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Stock Market & Financial Investment News

News Breaks
April 11, 2014
07:06 EDTAUXL, VVUS, SNYVIVUS announces avanafil clinical data presentation
VIVUS (VVUS) announced that a poster describing results of a clinical study examining onset of action of avanafil will be presented during the 29th Annual European Association of Urology Congress. STENDRA, or avanafil, is approved by the FDA in the U.S. for the treatment of erectile dysfunction. VIVUS has granted Auxilium Pharmaceuticals (AUXL) exclusive marketing rights to STENDRA in the U.S. and Canada. Auxilium is in the early stages of commercializing STENDRA in the U.S. SPEDRA is the trade name for avanafil in the European Union and is approved by the European Medicines Agency for the treatment of erectile dysfunction in the EU. VIVUS has granted an exclusive license to Sanofi (SNY) to commercialize avanafil in Africa, the Middle East, Turkey, and the Commonwealth of Independent States including Russia.
News For VVUS;SNY;AUXL From The Last 14 Days
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August 21, 2014
07:32 EDTAUXLAuxilium announces positive data from Phase 2a study of CCH with cellulite
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05:42 EDTSNYIllumina announces strategic partnership with AstraZeneca, Sanofi, Janssen
Illumina (ILMN) announced it has formed collaborative partnerships with leading pharmaceutical companies to develop a universal next-generation sequencing, or NGS,-based oncology test system. The system will be used for clinical trials of targeted cancer therapies with a goal of developing and commercializing a multi-gene panel for therapeutic selection, resulting in a more comprehensive tool for precision medicine. Initial strategic partners include AstraZeneca (AZN), Janssen Biotech, a Johnson & Johnson (JNJ) company, and Sanofi (SNY). Illumina is working with the strategic partners to develop assays that detect and measure multiple variants simultaneously to support partners’ clinical trials, with the objectives of securing regulatory agency approvals and test commercialization. In parallel, Illumina is working with key thought leaders to set standards for NGS-based assays in routine clinical oncology practice, as well as to define regulatory frameworks to enable this new testing paradigm. Together, Illumina and its strategic partners aim to transition from single-analyte companion diagnostics to panel-based assays that select for “companion therapeutics.”
August 19, 2014
16:46 EDTSNYFDA approves Genzyme Cerdelga capsules
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August 18, 2014
11:41 EDTAUXLCubist rises after report sparks takeover interest speculation
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August 14, 2014
09:11 EDTSNYOn The Fly: Pre-market Movers
UP AFTER EARNINGS: Kohl's (KSS), up 2.5%... Plug Power (PLUG), up 10%... Perrigo (PRGO), up 4.5%. HIGHER: Aruba Networks (ARUN), up 3% after shares upgraded at Stifel... KaloBios (KBIO), up 7.9% after publication shows EphA3 as target for anticancer therapy... Supernus (SUPN), up 4.4% after receiving FDA fast track designation for SPN-810. DOWN AFTER EARNINGS: Noodles & Company (NDLS), down 22%... Vipshop (VIPS), down 5.8%. LOWER: ExOne (XONE), down 10.7%, Voxeljet (VJET), down 6.6%, after earnings reports. Peers in the 3D space are lower as well, with Stratasys (SSYS) down 1% and 3D Systems (DDD) down 0.2%... Enphase Energy (ENPH), down 2.6% after filing to sell common stock for holders... InterMune (ITMN), down 3% after downgraded at Goldman following yesterday's advance on Bloomberg report that the company received takeover bids from Sanofi (SNY), Roche (RHHBY).
August 13, 2014
17:08 EDTSNYSanofi Pastuer annnounces positive results from trial of Fluzone
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16:19 EDTSNYOn The Fly: Closing Wrap
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13:13 EDTSNYInterMune exploring sale after bids from Sanofi, Roche, Glaxo, Bloomberg says
InterMune (ITMN) is working with its financial advisers Goldman Sachs (GS) and Centerview Partners to evaluate takeover bids it has received from Sanofi (SNY), Roche (RHHBY), GlaxoSmithKline (GSK) and Actelion (ALIOF), said Bloomberg, citing people with knowledge of the matter. The report noted that one of the sources said Sanofi has so far shown the most interest in a deal for InterMune, whose shares are up more than 13% to $51.56 following the first headlines from the report. Reference Link
13:00 EDTSNYInterMune received takeover bids from Sanofi, Roche, Bloomberg says
August 12, 2014
08:52 EDTSNYSanofi launches authorized generic version of Eloxatin through Winthrop US
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August 11, 2014
15:51 EDTSNYMannKind price target raised to $10 from $6.50 at Piper Jaffray
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11:58 EDTSNYMannKind rallies after inking licensing agreement with Sanofi
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11:04 EDTAUXLActive equity options trading on open
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09:06 EDTSNYOn The Fly: Pre-market Movers
HIGHER: PharmAthene (PIP), up 55% after announcing that a Delaware court awarded the company lump sum expectation damages for the value of its lost profits for SIGA Technologies' (SIGA) smallpox antiviral, Tecovirimat... MannKind (MNKD), up 19% after entering exclusive licensing agreement for development and commercialization of Afrezza inhaled insulin with Sanofi (SNY)... Kinder Morgan (KMI), up 19% after announcing it will acquire all of the outstanding equity securities of Kinder Morgan Energy Partners (KMP), Kinder Morgan Management (KMR) and El Paso Pipeline Partners (EPB)... Tesla (TSLA), up 2.7% following upgrade at Deutsche Bank... Achillion (ACHN), up 6% following upgrades at Wells Fargo and at Piper Jaffray... PepsiCo (PEP), up 0.9% following upgrade at UBS. LOWER: Dean Foods (DF), down 8.6% after reporting Q2 losses that were steeper than expected, saying balance of year "appears rocky," which makes it difficult to provide guidance beyond the immediate quarter... Priceline (PCLN), down 0.7% after reporting Q2 revenue that missed expectations, guiding Q3 EPS below consensus... SIGA Technologies, down 31% after ruling in suit with PharmAthene... 2U (TWOU), down 4.3% after downgraded at Goldman.
07:45 EDTSNYMannKind partnership likely to be viewed favorably, says Piper Jaffray
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07:07 EDTSNYIgnyta names Adrian Senderowicz as Chief Medical Officer
Ignyta (RXDX) announced that Adrian Senderowicz, M.D., has been appointed as Chief Medical Officer and SVP, Clinical Development and Regulatory Affairs. Senderowicz was most recently Vice President, Global Regulatory Oncology at Sanofi (SNY).
06:31 EDTSNYMannKind to host conference call
Conference call to discuss the collaboration with Sanofi about global licensing agreement for development and commercialization of Afrezza will be held on August 11 at 8:30 am. Webcast Link
06:09 EDTAUXLAuxilium appoints Andrew Saik as CFO
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05:13 EDTSNYSanofi, MannKind announce global licensing agreement for Afrezza
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August 8, 2014
08:34 EDTAUXLBioSpecifics announces initiation of Phase 2 clinical study of CCH
BioSpecifics (BSTC) announced that it has injected the first patient in its placebo-controlled Phase 2 clinical trial of CCH for the treatment of lipoma. The company expects to complete patient enrollment in this trial during the first quarter of 2015. The Phase 2 clinical trial is a randomized, double-blind, placebo-controlled study to assess the safety and efficacy of CCH for the treatment of lipoma. The primary endpoint of the Phase 2 clinical trial is the reduction in the measureable surface area of the target lipomas, as determined by caliper, at six months post injection. The secondary efficacy endpoints include responders at six months post injection who show a ≥50% decrease in lipoma surface area relative to baseline between CCH and placebo, the change in the length of the target lipoma, the relative change in lipoma surface area as measured by caliper at one month and three months, and the relative change in lipoma volume as measured by MRI. The study will also gather qualitative lipoma characteristics and an assessment of patient satisfaction through a questionnaire administered to each subject prior to injection and at each follow-up visit. BioSpecifics' strategic partner Auxilium (AUXL) has the option to license development and marketing rights to this indication based on a full analysis of the data from this Phase 2 clinical trial, which would transfer responsibility for the future development costs to Auxilium and trigger an opt-in payment and potential future milestone and royalty payments from Auxilium to BioSpecifics.
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