BPC June 6 updates: DNAI OCUL plummet following data. ADMP issued CRL. MSTX delays Phase 3 Sickle cell disease data + updates for ADXS AEZS ARRY CARA GLYC IMMU ONTY

Jun 07, 2016 No Comments by

Updates to the Company Pipeline Database for June 6, 2016, are as follows. Refer to the FDA Calendar for upcoming catalysts: Ticker Price Drug Indication Stage Summary ADMP 4.09 Epinephrine Pre-filled Syringe (PFS) Emergency treatment of anaphylaxis. CRL CRL issued March 27 2015. NDA resubmitted. CRL issued again June 6, 2016. Intends to submit more data 2H 2016 ADXS […]

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BPC May 19 updates – PTIE DRRX Advisory Committee Meeting set for August 5 + updates for AGIO ASND GBT IMMU INFI ONCE QURE STML TENX TNXP

May 19, 2016 No Comments by

Updates to the Company Pipeline Database for May 19, 2016, are as follows. Refer to the FDA Calendar for upcoming catalysts: Ticker Price Drug Indication Stage Summary AGIO 45.30 AG-348 Pyruvate kinase deficiency Phase 2 Phase 2 first data due at European Hematology Association (EHA) in June 11 2016 ASND 14.03 TransCon Growth hormone deficiency in children Phase 2 Phase […]

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HRTX says no substantive deficiencies with NDA filing + updates for FCSC IMMU OTIC RDHL STEM TTHI

Apr 18, 2016 No Comments by

Updates to the Company Pipeline Database for April 18, 2016 are as follows. Refer to the FDA Calendar for upcoming catalysts: Ticker Price Drug Indication Stage Summary FCSC 2.56 FCX-007 Recessive dystrophic epidermolysis bullosa Phase 1/2 Phase 1/2 to be initiated 2Q 2016 HRTX 21.49 APF530 – Sustol Prevention of acute- and delayed-onset chemotherapy-induced nausea and vomiting (CINV) PDUFA […]

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GWPH and CPXX rocket on positive data releases. IMMU terminates Phase 3 pancreatic trial. KMPH Adcom May 5 + ATNM BLCM BSTC CCXI CUR CYAD INO MSTX NERV PRTO QURE RTTR TSRO updates

Mar 14, 2016 No Comments

Updates to the Company Pipeline Database for March 14, 2016 are as follows. Refer to the FDA Calendar for upcoming catalysts: Ticker Price Drug Indication Stage Summary ATNM 1.99 Actimab-A Acute Myeloid Leukemia (AML) Phase 2 Phase 2 to commence mid-2016 BLCM 10.03 BPX-501 Adjunct T-cell therapy administered after allogeneic HSCT – (hematopoietic stem cell transplantation) Phase 1/2 Phase […]

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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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CANF data due by end of March. IMMU lupus data due 1H + pipeline updates for GWPH BIND IRWD MSTX

Feb 05, 2015 No Comments

Latest updates to the Company Pipeline Database for February 4, 2015. Refer to the FDA Calendar for upcoming catalysts: Ticker Price Drug Indication Stage Link Text Updated BIND 6.34 BIND-014 Cancer – KRAS mutant Non-small cell lung cancer (NSCLC) Phase 2 Preliminary data due 2H 2015 2/5/2015 BIND 6.34 BIND-014 Cancer – Squamous histology NSCLC […]

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Upcoming data for CUR KBIO NKTR. AVNR approval delay likely. DVAX reverse split + AEZS RMTI GNCA HRTX IMMU TLOG OPK DSCO ANAC IMMU HPTX SPPI RPTP CMRX VSAR

Nov 08, 2014 No Comments

Neuralstem, Inc. (NYSE MKT: CUR) announced that the Phase 2 data lock of NSI-566 spinal cord-derived stem cell therapy for the treatment of amyotrophic lateral sclerosis (ALS) is scheduled to conclude in late January 2015 at which time the company anticipates providing its Phase 2 ALS results. The company also noted that a Phase 2 trial of NSI-189 for […]

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ECYT Phase 3 trial halted + pipeline updates for ACOR MACK TRVN ITMN NBY VTL

May 04, 2014 No Comments

Merck (NYSE:MRK) and Endocyte, Inc. (NASDAQ:ECYT) announced that the Data Safety Monitoring Board (DSMB) of the PROCEED trial has recommended that the trial be stopped because vintafolide did not demonstrate efficacy on the pre-specified outcome of Progression-Free Survival (PFS) in patients with platinum-resistant ovarian cancer. Acorda Therapeutics, Inc. (Nasdaq:ACOR) announced that the FDA has issued […]

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ICPT wows the biotech world. ITMN Ph3 data due early 2Q. IMMU initiates Ph3 pancreatic trial + SNTA AEGR BOTA XLRN news

Jan 10, 2014 No Comments

Intercept Pharmaceuticals, Inc. (Nasdaq:ICPT $257.87) announced that the Phase 2 FLINT trial of obeticholic acid (OCA) for the treatment of nonalcoholic steatohepatitis (NASH) has been stopped early for efficacy based on a planned interim analysis showing that the primary endpoint of the trial has been met. They also noted that data from their Phase 3 POISE trial of obeticholic […]

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CPRX receives Breakthrough Designation. RIGL fails Phase 2 trial. OREX NDA due end of 2013 + updates for SGMO QRXPY OGXI ONXX AMGN IMMU

Aug 28, 2013 No Comments

Catalyst Pharmaceutical Partners, Inc. (Nasdaq:CPRX $2.01)  announced that Firdapse, currently in Phase 3 development, has received “Breakthrough Therapy Designation” by the FDA for the treatment of patients with Lambert-Eaton Myasthenic Syndrome (LEMS). Rigel Pharmaceuticals, Inc. (Nasdaq: RIGL $3.11) announced that R343, for patients with allergic asthma, did not meet the primary or secondary endpoints in a Phase 2 […]

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