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News Breaks
April 15, 2014
07:35 EDTALNY, NVSAlnylam outlook not affected by Novartis decision, says JMP Securities
After Novartis (NVS) discontinued its RNAi drug discovery program, JMP Securities does not think the decision should affect the potential of Alnylam's (ALNY) pipeline. The firm believes that Novartis' inability to figure out RNAi technology - and not problems with RNAi as a whole - led to Nvoartis' decision. The firm reiterates a $110 price target and Outperform rating on Alnylam.
News For ALNY;NVS From The Last 14 Days
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October 2, 2014
11:35 EDTALNYAlnylam added to Short-Term Buy List at Deutsche Bank
10:00 EDTNVSZimmer antitrust probe extended, Lilly/Novartis deal cleared by EU, Reuters says
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07:35 EDTNVSIncyte earns $60M milestone payment from Novartis related to Jakavi
Incyte (INCY) announced that it has earned a $60M milestone payment from Novartis (NVS) related to reimbursement of Jakavi in Europe. Incyte will record this amount as contract revenue in Q3, and expects to receive payment of $60M in Q4. Under the Incyte-Novartis Collaboration and License Agreement signed in 2009, Novartis received exclusive development and commercialization rights to ruxolitinib outside of the U.S. for all hematologic and oncologic indications, and sells ruxolitinib under the name Jakavi. Ruxolitinib is marketed by Incyte in the U.S. as Jakafi. The achievement of this milestone also triggers the obligation for Incyte to pay tiered, low-single digit royalties to Novartis on all future sales of Jakafi in the U.S.
October 1, 2014
16:18 EDTNVSNovartis Bioventures reports 21.3% stake in Tokai Pharmaceuticals
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08:07 EDTNVSEnanta regains full rights to EDP-239 for Hep C virus from Novartis
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08:06 EDTALNYAlnylam initiates EXPLORE trial
Alnylam Pharmaceuticals and collaborators from the American Porphyria Consortium and The European Porphyria Network have initiated the EXPLORE trial, a prospective observational study of patients with hepatic porphyrias, including Acute Intermittent Porphyria, Variegate Porphyria, and Hereditary Coproporphyria, suffering from recurrent attacks. With this study, Alnylam and clinical investigators aim to learn more about the clinical course, management, and disease burden of patients with hepatic porphyrias that suffer from recurrent attacks. Alnylam is currently advancing ALN-AS1, a subcutaneously administered investigational RNAi therapeutic targeting aminolevulinic acid synthase 1 for the treatment of hepatic porphyrias, and expects to file an IND or IND equivalent in late 2014 or early 2015. EXPLORE is a prospective, multi-center observational study designed to enroll up to 100 patients with hepatic porphyrias and a history of recurrent attacks. The study’s primary objective is to characterize the natural history, clinical management, and disease burden of patients with hepatic porphyrias. The study’s secondary objectives are to further characterize a number of disease features of hepatic porphyrias, including: (i) signs and symptoms of porphyria during acute attacks; (ii) levels of plasma and urinary aminolevulinic acid and porphobilinogen, the toxic intermediates of the heme biosynthesis pathway that cause the symptoms and disease pathology of the acute hepatic porphyrias; (iii) expression levels of aminolevulinic acid synthase-1 during acute attacks; and (iv) medical and family history of hepatic porphyria patients. Data obtained from EXPLORE are expected to further the understanding of hepatic porphyrias and to assist the design of clinical trials with ALN-AS1.
07:28 EDTALNYLeerink to hold a roundtable
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September 30, 2014
16:39 EDTNVSCMS discloses drug makers' payments to doctors, WSJ says
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07:30 EDTNVSSachs Associates to hold a conference
14th Annual Biotech in Europe Forum for Global Partnering and Investment to be held in Basel, Switzerland on September 30-October 1.
September 29, 2014
08:07 EDTNVSPhase 2 trial of binimetinib in NRAS melanoma shows promising clinical activity
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September 26, 2014
07:32 EDTALNYBioCentury to hold a conference
21st Annual NewsMakers in the Biotech Industry Conference to be held in New York on September 26.
07:30 EDTNVSNovartis drug Signifor LAR recommended by CHMP for EU approval
The Committee for Medicinal Products for Human Use, or CHMP, of the European Medicines Agency, or EMA, adopted a positive opinion for Signifor long acting release, or LAR, formulation to treat adult patients with acromegaly for whom surgery is not an option or has not been curative and who are inadequately controlled on treatment with a first-generation somatostatin analogue, or SSA. If approved in the EU, this next-generation SSA could fill a current unmet need, providing a new therapeutic option for the approximately 45% of acromegaly patients whose growth hormone, or GH, or insulin-like growth factor-1, or IGF-1, levels remain inadequately controlled despite treatment with currently available SSAs.
September 25, 2014
05:28 EDTNVSNovartis AIN457 meets primary endpoint in two Phase III studies
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September 24, 2014
08:08 EDTALNYAlnylam initiates DISCOVERY trial
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September 22, 2014
16:07 EDTNVSAnacor announces commercial launch of KERYDIN topical solution in U.S.
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September 18, 2014
07:49 EDTALNYAlnylam resumed with an Outperform at Leerink
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