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14:32 EDT uniQure announces follow-up data from Phase IIb study of AMT-061, AMT-060 - uniQure announced updated clinical data on the three patients treated in the company's ongoing Phase IIb study of AMT-061, an investigational AAV5-based gene therapy containing a patent-protected FIX-Padua variant for the treatment of patients with severe and moderately severe hemophilia B. In addition, the company presented up to 3.5 years of follow-up data on the 10 patients in the Phase I/II trial of AMT-060, its first-generation gene therapy for the treatment of hemophilia B. The Phase IIb study of AMT-061 is an open-label, single-dose, single-arm, multi-center trial being conducted in the U.S. Three patients with severe hemophilia were enrolled in the study and received a single intravenous infusion of 2x1013 vc/kg. Prior to the administration of AMT-061, all three patients showed low levels of pre-existing neutralizing antibodies to AAV5 but were not excluded from the trial on that basis. Patients in the Phase IIb study will be followed for 52 weeks to assess FIX activity, bleeding rates and usage of FIX replacement therapy, and will be monitored for five years to evaluate the safety of AMT-061. Featured in an oral presentation at ISTH, the 36 weeks of follow-up data show that all three patients have sustained increases in FIX levels after the one-time administration of AMT-061, with two of the three patients maintaining FIX activity in the normal range. Mean FIX activity for the three patients at 36 weeks after administration was 45% of normal, with the first patient achieving FIX activity of 54% of normal, the second patient achieving FIX activity of 30% of normal and the third patient achieving FIX activity of 51% of normal. The second and third patients had previously screen-failed and were excluded from another gene therapy study due to pre-existing neutralizing antibodies to a different AAV vector. Reported FIX activity was measured using an activated partial thromboplastin time assay performed at a central laboratory. No patient in the study has experienced a material loss of FIX activity, reported any bleeding events or required any infusions of FIX replacement therapy for bleeds. One patient underwent hip surgery due to a pre-existing condition and was treated perioperatively with short-acting factor replacement. This was reported by the investigator as a serious adverse event unrelated to AMT-061. In the ongoing Phase I/II study of AMT-060, all 10 patients continue to show long-term meaningful clinical impact, including sustained increases in FIX activity and improvements in their disease state as measured by reduced usage of FIX replacement therapy and decreased bleeding frequency. At up to 3.5 years of follow-up, AMT-060 continues to be safe and well-tolerated, with no new serious adverse events and no development of inhibitors since the last reported data. All five patients in the second dose cohort of 2x1013 gc/kg continue to be free of routine FIX replacement therapy at up to 3 years after treatment. During the last 12 months of observation, the mean annualized bleeding rate was 0.7 bleeds, representing an 83% reduction to the year prior to treatment. During this same period, the usage of FIX replacement therapy declined 96% compared to the year prior to treatment. Steady-state mean yearly FIX activity at 3 years was 7.9%, as compared to 7.1% in the first year and 8.4% in the second year. AMT-060 is uniQure's first-generation gene therapy, consisting of an AAV5 vector carrying a gene cassette with the wild-type FIX gene. Data from this Phase I/II trial of AMT-060 will be part of the regulatory submission for marketing approval of AMT-061.

14:23 EDT Sangamo, Pfizer announce updated Phase 1/2 Alta study results for SB-525 - Sangamo Therapeutics (SGMO) and Pfizer (PFE) announced updated results from the Phase 1/2 Alta study evaluating investigational SB-525 gene therapy for severe hemophilia A. The data showed that SB-525 was generally well-tolerated and demonstrated a dose-dependent increase in Factor VIII activity levels. The first two patients treated at the 3e13 vg/kg dose rapidly achieved normal levels of FVIII activity as measured using a chromogenic assay, with no reported bleeding events, and the response continues to be durable for as long as 24 weeks, the extent of follow-up. The two patients more recently treated at the 3e13 vg/kg dose level are demonstrating FVIII activity kinetics that appear consistent with the first two patients treated in this dose cohort at similar early time points. Data from 10 patients treated with SB-525 were presented at the XXVII Congress of the International Society on Thrombosis and Haemostasis, in Melbourne, Australia. The SB-525 ISTH presentation slides, which include the full data set, are available on Sangamo's website in the Investors and Media section under Events and Presentations. Based on the accumulating results from the Alta study, the U.S. Food and Drug Administration has granted regenerative medicine advanced therapy designation for SB-525 gene therapy to treat severe hemophilia A. The fifth patient in the 3e13 vg/kg cohort is expected to be treated soon. Sangamo and Pfizer are working on plans to advance SB-525 to a registrational study. Pfizer will assume responsibility for SB-525 late-stage development and manufacturing. Transfer of the SB-525 manufacturing process from Sangamo to Pfizer has been initiated. In addition to the collaboration for the development and commercialization of gene therapies for hemophilia A, Sangamo and Pfizer are also working together on the development of gene therapies for amyotrophic lateral sclerosis and frontotemporal lobar degeneration using Sangamo's proprietary zinc finger protein transcription-factor technology.

13:22 EDT Deutsche Bank targets fully-loaded leverage ratio of 4.5% by end of 2020 - Deutsche Bank said its Management Board believes that the future business mix is consistent with a lower capital requirement. After consultation with the bank's regulators, the bank now intends to operate with a minimum CET1 ratio of 12.5% going forward. As a result of the deleveraging actions, the bank targets a fully-loaded leverage ratio of 4.5% by the end of 2020 rising to approximately 5% by 2022.

13:20 EDT Deutsche Bank to implement cost reduction program, sees EUR 7.4B in charges - Deutsche Bank said it will implement a cost reduction program designed to reduce adjusted costs to EUR 17B in 2022 and is targeting a cost income ratio of 70% in that year. To facilitate its restructuring, Deutsche Bank expects to take approximately EUR 3B of aggregate charges in Q2, of which approximately EUR 0.2B would impact Common Equity Tier 1 capital. These charges include a Deferred Tax Asset write-down of approximately EUR 2B and impairments of approximately EUR 0.9B. Additional restructuring charges are expected in the second half of 2019 and subsequent years. In aggregate, Deutsche Bank currently expects cumulative charges of EUR 7.4B by the end of 2022.