Biotech Calendar: Key Dates for October
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) and Orexigen Therapeutics (OREX). Oct. 11 FDA drug approval decision: Alexza Pharmaceuticals' (ALXA) 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) 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) 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) Linjeta for diabetes. Exact Sciences (EXAS) presentation of external validation study of its genetic stool test for colon cancer. --Written by Adam Feuerstein in Boston.
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