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February 11, 2013
05:55 EDTLMNX, LMNX, LMNX, LMNX, LMNX, BIIB, BIIB, BIIB, BIIB, BIIB, VSTM, VSTM, VSTM, VSTM, VSTM, IMUC, IMUC, IMUC, IMUC, IMUC, PFE, PFE, PFE, PFE, PFE, AMGN, AMGN, AMGN, AMGN, AMGN, JNJ, JNJ, JNJ, JNJ, JNJ, REGN, REGN, REGN, REGN, REGNCambridge Healthtech Institute to host a conference
Molecular Med: Tri-Con 2013 is being held in San Francisco on February 11-15.
News For LMNX;BIIB;VSTM;IMUC;PFE;AMGN;JNJ;REGN From The Last 14 Days
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July 2, 2015
07:06 EDTBIIBBiogen, AGTC enter collaboration to develop gene therapies in ophthalmology
Biogen (BIIB) and AGTC (AGTC) announced a collaboration and license agreement to develop gene-based therapies for multiple ophthalmic diseases. The collaboration will focus on the development of a portfolio of AGTC’s therapeutic programs, including both a clinical stage candidate and a pre-clinical candidate for orphan diseases of the retina that can lead to blindness in children and adults. The agreement also includes options for early stage discovery programs in two ophthalmic diseases and one non-ophthalmic condition, as well as an equity investment in AGTC by Biogen and a license agreement for manufacturing rights. Biogen will make an upfront payment in the amount of $124M to AGTC, which includes a $30M equity investment in AGTC at a price equal to $20.63 per share and certain prepaid research and development expenditures. Biogen will be granted a license to the XLRS and XLRP programs and the option to license discovery programs for three additional indications at the time of clinical candidate selection. Under the collaboration, AGTC is eligible to receive upfront and milestone payments exceeding $1B. This includes up to $472.5M collectively for the two lead programs, which also will carry royalties in the high single digit to mid-teen percentages of annual net sales. In addition, Biogen will make payments up to $592.5M across the discovery programs, along with royalties in the mid single digits to low teen percentages of annual net sales. Biogen obtains worldwide commercialization rights for the XLRS and XLRP programs. AGTC has an option to share development costs and profits after the initial clinical trial data are available, and an option to co-promote the second of these products to be approved in the United States. AGTC will lead the clinical development programs of XLRS through product approval and of XLRP through the completion of first-in-human trials. Biogen will support the clinical development costs, subject to certain conditions, following the first-in-human study for XLRS and IND-enabling studies for XLRP. Under the manufacturing license, Biogen will receive an exclusive license to use AGTC’s proprietary technology platform to make AAV vectors for up to six genes, three of which are in AGTC’s discretion, in exchange for payment of milestones and royalties. The transaction is subject to customary closing conditions, including the expiration of the applicable waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976 in the United States, and is expected to close in the third calendar quarter of 2015.
July 1, 2015
16:33 EDTJNJGilead submits NDA to FDA for single tablet regimen for HIV containing R/F/TAF
Gilead Sciences (GILD) announced that it has submitted a New Drug Application, or NDA, to the FDA for an investigational, once-daily single tablet regimen that combines Gilead’s emtricitabine 200 mg and tenofovir alafenamide, or TAF, 25 mg with rilpivirine 25 mg, or R/F/TAF, from Janssen Sciences Ireland UC, one of the Janssen Pharmaceutical Companies of Johnson & Johnson (JNJ), for the treatment of HIV-1 infection in adult and pediatric patients 12 years of age and older. The data submitted in the NDA support the use of R/F/TAF among patients who are HIV treatment-naïve or who are virologically suppressed and want to replace their current antiretroviral treatment regimen. A Priority Review voucher acquired from Knight Therapeutics in November 2014 was submitted to the FDA along with the R/F/TAF NDA. Under the Prescription Drug User Fee Act, or PDUFA, the anticipated target action date for the R/F/TAF NDA is six months after the FDA’s acceptance of the filing. TAF is a novel, investigational nucleotide reverse transcriptase inhibitor, or NRTI, that has demonstrated high antiviral efficacy at a dose less than one-tenth that of Gilead’s Viread, as well as improved renal and bone laboratory parameters as compared to TDF in clinical trials in combination with other antiretroviral agents. In addition to R/F/TAF, two other TAF-based HIV treatments are also under FDA review.
16:00 EDTPFEOptions Update; July 1, 2015
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June 30, 2015
11:36 EDTAMGNRumor: Amgen moves up on speculation of an investor stake
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07:03 EDTAMGNCelgene leaps forward in immuno-oncology with Juno deal, says Piper Jaffray
Piper Jaffray analyst Joshua Schimmer said that Celgene (CELG) effectively spent $1B to buy into adoptive T cell therapy and own all of Juno Therapeutics' (JUNO) opportunities outside the U.S., leaping the company into a leading position in the immuno-oncology space. Schimmer additionally thinks Celgene's transaction should help boost investor confidence about the utility and value of CAR and TCR therapies, noting that he sees Bellicum Pharmaceuticals (BLCM), Cellectis (CLLS), Lion Biotechnologies (LBIO), bluebird bio (BLUE) and the Amgen (AMGN)-Kite Pharma (KITE) partnership as best positioned to compete in this rapidly advancing field. The analyst keeps an Overweight rating and $144 price target on Celgene.
June 29, 2015
07:36 EDTVSTMVerastem coverage assumed with a Buy at H.C. Wainwright
Target $17.
June 26, 2015
05:25 EDTREGNRegeneron reports approval of Eylea by Japan
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05:21 EDTBIIBBiogen, Sobi announce EMA validates MAA for Alprolix
Biogen and Swedish Orphan Biovitrum AB, or Sobi, announced that the European Medicines Agency, or EMA, has accepted the Marketing Authorization Application, or MAA, of Alprolix, a recombinant factor IX Fc fusion protein product candidate for the treatment of hemophilia B. This validation signifies the initiation of the EMA’s review process. The MAA includes results from two global, Phase 3 clinical trials examining the efficacy, safety and pharmacokinetics of ALPROLIX for hemophilia B: the pivotal B-LONG study for previously treated adults and adolescents, and Kids B-LONG study for previously treated children under age 12.
June 25, 2015
12:59 EDTBIIBOptions with increasing implied volatility
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June 24, 2015
13:23 EDTPFEPfizer says CDC committee votes to recommend MenB vaccine
Pfizer announced that the U.S. Centers for Disease Control and Prevention's Advisory Committee on Immunization Practices voted to recommend that decisions to vaccinate adolescents and young adults 16 through 23 years of age against serogroup B meningococcal disease should be made at the individual level with healthcare providers. It added, "Specifically, the ACIP voted that a serogroup B meningococcal vaccine series may be administered to adolescents and young adults 16 through 23 years of age to provide short term protection against most strains of serogroup B meningococcal disease. The preferred age for MenB vaccination is 16 through 18 years of age." Pfizer's Trumenba is FDA-approved for active immunization to prevent invasive disease caused by Neisseria meningitidis serogroup B in individuals 10 through 25 years of age. The ACIP recommendation will be forwarded to the director of the CDC and the U.S. Department of Health and Human Services for review and approval, Pfizer said.
11:16 EDTBIIBOptions with increasing implied volatility
Options with increasing implied volatility: WMB AMZN CMG BIIB VMW QLIK ISRG FB UA FFIV
11:02 EDTPFEPfizer lung cancer treatment granted FDA orphan drug designation
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09:07 EDTPFECAR-T cancer drug researchers seen as M&A targets, Bloomberg says
Juno Therapeutics (JUNO), Kite Pharma (KITE) and Bluebird Bio (BLUE) are trading well above their IPO levels as takeovers predictions have spurred interest and share increases for the developers of CAR-T gene therapies, said Bloomberg's "Real M&A" column, quoting Dimo Dimov, a professor at the University of Bath’s School of Management, as having said that companies such as Pfizer (PFE), Merck (MRK), Roche (RHHBY) and AstraZeneca (AZN) are "closely watching" the firms. Cellectis (CLLS), which is working with Pfizer on its own approach to CAR-T therapy, has said it wants to bring its therapy to market and doesn’t anticipate a sale, the report noted. Reference Link
07:56 EDTAMGNAmgen management to meet with Evercore ISI
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June 23, 2015
14:17 EDTPFEGlycoMimetics to receive $20M payment from Pfizer
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14:01 EDTPFEPfizer announces enrollment of first patient in RESET study
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11:00 EDTBIIBOptions with increasing implied volatility
Options with increasing implied volatility:TRIP WPZ CMG BIIB WMB AMZN ISRG VMW
09:53 EDTPFEPfizer management to meet with FBN Securities
Meeting to be held in New York on June 25 hosted by FBN Securities.
07:55 EDTBIIBBiogen's Tysabri in SPMS a $1B-$2B opportunity, says Morgan Stanley
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07:25 EDTPFE, AMGNPiper Jaffray to hold a summit
2015 Piper Jaffray Heartland Summit is being held in Minneapolis on June 23-24.
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