Tuesday, April 9, 2019
Piper encourages investors to start positions in Neuronetics
After hosting an investor call with the management team of Greenbrook TMS, a domestic transcranial magnetic stimulation provider, Piper Jaffray analyst Matt O’Brien reiterates an Overweight rating on Neuronetics with a $28 price target. Greenbrook’s goal of reaching 100-plus centers by Q1 of 2020 is on track and the company expects “robust” organic growth this year with further market development efforts, O’Brien tells investors in a research note. He points out that the majority of Greenbrook’s mix is weighted towards Neuronetics’ NeuroStar. Given the “variety of positives” on Neuronetics and the underlying TMS market landscape, investors “can put to bed any competitive concerns,” says the analyst. He encourages investors to start positions in the name.
ChromaDex reports results for preclinical study using B3 vitamin NR
ChromaDex reported that results of a new preclinical study showed that supplementation with B3 vitamin nicotinamide riboside, or NR, helps maintain heart function in mice by stimulating a conserved cellular response called the “mitochondrial unfolded protein response”, or UPRmt, that helps maintain mitochondrial function. The study also presents preliminary human data to support future testing of NR in humans. The independent study results were published yesterday in the Journal of the American College of Cardiology, or JACC. This study follows clinical results from last year highlighting the potential for NR supplemention to improve cardiovascular health
Mallinckrodt announces retrospective analysis on Acthar Gel published
Mallinckrodt announced data from a retrospective chart review that analyzed physician assessments of 91 U.S. patients diagnosed with uveitis who had been treated with Acthar Gel in the previous 12 months. All patients had completed or were still receiving treatment at the time of the review. In response to a survey question, physicians reported that 84% of patients who completed or were still in treatment with Acthar Gel had improvement in disease status overall, and 86% had improvements in vision. Uveitis is a cause of preventable blindness in adults. Results of the study were recently published online ahead of print in the Journal of Ocular Pharmacology and Therapeutics. Acthar Gel is FDA-approved for the treatment of severe acute and chronic allergic and inflammatory processes involving the eye and its adnexa such as: keratitis, iritis, iridocyclitis, diffuse posterior uveitis and choroiditis, optic neuritis, chorioretinitis and anterior segment inflammation. The study was a retrospective medical record review of physicians’ assessments of 91 patients diagnosed with uveitis, most of whom had moderate to severe visual impairment, who were treated with Acthar Gel. Average time since diagnosis was four years. All patients had received treatment with Acthar Gel in the past 12 months and had either completed a course of Acthar Gel or were receiving Acthar Gel treatment at the time of data collection. There were 17 different initial dosing regimens documented in the study, however, most patients were prescribed an initial regimen of 40-80 units, administered subcutaneously once or twice weekly. According to the Acthar Gel prescribing information, usual dosing of Acthar Gel is 40-80 units via subcutaneous or intramuscular injection every 1-3 days. Based on notes in medical records, physicians reported that overall disease status had improved in 84% of patients after therapy with Acthar Gel. Overall 86% had improvements in vision, 27% had improvements in eye pain, 26% had improvements in vitreous haze, 24% had reduction of background medication use, 23% had improvements in vitreous flare and 18% had improvements in macular edema. The study was a retrospective collection of data from medical records, which may be incomplete.
EMA agrees to Soligenix’s Pediatric Investigation Plan for SGX942
Soligenix announced that the Pediatric Committee, or PDCO, of the European Medicines Agency, or EMA, agreed to the Company’s Pediatric Investigation Plan, or PIP, for SGX942, or dusquetide. It was also agreed that the Company may defer conducting the PIP until successful completion of its ongoing pivotal Phase 3 clinical study evaluating SGX942 as a treatment for oral mucositis in patients with head and neck cancer, or HNC. As part of the regulatory process for the registration of new medicines in Europe, pharmaceutical companies are required to provide a PIP outlining their strategy for investigation of the new medicinal product in the pediatric population. Soligenix will be able to file the adult indication MAA prior to completion of the PIP because the PDCO permitted the Company to defer conducting the pediatric program until the benefit/risk of treatment has been established in the adult population. Following a potential approval of the SGX942 MAA for treatment of oral mucositis in adult patients with HNC, Soligenix will work with PDCO and EMA to include appropriate pediatric data in the approved labeling.
Alkermes says ALPINE study met pre-specified primary endpoint
Alkermes announced positive results from ALPINE, a first-of-its-kind, six-month study evaluating the efficacy, safety and tolerability of ARISTADA and INVEGA SUSTENNA when used to initiate patients experiencing an acute exacerbation of schizophrenia in the hospital and maintain treatment in an outpatient setting. Patients randomized to the ARISTADA treatment group were initiated using the ARISTADA INITIO regimen followed by ARISTADA every two months. Patients randomized to the INVEGA SUSTENNA treatment group were initiated using a loading dose of INVEGA SUSTENNA followed by INVEGA SUSTENNA every month. The ALPINE study met its pre-specified primary endpoint, demonstrating that both ARISTADA and INVEGA SUSTENNA had statistically significant and clinically meaningful reductions in Positive and Negative Syndrome Scale total scores from baseline at Week 4. Additionally, PANSS total scores continued to improve at Week 9 and Week 25, the study’s pre-specified secondary endpoints. Improvements in PANSS total scores from baseline were similar and not statistically different between treatment groups at any assessment time point during the study.
Subscribe to:
Posts (Atom)