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Stock Market & Financial Investment News

News Breaks
April 2, 2014
11:55 EDTQURE, BAX, PFE, SGMO, BMRN, NVO, BIIBUniqure 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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August 20, 2014
08:03 EDTPFEBristol-Myers Pfizer to present new Eliquis data
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August 19, 2014
16:33 EDTBAXBaxter to expand Alabama facility to increase dialyzers production
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August 18, 2014
11:41 EDTPFECubist rises after report sparks takeover interest speculation
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08:01 EDTPFEPfizer announces submission of Palbociclib NDA to FDA
Pfizer announced it has completed the submission of a New Drug Application to the United States Food and Drug Administration for palbociclib. This NDA requests FDA approval of palbociclib, in combination with letrozole, for the treatment of postmenopausal women with estrogen receptor positive, human epidermal growth factor receptor 2 negative advanced breast cancer who have not received previous systemic treatment for their advanced disease. The submission is based on the final results of PALOMA-1, a randomized, Phase 2 trial comparing palbociclib plus letrozole versus letrozole alone in this population of patients. Palbociclib received Breakthrough Therapy designation from the FDA in April 2013, for the first-line systemic treatment of women with advanced or metastatic ER+, HER2- breast cancer. This designation was based on interim data from the PALOMA-1 trial. The FDA has a 60-day filing review period to determine whether the NDA is complete and acceptable for filing. Pfizer will communicate the Agency’s decision.
07:57 EDTPFECambridge Healthtech Institute to hold a summit
6th Annual Bioprocessing Summit to be held in Boston on August 18-22.
August 15, 2014
18:35 EDTBIIBBiogen PLEGRIDY approved in U.S. for treatment of multiple sclerosis
Biogen Idec announced that the FDA has approved PLEGRIDY, a new treatment for people with relapsing forms of multiple sclerosis, or RMS. PLEGRIDY is dosed once every two weeks and can be administered subcutaneously with the PLEGRIDY PEN, a new, ready-to-use autoinjector, or a prefilled syringe. The FDA approval of PLEGRIDY is based on results from one of the largest pivotal studies of beta interferon conducted, ADVANCE, which involved more than 1,500 MS patients.
07:01 EDTBIIBIsis Pharmaceuticals earns $2M from advancement of ISIS-SMN from Biogen
Isis Pharmaceuticals (ISIS) announced that it has earned a $2M milestone payment from Biogen (BIIB) related to the advancement of the ongoing open-label extension study of ISIS-SMNRx in children with spinal muscular atrophy.
August 14, 2014
17:05 EDTPFEPfizer says FDA accepted for review BLA for bivalent recombinant LP2086
Pfizer announced that the FDA has accepted for review the Biologics License Application,BLA, for bivalent recombinant LP2086, the company’s vaccine candidate for the prevention of invasive meningococcal disease caused by Neisseria meningitidis serogroup B in 10 through 25 year olds. The FDA has also granted Priority Review designation for the BLA, providing an anticipated Prescription Drug User Fee Act, PDUFA, action date of February 14, 2015. “Pfizer has closely collaborated with the FDA since 2008 to develop our meningococcal B vaccine candidate with the intent to help prevent this devastating disease,” said Dr. Emilio Emini, senior vice president of Vaccine Research and Development for Pfizer. “Both the acceptance of Pfizer’s Biologics License Application today, and its Priority Review designation, are significant regulatory milestones that underscore the importance of our efforts to expedite the approval and subsequent availability of our meningococcal B vaccine for U.S. adolescents.”
08:07 EDTBAXKamada sees FY14 revenue $70M-$72M, consensus $75.4M
Kamada (KMDA) expects FY14 revenue $70M-$72M, with revenue from its Distribution Segment projected to be between $25M-$26M and revenue from its Proprietary Products Segment to be between $45M-$47M. The company notes that U.S. revenues from the agreement with Baxter (BAX) remain on track.
August 12, 2014
17:07 EDTPFEPfizer announces results from Lyrica studies conducted in China
Pfizer announced top-line results from two placebo-controlled studies conducted in China with Lyrica in patients with postherpetic neuralgia, pain after shingles or PHN, and painful diabetic peripheral neuropathy, pDPN, respectively.The PHN Phase 4 study, A0081276, met its primary endpoint by demonstrating a statistically significant reduction in pain when compared to placebo. Separately, the pDPN Phase 3 study, A0081265, did not meet its primary endpoint, a statistically significant change in endpoint mean pain score relative to placebo. The PHN study was an eight-week, randomized, double-blind, multi-center, placebo-controlled, post-marketing study evaluating the efficacy, safety and tolerability of pregabalin 300mg/day in the treatment of subjects with PHN. For the primary efficacy parameter, change from baseline in weekly mean pain scores, a significant treatment difference of -0.71 points for pregabalin relative to placebo was observed. The safety profile in this study was consistent with the known profile for Lyrica.
05:26 EDTQUREuniQure to host conference call
Conference call to discuss agreement to acquire InoCard will be held on August 12 at 8:30 am. Webcast Link
August 11, 2014
16:53 EDTQUREuniQure acquires InoCard in cash, stock
uniQure announced the acquisition of InoCard GmbH, an innovative, early-stage biotechnology company focused on the development of gene therapy approaches for cardiac disease. InoCard founders Patrick Most and Hugo Katus will join uniQure as managing director of uniQure in Germany and chairman of the scientific advisory board, for cardiovascular diseases, respectively. Under the terms of the agreement, InoCard shareholders will receive an upfront payment of €3M, €1.5M in cash and €1.5M in uniQure stock, and certain success-based milestones and royalties.
15:27 EDTSGMOWedbush to hold a conference
Life Sciences Management Conference to be held in New York on August 12-13.
11:58 EDTNVOMannKind rallies after inking licensing agreement with Sanofi
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10:50 EDTBIIBBiogen weakness attributed to Forward Pharma IPO filing
Shares of Biogen Idec (BIIB) came off their earlier highs and moved into negative ground in early trading, with some attributing the move lower to another pharmaceutical company, Forward Pharma (FWP), filing its registration statement with the SEC relating to a proposed initial public offering and reporting that Joel Sendek has been appointed CFO. WHAT'S NOTABLE: Forward Pharma focuses on a proprietary formulation of dimethyl fumarate, or DMF, for the treatment of multiple sclerosis. DMF is the Active Pharmaceutical Ingredient, or API, found in Tecfidera, which Biogen Idec began selling for the treatment of RRMS following approval by the FDA in March 2013 and approval by the European Commission in February 2014, Forward Pharma indicated in its IPO filing. In addition to its filing, Forward Pharma announced this morning that it has hired Joel Sendek from Stifel Financial, where he served as Managing Director, Biotechnology and led the firm's healthcare equity research group. PRICE ACTION: Shares of Biogen are down fractionally in mid-morning trading after being up over 1% soon after today's opening bell.
August 8, 2014
09:16 EDTNVONovo Nordisk management to meet with JPMorgan
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06:39 EDTPFEPfizer faces torrent of Lipitor suits, Reuters says
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August 7, 2014
10:51 EDTBIIBOptions with increasing implied volatility
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09:03 EDTBAXBaxter opens biologics facility in Singapore
Baxter International announced the formal opening of its first advanced recombinant biologic facility in Singapore, and expansion plans for a new recombinant protein processing suite. The current suite supports the processing of ADVATE.The second suite will initially process RIXUBIS, a recombinant factor IX protein for the treatment of adults with hemophilia B and, when operational, will be the primary global commercial processing facility. It will also support production of the company’s investigational extended half-life recombinant FVIII treatment BAX 855 upon regulatory approval. The Singapore facility received regulatory approval from the European Medicines Agency in January 2014 for the production of ADVATE2. This allows the facility to process and supply ADVATE to the European Union, Iceland and Norway. The biologics facility in Singapore currently employs more than 400 production staff and expects to reach 450 by 2015 to support the second processing suite.
08:12 EDTPFEPfizer says EMA accpets application seeking new indication for Prevenar 13
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