CLVS Advisory Committee date set for April 12 + EPIX update

Feb 13, 2016 No Comments by

Updates to the Company Pipeline Database for February 12, 2016 are as follows. Refer to the FDA Calendar for upcoming catalysts: Ticker Price Drug Indication Stage Summary CLVS 18.97 Rociletinib Cancer – mutant EGFR T790M-positive lung cancer PDUFA Original PDUFA date of March 30, 2016 delayed due to release of data during review cycle of much lower than expected […]

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INCY discontinues Phase 3 JANUS trial + updates for GNCA ALNY NAVB

Feb 12, 2016 No Comments by

Updates to the Company Pipeline Database for February 11, 2016 are as follows. Refer to the FDA Calendar for upcoming catalysts: Ticker Price Drug Indication Stage Summary ALNY 56.96 Patisiran APOLLO Familial Amyloidotic Polyneuropathy (FAP) in Patients with ATTR Phase 3 Phase 3 enrolment completed late January 2016. Data due 2017, with NDA to be filed late 2017 assuming […]

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KMPH PDUFA date set and granted priority review. GWPH data due March + updates for XENE HTBX NBIX VNDA

Feb 11, 2016 No Comments by

Updates to the Company Pipeline Database for February 10, 2016 are as follows. Refer to the FDA Calendar for upcoming catalysts: Ticker Price Drug Indication Stage Summary GWPH 43.62 GWP42004 Type 2 diabetes Phase 2 Phase 2 data due 2Q 2016 GWPH 43.62 Sativex Multiple Sclerosis (MS) spasticity Phase 2 Phase 2 data due 2H 2016 GWPH 43.62 Sativex […]

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CTIC NDA withdrawn following full clinical hold + updates for BLPH EPRS INSY NYMX OHRP SGEN TBRA VTVT

Feb 10, 2016 No Comments

Updates to the Company Pipeline Database for February 9, 2016 are as follows. Refer to the FDA Calendar for upcoming catalysts: Ticker Price Drug Indication Stage Summary BLPH 2.84 INOpulse delivery device Pulmonary Arterial Hypertension (PAH) Phase 3 Phase 3 to commence in 2016 CTIC 0.50 Pacritinib -PERSIST-1 Myelofibrosis NDA filing withdrawn Announced February 9, 2016 that NDA submission […]

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SRPT PDUFA date extension. BCRX Phase 2 trial fail. CTIC Pacritinib placed on clinical hold + AVXL OMED BOTA CYTX RNN updates

Feb 09, 2016 No Comments

Updates to the Company Pipeline Database for February 8, 2016 are as follows. Refer to the FDA Calendar for upcoming catalysts: Ticker Price Drug Indication Stage Summary AVXL 4.32 ANAVEX 2-73 Mild to moderate Alzheimer’s disease Phase 2a Phase 2a interim data released January 2016. Trial is ongoing. Additional Phase 2/3 trial planned BCRX 1.78 BCX4161 – OPuS-2 Hereditary […]

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VRTX issued CRL for KALYDECO + updates for BOTA CEMP DPRX IMMU OGXI SPHS

Feb 05, 2016 No Comments

Updates to the Company Pipeline Database for February 4 and 5, 2016 are as follows. Refer to the FDA Calendar for upcoming catalysts: Ticker Price Drug Indication Stage Summary BOTA 1.51 Vapendavir – SPIRITUS trial Human rhinovirus (HRV) Phase 2b Phase 2b top-line data due 2H 2016 BOTA 1.51 BTA074 5% topical gel Condyloma Phase 2 Phase 2 patient […]

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HTBX Phase 2 bladder cancer trial placed on clinical hold + updates for IMMU OXGN

Feb 04, 2016 No Comments

Updates to the Company Pipeline Database for February 3, 2016 are as follows. Refer to the FDA Calendar for upcoming catalysts: Ticker Price Drug Indication Stage Summary HTBX 2.02 HS-410 Cancer – bladder cancer Phase 2 Phase 2 initiated Oct 2014. Data due 4Q 2016. Trial placed on partial clinical hold in early February 2016. IMMU 1.72 Clivatuzumab tetraxetan […]

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BNHLF receives expected CRL. SYN Phase 2 trial fail. ARRY Phase 3 data due 2016 + MDWD NBIX HSGX updates

Feb 03, 2016 No Comments

Updates to the Company Pipeline Database for February 2, 2016 are as follows. Refer to the FDA Calendar for upcoming catalysts: Ticker Price Drug Indication Stage Summary ARRY 3.05 Binimetinib (NEMO) Cancer – NRAS melanoma Phase 3 Endpoint met December 2015. NDA filing expected 1H 2016 ARRY 3.05 Selumetinib – SELECT-1 Cancer – differentiated thyroid cancer Phase 3 Phase […]

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ALNY completes Phase 3 APOLLO enrollment + updates for ARIA CBYL DSCO REPH TENX TTHI

Feb 02, 2016 No Comments

Updates to the Company Pipeline Database for February 1, 2016 are as follows. Refer to the FDA Calendar for upcoming catalysts: Ticker Price Drug Indication Stage Summary ALNY 69.75 Patisiran APOLLO Familial Amyloidotic Polyneuropathy (FAP) in Patients with ATTR Phase 3 Phase 3 enrolment completed late January 2016. Data due 2017, with NDA to be filed late 2017 assuming […]

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