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Stock Market & Financial Investment News

News Breaks
May 19, 2014
16:10 EDTNVS, OPHTOphthotech, Novartis enter into ex-U.S. licensing, commercialization agreement
Ophthotech (OPHT) announced that the company has entered into an ex-US licensing and commercialization agreement with Novartis Pharmaceuticals (NVS) focused on the treatment of wet age-related macular degeneration, or AMD. Under the agreement, Ophthotech grants Novartis exclusive rights to commercialize Ophthotech’s lead product candidate, Fovista, in markets outside the United States while Ophthotech retains sole rights to commercialize Fovista in the U.S. Potential payments to Ophthotech under the agreement could total over $1B in upfront and milestone payments, not including future royalties. Ophthotech will continue to lead the global Fovista Phase 3 wet AMD pivotal clinical program which is expected to have initial, topline data available in 2016. Ophthotech will continue its lead role in the potential registration of Fovista in the U.S., while Ophthotech and Novartis will collaborate to seek regulatory approvals outside the U.S. This collaboration continues the Fovista development strategy to remain agnostic with respect to the choice of the anti-VEGF agent administered in combination with Fovista. Separate injections of the anti-VEGF agent and Fovista would allow physicians to choose their preferred anti-VEGF agent for the combination therapy. The collaboration also provides for the potential development of a fixed combination delivery of a co-formulation of Fovista with a Novartis proprietary anti-VEGF product which would result in additional flexibility for physicians. Novartis will also seek to develop and commercialize alternative innovative delivery technologies such as a Fovista pre-filled syringe as part of this collaboration.
News For OPHT;NVS From The Last 14 Days
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September 4, 2015
09:42 EDTOPHTBattleground: Will this $5 biotech stock go to $22 or $1.50?
In the last two days, analysts have issued widely divergent opinions and price targets on Keryx Biopharmaceuticals, a small-cap biotech company focused on the treatment of renal diseases. CITI SAYS SELL: Citi analyst Yigal Nochomovitz started shares of Keryx yesterday with a Sell rating and $1.50 price target. Nochomovitz expects the Auryxia launch and long-term sales trends to "materially underperform" consensus expectations. Auryxia is a phosphate binder used for the control of serum phosphorus levels in patients with chronic kidney disease on dialysis. Nochomovitz estimates Auryxia has peak U.S. sales potential of $57M, well below the consensus estimate of $485M. BREAN SAYS BUY: Brean Capital analyst Jonathan Aschoff told investors this morning that he views the recent selloff in shares of Keryx as overdone. The bearish assessment of Auryxia's ultimate market potential is premature, Aschoff contends. Auryxia "finally achieved" a majority of insurance coverage in early August, which will facilitate prescription writing, the analyst argues. He also believes Keryx's 50% salesforce increase should make a "noticeable impact" on revenue. Aschoff reiterated a Buy rating on the stock with a $22 price target. WHAT'S NOTABLE: Along with yesterday's note on Keryx, Nochomovitz expanded Citi's coverage of the Biotech space by initiating seven other small- and mid-cap names. Chimerix (CMRX) is Nochomovitz's top pick with a Buy rating and $80 price target. Other stocks to which he assigned Buy ratings include Ophthotech (OPHT), Relypsa (RLYP) and ZS Pharma (ZSPH). In addition to placing a Sell rating on Keryx, Nochomovitz started Ultragenyx (RARE) with a sell and an $87 price target. He rounded out his coverage with Neutral ratings on Medivation (MDVN) and Puma Biotechnology (PBYI). PRICE ACTION: In early trading, Keryx shares fell 40c, or 7,9%, to $4.66, which comes on top of the 16% decline the stock suffered yesterday. Over the last three months, Keryx shares have fallen more than 50%.
05:17 EDTNVSNovartis receives EU approval for Farydak
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September 3, 2015
10:04 EDTOPHTOn The Fly: Analyst Initiation Summary
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08:15 EDTOPHTChimerix rallies, Keryx falls after Citi expands Biotech coverage
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06:39 EDTOPHTOphthotech initiated with a Buy at Citi
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September 2, 2015
16:20 EDTNVSHealth Canada approves new indications for PrOmnitrope
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12:22 EDTNVSAmgen denied injunction to block Novartis copy of Neupogen, Reuters reports
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12:15 EDTNVSAmgen denied injunction to block Novartis copy of Neupogen, Bloomberg reports
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05:35 EDTNVSNovartis receives EU approval for Revolade
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September 1, 2015
16:33 EDTNVSAmgen, Novartis enter agreement for Alzheimer's, migraine research
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August 28, 2015
05:32 EDTNVSNovartis renews pledge with WHO to end leprosy
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August 25, 2015
15:02 EDTNVSMylan says USPTO institutes IPR of two Copaxone patents
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August 24, 2015
13:15 EDTNVSFDA expands use of Novartis' Promacta to include children ages 1 and older
Ligand Pharmaceuticals (LGND) announced that the FDA has approved an expanded use for Promacta, a Novartis (NVS) product, to include children 1 year of age and older with chronic immune thrombocytopenia who have had an insufficient response to corticosteroids, immunoglobulins or splenectomy. Promacta was acquired by Novartis in March from GlaxoSmithKline (GSK). Promacta was discovered as a result of research collaboration between GSK and Ligand Pharmaceuticals and was developed by GSK. The updated label also includes a new oral suspension formulation of Promacta that is designed for younger children who may not be able to swallow tablets. Promacta was approved by the FDA as a tablet formulation in June 2015 for children 6 years of age and older and in 2008 for use in adult patients with the same condition. The label expansion of Promacta was based on data from two double-blind, placebo-controlled trials, including the largest Phase 3 clinical trial in this patient population. Treatment with Promacta significantly increased and sustained platelet counts among pediatric patients with chronic ITP with an insufficient response to prior chronic ITP therapies, and some patients taking concomitant ITP medications were able to reduce or discontinue their use of these medications, primarily corticosteroids. Promacta should be used only in those whose degree of thrombocytopenia and clinical condition increase the risk for bleeding.
12:11 EDTNVSNovartis announces FDA approves expanded use for Promacta
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