BOSTON ( TheStreet) -- The October biotech calendar is chock-full of potentially stock moving events, including a dozen drugs facing U.S. approval decisions.
Phase III or pivotal studies that could report results in October:
- Bristol-Myers (BMY) Squibb's melanoma drug ipilimumab.
- Corcept Therapeutics' (CORT) Corlux in Cushing's syndrome.
- Seattle Genetics' (SGEN) brentuximab vedotin in anaplastic large cell lymphoma.
- Cyclacel Pharmaceuticals' (CYCC) seliciclib in non-small cell lung cancer.
FDA drug approval decision: Hospira' (HSP) Dyloject for acute moderate-to-severe pain in adults.FDA drug approval decisions: Johnson & Johnson (JNJ) Nucynta for pain indications. Oct. 4 FDA drug approval decision: Human Genome Sciences' (HGSI) Zalbin for hepatitis C. Oct. 8-12 European Society for Medical Oncology annual meeting. Data presentations to include Johnson & Johnson (JNJ) (abiraterone), Oxigene (OXGN) (Zybrestat), Seattle Genetics (SGN-75), Allos Therapeutics (ALTH) (Folotyn) and Arqule (ARQL) (ARQ197). The Obesity Society annual meeting. Stocks of interest include Arena Pharmaceuticals (ARNA), Vivus (VVUS - Get Report) and Orexigen Therapeutics (OREX). Oct. 11 FDA drug approval decision: Alexza Pharmaceuticals' (ALXA - Get Report) AZ-004 for agitation in patients with schizophrenia or bipolar disorder. FDA drug approval decision: Jazz Pharmaceuticals' (JAZZ) JZP-6 for fibromyalgia. Oct. 12 FDA drug approval decision: Alkermes (ALKS - Get Report) Vivitrol for opioid addiction. Oct 13-16 European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) annual meeting. Data presentations to include Sanofi-Aventis (SNY) (Teriflunomide), Biogen Idec (BIIB) and Elan (ELN) (Tysabri) and Genzyme (GENZ) (Campath). Oct. 18 FDA advisory panel to discuss the use of erythropoeisis-stimulating agents in the treatment of patients with chronic kidney failure. Amgen (AMGN) (Aranesp, Epogen), Johnson & Johnson (Procrit) and Affymax (AFFY) (Hematide). Oct. 19 BioMarin Pharmaceuticals (BMRN) analyst/investor day. Oct. 20 Genzyme third-quarter earnings announcement. Oct. 22 FDA drug approval decision: Arena Pharmaceuticals' (ARNA) lorcaserin for obesity FDA drug approval decision: Amylin Pharmaceuticals (AMLN), Alkermes and Eli Lilly's (LLY) Bydureon for diabetes. Oct. 28 FDA drug approval decision: Vivus' (VVUS - Get Report) Qnexa for obesity. Oct. 29 FDA drug approval decision: Avanir Pharmaceuticals' (AVNR) Zenvia for pseudobulbar affect. FDA drug approval decision: Forest Labs (FRX) ceftaroline for Community Acquired Pneumonia. Oct. 30 FDA drug approval decision: Biodel's (BIOD - Get Report) Linjeta for diabetes. Exact Sciences (EXAS - Get Report) presentation of external validation study of its genetic stool test for colon cancer. --Written by Adam Feuerstein in Boston.
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