Upcoming PDUFA dates, Adcom meetings and clinical catalysts as of January 12 2012

Jan 12, 2012 No Comments by

Some short and long term potential catalysts as of January 12, 2012 (share prices as at the close of trading Wednesday, January 11, 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.

Aeterna Zentaris Inc. (NASDAQ: AEZS) $1.69 and Keryx Biopharmaceuticals, Inc. (Nasdaq: KERX) – Phase 3 Perifosine for metastatic colorectal cancer to be completed 1Q 2012.

Affymax, Inc. (Nasdaq:AFFY) $6.94 – PDUFA date of March 27, 2012 for peginesatide for anemia associated with chronic kidney disease (CKD) in adult patients on dialysis.

Amylin Pharmaceuticals, Inc. (Nasdaq: AMLN) $11.15, Eli Lilly  (NYSE: LLY) and Alkermes, Inc. (Nasdaq: ALKS) $18.14 – PDUFA date  January 28, 2012 for BYDUREON for type 2 diabetes.

Alexza Pharmaceuticals, Inc. (NASDAQ: ALXA) $0.86 – PDUFA date February 4, 2012 for AZ-004 (Staccato Loxapine) for agitation in schizophrenic or bipolar disorder patients. EDIT PDUFA date extended to May 4, 2012.

Anthera Pharmaceuticals, Inc. (Nasdaq: ANTH) $6.64 – Phase 3 VISTA-16 trial of varespladib for the treatment in high-risk Acute Coronary Syndrome (ACS) patients, due to accrue the final event during 1Q 2012. Also, Phase 2b top-line data of PEARL-SC trial for lupus due 2Q 2012.

Arena Pharmaceuticals, Inc. (NASDAQ: ARNA) $1.66  –  PDUFA target date of June 27, 2012 for lorcaserin in patients with obesity. A possible Advisory Committee meeting March 28/29, 2012 ( YET TO BE CONFIRMED).

ArQule, Inc. (NASDAQ: ARQL) $5.99 – Phase 2 data of Tivantinib (ARQ 197) for hepatocellular carcinoma (HCC) due early 2012.

Astex Pharmaceuticals, Inc. (NASDAQ: ASTX) $2.06 – PDUFA date March 6, 2012 for sNDA of Dacogen in the elderly Acute Myeloid Leukemia indication despite average trial data. Oncologic Drugs Advisory Committee Meeting scheduled for February 9, 2012.

Cell Therapeutics, Inc.  (Nasdaq: CTIC) $1.16 – Oncologic Drugs Advisory Committee scheduled to review resubmitted NDA for pixantrone for the treatment of relapsed or refractory aggressive non-Hodgkin’s lymphoma (NHL), on February 9, 2012. PDUFA date April 24, 2012. The company has given guidance that it tentatively expects the Committee for Human Medicinal Products (CHMP) to render an opinion on its European Marketing Authorisation Application on January 19, 2012.

Columbia Laboratories, Inc. (NASDAQ: CBRX) $2.66 – PDUFA date of February 26, 2012 for PROCHIEVE for the reduction of risk of preterm birth in women with short uterine cervical length in the mid-trimester of pregnancy. Advisory Committee meeting scheduled for January 20, 2012.

Chelsea Therapeutics International, Ltd. (Nasdaq:CHTP) $5.12 – Cardiovascular and Renal Drugs Advisory Committee meeting on February 23, 2012, for NORTHERA for the treatment of Symptomatic NOH. PDUFA date March 28, 2012.

Corcept Therapeutics Incorporated (NASDAQ: CORT) $3.00 – PDUFA date February 17, 2012 for CORLUX for Cushings Syndrome.

Curis, Inc. (NASDAQ: CRIS) $4.55 – PDUFA date set for March 8, 2012 for Vismodegib as a treatment for Advanced Basal Cell Carcinoma.

Discovery Laboratories, Inc. (NASDAQ: DSCO) $2.10 – PDUFA date March 6, 2012 for SURFAXIN (lucinactant) for the prevention of Respiratory Distress Syndrome (RDS) in premature infants.

GTx, Inc. (Nasdaq: GTXI) $3.79 – Preliminary topline results due 1Q 2012 of  TWO Phase 2 Capesaris clinical trials (maintenance dose finding trial and  loading dose finding) for advanced prostate cancer.

MAP Pharmaceuticals, Inc. (Nasdaq: MAPP) $14.83 – PDUFA date March 26, 2012 for LEVADEX orally inhaled migraine drug for the potential treatment of migraine.

NeurogesX, Inc. (Nasdaq:NGSX) $0.92 -PDUFA action date of March 7, 2012 for sNDA of Qutenza for the management of neuropathic pain associated with HIV-associated peripheral neuropathy (HIV-PN). Anesthetic and Analgesic Drug Products Advisory Committee (AADPAC) meeting on February 9, 2012.

Omeros Corporation (NASDAQ: OMER) $5.45 – Phase 3 data of OMS302 for intra-ocular lens replacement surgery due 1Q 2012. Phase 3 OMS103HP for arthroscopy data due mid 2012.

Sunesis Pharmaceuticals, Inc. (Nasdaq:SNSS) $1.27 – Phase 3 interim analysis of  vosaroxin in patients with first relapsed or refractory acute myeloid leukemia (AML), due mid-2012.

Synta Pharmaceuticals Corp. (NASDAQ: SNTA) $4.54 – Phase 2b data of ganetespib in combination with docetaxel in non-small cell lung cancer (NSCLC) due 2Q 2012.

Threshold Pharmaceuticals, Inc. (NASDAQ: THLD) $1.56 – TH-302 Phase 2 topline data for pancreatic cancer due mid-late February 2012. Also interim Phase 3 data for soft tissue sarcoma due late 2012.

Ventrus BioSciences, Inc. (Nasdaq:VTUS) $7.99 – 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) $12.05 – QNEXA for obesity. PDUFA date April 17, 2012.  Endocrinologic and Metabolic Drugs Advisory Committee meeting scheduled for February 22, 2012. PDUFA April 29 2012 of Avanafil for Erectile Dysfunction.

ZIOPHARM Oncology, Inc. (Nasdaq: ZIOP) $5.15- 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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