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Stock Market & Financial Investment News

News Breaks
April 2, 2014
11:55 EDTBMRN, BAX, BIIB, SGMO, QURE, NVO, PFEUniqure 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 Chatham’s outstanding membership interests and as a result will acquire Chatham’s 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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December 15, 2014
10:19 EDTPFEOPKO Health soars after entering hGP-CTP agreement with Pfizer
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09:03 EDTBAX, PFEBaxter to divest Vero cell vaccines platform to Nanotherapeutics
Baxter International (BAX) announced that it has entered into a definitive agreement to sell its proprietary Vero cell technology and related assets, including its production facility in Bohumil, Czech Republic, to Nanotherapeutics, Inc. Financial details were not disclosed. The agreement with Nanotherapeutics includes all assets related to the platform, including vaccines for H5N1, H1N1 and seasonal influenza. The agreement also includes investigational vaccine programs for Ross River virus, Chikungunya disease and West Nile virus. In recent weeks, the company has also completed the sale of its commercial vaccines business and related manufacturing facilities to Pfizer (PFE).
08:02 EDTPFEPfizer, OPKO Health enter into global agreement for hGH-CTP
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December 12, 2014
08:01 EDTBMRN, BIIBPiper predicts two large-cap biotechs could be acquired in 2015
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December 11, 2014
10:21 EDTBMRNHigh option volume stocks
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07:46 EDTBMRNBioMarin could be $150 in 'blue skies' scenario, says UBS
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07:35 EDTBMRNBioMarin price target raised to $107 from $92 at Leerink
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07:24 EDTBMRNBioMarin price target raised to $104 from $90 at William Blair
William Blair raised its price target for BioMarin shares to $104 following the company's R&D day and keeps an Outperform rating on the stock. The firm expects the Vimizim launch to remain strong and believes BioMarin holds one of the strongest pipelines in the sector.
07:19 EDTBMRNBioMarin price target raised to $118-$122 from $103-$107 at Wells Fargo
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December 10, 2014
17:19 EDTBAXBaxter announces filing of Form 10 in connection with planned spin-off
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08:31 EDTPFETeva announces launch of first generic Celebrex capsules in the U.S.
Teva Pharmaceutical Industries (TEVA) announces the launch of the first FDA-approved generic equivalent to Celebrex Capsules in the United States. Teva is offering 50, 100, 200, and 400 mg strengths of Celecoxib Capsules. Celebrex Capsules, marketed by Pfizer (PFE) had annual sales of approximately $2.56B in the United States, according to IMS data as of October 2014.
08:14 EDTBMRNBioMarin VIMIZIM approved in Brazil
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08:13 EDTBMRNBioMarin NAGLU granted ODD by FDA
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07:38 EDTPFEMylan launches generic version of Pfizer's Celebrex capsules
Mylan (MYL) announced the U.S. launch of its Celecoxib Capsules, 50 mg, 100 mg, 200 mg, and 400 mg, one of the first available generic versions of Pfizer's (PFE) Celebrex Capsules, indicated for the relief of the signs and symptoms of osteoarthritis, rheumatoid arthritis, and ankylosing spondylitis, and for the management of acute pain in adults. Celecoxib Capsules had U.S. sales of approximately $2.5B for the 12 months ending September 30, 2014.
December 9, 2014
12:22 EDTBIIB, BAX, QURE, BMRN, SGMO, NVO, PFEPiper Jaffray biopharm analyst holds an analyst/industry conference call
Senior Research Analyst Schimmer, along with Biopharmaceuticals Analyst Breazzano, discuss gene therapy for hemophilia on an Analyst/Industry conference call to be held on December 11 at 10 am.
10:32 EDTPFEPfizer says in talks with FDA on path forward for Mylotarg
Pfizer announced the presentation of encouraging early- and late-stage data from clinical studies across several hematologic malignancies, including acute myeloid leukemia, acute lymphoblastic leukemia and chronic myeloid leukemia. Among the highlights are results from several investigator-led, large, randomized studies evaluating the antibody-drug conjugate MYLOTARG in select adult AML populations. Research was presented at the 56th Annual Meeting of the American Society of Hematology in San Francisco, December 6-9. Mace Rothenberg, senior vice president of Clinical Development and Medical Affairs and chief medical officer for Pfizer Oncology, said “In particular, we are encouraged by the significant clinical evidence emerging from large randomized trials, such as AML-19 and ALFA-0701, demonstrating a positive impact of MYLOTARG when added to standard first-line treatment for patients with acute myeloid leukemia. We are engaging in discussions with the U.S. FDA and other health authorities to determine the best path forward for MYLOTARG. In addition, we plan to initiate an expanded access protocol for the therapy by the end of 2014 in the United States in patients with relapsed or refractory acute myeloid leukemia for whom there are no other treatment options.”
07:44 EDTPFE, BMRNAmerican Association for Cancer Research to hold a symposium
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December 8, 2014
13:32 EDTPFEPfizer, Bristol-Myers announce results of human study on Eliquis
Bristol-Myers Squibb Company (BMY) and Pfizer (PFE) announced results of the first human study evaluating the reversal of the anticoagulant effect of Eliquis by 4-factor prothrombin complex concentrates in healthy subjects. The study results demonstrated that both PCCs, Sanquin’s Cofact and CSL Behring’s Beriplex P/N reversed the steady-state pharmacodynamic effects of Eliquis in several coagulation assessments, including endogenous thrombin potential. The full data will be presented today during the Antithrombotic Therapy: Anticoagulant Therapy session at the 56th annual meeting of the American Society of Hematology in San Francisco, CA. The study was an open label, randomized, placebo-controlled, three-period crossover study in 15 healthy, adult subjects. Within each period, subjects received Eliquis 10 mg twice daily. On day four, three hours after Eliquis administration, subjects received a 30-minute infusion of 4-factor PCCs, either 50 IU/kg Cofact or Beriplex P/N, or an equivalent volume of saline solution. The effect of Cofact and Beriplex P/N on the pharmacodynamics of Eliquis was based upon changes in endogenous thrombin potential, a measure of thrombin-mediated coagulation. Treatment periods were separated by an 11-day washout, after which the alternate treatment was administered. In this study, no serious adverse events, bleeding-related events or signs of thrombosis were reported with Eliquis administration with or without PCC treatment. Overall, these data demonstrate that Cofact and Beriplex P/N reversed the steady-state pharmacodynamic effects of Eliquis as measured by ETP and support further evaluation of PCCs in the management of patients treated with Eliquis who require reversal of its anticoagulant effect.
08:03 EDTPFEPfizer announces agreement with Spark Therapeutics to develop SPK-FIX
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07:11 EDTSGMOSangamo presents new data for Vivo Protein Replacement Platform
Sangamo announced the presentation of new preclinical data from its proprietary programs for the treatment of lysosomal storage disorders and Shire-partnered hemophilia program. These studies demonstrate the broad applicability of Sangamo's In Vivo Protein Replacement Platform for the potentially curative treatment of such diseases. The data presented at ASH from Sangamo's proprietary IVPRP applications demonstrated the efficient production, secretion and tissue uptake of functional iduronate-2-sulfatase and alpha-L-iduronidase, enzymes that are deficient in the LSDs, Hunter and Hurler's disease, respectively. Data were also presented from Sangamo's partnered program with Shire that demonstrated that therapeutic levels of Factor IX, the human clotting factor that is deficient in hemophilia B, could be generated in a dose-dependent manner in non-human primates. There were no significant alterations in circulating albumin levels. Studies in mice also demonstrated stable Factor IX production from Sangamo's IVPRP for over 1 year.
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