GSK’s guidance for full-year 2018 Adjusted EPS growth remains unchanged at 8 to 10% at CER. GSK continues to expect to deliver on its previously published Group Outlooks to 2020, but following the acquisition of TESARO now expects Adjusted EPS growth at CER for the period 2016-2020 to be at the bottom end of the mid to high single digit percentage CAGR range.
Monday, December 3, 2018
Oncolytics presents pelareorep data at ASH
Oncolytics announced a poster presentation made at the American Society of Hematology, or ASH. The poster highlights pelareorep’s ability to increase PD-L1 expression on tumor cells in patients with relapsed myeloma. This phase 1 study enrolled 15 patients with relapsed myeloma. Responses include: three very good partial responses, three partial remissions, three minimal responses and three stable disease. In patients receiving pelareorep with a clinical response, there was simultaneous CD8, PD-L1 and NK cell response, as well as activated caspase-3 expression. In patients treated with pelareorep, PD-L1 expression increased significantly more in patients with clinical response
Quest Diagnostics price target lowered to $96 from $110 at SunTrust
SunTrust analyst David MacDonald lowered his price target on Quest Diagnostics to $96 and kept his Hold rating after its analyst day. MacDonald notes that the presentation indicated that the headwinds around reimbursements will accelerate in 2019, adding that the trends around organic volume and patient concessions also “bear watching”. Longer term, the analyst remains positive on Quest Diagnostics’ fundamentals, stating that the “expanded health plan access” is also a meaningful opportunity for the company.
uniQure announces updated AMT-060 results, AMT-061 update at ASH
uniQure announced updated results from its ongoing Phase I/II trial of AMT-060, and provided an update on AMT-061, the company’s next-generation gene therapy candidate currently in late-stage clinical development for patients with hemophilia B. AMT-060 is a gene therapy consisting of an AAV5 vector carrying a gene cassette with the wild-type FIX gene. The data on AMT-060 includes up to two and a half years of follow-up from the low-dose cohort and up to two years of follow-up from the second, higher-dose cohort. These clinical data were presented in a poster presentation at the American Society of Hematology, or ASH. AMT-060 continues to be safe and well-tolerated, with no new serious adverse events and no development of inhibitors. All 10 patients sustained increases in FIX activity and improvements in their disease state as measured by reduced usage of FIX replacement therapy and decreased bleeding frequency. All five patients in the second dose cohort of 2×1013 gc/kg continue to be free of routine prophylaxis at up to two years after treatment. During the last 12 months of observation, the mean annualized bleeding rate was 0.5 bleeds, representing an 88% reduction compared to the year prior to treatment. During the same period, the usage of FIX replacement therapy declined 93% compared to the year prior to treatment. Mean FIX activity increased from 7.1% in the first year after treatment to 8.3% in the second year and was 8.9% of normal at the last measurement.
Aptinyx: NYX-29254 achieved statistical significance on primary endpoint
Aptinyx announced results from an interim analysis of an exploratory study of its novel NMDA receptor modulator, NYX-2925, in subjects with fibromyalgia. Subjects in the study receive daily oral doses of NYX-2925 at two dose levels, 20 mg and 200 mg, as well as placebo, over the course of six weeks. The interim analysis was conducted on data from the first 11 subjects who have completed the study. Administration of NYX-2925 resulted in statistically significant effects on the primary endpoint, changes in markers of central pain processing as measured by advanced imaging techniques, including changes in combined glutamate and glutamine levels in brain regions that were pre-specified and selected for analysis based on their known involvement in processing pain. Improvement trends were also observed on multiple secondary endpoints, including patient-reported pain scores, as measured by the Numeric Pain Rating Scale, and the Revised Fibromyalgia Impact Questionnaire. NYX-2925 was well tolerated with no subjects reporting treatment-related serious adverse events. Based on these positive interim data, Aptinyx expects to initiate a larger Phase 2 study of NYX-2925 in subjects with fibromyalgia in 2019. The study is ongoing with the full data expected to read out in the first half of 2019. Once completed, the company plans to submit the detailed results from this study for publication and presentation at future scientific and medical meetings.
RedHill Biopharma: ERADICATE Hp2 study meets primary endpoint
RedHill Biopharm announced positive top-line results from the ERADICATE Hp2 study, a two-arm, randomized, double-blind, active comparator-controlled, confirmatory Phase 3 study with Talicia for H. pylori infection. The ERADICATE Hp2 study successfully met its primary endpoint with a high degree of statistical significance, demonstrating 84% eradication of H. pylori infection with Talicia versus 58% in the active comparator arm in the intent-to-treat, or ITT, population. No safety issues were reported in the study and Talicia was found to be well tolerated. Talicia is a proprietary fixed-dose, all-in-one oral capsule combination of two antibiotics, rifabutin and amoxicillin, and a proton pump inhibitor, or PPI, omeprazole. The ERADICATE Hp2 two-arm, randomized, double-blind, active comparator-controlled study investigated 455 dyspepsia patients with confirmed H. pylori infection at 55 clinical sites across the U.S. Subjects were randomized 1:1 to receive four capsules, three times daily, of either Talicia or the active comparator, a dual therapy amoxicillin and omeprazole regimen at equivalent doses, for a period of 14 days. The efficacy of current standard-of-care therapies continues to decline and has been reported in literature to be approximately 60% due to high resistance of H. pylori bacteria to the antibiotics commonly used in these therapies, primarily clarithromycin and metronidazole. Preliminary H. pylori culture results taken throughout the ERADICATE Hp2 study from patients across 20 U.S. states confirmed the high resistance3 of H. pylori to the antibiotics most commonly used for treatment, clarithromycin and metronidazole. Importantly, no resistance to rifabutin, a key component in Talicia’s unique and proprietary formulation, was detected in the study. Moreover, consistent with the literature describing the diminished efficacy of standard-of-care therapies, preliminary results from the open-label part of the ERADICATE Hp2 Phase 3 study showed 64% eradication of H. pylori with these therapies. Results from the ERADICATE Hp2 study showed consistent 21%-29% treatment benefit of Talicia versus the active comparator across all H. pylori culture susceptibility and resistance subgroups, including amoxicillin, clarithromycin and metronidazole.
GW demand, reimbursement trends for Epidiolex look encouraging, says Stifel
Stifel analyst Paul Matteis said each epileptologist he talked to at the American Epilepsy Society meeting said that patients are frequently asking for GW Pharmaceuticals’ Epidiolex. Additionally, the doctors he spoke to said they are already writing prescriptions for the drug. Early headaches with GW’s specialty pharmacy hub, which were cited by a few physicians, appear to have been addressed by the company, added Matteis, who reiterated his Buy rating on GW Pharmaceuticals shares following the AES meeting.
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