATH) $7.90 – PDUFA date of August 29, 2011 for Zelrix, a transdermal patch for the treatment of migraine.
Omeros Corporation (OMER) $6.56 – Phase 3 data of OMS103HP in ACL reconstruction due 1Q. Phase 2b OMS302 data in cataract surgery also due 1Q, 2011.
Optimer Pharmaceuticals, Inc. (OPTR) $12.19 – Fidaxomicin for the treatment of Clostridium difficile infection (CDI). Anti-Infective Drugs Advisory Committee meeting April 5, 2011. PDUFA date May 30, 2011.
Pacira Pharmaceuticals, Inc (PCRX) $7.09 – PDUFA date of July 28, 2011 for EXPAREL, a long-acting bupivacaine for postsurgical pain management.
Peregrine Pharmaceuticals, Inc. (PPHM) $2.23 – top-line survival data of Phase 2 dose confirmation trial of Cotara in patients with recurrent glioblastoma multiforme (GBM) during mid-2011.
Repligen Corporation (RGEN) $4.84 – Phase 3 re-read of topline data for pancreatic imaging and Phase 2b Data for bipolar disorder both due 1Q 2011.
Raptor Pharmaceutical Corp (RPTP) $2.61, expects to release Phase 3 data of cysteamine bitartrate in patients with nephropathic cystinosis 2Q 2011.
Spectrum Pharmaceuticals (SPPI) $6.22 – 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) $8.83 – PDUFA date of July 14, 2011 following its Class 2 resubmission.
XenoPort, Inc. (XNPT) $7.18 – Horizant for the treatment of moderate-to-severe primary Restless Legs Syndrome.PDUFA date April 6, 2010. Also waiting on Phase 2b GERD data due 1Q, 2011.
XOMA Ltd. (XOMA) $5.02 – Phase 2b topline data of XOMA 052 for diabetes due 1Q 2011.
YM BioSciences Inc. (YMI) $2.42 – Phase 2 Nimotuzmab European data for Glioma and Phase 2 NSCLC expected 1H. Phase 2 Nimotuzmab data for Diffuse intrinsic pontine glioma (DIPG) expected 1Q. Phase 2 interim data for CYT387 for Myelofibrosis expected 2Q, full data 4Q 2011.