Archive for Daily News

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

Feb 05, 2016 No Comments by

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 by

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 by

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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ACAD Advisory Committee date set. SGYP submits Plecanatide NDA filing + IMGN GNCA SPPI updates

Jan 30, 2016 No Comments

Updates to the Company Pipeline Database for January 28, 2016 are as follows. Refer to the FDA Calendar for upcoming catalysts: Ticker Price Drug Indication Stage Summary ACAD 20.69 Pimavanserin Parkinson’s disease psychosis (PDP) PDUFA PDUFA date May 1 2016 of Pimavanserin for Parkinson’s disease psychosis (PDP) – under priority review. Psychopharmacologic Drugs Advisory Committee Meeting March 29 2016 […]

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EXEL PDUFA date set for June 22. RIGL Phase 3 data due mid year + updates for CORT NBIX

Jan 29, 2016 No Comments

Updates to the Company Pipeline Database for January 28, 2016 are as follows. Refer to the FDA Calendar for upcoming catalysts: Ticker Price Drug Indication Stage Summary CORT 3.28 Mifepristone in combination with eribulin Cancer – triple-negative breast cancer Phase 1/2 Phase 1/2 data due mid 2016 CORT 3.28 CORT125134 Cushing’s syndrome Phase 2 Phase 2 trial to be […]

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NEOS FDA Approval. INCY stops Phase 2 CRC trial. BIND NSCLC data due 1Q + CLVS VRTX TCON REPH OPHT FGEN updates

Jan 28, 2016 No Comments

Updates to the Company Pipeline Database for January 27, 2016 are as follows. Refer to the FDA Calendar for upcoming catalysts: Ticker Price Drug Indication Stage Summary BIND 1.75 BIND-014 iNSITE 1 Cancer – Non-small cell lung cancer (NSCLC) with squamous histology Phase 2 Phase 2 data due by end of 1Q 2016 BIND 1.75 BIND-014 iNSITE 2 Cancer […]

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MDWD Phase 2 data now due early February + updates for IMGN SNGX

Jan 27, 2016 No Comments

Updates to the Company Pipeline Database for January 26, 2016 are as follows. Refer to the FDA Calendar for upcoming catalysts: Ticker Price Drug Indication Stage Summary IMGN 9.18 Anetumab ravtansine Mesothelioma Phase 2 Announced late January 2016 that a milestone payment has been received from partner Bayer following the initiation of a Phase 2 trial MDWD 6.72 EscharEx […]

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ARQL Phase 3 interim analysis due early 2Q. OMED trial failure + CTIX CATB CYTX updates

Jan 26, 2016 No Comments

Updates to the Company Pipeline Database for January 25, 2016 are as follows. Refer to the FDA Calendar for upcoming catalysts: Ticker Price Drug Indication Stage Summary ARQL 1.82 Tivantinib (ARQ 197) METIV-HCC trial Inoperable Hepatocellular Carcinoma Who Have Been Treated With One Prior Therapy Phase 3 Phase 3 SPA agreed upon. Enrolment initiated Jan 2013. Dosage reduced following […]

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Clinical trial updates for ALKS CYTX RGLS VTVT

Jan 24, 2016 No Comments

Updates to the Company Pipeline Database for January 21-22, 2016 are as follows. Refer to the FDA Calendar for upcoming catalysts: Ticker Price Drug Indication Stage Summary ALKS 36.16 ALKS 5461 Major depressive disorder Phase 2 Phase 3 data from first two trials did not meet their endpoints. Update to be provided later in 1Q 2016 on the projected […]

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SRPT Adcom Meeting postponed. OGXI trial failure and updates for CBAY, AUPH

Jan 21, 2016 No Comments

Updates to the Company Pipeline Database from January 20, 2016 are as follows. Refer to the FDA Calendar for upcoming catalysts:   Ticker Price Drug Indication Stage Summary AUPH 1.86 Voclosporin Lupus Phase 2b Enrolment completed January 2015. Data due 3Q 2016 CBAY 1.00 Arhalofenate Gout Phase 3 Phase 3 planned for 2016 OGXI 0.76 Apatorsen and carboplatin and […]

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