Updates for GALE SCMP BLRX APPA RPTP ACOR RLYP INFI HALO ARNA CLVS SGEN ICPT GILD CUR MRK CYCC CRIS ACHN

Jan 13, 2014 No Comments by

Curis, Inc.(NASDAQ:CRIS) provided an update noting that Phase 2 data of everolimus for Operable Nodular BCC (basal cell carcinoma) are due 1Q 2014. Their submission to the FDA regarding the partial clinical hold of CUDC-427 is due shortly. A Phase 2 trial of Debio 0932 is due to be to initiated in 2H 2014. Galena Biopharma (Nasdaq:GALE) announced it has […]

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CNDO Phase 2 trial halted. MACK data release delay. ARQL data due 1Q 2014 + pipeline updates for AVEO APPY INSV NKTR APPY CCXI BCRX OXXI ANAC AMBI TSRO INFI + SLXP SNTS TTPH news

Nov 08, 2013 No Comments by

Coronado Biosciences, Inc. (NASDAQ: CNDO $1.63) announced that the Independent Data Monitoring Committee (IDMC) recommended that their Phase 2 clinical trial in Europe evaluating Trichuris suis ova (TSO) in Crohn’s disease be stopped due to lack of efficacy. AVEO Oncology (NASDAQ: AVEO $2.07) provided an update noting that data are anticipated in 2014 from the Phase 2 trial […]

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NKTR misses Phase 2 endpoint. DRTX files NDA + updates for SNSS SRPT INFI EXEL ACOR AMAG NYMX

Sep 26, 2013 No Comments by

Nektar Therapeutics (Nasdaq: NKTR $10.44) announced that it failed to meet the primary endpoint in its Phase 2 trial of NKTR-181 for the treatment of moderate-to-severe chronic pain in patients with osteoarthritis of the knee. The company noted that the placebo did not show the expected increase in pain scores as expected. Durata Therapeutics, Inc. (Nasdaq:DRTX […]

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Updates for ALNY ZGNX INSV DNDN OGXI ANAC RPTP NPSP NKTR KERX APPA SRPT THLD OPXA BCRX IMUC INFI

Aug 09, 2013 No Comments

Zogenix, Inc. (Nasdaq:ZGNX $1.52) said it continues to expect that the FDA will reach a decision regarding the Zohyrdo ER New Drug Application(NDA), during the summer of 2013. NPS Pharmaceuticals, Inc. (NASDAQ: NPSP $18.10) said that it expects to submit its Biologic License Application in 4Q 2013 for Natpara for patients with hypoparathyroidism. It also plans to initiate […]

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Pipeline updates for ACHN BCRX BLRX CLVS RIGL INSM TRGT CBST INFI AEZS SCMP SGEN FURX EXEL FLML TSRX KERX ZIOP ISIS

May 08, 2013 No Comments

Achillion Pharmaceuticals, Inc. (Nasdaq:ACHN) provided an update noting that interim RVR results from its Phase 2 ACH-3102 trials for the treatment of genotype 1 HCV are due in 3Q 2013 (-007 trial), followed by SVR results during 4Q 2013. BioCryst Pharmaceuticals, Inc. (NASDAQ:BCRX) said it plans to initiate a Phase 2 trial of BCX4161 in patients with hereditary angioedema, later in 2013 […]

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ABIO reverse split. NRIFF receives CRL. Updates for RIGL INFI NYMX TRGT VPHM NWBO.

Mar 05, 2013 No Comments

Targacept, Inc. (NASDAQ: TRGT) announced that AstraZeneca will return all rights to the alpha4beta2 modulator TC-1734 (also known as AZD3480), which is currently in a Phase 2b clinical trial in mild to moderate Alzheimer’s disease. It will also give up the option to license any alpha7 NNR modulator that was developed by Targacept for a cognitive disorder or schizophrenia Nuvo […]

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DCTH expects May Adcom meeting. EDIT – BLRX + Pipeline updates for ALNY CLVS INFI OREX FOLD ICPT

Jan 07, 2013 No Comments

BioLineRx (NASDAQ: BLRX) announced today that the results of the interim analysis of its Phase 2/3 CLARITY trial of BL-1020, for the treatment of schizophrenia, are expected during the week beginning March 18, 2013. EDIT: DMC will provide estimate of the total number of patients required in the study in order to achieve statistical significance in the Phase 2/3 data […]

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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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PATH expects to resubmit NDA in July. CORT offering. AMLN buyout + CRTX MNTA INFI INSM MDCO news

Jul 02, 2012 No Comments

NuPathe Inc. (NASDAQ: PATH) announced that it expects to resubmit its NDA in July 2012, for its  migraine patch (NP101) and anticipates a six-month review by the FDA. Corcept Therapeutics Incorporated (NASDAQ: CORT)  today announced that it intends to issue 11m shares of its common stock in an underwritten public offering, with an option to issue to an additional […]

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FDA approves ARNA Belviq for obesity. ANTH fails Phase 2b trial. Pipeline updates for XOMA INSM INFI. EMA rejects Folotyn + SNSS news

Jun 28, 2012 No Comments

Arena Pharmaceuticals, Inc. (NASDAQ: ARNA) and Eisai Inc. announced that the FDA has approved BELVIQ  for the treatment of obesity. Anthera Pharmaceuticals, Inc. (Nasdaq: ANTH) announced results from the Phase 2b PEARL-SC clinical study in patients with systemic lupus erythematosus.  The pre-specified primary efficacy endpoint, clinical improvement at 24 weeks in the SLE responder index for the pooled blisibimod dose […]

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