Oramed Pharmaceuticals Inc Stock Price, News & Analysis

Oramed Pharmaceuticals Inc. (NASDAQ: ORMP) announced significant updates regarding its majority-owned company, Oravax Medical Inc., which is advancing an oral COVID-19 vaccine utilizing proprietary protein oral delivery technology. Preclinical trials are underway against COVID-19 variants, with plans to initiate clinical trials in Israel soon. The vaccine targets multiple viral proteins to enhance its efficacy against current and future variants. Additionally, Oravax has out-licensed the rights for an injectable version of the vaccine in India to Premas Biotech, aiming to address urgent vaccination needs.

Oramed Pharmaceuticals Inc. (NASDAQ: ORMP) will join the U.S. small cap Russell 2000® and broad-market Russell 3000® Index, effective June 28, 2021. This inclusion follows the annual reconstitution and provides significant visibility among institutional investors, as approximately $10.6 trillion is benchmarked against Russell's indexes. Oramed specializes in oral drug delivery systems, aiming to innovate diabetes treatment with its lead candidate, ORMD-0801, targeting the development of the first commercial oral insulin capsule.

Oramed Pharmaceuticals, focused on oral drug delivery systems, has announced it has enrolled over 50% of the 675 patients for its Phase 3 ORA-D-013-1 study of oral insulin capsule ORMD-0801 for type 2 diabetes. The study aims to compare the efficacy of ORMD-0801 to placebo over 6 to 12 months, assessing glycemic control via A1c levels. Concurrently, ORA-D-013-2 is enrolling 450 patients. Topline results are expected in 2022, positioning ORMD-0801 to potentially be the first commercial oral insulin for diabetes treatment.

Oramed Pharmaceuticals has achieved significant milestones in developing its oral drug delivery system. The company is advancing its lead programs: ORMD-0801, aimed at type 2 diabetes, with two Phase 3 studies currently underway, and an oral COVID-19 vaccine via Oravax Medical, set for clinical trials in H2 2021. Oramed boasts a strong financial position with over $75 million in cash and no debt, allowing for further progress in its initiatives. Shareholders may benefit from potential dividends from Oravax shares, enhancing overall company value.

Oramed Pharmaceuticals (Nasdaq: ORMP) announced that CEO Nadav Kidron will participate in a webinar on April 26, 2021, focusing on biotech and specialty pharma. During the session, he will discuss Oramed's oral insulin drug, currently in Phase 3 trials, and the oral COVID-19 vaccine candidate from Oravax Medical, in which Oramed holds a 63% stake. Pre-clinical results indicate the vaccine may perform well against COVID-19 variants. The company is poised to begin clinical trials for the vaccine this quarter.

Oramed Pharmaceuticals (Nasdaq: ORMP) has screened the first patients in its ORA-D-013-2 study, part of two concurrent Phase 3 trials for its oral insulin capsule, ORMD-0801, aimed at treating type 2 diabetes. The study targets 450 patients on diet or diet plus metformin and is expected to generate efficacy data after a 6-month treatment. Oramed aims to evaluate this oral insulin in varying patient populations to potentially secure FDA approval, marking a significant milestone as it is the only company conducting two Phase 3 oral insulin studies simultaneously.

Oramed Pharmaceuticals Inc. (Nasdaq: ORMP) announced the screening of the first patients in its ORA-D-013-2 study, the second Phase 3 trial for its oral insulin capsule, ORMD-0801, targeting type 2 diabetes. This study, alongside ongoing ORA-D-013-1, will recruit a total of 1,125 patients under FDA protocols. The primary endpoint is to compare ORMD-0801's efficacy against a placebo in improving glycemic control. Successful outcomes could position ORMD-0801 as the first commercial oral insulin capsule, highlighting Oramed's innovative approach in diabetes treatment.

Oramed Pharmaceuticals has formed a joint venture, Oravax Medical Inc., to develop novel oral COVID-19 vaccines using its proprietary POD™ technology. The vaccine candidate targets three structural proteins, potentially enhancing protection against variants. A preclinical study showed effective immunity through IgG and IgA response with a single oral dose. Clinical trials are anticipated to begin in Q2 2021. The oral delivery method aims to simplify distribution, allowing for self-administration and potentially addressing barriers to widespread inoculation.

Oramed Pharmaceuticals has reached a milestone in its Phase 3 ORA-D-013-1 study of oral insulin capsule ORMD-0801 for type 2 diabetes, with 25% of the 675 patients randomized. This study, pivotal for assessing ORMD-0801's efficacy and safety, will compare its effects against a placebo over a 6 to 12-month period. The company aims to complete patient randomization by the end of 2021, expecting topline results in the following year. This trial represents a significant step towards the potential commercialization of the first oral insulin treatment.