Originally Posted by glsharsha  Small Cap Biotech Pharma in Phase III
ACADIA Pharmaceuticals (ACAD)
Phase III: Pimavanserin development for Parkinson's disease psychosis in collaboration with Biovail. ACADIA completed enrollment in the first pivotal Phase III trial of Pimavanserin in patients with Parkinson’s disease psychosis (PDP) in May 2009.
UPDATED: ACADIA expects to report top-line results from this trial in the third quarter of 2009 (November 5 2009).
ARIAD Pharmaceuticals, Inc. (ARIA)
Phase III: Ridaforolimus in treatment for Sarcoma. ARIAD is collaborating with Merck & Co., Inc. (“Merck”) to globally develop and commercialize ridaforolimus
Medivation, Inc. (MDVN)
Phase III: Dimebon an investigational drug for treatment in patitients with Huntington disease.
Update: July 30, 2009. Pfizer Inc (PFE) and Medivation, Inc. (MDVN) announced the initiation of a Phase 3 trial of the investigational drug dimebon (latrepirdine) in patients with Huntington disease.
Amicus Therapeutics (FOLD)
Phase III: Amigal(TM) (migalastat hydrochloride) for the treatment of Fabry disease
Update: June 23, 2009. Amicus Therapeutics today announced it has commenced the U.S. registration Phase 3 trial with its investigational drug, Amigal(TM) (migalastat hydrochloride) for the treatment of Fabry disease.
Oncothyreon Inc (ONTY)
Phase III: Stimuvax(R) treatment of metastatic breast cancer
Update: June 22, 2009. Today announced that Merck KGaA of Darmstadt, Germany, has initiated a global Phase 3 trial of Stimuvax(R) (BLP25 liposome vaccine, L-BLP25) in patients with hormone receptor-positive, locally advanced, recurrent or metastatic breast cancer.
OSI Pharmaceuticals, Inc. (OSIP)
Phase III: Tarceva in treatment of patients with advanced non-small cell lung cancer (NSCLC)
Update: August 3, 2009, announced further results from the Phase III SATURN study showing that Tarceva extended the survival of patients with advanced non-small cell lung cancer (NSCLC) when used as single agent, maintenance therapy in patients who did not progress following first-line treatment with platinum-based chemotherapy.
VIVUS, Inc.(VVUS)
Phase III: Qnexa in treatment of obesity
Update: Jul 7, 2009, Qnexa is a combination of two existing drugs, phentermine and topiramate (marketed for epilepsy and migraine as Topamax) obesity candidate under development today. EQUIP and CONQUER data on track for mid-2009 year end.
Orexigen Therapeutics, Inc. (OREX)
Phase III: Contrave investigational drug for the treatment of obesity, met their co-primary endpoints
Update: July 20, 2009. OREX announced that all three remaining Phase 3 trials evaluating Contrave(R), its investigational drug for the treatment of obesity, met their co-primary endpoints. The results from the successfully completed Contrave Obesity Research, or COR, program of more than 4,500 patients exceed the FDA categorical efficacy benchmark for clinically significant weight loss, supporting the Company's plan to file a New Drug Application (NDA) with the US Food and Drug Administration (FDA) in the first half of 2010.,
MAP Pharmaceuticals, Inc. (MAPP)
Phase III: Levadex, novel in treatment of migraine
Update: May 26, 2009. MAP Pharmaceuticals, Inc. (Nasdaq: MAPP) announced that the efficacy portion of its first Phase 3 clinical trial evaluating its novel LEVADEX(TM) orally inhaled migraine therapy met all four primary endpoints.
Avanir Pharmaceuticals(AVNR)
Phase III: Zenvia drug reduced emotional outbursts tied to a little-known neurological disorder, meeting the main goal of a late-stage study.
Update: Aug 11, 2009 drug to treat pseudobulbar affect met its primary efficacy endpoint in a Phase III trial
Halozyme Therapeutics, Inc. (HALO)
Phase III: GAMMAGARD LIQUID with rHuPH20 for the treatment of primary immunodeficiency disorder
Update: Aug 07, 2009. Patient enrollment has been completed in the Phase 3 pivotal study of GAMMAGARD LIQUID with rHuPH20 for the treatment of primary immunodeficiency disorder
Keryx Biopharmaceuticals, Inc. (KERX)
Phase III: PI3K/Akt pathway inhibitor, KRX-0401 (perifosine)
Update: August 3, 2009. announced today that it has reached agreement with the U.S. FDA regarding a Special Protocol Assessment on the design of a Phase 3 trial for its PI3K/Akt pathway inhibitor, KRX-0401 (perifosine), in relapsed or relapsed / refractory multiple myeloma patients previously treated with bortezomib (VELCADE((R)))
Osiris Therapeutics, Inc. (OSIR)
Phase III: Prochymal
Update: Prochymal is being evaluated in Phase III clinical trials for three indications, including acute and steroid refractory Graft versus Host Disease (GvHD), Crohn's disease and for the repair of gastrointestinal injury resulting from radiation exposure, and is the only stem cell therapeutic granted both Orphan Drug and Fast Track status by the United States Food and Drug Administration (FDA)
Inspire Pharmaceuticals, Inc (ISPH)
Phase III: Denufosol for CF
Update: August 04, 2009. Inspire just reported positive phase III data of Denufosol for CF. Company has a strong collaborative alliance with Allergan Pharmaceuticals for key products that treat dry eyes and allergic conjunctivitis
Vical Incorporated (VICL)
Phase 3: Allovectin-7(r) Immunotherapeutic for Metastatic Melanoma
Isis Pharmaceuticals, Inc. (ISIS)
Phase III: of mipomersen, a novel lipid-lowering drug
Update: Aug 2008 (GENZ) and Isis Pharmaceuticals, Inc. (ISIS) announced that they have begun a phase 3 study of mipomersen in patients with heterozygous familial hypercholesterolemia (heFH), a genetic disorder that causes exceptionally high levels of LDL cholesterol. It is the first of four new trials the companies plan to initiate by the end of this year, and the second late-stage study of mipomersen, a novel lipid-lowering drug that utilizes antisense technology. The primary endpoint will be percent reduction in LDL cholesterol, and data are expected to be available in 2010
Dyax Corp (DYAX)
Phase III: DX-88 in the treatment of hereditary angioedema (HAE)
Update: The second Phase 3 trial, EDEMA4, was conducted under a Special Protocol Assessment (SPA). DX-88 has orphan drug designation in the U.S. and E.U., as well as Fast Track designation in the U.S. for the treatment of acute attacks of HAE.
JAZZ Pharmaceutical (JAZZ)
Phase III: JZP-6 (sodium oxybate) to address three important symptoms of fibromyalgia: pain, fatigue and sleep disturbances
Update: On June 24, 2009, Jazz Pharmaceuticals announced that the results of its second Phase III clinical trial of the JZP-6 product candidate were positive and consistent with the results of the first Phase III study, and that JZP-6 achieved its primary endpoint in both Phase III studies. New Drug Applications is expected to be submitted to the Food and Drug Administration later this year for JZP-6.
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