Author Archive

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

Sep 02, 2014 No Comments by

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 by

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 by

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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Updates to Company Pipeline database

Aug 09, 2014 No Comments

This is a brief note to inform readers that although there have not been daily posts made over the last few days, the Company Pipeline Database continues to be updated. Over 100 updates have been made to the Company Pipeline Database over the last week. Corresponding updates have also been made to the FDA Calendar. Click the “Updated” […]

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INSM to initiate two Phase 3 ARIKAYCE trials. HRTX NDA filing due 4Q + NPSP IRWD HTBX trial updates

Aug 05, 2014 No Comments

Heron Therapeutics, Inc. (NASDAQ: HRTX) noted that their new drug application (NDA) of SUSTOL for the prevention of delayed-onset chemotherapy-induced nausea and vomiting (CINV) in patients receiving highly emetogenic chemotherapy (HEC) agents will be filed in 4Q 2014. Insmed Incorporated (Nasdaq: INSM) announced that it will initiate two Phase 3 studies of ARIKAYCE for the treatment of nontuberculous mycobacteria (NTM) lung […]

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Pipeline updates and news over the previous week from 20 companies.

Aug 03, 2014 No Comments

Pacira Pharmaceuticals, Inc.(NASDAQ: PCRX) noted that the FDA has set a PDUFA date of March 5, 2015 for the supplemental New Drug Application (sNDA) for a nerve block indication for EXPAREL. NovaBay Pharmaceuticals, Inc. (NYSE MKT:NBY) said that their BAYnovation trial for viral conjunctivitis has been completed and top-line results are due in mid-August 2014. Threshold Pharmaceuticals, Inc. (NASDAQ: THLD) maintained guidance that the pre-planned […]

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ACRX receives CRL. TSRO NDA filing due by early September + pipeline updates for GLMD ESPR

Jul 27, 2014 No Comments

AcelRx Pharmaceuticals, Inc. (Nasdaq: ACRX) announced that the FDA has issued a Complete Response Letter (CRL) for the new drug application (NDA) for Zalviso. The CRL contains requests for additional information on the Zalviso System to ensure proper use of the device. Galmed Pharmaceuticals Ltd. (Nasdaq: GLMD) provided an update noting that Phase 2b interim data from their […]

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