Author Archive

Database updates for ACOR ACRS AEZS CTIX CYTX DCTH EYEG INCY SYN TGTX TRVN ZGNX

Jan 20, 2016 No Comments

Updates to the Company Pipeline Database from January 19, 2016 are as follows. Refer to the FDA Calendar for upcoming catalysts: Ticker Price Drug Indication Stage Summary ACOR 37.55 Tozadenant Parkinson’s disease Phase 3 Announced January 2016 that it entered into an agreement to acquire Biotie Therapies Corp which is currently in Phase 3 development of Tozadenant for Parkinson’s […]

Read more

SRPT down by over half following release of briefing documents. HRTX PDUFA delay. EBIO trial failure

Jan 16, 2016 No Comments

All updates to the Company Pipeline Database from January 15, 2016 are as follows. Refer to the FDA Calendar for upcoming catalysts: EBIO Loading… Isunakinra (EBI-005) Moderate to severe allergic conjunctivitis Phase 3 Phase 2 primary endpoint not met October 2014. Phase 3 data released January 2016, endpoint not met HRTX 22.71 APF530 – Sustol Prevention of acute- and […]

Read more

BMRN issued CRL for drisapersen. ADMP PDUFA date set. GERN KPTI initiate trials.

Jan 15, 2016 No Comments

BioMarin Pharmaceutical Inc. (Nasdaq:BMRN) announced on Thursday that the FDA issued a Complete Response Letter for Kyndrisa (drisapersen) for the treatment of Duchenne muscular dystrophy (Duchenne) amenable to exon 51 skipping. Investors now eagerly await the Peripheral and Central Nervous System Drugs Advisory Committee meeting on January 22, 2016 that will review the NDA for eteplirsen by Sarepta Therapeutics, Inc. (NASDAQ:SRPT). […]

Read more

AEZS and GALE give pipeline updates. GTXI and ESPR initiate Phase 2 and 3 trials

Jan 14, 2016 No Comments

Updates to the Company Pipeline Database from January 13, 2016 are as follows. Refer to the FDA Calendar for upcoming catalysts: AEZS 2.77 Zoptrex Cancer – castration- and taxane-resistant prostate cancer Phase 3 Phase 3 trial to be completed 2H 2016 ESPR 14.11 Bempedoic acid (ETC-1002-040) Hyperlipidemia whose LDL-C is not adequately controlled with low- and moderate-dose statins Phase […]

Read more

TTNP wins positive Advisory Committee vote for Probuphine + updates for ABIO PVCT ESPR IONS

Jan 13, 2016 No Comments

Titan Pharmaceuticals, Inc. (NASDAQ:TTNP) announced that the Psychopharmacologic Drugs Advisory Committee (PDAC) of the FDA voted 12 to 5 in favor of approving Probuphine, for the maintenance treatment of opioid addiction. Previously, the FDA issued a Complete Response Letter (CRL) in April 2013. The company resubmitted their New Drug Application (NDA) in August 2015 and their PDUFA date […]

Read more

65 pipeline updates predominantly from companies attending the JP Morgan Healthcare Conference

Jan 12, 2016 No Comments

Pipeline updates galore as companies give latest guidance at the JP Morgan Healthcare Conference. Click HERE to register for meeting information and webcasts. Latest updates to the Company Pipeline Database from January 11, 2016. Refer to the FDA Calendar for upcoming catalysts: ACOR 39.98 Dalfampridine Post stroke deficits Phase 2b/3 Phase 3 interim data due 2016 ACOR 39.98 CVT-301 […]

Read more

Pipeline updates from VRTX IMGN ABUS

Jan 10, 2016 No Comments

Latest updates to the Company Pipeline Database from January 10, 2016. Refer to the FDA Calendar for upcoming catalysts: ABUS 4.02 ARB-1467 (TKM-HBV, RNAi) Hepatitis B virus infection (HBV) Phase 2 Phase 2 initiated December 2015.HBsAg reduction results from single dose due 3Q 2016, multiple dose data due 4Q 2016 ABUS 4.02 TKM-PLK1 Hepatocellular carcinoma (HCC) Phase 2 Phase […]

Read more

Latest pipeline updates for ADXS CEMP CHMA CLBS CTIC CVM CYTK DERM KMDA OCRX ONTX ORMP RVNC SYN TKAI

Jan 09, 2016 No Comments

Please find below latest updates to the Company Pipeline Database added on January 8, 2016. Refer to the FDA Calendar for upcoming catalysts: Ticker Price Drug Indication Stage Summary ADXS 7.94 Axalimogene filolisbac – AIM2CERV Trial High-risk, locally advanced cervical cancer Phase 3 Phase 3 to commence in mid-2016 ADXS 7.94 Axalimogene filolisbac – GOG 0265 study Cervical cancer […]

Read more

33 IPOs added to the Pipeline Database + updates from DVAX QURE FGEN MSTX ARWR ANAC

Jan 08, 2016 No Comments

2015 IPOs have been added to the Company Pipeline Database and FDA Calendar, accordingly. The companies added are as follows: COLL, AAAP, ACRS, ADAP, ADRO, AIMT, AXON, AXSM, BLPH, CATB, CDTX, CHMA, CLCD, DMTX, DNAI, EDGE, EYEG, GBT, ITEK, KMPH, LIFE, LNTH, MCRB, NBRV, NEOS, NVCR, NVLS, RGNX, RTTR, VKTX, VTVT, VYGR, ZYNE. In addition, […]

Read more

Pipeline and trial updates for APRI CCXI TLOG REPH PRTK

Jan 07, 2016 No Comments

Latest updates to the Company Pipeline Database for January 6, 2016. Refer to the FDA Calendar for upcoming catalysts: APRI 4.17 RayVa Secondary Raynaud’s Phenomenon Phase 2a Phase 2b trial to be initiated 2H 2016 APRI 4.17 Fispemifene Men with symptomatic secondary hypogonadism. Phase 2 Phase 2b initated June 2015. Topline data due 1Q 2016 APRI 4.17 […]

Read more

Pipeline updates for ARDX CANF CNAT VCEL RDUS

Jan 06, 2016 2 Comments

Latest updates to the Company Pipeline Database for January 4, 2016. Refer to the FDA Calendar for upcoming catalysts: ARDX 16.46 RDX022 Hyperkalemia Phase 3 Phase 3 program to be initiated 2H 2016 CANF 2.85 CF101 Rheumatoid arthritis Phase 3 Phase 3 trial protocal submitted January 2016 – Israel CNAT 2.87 Emricasan Liver Cirrhosis Phase 2 Phase […]

Read more