OXGN hits primary endpoint. SNTA data release extension +updates for SSH and OGXI

Mar 12, 2014 No Comments by

OXiGENE, Inc. (Nasdaq:OXGN) announced that it met its primary endpoint of a statistically significant increase in progression-free survival in its Phase 2 clinical trial evaluating Avastin(bevacizumab) with or without ZYBRESTAT to treat patients with recurrent ovarian cancer. One of their secondary endpoints, objective response rate, was higher but not statistically significant. All patients will continue to be followed for […]

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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 by

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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PCYC FDA Approval. Offering priced for CHTP SNTA + updates for DSCI SGYP NKTR

Nov 13, 2013 No Comments by

Pharmacyclics, Inc. (NASDAQ: PCYC $123.82) announced that the FDA has approved IMBRUVICA (ibrutinib) as a single agent for the treatment of patients with mantle cell lymphoma (MCL) who have received at least one prior therapy. Synta Pharmaceuticals Corp. (NASDAQ: SNTA $3.78) announced that it has priced an underwritten public offering of 14,000,000 shares at a price to the […]

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FDA says no to early NDA filing for SRPT + CHTP offering+ updates for APPA GTXI OREX SNSS SNTA SPPI ARIA PBYI CLSN KBIO ARIA PBYI OXGN BDSI SGYP ONTX MGNX

Nov 13, 2013 No Comments

Chelsea Therapeutics International, Ltd. (Nasdaq:CHTP) announced that it plans to offer shares of its common stock in an underwritten public offering. A.P. Pharma, Inc. (OTCBB: APPA.OB) said that their resubmission of the NDA for Sustol (formerly known as APF530) is targeted for 1Q 2014 GTx, Inc. (Nasdaq: GTXI) said that they expect to complete enrollment of their Phase […]

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RPTP FDA Appovel + Pipeline updates for GTXI SNTA OGXI MNTA IDIX DVAX QCOR

May 01, 2013 No Comments

Raptor Pharmaceutical Corp. (Nasdaq: RPTP) announced that the FDA has approved PROCYSBI (cysteamine bitartrate) delayed release capsules for the treatment of nephropathic cystinosis in adults and children 6 years and older. Dynavax Technologies Corporation (NASDAQ: DVAX) reported that it will meet in the first half of June with the FDA regarding the its Biologic License Application (BLA) for HEPLISAV, […]

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Pipeline updates and news for MACK NBY ANAC CCXI VNDA SNTA CERS

Mar 15, 2013 No Comments

Synta Pharmaceuticals Corp. (NASDAQ: SNTA) announced that it expects to release overall survival results from its GALAXY-1 trial evaluating ganetespib as second-line treatment of non-small cell lung cancer, during mid-2013 and intends to commence enrolment in its Phase 3 GALAXY-2 trial this month. Interim and final data are expected in 2014. Updates from its Phase 2 ENCHANT trial, of ganetespib monotherapy […]

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CHMP issues negative opinion for VNDA. LGND PDUFA date set + news from CYTX INFI SRPT SNTA AUXL CERS THRX YMI SCMP ACAD SOMX

Dec 14, 2012 No Comments

Vanda Pharmaceuticals Inc.(NASDAQ: VNDA), announced today that the European Medicines Agency’s (EMA) Committee for Medicinal Product for Human Use (CHMP) has issued a negative opinion recommending against approval of Fanaptum (oral iloperidone tablets) for the treatment of schizophrenia in adult patients in the European Union. Cytori Therapeutics, Inc. (NASDAQ: CYTX) today announced that it intends to […]

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IMGN PDUFA date set. Pipeline updates from ACRX ALXA ARNA TRGT INFI ISIS RIGL OGXI

Nov 07, 2012 No Comments

ImmunoGen, Inc. (Nasdaq: IMGN) announced that Roche has been granted priority review for trastuzumab emtansine for the treatment of people with HER2-positive, unresectable locally advanced or metastatic breast cancer who have received prior treatment with Herceptin and a taxane chemotherapy. The PDUFA date is February 26, 2013. It also disclosed that its Marketing Authorization Application for trastuzumab emtansine for people […]

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THR/TBGNF positive Adcom vote. AMRN and HZNP FDA Approval. SCMP files sNDA. SNTA offering. EXEL initiates Phase 2 NSCLC trial.AEZS update.

Jul 27, 2012 No Comments

ThromboGenics NV (Euronext Brussels: THR) (PINK:TBGNF) - The FDA Dermatologic and Ophthalmic Drugs Advisory Committee recommended that ocriplasmin be granted approval for the treatment of symptomatic Vitreomacular Adhesion (VMA) by a vote of 10 to 0. The PDUFA date is 17 October, 2012. Amarin Corporation plc (Nasdaq:AMRN) announced the FDA has approved Vascepa capsules (AMR101) as a treatment to reduce triglyceride levels in […]

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IDRA Phase 2 trial failure. Pipeline updates for GERN CLDX NBY ONCY + SNSS news

May 03, 2012 No Comments

Geron Corporation (Nasdaq: GERN) today announced that it has completed enrollment of its Phase 2 trial of imetelstat, as maintenance therapy following platinum-based induction therapy for patients with advanced non-small cell lung cancer (NSCLC). Top-line results are expected by before the end of 4Q 2012. Synta Pharmaceuticals Corp. (NASDAQ: SNTA) today provided an update on its Phase […]

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Upcoming FDA and clinical catalysts as of April 10 2012

Apr 10, 2012 No Comments

Some short and long term potential catalysts as of April 9, 2012 (share prices as at the close of trading Monday, April 9, 2012). See the links in the FDA Calendar for more details about each catalyst. The possible catalysts listed below represent both short and long opportunities. It is NOT a recommendation to take […]

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