Supernus Pharmaceuticals (NASDAQ:SUPN) has submitted a marketing application with the FDA seeking approval for apomorphine infusion pump (SPN-830) for the continuous treatment of ON-OFF episodes in Parkinson’s disease who have failed two treatments.
“SPN-830, if approved by the FDA, would offer patients a less invasive and a convenient option in the form of a continuous subcutaneous infusion of apomorphine.” said Jack Khattar, President and CEO
Fortress Biotech (NASDAQ:FBIO) announces that Caelum Biosciences in collaboration with Alexion Pharmaceuticals (NASDAQ:ALXN) have initiated the Cardiac Amyloid Reaching for Extended Survival (CARES) Phase 3 clinical program to evaluate CAEL-101, an amyloid fibril targeted therapy, in combination with standard-of-care (SoC) therapy in AL amyloidosis, a rare systemic disorder caused by an abnormality of plasma cells in the bone marrow that leads to heart and kidney damage.
Caelum, founded by Fortress, collaborated with Alexion in 2019, under which ALXN acquired a minority equity interest in Caelum and an exclusive option to acquire the remaining equity based on Phase 3 CAEL-101 data.
The CARES clinical program includes two parallel Phase 3 studies – one in patients with Mayo stage IIIa disease and one with Mayo stage IIIb disease – and will collectively enroll ~370 patients globally.
Enrollment is underway in both studies. The primary objective of the clinical program is to assess overall survival and the safety and tolerability of CAEL-101.
Key secondary objectives will assess functional improvement in the six-minute walk test (6MWT), quality of life measures and cardiac improvement.
Centene Corporation (CNC +1.8%) announces that its membership has increased from 1.1M members since March 31, 2020, in line with expectations.
Company reaffirms its previously issued 2020 adjusted diluted EPS annual guidance of $4.76 to $4.96.
Utilization and risk sharing mechanism continue to be in line with expectations.
https://seekingalpha.com/news/3613687-centene-corporation-provides-eps-guidance-update
Rennova Health (OTCPK:RNVA +20.9%) announced that it has purchased and taken delivery of equipment to provide rapid testing for ((COVID-19)) at three sites, two of its hospitals in East Tennessee and its rural clinic in Kentucky.
Rennova entered an agreement with Abbott Laboratories to install and provide the ID NOW testing facilities.
ID NOW provides results in 15 minutes utilizing state of the art molecular techniques. This test is approved under U.S. Food and Drug Administration Emergency Use Authorization (EUA) from direct nasal or noso-pharyngeal swabs. Testing is expected to begin in September at all 3 facilities. Patients may come to the facilities at their own wish or with a doctor’s order for the testing and leave with a result.
Gilead Sciences’ (NASDAQ:GILD) announced $21B takeout of Immunomedics (NASDAQ:IMMU), a developer of therapeutic antibodies, including antibody-drug conjugates (ADCs), has stoked premarket action in fellow ADC players Seattle Genetics (NASDAQ:SGEN) (+9%) and Mersana Therapeutics (NASDAQ:MRSN) (+17%), both on light volume.
Vaxart (NASDAQ:VXRT) jumps 16% premarket after the FDA completed review of its Investigational New Drug (IND) application for Phase 1 clinical trial evaluating the Company’s oral COVID-19 vaccine candidate. VXRT also provided an update on its COVID-19 program.
“The IND clearance and the initiation of our Phase 1 clinical trial moves us a step closer to proving the superiority of our convenient oral COVID-19 solution in the clinic. We are thus excited to start enrollment for our Phase 1 this month,” said Andrei Floroiu, CEO.
The Phase 1, dose-ranging study will be conducted in healthy adults ages 18 to 55 years old. The study’s primary objective is to examine the safety and reactogenicity of two-doses of the vaccine.
Secondary objectives include immunogenicity, duration of immune response and occurrence of symptomatic COVID-19.
Vaxart is conducting a SARS-CoV-2 challenge study in hamsters to provide efficacy data and insights into the optimal dose regimen. Results from this study are expected mid-October.
In addition, Vaxart is awaiting results from a non-human primate (NHP) challenge study that is testing its vaccine in a harmonized protocol as part of Operation Warp Speed.
https://seekingalpha.com/news/3613608-vaxart-on-go-human-trials-of-covidminus-19-vaccine-candidate
89bio (NASDAQ:ETNB) announces positive results from a Phase 1b/2a clinical trial evaluating lead candidate BIO89-100 in patients with nonalcoholic steatohepatitis (NASH).
All dose groups experienced significant reductions in liver fat at week 13. Reductions of up 60% versus baseline and relative reductions of up to 70% versus placebo, measured by MRI-PDFF, were observed. 88% of treated patients achieved at least a 30% reduction in liver fat from baseline while 71% achieved at least a 50% reduction.
Significant reductions in triglycerides (up to 28%), non-HDL cholesterol (up to 16%) and LDL-C (“bad” cholesterol) (up to 16%) were also noted.
On the safety front, the profile of BIO89-100 was comparable to control. The most frequent treatment-related adverse events were diarrhea (12.7%) (22.2% in the control arm) and nausea (7.9%) (16.7% in the control arm).
The next NASH study should launch in H1 2021.
BIO89-100 is a pegylated (long-acting) analog of a protein called fibroblast growth factor 21 (FGF21) that plays a key role in regulating certain metabolic pathways.
https://seekingalpha.com/news/3613614-89bios-lead-drug-shows-positive-effect-in-nash-study
