Author Archive

EVOK Phase 3 data due ahead of schedule + updates for PTN EVOK GALE

Sep 10, 2014 No Comments

Evoke Pharma, Inc. (Nasdaq:EVOK) announced that it has completed enrollment of its Phase 3 trial of EVK-001 for the relief of symptoms associated with acute and recurrent gastroparesis in women with diabetes mellitus. Top-line data are due later in 2014, rather than in mid-2015 as was noted in previous guidance. Palatin Technologies, Inc. (NYSE MKT: PTN) provided […]

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TSRO OPK submit rolapitant NDA. HPTX terminates DiaPep277 trial + VTL update

Sep 09, 2014 No Comments

OPKO Health, Inc. (NYSE:OPK) announced that TESARO, Inc. (Nasdaq:TSRO) has submitted a New Drug Application (NDA) to the FDA for oral rolapitant, for the prevention of chemotherapy-induced nausea and vomiting (CINV). Vital Therapies, Inc. (Nasdaq:VTL) provided an update on their VTI-208 clinical trial  in alcohol induced liver decompensation noting that preliminary results are expected in 1H 2015. Hyperion […]

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KERX FDA Approval + updates for ALKS FLXN BLRX

Sep 06, 2014 No Comments

Keryx Biopharmaceuticals, Inc. (Nasdaq:KERX) announced that the FDA has approved Ferric Citrate (formerly known as Zerenex) for the control of serum phosphorus levels in patients with chronic kidney disease (CKD) on dialysis. Alkermes plc (NASDAQ: ALKS) announced completion of patient enrollment in a Phase 2 trial of ALKS 3831, for the treatment of schizophrenia. Top-line data are […]

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Clinical updates for SPHS MEIP SLXP CLSN CNAT ADHD TTPH

Sep 03, 2014 No Comments

Sophiris Bio Inc. (NASDAQ: SPHS) announced that it has fully enrolled its ongoing Phase 3 trial (referred to as PLUS-1) of PRX302 as a treatment for lower urinary tract symptoms of BPH. An interim analysis is due around the end of 2014, with complete data in 2H 2015. MEI Pharma, Inc. (Nasdaq: MEIP) announced that it has completed […]

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EXEL Phase 3 COMET-1 trial fails to meet primary endpoint.

Sep 02, 2014 No Comments

Exelixis, Inc. (NASDAQ:EXEL) announced that it did not meet the primary endpoint following release of top-line results from their Phase 3 COMET-1 of cabozantinib in men with metastatic castration-resistant prostate cancer (mCRPC) whose disease progressed after treatment with docetaxel as well as abiraterone and/or enzalutamide. The median OS for the cabozantinib arm of the trial was 11.0 […]

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Updates for AVNR and ZSPH

Aug 27, 2014 No Comments

Avanir Pharmaceuticals, Inc. (NASDAQ: AVNR) announced the enrollment of the first patient into a Phase 2 trial to evaluate the efficacy and safety of AVP-786 for the adjunctive treatment of major depressive disorder (MDD). Concert Pharmaceuticals, Inc. (NASDAQ:CNCE) receives a $2 million milestone under its development and license agreement with Avanir Pharmaceuticals, Inc. ZS Pharma (Nasdaq: ZSPH) announced that a […]

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ITMN to be acquired by Roche. RGDO halts Phase 3 trial. ALKS files NDA. IMMU lupus data due 1H 2015

Aug 26, 2014 No Comments

Regado Biosciences, Inc. (NASDAQ: RGDO) announced the permanent termination of enrollment in its REGULATE-PCI Phase 3 trial following a recommendation from the trial’s Data and Safety Monitoring Board (DSMB) following their analysis of serious allergic adverse events. Roche (SIX: RO, ROG; OTCQX: RHHBY) and InterMune, Inc. (NASDAQ: ITMN) announced they have entered into a definitive merger agreement […]

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NKTR AUXL OGXI clinical trial data and updates

Aug 21, 2014 No Comments

Nektar Therapeutics (NASDAQ: NKTR) noted that their partner Baxter International Inc.  will file a Biologics License Application (BLA) for BAX 855 for hemophilia A before the end of 2014. This follows positive data released from a Phase 3 trial. Auxilium Pharmaceuticals, Inc.(NASDAQ: AUXL) noted that it will initiate a Phase 2b trial of collagenase clostridium histolyticum (or […]

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FOLD meets endpoints in Phase 3 trial. NBY fails Phase 2 conjunctivitis trial.

Aug 21, 2014 No Comments

NovaBay Pharmaceuticals, Inc. (NYSE MKT:NBY) announced that its NVC-422 ophthalmic formulation did not meet the primary or secondary endpoints in a Phase 2 clinical study in patients with adenoviral conjunctivitis. Amicus Therapeutics (Nasdaq:FOLD) announced that it met both co-primary endpoints following positive 18-month data from its second Phase 3 study (Study 012) of  migalastat HCl (migalastat) in […]

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ASPX Phase 3 data due 4Q. ONTY fails Phase 1/2 NSCLC trial.

Aug 19, 2014 No Comments

Auspex Pharmaceuticals, Inc. (Nasdaq:ASPX) announced that it has completed the enrollment in its Phase 3 trial of SD-809 for the treatment of chorea associated with Huntington’s disease (HD). The company expects to announce top-line data in 4Q 2014. Oncothyreon Inc. (NASDAQ:ONTY) was informed by their partner Merck KGaA that a Phase 1/2 study, EMR 63325-009, of tecemotide […]

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Updates to FDA Calendar

Aug 18, 2014 No Comments

BioPharmCatalyst is pleased to update readers that following the recent filing of financial reports for 2Q, all catalysts in the FDA Calendar have been updated using the most recent press releases and filings. Readers can find the updated FDA Calendar HERE. Daily news updates will resume from tomorrow.

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