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April 2, 2014
11:55 EDTNVO, PFE, BMRN, BAX, BIIB, SGMO, QUREUniqure 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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August 21, 2015
06:23 EDTBMRNUBS sees 'meaningful' upside to BioMarin on positive Hemophilia data
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August 20, 2015
16:24 EDTBIIBBiogen reports 8.1% passive stake in Applied Genetic
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11:33 EDTNVOLeerink major pharmaceuticals analyst holds an analyst/industry conference call
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11:24 EDTPFEPfizer says Ibrance application validated by EMA
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August 19, 2015
17:46 EDTBIIBApplied Genetic says Biogen collaboration effective, equity investment closed
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16:06 EDTBMRNBioMarin receives rare pediatric disease designation from FDA for drisapersen
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09:17 EDTBMRN'Female Viagra' approval seen as positive for Sarepta, BioMarin
The FDA's approval of the world's first drug designed to boost a woman's sexual desire is seen as boding well for companies awaiting critical decisions by the agency. FEMALE VIAGRA: The Food and Drug Administration yesterday approved flibanserin to treat acquired, generalized hypoactive sexual desire disorder in premenopausal women. The drug, which will be sold under the name "Addyi" and is commonly referred to as the "female Viagra," is the first FDA-approved treatment for sexual desire disorders in men or women, the agency prominently stated in its press release. HSDD is characterized by low sexual desire that causes marked distress or interpersonal difficulty and is not due to a co-existing medical or psychiatric condition, problems within the relationship, or the effects of a medication or other drug substance, the FDA explained. Addyi was approved with a risk evaluation and mitigation strategy as well as a Boxed Warning given the risk of severe hypotension and syncope in patients who drink alcohol during treatment. The drug is made by privately held Sprout Pharmaceuticals. ANALYST REACTION: Addyi's approval is "another sign of flexibility" by the FDA, especially for first-in-class therapies, Roth Capital analyst Debjit Chattopadhyay writes this morning in a note to investors. This bodes well for the approval of eteplirsen, drisapersen and Translarna, the analyst contends. Eteplirsen, designed by Sarepta Therapeutics (SRPT), and drisapersen, designed by BioMarin (BMRN), are experimental drugs being developed to treat Duchenne muscular dystrophy. Translarna, designed by PTC Therapeutics (PTCT), is already being sold in Europe as a treatment for DMD and is awaiting approval from the FDA. Duchenne muscular dystrophy is a form of muscular dystrophy affecting around 1 in 3,600 boys, which results in muscle degeneration and premature death. SAVING LIVES: While female sexual dysfunction is a clinical problem, eteplirsen is designed to save lives, Chattopadhyay points out. He has a Buy rating on Sarepta and noted his price target of $45 assumes accelerated approval for eteplirsen in the first quarter of 2016. Shares of the Massachusetts-based biopharmaceutical company closed yesterday at $35.69.
08:29 EDTBMRNFlibanserin approval bodes well for Sarepta, others, says Roth Capital
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August 18, 2015
08:21 EDTBIIBBiogen long-term outlook still positive, says RBC Capital
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07:05 EDTBIIBBiogen, ALS Association, Columbia collaborate to drive understanding of ALS
Biogen, the ALS Association and Columbia University Medical Center announced a new collaboration to better understand the differences and commonalities in the ALS disease process and how genes influence the clinical features of the disease. The project, "Genomic Translation for ALS Clinical care", will involve a combination of next generation genetic sequencing and detailed clinical phenotyping in 1500 people with ALS. The goal of the project is to provide a basis for the development of precision medicine, or more individually tailored therapies for ALS. "We want to bring genomics right to the point of care in ALS where instead of focusing on retrospective DNA samples with limited clinical information, we focus on patients who are under active clinical management," said ALS Association Chief Scientist Lucie Bruijn, Ph.D., M.B.A. "By focusing on patients seen by participating ALS clinics, this project will allow investigators to ask how different genetic causes of ALS translate into different clinical consequences."
August 17, 2015
09:13 EDTQUREuniQure data positive, says Roth Capital
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07:03 EDTBIIBBiogen: Clinical data supports long-term safety, efficacy of Alprolix
New clinical data support the long-term safety and efficacy of ALPROLIX in people with severe hemophilia B treated for up to two years, Biogen announced. Participants in the Phase 3, open-label extension study, B-YOND, maintained low bleeding rates with one to two week prophylaxis regimens, according to data from an interim analysis. Investigators presented these interim results for the first time at the 67th Annual Meeting for the National Hemophilia Foundation in Dallas. B-YOND is a multi-year study for people with severe hemophilia B who completed the Phase 3 pivotal B-LONG or Kids B-LONG studies. In this interim analysis, the median time on ALPROLIX during B-YOND was 27.6 months for adults and adolescents, and 47.7 weeks for children under age 12. The study's primary endpoint is inhibitor development, and no inhibitors have been reported to-date. There were three prophylactic dosing options for adult, adolescent, and pediatric participants in the B-YOND trial - weekly, individualized, and modified prophylaxis. An episodic treatment arm was also available for adult and adolescent patients.
August 14, 2015
16:44 EDTBAXThird Point gives quarterly update on stakes
NEW STAKES: Baxter (BAX), T-Mobile (TMUS), Sealed Air (SEE), Devon (DVN), and Perrigo (PRGO). INCREASED STAKES: SunEdison (SUNE), Dow Chemical (DOW), Mohawk (MHK), Yum! Brands (YUM), and IAC/InterActiveCorp (IACI). DECREASED STAKES: Ally Financial (ALLY), Amgen (AMGN), Sensata (ST), Masco (MAS), and Delta (DAL). LIQUIDATED STAKES: Dollar General (DG), McKesson (MCK), Edgewell Personal Care (EPC), Maxim (MXIM), and FleetCor (FLT).
10:21 EDTNVONovo Nordisk management to meet with Jefferies
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09:01 EDTBAXBaxter, Water Street announce FDA approval for CEFAZOLIN 2 Gram Premix
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08:36 EDTPFEPfizer's pending Hospira acquisition approved by Canadian Competition Bureau
Pfizer (PFE) announced that it received approval from the Canadian Competition Bureau with respect to its pending acquisition of Hospira (HSP). As part of its agreement with the Canadian Competition Bureau, Pfizer has committed to divest certain assets in Canada. "We are pleased the Canadian Competition Bureau concluded its review of the transaction and approved the pending combination of Pfizer and Hospira," said Ian Read, chairman and CEO of Pfizer. "We continue to work cooperatively with the regulatory agencies to obtain the requisite approvals, and continue to expect the transaction to close in the second half of 2015."
08:35 EDTPFEHayman takes Mylan, Perrigo stakes, boasts exposure to energy
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08:26 EDTPFEPiper says Street $4B too low on Pfizer 2019 sales estimates
Piper Jaffray analyst Richard Purkiss believes the Street is underestimating Pfizer's 2019 sales by $4B. The consensus 2019 revenue estimate is $58.7B. Analysts are factoring in "overly conservative" growth assumptions for five of Pfizer's key brands, namely Prevnar, Ibrance, Xeljanz, Eliquis and Lyrica, Purkiss tells investors in a research note. Sentiment towards the stock will "improve meaningfully" as investors "wake up" to the sales turnaround from 2015, the analyst believes. Purkiss expects Pfizer's 36% discount to his $48 target price to close as sentiment improves and reiterates an Overweight rating on the pharma giant. The stock end yesterday's trading down 1c to $35.36.
06:39 EDTNVOGenmab enters commercial license agreement with Novo Nordisk
Genmab (GNMSF) announced it has entered an agreement to grant Novo Nordisk (NVO) commercial licenses to use the DuoBody technology platform to create and develop bispecific antibody candidates for two therapeutic programs. The bispecific antibodies will target a disease area outside of cancer therapeutics. Under the terms of the agreement, Genmab will receive an upfront payment of $2M from Novo Nordisk. After an initial period of exclusivity for the two target combinations, Novo Nordisk has an option to maintain exclusivity or take the licenses forward on a non-exclusive basis. Genmab is entitled to potential development, regulatory and sales milestones of up to approximately $250M for each exclusive license, or approximately $200M for each non-exclusive license. In addition, Genmab will be entitled to single-digit royalties on sales of any commercialized products.
06:00 EDTBIIBStocks with implied volatility below IV index mean; BIIB GOOG
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