|Over a week ago|
Oramed price target lowered to $16 from $20 at H.C. Wainwright » 07:5706/2206/22/20
H.C. Wainwright analyst…
H.C. Wainwright analyst Raghuram Selvaraju lowered the firm's price target on Oramed to $16 from $20 and reiterates a Buy rating on the shares. The analyst views the pilot study of the company's oral insulin candidate ORMD-0801 in type 2 diabetes patients with non-alcoholic steatohepatitis as encouraging. However, he attributes the price target reduction to recent dilution.
Oramed: Pilot study shows ORMD-0801 'to be safe and well tolerated' » 08:2706/1506/15/20
Oramed Pharmaceuticals announced that its pilot study of its oral insulin candidate ORMD-0801 in type 2 diabetes patients with non-alcoholic steatohepatitis, has shown ORMD-0801 to be safe and well tolerated thus far, with an encouraging lowering of fatty liver content, as seen by MRI- derived proton density fat fraction. The pilot, open-label study of the first 8 patients of a planned 40-patient multi-center study, aimed to assess the safety, tolerability, and early effects of 16 mg ORMD-0801 on liver fat in type 2 diabetes patients with NASH. The 12-week, once-daily treatment had no serious adverse events, and induced an observed mean 6.9+/-6.8% reduction in liver fat content, and the relative reduction was 30%, as measured by MRI-PDFF. In parallel, concentrations of gamma-glutamyltransferase, a key marker of chronic hepatitis, were significantly lower after 12 weeks of treatment as compared to baseline, as were fasting insulin levels.
|Over a month ago|
Oramed announces Canadian authorities intention to grant patent to the company » 07:4204/0704/07/20
Oramed Pharmaceuticals announced that the Canadian Patent Office has indicated its intent to grant the Company a patent for its invention titled "Methods and Compositions for Oral Administration of Proteins."
|Over a quarter ago|
Oramed CEO issues shareholder letter providing pipeline update » 08:4904/0104/01/20
Oramed Pharmaceuticals CEO Nadav Kidron provided a letter to shareholders. Highlights of the letter include: "(...) At this time, we continue to move ahead with all strategic initiatives and anticipate limited long-term impact from COVID-19. As our platform technology could be effective for protein-based vaccines, we are closely monitoring developments on the efforts to find a vaccine for COVID-19 and any potential partnerships on this front. We are moving ahead with the planning for our oral insulin Phase 3 clinical studies and have accomplished several key milestones to this end. In February, Oramed conducted its initial End-of-Phase 2 meeting with the FDA to discuss Chemistry Manufacturing and Control of ORMD-0801 (...) the second of the EoP2 meetings with FDA will include a discussion of the results from the Phase 2 study and the design of the Phase 3 clinical studies proposed to support a license application for a Type 2 diabetes indication if the Phase 3 studies are successfully completed. (...) We have also requested a meeting with the European Medicines Agency regarding our Phase 3 study design (...) Our NASH exploratory clinical study of oral insulin for the treatment of chronic liver disease assesses the efficacy of ORMD-0801 in reducing liver fat content, inflammation, and fibrosis. We intend to present data on the early patient cohort in the near future. (...) We previously communicated our expectation of initiating and completing a Leptin proof-of-concept single dose study, evaluating the pharmacokinetic and pharmacodynamics of our oral Leptin drug candidate in 10 type 1 adult diabetic patients, during Q1. Due to the COVID-19 pandemic, enrollment has been delayed. The trial, however, is ready to resume once the health crisis is contained. Due to COVID-19 our Chinese partner's development progress was understandably slowed over the past few months. HTIT has confirmed that they are now fully back to work and in contact with the Chinese regulatory agency on moving forward to the next trials.(...) Oramed is well funded with a cash position of roughly $50M, which will allow us to progress smoothly into later-stage clinical trials. Our balance sheet remains flexible and strong with zero debt. (...)"
Oramed receives positive feedback from EoP2 meeting with FDA » 08:4203/1903/19/20
Oramed announced positive…
Oramed announced positive feedback from its initial End-of-Phase 2 meeting with the U.S. FDA to discuss Chemistry Manufacturing and Control of its lead oral insulin capsule ORMD-0801. The meeting, held in February, followed the successful completion of Oramed's Phase 2b trial of ORMD-0801 for the treatment of type 2 diabetes, which achieved its primary endpoint, the reduction in HbA1c compared to placebo at week 12. During this meeting the FDA provided feedback on key issues relating to Drug Product manufacture and supported continuing to Phase 3 clinical development. The company expects an additional meeting with the FDA following deeper analysis of the data from the Phase 2b trial, during which the company anticipates receiving the FDA's guidance on the Phase 3 study design. Oramed's CEO, Nadav Kidron, said, "We are very pleased with the productive and constructive feedback from the FDA as we continue on the path to bring oral insulin to market. We look forward to further discussions with the FDA and to their guidance in regards to our anticipated Phase 3 trial."
Oramed initiated with a Buy at Aegis » 12:1003/1103/11/20
Aegis analyst Nathan…
Aegis analyst Nathan Weinstein initiated coverage of Oramed with a Buy rating and $5.50 price target.
Oramed 5.25M share Spot Secondary priced at $4.00 » 09:2202/2702/27/20
National Securities acted…
National Securities acted as lead book running manager for the offering.
Oramed announces common stock offering, no amount given » 16:3202/2602/26/20
Oramed Pharmaceuticals announced that it intends to offer and sell shares of its common stock in an underwritten public offering. The company intends to use the net proceeds of the offering for its anticipated Phase 3 clinical trial in ORMD-0801 and for other clinical trials and research and development activities as well as for general corporate purposes. National Securities Corporation, a wholly owned subsidiary of National Holdings Corporation, is acting as the sole book running manager for the offering.
Oramed trading resumes 09:1502/2602/26/20
Oramed's oral insulin candidate meets primary Phase 2b endpoints » 08:0402/2602/26/20
Oramed announced 'positive' topline data from the second and final cohort of its Phase 2b trial evaluating the efficacy and safety of its lead oral insulin candidate, ORMD-0801, at lower dose regimens. ORMD-0801 has the potential to be the first commercially available oral insulin capsule for the treatment of diabetes. The Phase 2b trial in type 2 diabetes patients with inadequate glycemic control on oral antihyperglycemic agents, assessed the change in A1C, the primary efficacy endpoint, from baseline to week 12, as well as safety endpoints, when ORMD-0801 was given in different regimens across three daily dose ranges. Patients randomized in the trial treated with 8 mg of ORMD-0801 once daily achieved an observed mean reduction of 1.29% from baseline and a least square mean reduction of 0.95% from baseline, or 0.81% adjusted for placebo. Patients who had A1C readings above 9% at baseline and received 8 mg of oral insulin once daily experienced a 1.26% reduction in A1C by week 12. Treatment with ORMD-0801 at all doses demonstrated an 'excellent' safety profile, with no serious drug-related adverse events and no increased frequency of hypoglycemic episodes or weight gain compared to placebo. The company believes that the results now pave the way for FDA discussions regarding the initiation of a Phase 3 trial.