Imprimis initiated with a Buy at B. Riley FBR. B. Riley FBR analyst Andrew D’Silva started Imprimis Pharmaceuticals with a Buy rating and $11.50 price target.
Thursday, December 13, 2018
FDA says Ampio to complete additional trial under SPA for Ampion study
Ampio updated the regulatory status of Ampion. Statisticians representing Ampio and the FDA were to meet and discuss the clinical pathway of Ampion, the company’s lead drug, for the treatment of severe osteoarthritis of the knee, or OAK, followed by an additional, internal meeting that included reviewers from the FDA Office of Tissue and Advanced Therapies, or OTAT. That meeting has taken place and OTAT has provided final guidance that Ampio should complete an additional trial of KL4 osteoarthritis patients with concurrent controls that would be carried out under a special protocol assessment, or SPA, to obtain FDA concurrence on the trial design. A trial of approximately 150 KL4 patients, half in the treatment arm and half in the control arm has been designed, and Ampio will be filing the SPA submission in the near future. The trial is designed to expand by 150 patients if necessary.
Eli Lilly partners with DCRI for type 2 Diabetes care study
The Duke Clinical Research Institute, or DCRI, will lead a new clinical study to optimize care for people with type 2 diabetes and cardiovascular disease through evaluation of a multidisciplinary approach at cardiology clinics across the U.S. The research program, COORDINATE-Diabetes, will be funded by Boehringer Ingelheim and Eli Lilly. People with diabetes are up to four times more likely to develop cardiovascular disease than those without diabetes and cardiovascular disease ranks as their leading cause of death and disability despite available treatments. To help improve these statistics, COORDINATE-Diabetes will examine the impact of multifaceted interventions involving guideline-based therapies among cardiologists, endocrinologists, primary care providers and patients, including the recommendations outlined in the American Diabetes Association, or ADA, Standards of Medical Care in Diabetes and the American College of Cardiology, or ACC, Expert Consensus Decision Pathway on novel therapies for cardiovascular risk reduction in adults with type 2 diabetes and atherosclerotic cardiovascular disease. The trial will include 46 cardiology clinics in the U.S. and aims to enroll 30 patients at each site. The clinics will be randomized to a basic education arm or an intensive intervention arm. The care teams at the intervention sites will be encouraged to communicate with patients’ primary care physicians to facilitate a well-rounded, multidisciplinary approach to patient care. The trial will measure the impact of the intervention on the sites’ use of guideline-recommended therapies after 12 months. The trial will also leverage the power of electronic health record data from a consortium of health systems across the U.S. that have curated their data to support research and improve outcomes. Researchers will begin enrolling clinics and patients for the study in 2019 with the goal of sharing the main results by 2021.
Protagonist Therapeutics begins Phase 1 trial of inflammatory bowel disease drug
Protagonist Therapeutics initiated dosing in the Phase 1 study of PN-10943, an oral, gut-restricted alpha-4-beta-7 integrin antagonist peptide in development for the potential treatment of inflammatory bowel disease. The study is designed to evaluate safety, tolerability, pharmacokinetics and pharmacodynamic parameters of PN-10943. The Phase 1 data will be used to design a Phase 2a study in ulcerative colitis patients expected to begin in 2H19. Primary endpoints for the study are safety and tolerability. Secondary endpoints include evaluation of pharmacokinetic properties and pharmacodynamic parameters of blood receptor occupancy.
Arena Pharmaceuticals initiated at Berenberg
Arena Pharmaceuticals initiated at Berenberg Arena Pharmaceuticals initiated with a Buy at. Berenberg analyst Patrick Trucchio initiated Arena Pharmaceuticals with a Buy rating and $55 price target, citing his view that ralinepag still has upside potential and that etrasimod may “emerge a winner in the crowded IBD area.” He also believes that olorinab, which is in Phase 2 development for visceral pain associated with IBD and IBS, may eventually be worth as much, or more, than ralinepag, Trucchio tells investors.
Organovo initiated at H.C. Wainwright
Organovo initiated with a Buy at H.C. Wainwright. H.C. Wainwright analyst Ed Arce started Organovo Holdings with a Buy rating and $2.50 price target. Though early, the therapeutic tissue opportunity is compelling, Arce tells investors in a research note. The analyst views Organovo as the “clear leader in the early, pioneering technology of 3D bioprinting of solid organs.”
Millendo Therapeutics initiated at Leerink
Millendo Therapeutics initiated with an Outperform at Leerink. Leerink analyst Joseph Schwartz started Millendo Therapeutics with an Outperform rating and $24 price target.
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