Some short and long term potential catalysts as of May 22 2011 (share prices as at the close of trading Friday, May 20, 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) $4.68 – PDUFA date June 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. (AFFY) $6.70 – submit NDA for Hematide (peginesatide) during 2Q for the treatment of anemia associated with chronic renal failure.
Antares Pharma, Inc. (AIS) $1.73 – PDUFA date December 8, 2011 for Anturol Gel in patients with overactive bladder (OAB).
BioSante Pharmaceuticals, Inc. (NASDAQ: BPAX) $2.63 – Phase 3 efficacy data for LibiGel in patients with female sexual dysfunction (FSD) between September and November, 2011.
Celsion Corporation (CLSN) $2.89 – Pivotal Phase 3 ThermoDo clinical study (HEAT Study) for primary liver cancer. Interim analysis due mid-2011.
Corcept Therapeutics Incorporated (CORT) $4.38 – seeking 6-month priority review for Corlux for Cushings Syndrome. PDUFA mid-October assuming 6-month review. They will be releasing as yet to be released detailed findings from the CORLUX Phase 3 Trial at the Endocrine Society Annual Meeting, June 4-7. Shortly after, by about June 15, they should also hear back from the FDA as to whether their NDA filing has been accepted.
Curis, Inc. (CRIS) $3.62 will be presenting unreleased data from their Phase 2 pivotal trial at the 7th Annual Congress of the European Association of Dermato-Oncology, in Nantes, France, June 20-23, 2011. They intend to file an NDA, through Roche, later this year pending positive data.
Depomed, Inc. (Nasdaq:DEPO) $8.23 – Phase 3 data BREEZE trial data evaluating Serada for menopausal hot flashes due 4Q.
DURECT Corporation (DRRX) $3.24 and Pain Therapeutics, Inc. (PTIE) $9.15 – PDUFA date of June 23, 2011 for REMOXY by King Pharmaceuticals, Inc. (KG) for moderate-to-severe chronic pain.
EPICEPT Corp (EPCT) $0.65 – 1:2 to 1:6 Reverse Split vote, to be held June 11, 2011.
Exelixis, Inc. (EXEL) $11.34 – Top-line data from Phase 3 trial of XL184 for medullary thyroid cancer (MTC) during 1H 2011 and potentially file NDA during 2H 2011.
Immunomedics, Inc. (IMMU) $4.00 – Phase 2 update for clivatuzumab tetraxetan in patients with pancreatic cancer at the at the Society of Nuclear Medicine annual meeting, June 4-8, 2011.
Keryx Biopharmaceuticals (KERX) $5.19 – Phase 3 completion of KRX-0401 (perifosine) in patients with colorectal cancer during 2H 2011.
Lexicon Pharmaceuticals, Inc. (LXRX) $1.51 – Phase 2a data of LX 1032 for Carcinoid Syndrome due 2Q 2011.
Micromet, Inc. (NASDAQ: MITI) $6.20 – Phase 2 interim data of blinatumomab in patients with relapsed/refractory ALL to be presented at the EHA Annual Congress June 10-12, 2011.
NuPathe Inc. (PATH) $7.83 – PDUFA date of August 29, 2011 for Zelrix, a transdermal patch for the treatment of migraine.
Optimer Pharmaceuticals, Inc. (OPTR) $13.93 – PDUFA date May 30, 2011 for Fidaxomicin for the treatment of Clostridium difficile infection (CDI).
Pacira Pharmaceuticals, Inc (PCRX) $10.97 – PDUFA date of July 28, 2011 for EXPAREL, a long-acting bupivacaine for postsurgical pain management.
Repros Therapeutics Inc. (RPRX) $5.86 – Phase 2 interim analysis of Androxal in men with Type 2 Diabetes due September, 2011.
QLT Inc. (QLTI) $7.49 – Phase 2 data of latanoprost punctal plug drug delivery system (L-PPDS) in glaucoma. Data due 2Q or 3Q 2011.
Raptor Pharmaceutical Corp (RPTP) $3.99 – Phase 3 data of cysteamine bitartrate in patients with nephropathic cystinosis due June 2011.
Stemcells Inc. (STEM) – 1:7 to 1:11 Reverse split vote to be held June 30. Also voting to decrease Authorised shares from 250m to 75m.
Transcept Pharmaceuticals, Inc. (TSPT) $10.36 – PDUFA date of July 14, 2011 following Class 2 resubmission.
Vical Incorporated (Nasdaq:VICL) $4.17 – Phase 3 data of Allovectin-7 for melanoma due 2H 2011.
Zogenix, Inc. (ZGNX) $3.75 – Phase 3 data of ZX002 (Hydrocodone) for moderate to severe chronic pain in patients requiring around-the-clock opioid therapy due 3Q 2011.