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Stock Market & Financial Investment News

News Breaks
April 2, 2014
11:55 EDTBIIB, SGMO, QURE, NVO, PFE, BMRN, BAXUniqure rises after Baxter acquires Chatham Therapeutics
U.S.-listed shares of Netherlands-based pharmaceutical company Uniqure (QURE) are rising after Baxter International (BAX) acquired Chatham Therapeutics, which is developing gene therapy treatments intended for patients with hemophilia. WHAT'S NEW: Baxter agreed to acquire all of Chathamís outstanding membership interests and as a result will acquire Chathamís developmental gene therapy programs directed toward the development and commercialization of treatments for hemophilia. Under the terms of the agreement, Baxter will make an initial payment of $70M to acquire all of the outstanding membership interests of Chatham and may make additional payments in the future. Baxter will continue the ongoing Phase I/II open-label clinical trial to assess the safety and optimal dosing schedule of hemophilia treatment BAX 335. ANALYST REACTION: Research firm Piper Jaffray said the Baxter acquisition has a positive read-through for Uniqure. The deal validates other hemophilia gene therapy programs in development, most notably Uniqure's, according to the firm. Analyst Joshua Schimmer wrote that there are other gene therapy programs for hemophilia in development beside Uniqure's and Baxter's, but he believes Uniqure has an advantage since it will be important to be among the first to market. The analyst also said that the market is large enough to accommodate more than one gene therapy option. Piper reiterated its Overweight rating and $35 price target on Uniqure. OTHERS TO WATCH: Other companies noted by Piper as currently offering hemophilia treatments or working on hemophilia therapies include Pfizer (PFE), Novo Nordisk (NVO), Biogen (BIIB), Sangamo (SGMO) and BioMarin (BMRN). PRICE ACTION: During late morning trading, shares of Uniqure rose 77c or 4.92% to $16.43, while Baxter slid 33c, or 0.45%, to $73.34.
News For QURE;BAX;PFE;SGMO;BMRN;NVO;BIIB From The Last 14 Days
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April 20, 2015
07:18 EDTBMRN, BIIBAmerican Academy of Neurology to hold annual meeting
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06:05 EDTPFEProvectus receives notice of allowance for PV-10 combined with other drugs
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April 17, 2015
16:36 EDTBAXBaxter says results of Phase III clinical trial of BAX 111 met primary endpoint
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10:14 EDTBMRNOptions with decreasing implied volatility
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07:00 EDTQUREUniQure gene therapy assessment held up by German regulator, Reuters says
German regulator G-BA, which was expected to issue an assessment of the benefits of UniQure's gene therapy Glybera by the end of this month, said late Thursday that it will miss the legal deadline to get more clarity after an adviser for biotech drugs to the European Medicines Agency last week said in a report that Glybera lacked efficacy, reported Reuters. "Even if the suspension of the procedure violates the legal deadline, the decision is justified and without alternative," G-BA said in a statement, according to Reuters. Reference Link
April 16, 2015
09:03 EDTBAXBaxter submits application to Japan's MHLW for approval of BAX 855
Baxter International (BAX) announced that the company has submitted a new drug application to Japanís Ministry of Health, Labour and Welfare for the approval of BAX 855, an investigational, extended half-life recombinant factor VIII treatment based on ADVATE for patients over 12 years of age with hemophilia A. The submission follows the filing to the United States Food and Drug Administration in late 2014 and is based on positive results from a prospective, global, Phase 3 study of 137 previously treated patients. The results, presented during the European Association for Haemophilia and Allied Disorders meeting in February 2015, demonstrated that BAX 855 met its primary endpoint in the control and prevention of bleeding episodes and routine prophylaxis for patients who were 12 years or older. Baxter continues to advance a continuation study for patients who completed the pivotal trial and a Phase 3 study among previously treated patients under the age of 12 with severe hemophilia A. Once the pediatric study has been completed, the company expects to file for marketing authorization with the European Medicines Agency in 2016 and intends to seek post-approval label expansion in the U.S. for previously-untreated pediatric patients. BAX 855 is based on ADVATE, a full-length FVIII molecule with more than 12 years of real-world experience. Through a collaboration with Nektar Therapeutics (NKTR), BAX 855 leverages proprietary pegylation technology designed to extend the duration of activity of the protein in the body. This proprietary technology has been used for over 10 years in a number of approved medicines that treat chronic or serious conditions.
08:59 EDTQUREGene therapy companies could benefit from increased attention, says Roth Capital
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April 15, 2015
11:55 EDTNVONovo Nordisk initiated with a Sell at Societe Generale
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08:13 EDTBAXCoherus, Baxter announce amendment to etanercept biosimilar agreement
Coherus BioSciences (CHRS) and Baxter International (BAX) announced that they have amended certain financial terms of their collaboration agreement established in August 2013 regarding the development and commercialization of CHS-0214, an etanercept biosimilar product candidate, for Europe, Canada, Brazil, and certain other markets. Under the terms of the amended agreement, certain existing milestones and funding obligations have been revised, and the collaboration has been expanded to include select pre-commercialization activities. In aggregate, the revised milestone payments may exceed the previous Baxter funding obligations by approximately $12M. Additionally, Baxter has agreed to purchase Coherus common stock in a private placement transaction. All other contractual provisions remain materially unchanged.
08:04 EDTPFEPfizer: PALOMA-3 trial for IBRANCE met primary endpoint, trial stopped early
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07:41 EDTNVOEBD Group to hold a forum
ChinaBio Partnering Forum 2015 is being held in Shanghai, China on April 15-16.
07:14 EDTBIIBBiogen volatility flat into new drug data
Biogen overall option implied volatility of 35 compares to its 26-week average of 34 according to Track Data, suggesting non-directional into results as shares rally in the preopen on Phase 2 RENEW study of anti-LINGO-1 in acute optic neuritis clinical data.
April 14, 2015
18:30 EDTBIIBOn The Fly: After Hours Movers
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16:12 EDTBIIBBiogen presents new Anti-LINGO-1 Phase 2 AON data
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11:25 EDTBIIBPTAB declares interference between Forward Pharma and Biogen regarding treatment
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10:01 EDTQUREOn The Fly: Analyst Initiation Summary
Today's noteworthy initiations include: AB InBev (BUD) initiated with a Neutral at Susquehanna... AMC Networks (AMCX) initiated with an Overweight at Piper Jaffray... Avery Dennison (AVY) initiated with a Hold at BB&T... Boston Beer (SAM) initiated with a Neutral at Susquehanna... Brocade (BRCD) initiated with a Neutral at Wedbush... Bunge (BG) initiated with an Overweight at Stephens... CIRCOR (CIR) initiated with a Speculative Buy at Global Hunter... Cabot Microelectronics (CCMP) initiated with a Buy at BB&T... Canadian Natural (CNQ) initiated with a Buy at GMP Securities... Cenovus Energy (CVE) initiated with a Hold at GMP Securities... China Distance Education (DL) initiated with a Buy at Brean Capital... Coca-Cola Enterprises (CCE) initiated with a Negative at Susquehanna... Coca-Cola (KO) initiated with a Negative at Susquehanna... Constellation Brands (STZ) initiated with a Neutral at Susquehanna... Discover (DFS) initiated with an Outperform at Wells Fargo... Dr Pepper Snapple (DPS) initiated with a Neutral at Susquehanna... Flex Pharma (FLKS) initiated with a Buy at H.C. Wainwright... Flowserve (FLS) initiated with a Neutral at Global Hunter... Goldman Sachs BDC (GSBD) initiated with a Neutral at BofA/Merrill... ITT Corp. (ITT) initiated with an Accumulate at Global Hunter... Intra-Cellular (ITCI) initiated with an Outperform at RBC Capital... Keurig Green Mountain (GMCR) initiated with a Positive at Susquehanna... Microsemi (MSCC) initiated with a Buy at Topeka... Molson Coors (TAP) initiated with a Positive at Susquehanna... Monster Beverage (MNST) initiated with a Neutral at Susquehanna... New Oriental Education (EDU) initiated with a Hold at Brean Capital... OM Group (OMG) initiated with a Buy at BB&T... Pattern Energy (PEGI) initiated with a Buy at Citigroup... Pentair (PNR) initiated with a Neutral at Global Hunter... PepsiCo (PEP) initiated with a Positive at Susquehanna... Ply Gem (PGEM) initiated with an Overweight at KeyBanc... SodaStream (SODA) initiated with a Positive at Susquehanna... Splunk (SPLK) initiated with an Outperform at Baird... SteadyMed (STDY) initiated with an Outperform at JMP Securities... Suncor (SU) initiated with a Hold at GMP Securities... SuperCom (SPCB) initiated with a Buy at B. Riley... TAL Education (XRS) initiated with a Buy at Brean Capital... Tarena (TEDU) initiated with a Buy at Brean Capital... Ulta Salon (ULTA) initiated with a Buy at Evercore ISI... Versartis (VSAR) initiated with a Buy, $50 target at SunTrust... WisdomTree (WETF) initiated with a Market Perform at Keefe Bruyette... uniQure (QURE) initiated with a Buy at Roth Capital.
07:48 EDTQUREuniQure initiated with a Buy at Roth Capital
Target $38.
07:38 EDTBAXBaxter removed from the short-term buy list at Deutsche Bank
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April 13, 2015
15:12 EDTPFEMylan enters settlement, license agreement with Pfizer regarding Viagra
Mylan (MYL) announced that its subsidiaries Mylan Inc. and Mylan Pharmaceuticals have entered into a settlement and license agreement with Pfizer (PFE), Pfizer Limited and Pfizer Ireland Pharmaceuticals to settle patent litigation relating to Mylan's Abbreviated New Drug Application filed with the U.S. FDA for Sildenafil Citrate Tablets 25 mg, 50 mg, and 100 mg. This product is the generic version of Viagra, which is indicated to treat erectile dysfunction. Under the terms of the agreement, Mylan will be able to launch its ANDA products pursuant to a royalty-bearing license as early as December 11, 2017, or sooner under certain conditions, subject to FDA approval. All other terms and conditions of the settlement and license agreement are confidential, and the agreement itself is subject to review by the U.S. Department of Justice and the Federal Trade Commission. For the 12 months ending Dec. 31, 2014, Viagra had U.S. sales of approximately $1.3B, according to IMS Health.
08:10 EDTQUREuniQure risk/reward compelling after pullback, says Leerink
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