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News Breaks
April 7, 2014
14:18 EDTAGTC, GSKGlaxoSmithKline reports 14.1% stake in Applied Genetic Technologies
News For GSK;AGTC From The Last 14 Days
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October 8, 2015
07:08 EDTGSKCodexis earns $6.5M milestone payment from GlaxoSmithKline
Codexis (CDXS) announced that it successfully completed Wave 2 of the transfer of its proprietary CodeEvolver protein engineering platform technology to GlaxoSmithKline (GSK) in Q3 of 2015. Codexis expects to receive a $6.5M payment from GSK for completion of this milestone in Q4. Codexis has received a $6M upfront payment and a $5M Wave 1 technology transfer milestone payment from GSK since announcing the technology collaboration and license agreement with GSK in July 2014. The agreement grants GSK a license to use Codexis' CodeEvolver platform technology to develop novel enzymes for use in the manufacture of GSK's pharmaceutical and health care products. The CodeEvolver platform technology has been installed and is operational at a GSK facility in Pennsylvania. Codexis is eligible to receive an additional $7.5M payment from GSK subject to the satisfactory completion of the final CodeEvolver technology transfer milestone. Codexis also has the potential to receive numerous additional contingent milestone payments under the agreement with GSK that range from $5.75M-$38.5M per project based on GSK's successful application of the licensed technology. In addition, Codexis will be eligible to receive royalties based on net sales, if any, of a limited set of products developed by GSK using Codexis' CodeEvolver protein engineering platform technology.
October 7, 2015
07:34 EDTAGTCAlliance for Regenerative Medicine to hold a meeting
Stem Cell Meeting on the Mesa is being held in La Jolla, California on October 7-9.
October 6, 2015
13:32 EDTGSKBiotechs plummet with TPP seen as industry negative
Biotechs are falling intraday after reports that the Trans-Pacific Partnership, or TPP, has language that the exclusivity period for bioligics, or drugs derived from a biological sources, would be eight years, less than the twelve years it is currently in the United States. WHAT'S NOTABLE: In the U.S., biologics are protected from competition by follow-on products for twelve years from the time they are first granted marketing approval by the U.S. Food and Drug Administration, a protection that is distinct from patent protection. Recent reports on the TPP suggest that the protection will last five years with an additional safety monitoring period of up to three years before a biosimilar can be registered, which would effectively be an eight year exclusivity period. ANALYST REACTION: Piper Jaffray analyst Joshua Schimmer, however, said the development is a "step forward," especially since it does not overrule the 12 years' exclusivity for the drugs in the U.S. While the sector asked for twelve years' exclusivity to match the U.S., eight years is a "reasonable compromise," the analyst argued. His top picks were Alexion (ALXN), Celgene (CELG), and Amgen (AMGN) in the large-cap space, GW Pharmaceuticals (GWPH) and bluebird bio (BLUE) among mid-caps, and Flex Pharma (FLKS), Lion Biotechnologies (LBIO), Otonomy (OTIC), and Ignyta (RXDX) in the small-cap sector. Further, Schimmer stated that more names look "increasingly compelling" amid the selloff. NOTABLE DECLINERS: Alexion is lower by 2.53%, Celgene is down 4.32%, Amgen is declining 1.91%, Biogen (BIIB) is down 3.4%, and Gilead Sciences (GILD) is falling 2.22%. STOCKS TO WATCH: Other publicly traded companies in the pharmaceutical space include AstraZeneca (AZN), Bristol-Myers (BMY), Eli Lilly (LLY), GlaxoSmithKline (GSK), Johnson & Johnson (JNJ), Merck (MRK), Novartis (NVS), Pfizer (PFE), Roche (RHHBY) and Sanofi (SNY).
October 5, 2015
10:19 EDTAGTCSpark trial success a positive for gene therapy sector, says Piper Jaffray
Piper Jaffray analyst Joshua Schimmer said he views the news that Spark Therapeutics (ONCE) "highly anticipated" SPK-RPE65 Phase 3 gene therapy study for congenital blindness met its primary endpoint as a positive for the ophthalmology gene therapy field as well as the broader gene therapy sector. Schimmer added that Applied Genetic Technologies' (AGTC) early clinical data in the second half of this year will be a further test of the ophthalmology gene therapy platform. The analyst noted that other companies with gene therapy programs include Avalanche (AAVL), Biogen (BIIB), bluebird bio (BLUE), BioMarin (BMRN), Cellectis (CLLS), Medgenics (MDGN), uniQure (QURE), Pfizer (PFE), Regeneron (REGN) and Sangamo (SGMO).
10:06 EDTAGTCStreet Check: Analyst made right call on Spark Therapeutics trial success
The shares of Spark Therapeutics (ONCE) are surging after the company announced that its lead gene therapy product candidate, SPK-RPE65, had met its primary endpoint in a Phase 3 trial. In a note to investors on September 24, research firm Cowen said it was optimistic about the trial's outcome and predicted that the stock could reach $70 per share if the results of the trial were positive. The stock traded to as high as $66 per share in the early going today. The Fly published a summary of Cowen's note on the day it was circulated. WHAT HAPPENED: Spark Therapeutics announced this morning that SPK-RPE65, which is supposed to treat gene-induced blindness, had met its primary endpoint in a Phase 3 trial. Specifically, patients taking the product experienced a significant improvement in their vision, compared with those who did not receive the treatment, the company stated. In his prior note, Cowen analyst Phil Nadeau had estimated that the trial had roughly a 70% chance of being successful and predicted that the stock could rise $30 from it trading price at the time of the note if the outcome was positive. The stock was trading near $46 on the afternoon of September 24. ANOTHER TO WATCH: Applied Genetic Technologies (AGTC) is expected to report early data on its own gene therapy for patients with X-linked retinoschisis by year end. Wedbush analyst David Nierengarten has said he also expects the company's gene therapy for achromatopsia patients to enter the clinic "shortly," with data expected in 2016. PRICE ACTION: In early trading, Spark surged 32% to $58 per share. Meanwhile, Applied Genetic Technologies gained 4% to $13.57.
October 1, 2015
08:04 EDTGSKPfizer completes acquisition of Nimerix, Mencevax from GSK
Pfizer (PFE) announced that it has completed the acquisition of GlaxoSmithKline's (GSK) quadrivalent meningococcal ACWY vaccines Nimenrix and Mencevax.
September 30, 2015
16:24 EDTAGTCApplied Genetic reports publication of data supporting AAV-based gene therapies
Applied Genetic Technologies announced two studies supporting further clinical investigation of the company's novel investigational gene therapy candidate for treating XLRS were published in Human Gene Therapy Clinical Development. One study evaluated the safety and biodistribution profiles of rAAV2tYF-CB-hRS1, a recombinant AAV vector expressing retinoschisin, or RS1, in RS1-deficient mice. Three groups of 20 mice each received an intravitreal injection in one eye of either vehicle or a higher or lower dose of vector. Results demonstrated that intravitreal injection of rAAV2tYF-CB-hRS1 was well tolerated in all groups with no test article-related changes in ophthalmic examinations. Microscopic pathology results demonstrated minimal to slight mononuclear cell infiltrates in 80% of vector-injected eyes at day 30, decreasing to 20% at day 90, with minimal ocular inflammatory cells detected by histopathology. RS1 expression, measured by immunohistochemistry, was demonstrated in all vector-injected eyes and was associated with decreased severity of splitting and disorganization of the inner nuclear layer of the retina at the higher dose level. Biodistribution studies demonstrated vector DNA in the injected eye and no vector DNA in any other tissue. The other study evaluated the safety and biodistribution of the same AAV vector in three groups of normal male cynomolgus macaques administered either vehicle or a higher or lower dose of vector in one eye. Intravitreal administration of rAAV2tYF-CB-hRS1 was well-tolerated in all groups and was associated with dose-related anterior and posterior segment inflammatory responses that improved over time. There were no test article-related effects on intraocular pressure, electroretinography, visual evoked potential, hematology, coagulation, clinical chemistry or gross pathology observations. Microscopic pathology results demonstrated mononuclear cell infiltrates of minimal to moderate intensity in vector-injected eyes. RS1 expression, measured by immunohistochemistry, was seen in the retinal ganglion cell ring in all vector-injected eyes. Biodistribution studies demonstrated high levels of vector DNA in the injected eye with minimal or no vector DNA in other tissue.
12:41 EDTGSKGlaxoSmithKline exercises option for Liquidia Technologies' inhaled therapeutics
Liquidia Technologies announced that GlaxoSmithKline has exercised its option under a Collaboration and Option Agreement signed in 2012 to exclusively license the right to research, develop, and commercialize inhaled therapeutics derived from the company's proprietary PRINT technology. Through this collaboration, Liquidia and GSK will continue to work together with the goal of advancing inhaled therapeutics into clinical studies. According to the agreement signed in June 2012, Liquidia was granted an upfront payment comprised of cash and equity, R&D funding, and potential development milestones and royalties. As a result of the GSK decision to exercise the option, Liquidia will receive an option fee, continued R&D funding, and potential product-based development and regulatory milestone payments. Liquidia has also retained the ability to independently develop an inhaled treatment for a particular disease field.
07:11 EDTAGTCLeerink to hold a roundtable
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September 28, 2015
07:52 EDTGSKIIR Holdings to hold a conference
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September 27, 2015
16:58 EDTGSKGlaxoSmithKline, Theravance report Phase 3 data on Anoro Ellipta for COPD
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September 24, 2015
11:24 EDTGSKGlaxoSmithKline receives positive CHMP opinion in Europe for Nucala
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05:24 EDTGSKGlaxoSmithKline and Theravance intend to file Relvar Ellipta for COPD in Japan
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