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News Breaks
February 10, 2014
04:55 EDTALKS, ALKS, RGDO, RGDO, LXRX, LXRX, ZIOP, ZIOP, RNA, RNA, AUXL, AUXL, XON, XON, SIGA, SIGA, GALE, GALE, MSTX, MSTXBiotech Industry Organization to hold a conference
16h Annual BIO CEO & Investor Conference is being held in New York on February 10-11.
News For ALKS;GALE;SIGA;XON;AUXL;RNA;ZIOP;LXRX;RGDO;MSTX From The Last 14 Days
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December 17, 2014
06:14 EDTALKSAlkermes price target raised to $72 from $60 at Citigroup
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December 16, 2014
16:53 EDTAUXLAuxilium updates court findings in Actavis testosterone gel patent suit
Auxilium (AUXL) disclosed in a filing that as previously disclosed, on May 23 , Auxilium Pharmaceuticals, and FCB I LLC, as licensor of Testim, filed a lawsuit in the U.S. District Court for the District of New Jersey against Actavis (ACT) for infringement of FCBís 10 patents listed in the Orange Book as covering Testim testosterone gel. The lawsuit was filed in response to a notice letter, dated April 12, 2012, sent by Actavis Laboratories, regarding its filing with the U.S. Food and Drug Administration of an Abbreviated New Drug Application for a generic 1% testosterone gel product. This letter also stated that the ANDA contained Paragraph IV certifications with respect to the nine patents listed in the Orange Book on that date as covering Testim. The companyís lawsuit filed against Actavis initially involved those nine patents, as well as a 10th patent covering Testim that was issued on May 15, 2012 and is listed in the Orange Book. By the time that the trial commenced in September 2014, the parties had agreed to remove all but one of those patents from the litigation, with the trial focused solely on claim 3 of U.S. Patent # 7,608,607 . The trial commenced in September 2014 and closing arguments occurred in November 2014. On December 16 , the company learned that Judge Linares held that claim 3 of the Ď607 patent is invalid for obviousness. The Judge also found claim 3 invalid for derivation and improper inventorship, but he declined to rule on whether correction of inventorship would be appropriate because it would be futile in light of his ruling on obviousness. Auxilium believes that Actavis is now free to enter the market with its testosterone gel product once it obtains approval from the FDA. At this time, Auxilium is not aware of Actavis having received tentative approval or final approval from the FDA for its testosterone gel product. Auxilium is analyzing the District Courtís opinion and will explore its available options with regard to this matter.
08:58 EDTAUXLEndo a top pick for 2015, says Sterne Agee
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December 15, 2014
07:02 EDTALKSAlkermes announces initiation of Phase 1 aripiprazole lauroxil study
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December 11, 2014
17:04 EDTAUXLEndo registration statement relating to Auxilium declared effective by SEC
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08:40 EDTGALEGalena presents HER2 screening data results from NeuVax Phase 3 clinical trial
Galena Biopharma announced that initial immunohistochemistry, or IHC, screening data from the NeuVax Phase 3 PRESENT, or Prevention of Recurrence in Early-Stage, Node-Positive Breast Cancer with Low to Intermediate HER2 Expression with NeuVax Treatment, trial was presented at the 2014 San Antonio Breast Cancer Symposium, or SABCS. The poster, entitled, "HER2 Discordant Results in Local vs. Central Testing in the Phase 3 Nelipepimut-S Trial and Implementation of Leica Bond Oracle HER2 Immunohistochemistry System for Low and Intermediate Levels of HER2 Protein Expression as a Companion Diagnostic," demonstrated that with the implementation of the Leica Bond Oracle HER2 IHC assay, preliminary limited data indicated additional patients met HER2 eligibility for PRESENT and the assay identified more precisely patients at HER2 1+ and 2+. As part of the PRESENT trial, Galena has implemented central laboratory testing for all potential patients to confirm validated and robust entry criteria, and ensure the enrollment of the targeted patient population. To improve accuracy and specificity for the HER2 1+ and 2+ status testing, and develop a companion diagnostic for NeuVax, the Leica Bond Oracle HER2 IHC system has been incorporated as central HER2 IHC screening for the PRESENT study.
December 9, 2014
09:21 EDTMSTXOn The Fly: Pre-market Movers
UP AFTER EARNINGS: AutoZone (AZO), up 3.8%... Burlington Stores (BURL), up 3.3%. ALSO HIGHER: bluebird bio (BLUE), up 56.5% after price target raised at Piper Jaffray and SunTrust... Camtek (CAMT), up 6.7% after being awarded a $2.8M order from a semiconductor manufacturer... PDC Energy (PDCE), up 5.8% after providing fiscal 2015 production guidance... Mast Therapeutics (MSTX), up 3.1% after reporting that it will begin recruiting patients for MST-188 study in first half of fiscal 2015... Idera Pharmaceuticals (IDRA), up 1.4% after announcing data for its lead product candidate, IMO-8400. DOWN AFTER EARNINGS: UTi Worldwide (UTIW), down 10.8%... CONN'S (CONN), down 35.9% after reporting third quarter results, withdrawing fiscal 2015 guidance, stating that there is no timetable set for completion of strategic alternatives, and announcing the departure of its CFO. ALSO LOWER: Apple (AAPL), down 1.6% after Pacific Crest says that weak iPad demand could cause Apple to miss estimates and following a Wall Street Journal report that a judge denied Apple's efforts to throw out iPod pricing lawsuit... Allied Nevada Gold (ANV), down 30.1% after announcing pricing of common stock and warrant offering... United Continental (UAL), down 2.7% after reporting November traffic.
08:12 EDTMSTXMast Therapeutics to begin recruiting patients for MST-188 study in H1 of FY15
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December 8, 2014
09:20 EDTGALEOn The Fly: Pre-market Movers
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08:50 EDTALKSAlkermes price target raised to $63 on pipeline catalysts at Credit Suisse
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07:08 EDTGALEGalena GALE-401 Phase 1 results show reduced platelet counts, tolerable safety
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December 5, 2014
10:35 EDTALKSHigh option volume stocks
High option volume stocks: NOAH FRAN BIG GREK KEY VIAB STRZ ALKS QTWW ONNN

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