CCXI topline CCX140 data due Fri + updates for FOLD BLUE KPTI VICL NKTR

Dec 12, 2014 No Comments by

Latest updates to the Company Pipeline Database from December 11 2014. Refer to the FDA Calendar for upcoming catalysts. Ticker Price Drug Indication Stage Link Text Updated BLUE  86.12 LentiGlobin – HGB-206 Sickle disease Phase 1/2 Most likely to have initial data 1H 2015, as per JPM estimate 12/12/2014 CCXI 4.49 CCX140 Diabetic nephropathy Phase […]

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CHMP agendas now online. ONTX fails Ph3 pancreatic trial. NAVB files sNDA + updates for SCMP VICL PBYI

Dec 17, 2013 No Comments by

The European Medicines Agency (EMA) announced that they are publishing, for the first time, the agendas of the Committee for Medicinal Products for Human Use (CHMP) meetings. The minutes of each of these meetings held in December will be published once they have been adopted by the relevant Committee at its meeting in January. It will then […]

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CYTR data due Wednesday. AVNR fails Phase 2 PRIME trial. SPPI files Belinostat NDA + VICL NWBO news

Dec 10, 2013 No Comments by

CytRx Corporation (NASDAQ: CYTR $2.39) announced that it will issue a news release at 8:00 a.m. Eastern time on Wednesday December 11 2013, announcing top-line results from their Phase 2b trial of aldoxorubicin as a first-line treatment for advanced soft tissue sarcomas (STS). They will host a conference call beginning at 10:30 a.m. EST. Avanir Pharmaceuticals, Inc. (NASDAQ: AVNR $4.29) […]

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Pipeline and news updates for INCY ARRY CLVS VICL BMRN SGYP ACOR GENT ENMD DSCO MACK ARIA

Nov 02, 2013 No Comments

Incyte Corporation(Nasdaq: INCY $40.40) provided a pipeline update noting that Phase 3 data of Jakafi (ruxolitinib) in patients with polycythemia vera (PV), are expected in early 2014, with a potential NDA filing in 1H 2014. Data from their Phase 3 trial measuring disease-related symptoms in patients with PV (RELIEF) are due in mid-2014. In addition, Phase 2 data from […]

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VICL fails Phase 3 trial. BIOD still on track for 3Q data release. ACRX NDA filing due 3Q. MDCO offering + updates for PTCI CCXI DSCI ENTA ESPR

Aug 13, 2013 No Comments

Vical Incorporated (Nasdaq:VICL) announced that their Phase 3 trial of Allovectin, in patients with metastatic melanoma, failed to meet both the primary endpoint of objective response rate at 24 weeks and the secondary endpoint of overall survival. Biodel Inc. (Nasdaq:BIOD) maintained guidance that it expects data from their Phase 2 trial of BIOD-123 in 3Q 2013. Esperion […]

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ETRM submits PMA. VICL initiates Phase 3 TransVax trial.

Jun 26, 2013 No Comments

EnteroMedics Inc. (NASDAQ: ETRM) announced that it has submitted a Premarket Approval (PMA) application to the FDA for approval of the Maestro Rechargeable System’s VBLOC vagal blocking therapy as a treatment for obesity. Vical Incorporated (Nasdaq:VICL) and Astellas Pharma Inc. (TOKYO:4503) announced the initiation of a multinational Phase 3 trial of TransVax in approximately 500 hematopoietic cell transplant (HCT) recipients.

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Pipeline updates for OPK VNDA SNSS SRPT NKTR INSV VICL PBYI ANAC SPPI NPSP IMUC ZGNX + OMER offering

May 10, 2013 No Comments

OPKO Health, Inc. (NYSE: OPK) noted that Phase 3 data of CTAP 101 Capsules for the treatment of Secondary Hyperparathyroidism (SHPT) are due mid-2014, while Phase 3 data from its licensee trial (TESARO, Inc.) of rolapitant for the prevention of chemotherapy induced nausea and vomiting, are expected during 2H 2013. Vanda Pharmaceuticals Inc.(Vanda) (NASDAQ: VNDA) maintained guidance […]

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20 Upcoming Non-PDUFA Catalysts as of April 29 2013

Apr 29, 2013 No Comments

20 short and long term potential catalysts as of April 29, 2013. See the links in the FDA Calendar for more details about some of the catalysts. AcelRx Pharmaceuticals, Inc. (Nasdaq: ACRX): Phase 3 topline data for Sufentanil NanoTab PCA System in patients after major orthopedic surgery (second pivotal) due 2Q 2013. Ampio Pharmaceuticals, Inc. (NASDAQ: AMPE): Phase 3 data […]

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VICL Phase 3 Allovectin data due mid 2013. OXGN Phase 2 ovarian data due 2013

Feb 07, 2013 No Comments

Vical Incorporated (Nasdaq:VICL) gave a pipeline update noting that top-line data from its Phase 3 registration trial of Allovectin vs. chemotherapy in patients with metastatic melanoma, are expected to be released in mid-2013. It also said that its partner Astellas, is planning to initiate a Phase 3 trial of TransVax for hematopoietic stem cell transplant (HSCT) recipients and to […]

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Pipeline updates for SNTS BCRX ANAC VNDA ATRS AUXL ITMN ALIM NKTR CHTP VICL

Nov 08, 2012 No Comments

Vical Incorporated (Nasdaq:VICL) said that it has revised  its projection for reaching the target number of death events in its Phase 3 Allovectin melanoma trial, to mid-2013. The company also noted that Astellas is planning to initiate a multinational pivotal Phase 3 trial of TransVax in hematopoietic cell transplant (HCT) recipients and a Phase 2 trial of TransVax for solid organ […]

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MAPP on target to meet FDA 2Q regarding CRL. GENT MAA update. VICL files $150m shelf + ISIS

May 04, 2012 No Comments

Vical Incorporated (Nasdaq: VICL) filed a mixed shelf allowing it to issue common stock and preferred stock, debt securities and/or warrants, either individually or in combination, with a total value of up to $150,000,000 from time to time. Gentium S.p.A. (Nasdaq:GENT) announced today that it has received the Day 180 List of Outstanding Issues (the “LoOIs”) […]

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