FDA Calendar updated + change in news format

Nov 27, 2014 2 Comments

BioPharmCatalyst is pleased to let readers know that the FDA Calendar has been fully updated following the recent publication of 3Q financial results. BioPharmCatalyst will also be trialing a new format to inform readers of the latest changes to the website. Instead of providing a daily summary of day’s news, readers will be provided with […]

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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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BDSI Phase 3 data due 1Q 2015 + updates for CCXI INSV DCTH TRGT MSTX MDCO

Nov 05, 2014 No Comments

BioDelivery Sciences International, Inc. (NASDAQ: BDSI) provided an update that  top-line results from their pivotal Phase 3 trial for Clonidine Topical Gel for the treatment of painful diabetic neuropathy (PDN), are due near the end of 1Q 2015. They also noted that they intend to submit a New Drug Application (NDA) by year-end or early 2015 for BEMA Buprenorphine. […]

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EXEL Phase 3 data due 2Q 2015 + upcoming catalyst dates for XNPT IRWD ACHN AQXP + LXRX XOMA updates

Nov 04, 2014 No Comments

Exelixis, Inc. (NASDAQ:EXEL) provided an update noting that top-line results from their pivotal Phase 3 trial METEOR in metastatic renal cell carcinoma, are now anticipated in 2Q 2015. XenoPort, Inc. (Nasdaq: XNPT) provided an update noting that top-line data from their Phase 2 XP23829 trial as a potential treatment for patients with moderate-to-severe chronic plaque-type psoriasis and/or relapsing forms of […]

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NBIX Phase 3 data due January + other catalyst dates for ALDR MCUR THLD

Nov 04, 2014 No Comments

Neurocrine Biosciences, Inc. (NASDAQ:NBIX) provided an update noting that Phase 3 topline efficacy data for elagolix in endometriosis are due in January 2015 and Phase 2b efficacy data for elagolix in uterine fibroids are due later in 2015. Also, top-line efficacy data from the initial six weeks of the Kinect 3 trial of NBI-98854 in tardive dyskinesia are due […]

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NYMX fails to reach endpoints in Phase 3 BPH trial

Nov 02, 2014 No Comments

Nymox Pharmaceutical Corporation (NASDAQ: NYMX) announced on Sunday that the their two Phase 3 studies of NX-1207 for the treatment of BPH, NX02-0017 and NX02-0018, failed to meet their primary efficacy endpoints. Full results will be reported at a later date. The company will hold a teleconference for shareholders on Monday, November 3, 2014 at 4:30 pm Eastern […]

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Pipeline updates for ZIOP OGXI VSTM GWPH AUXL ASPX GEVA ACOR INCY

Oct 30, 2014 No Comments

Incyte Corporation(Nasdaq: INCY) provided an update noting that data from two pivotal double-blind, placebo-controlled Phase 3 trials (JANUS 1 and JANUS 2) of ruxolitinib for advanced or metastatic pancreatic cancer are expected in 2016. Data from the first of the Phase 3 trials of baricitinib in patients with rheumatoid arthritis, being conducted by Lilly are is expected […]

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CTIC and CEMP Phase 3 data due 1Q 2015 + pipeline updates for SNTA + CMRX offering

Oct 29, 2014 No Comments

CTI BioPharma Corp. (CTI) (NASDAQ: CTIC) provided an update, maintaining previous guidance that they continue to expect data from their PERSIST-1 pivotal Phase 3 trial of pacritinib for patients with myelofibrosis in 1Q 2015. Cempra, Inc. (Nasdaq:CEMP) also provided an update noting that data from their Phase 3 trial of oral solithromycin in adult patients with moderate […]

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RCPT hits endpoints. PFE returns Remoxy rights. SRPT NDA filing delay. RGLS VNDA offerings + HTBX ADMS updates.

Oct 28, 2014 No Comments

Receptos, Inc. (Nasdaq:RCPT) announced that TOUCHSTONE, the Phase 2 trial of RPC1063 in ulcerative colitis (UC), met its primary endpoint and all secondary endpoints with statistical significance in patients on the 1 mg dose of RPC1063 in the 8-week induction period. A Phase 3 trial is planned for 2015. The company also plan to initiate a […]

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