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April 9, 2014
12:00 EDTAGTCApplied Genetic Technologies falls 7.5%
Applied Genetic Technologies is down 7.5%, or $1.12, to $13.72
News For AGTC From The Last 14 Days
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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.
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.
07:11 EDTAGTCLeerink to hold a roundtable
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