Oramed Pharmaceuticals Inc Stock Price, News & Analysis

On February 9, 2023, Oramed Pharmaceuticals (Nasdaq: ORMP) provided a shareholder update, emphasizing its ongoing analysis of data from its halted Phase 3 oral insulin trials. The management and Board are currently reviewing the company's pipeline and exploring strategic alternatives to enhance shareholder value, including potential mergers or acquisitions. CEO Nadav Kidron stated the clinical team will analyze the unblinded Phase 3 data to determine the future of their oral insulin assets and platform technology. No timetable for completion has been established, nor can any assurance be given that the review will yield a transaction.

Oramed Pharmaceuticals announced negative top-line results from its Phase 3 trial (ORA-D-013-1) of ORMD-0801 for Type 2 Diabetes, involving 710 patients over 26 weeks. The trial failed to meet both primary and secondary endpoints for improving glycemic control and fasting plasma glucose levels. Consequently, Oramed plans to discontinue its oral insulin clinical activities for Type 2 Diabetes. The CEO expressed disappointment but acknowledged the prior positive trial results, indicating that future updates will follow as data is analyzed.

Oramed Pharmaceuticals (Nasdaq: ORMP) has received a new patent from the US Patent and Trademark Office titled "Methods and Compositions for Treating Diabetes," building on a previous patent from May 2022. This patent focuses on oral pharmaceutical compositions combining insulin and GLP-1 for diabetes treatment. With topline data from their first Phase 3 oral insulin trial expected soon, Oramed aims to strengthen its intellectual property portfolio in oral drug delivery.

Oramed Pharmaceuticals reported a strong performance in 2022, highlighted by the completion of enrollment in its Phase 3 oral insulin trial, ORA-D-013-1, with results expected in mid-January 2023. The Phase 2 NASH trial achieved key endpoints, confirming the safety and efficacy of ORMD-0801. A significant distribution deal was signed with Medicox for South Korea, including up to $18 million in milestone payments. Oramed also has $160 million in cash with no debt, positioning it well for future growth and FDA submissions.

Oramed Pharmaceuticals Inc. (Nasdaq: ORMP) announced a significant development with the publication of a peer-reviewed article in Diabetes, Obesity, and Metabolism. The study evaluates the safety and efficacy of ORMD-0801, an oral insulin for Type 2 Diabetes, showing statistically significant reductions in HbA1c levels over a 12-week placebo-controlled trial. The results support advancing to Phase 3 studies with an 8 mg bedtime dose. Oramed's innovative approach aims to transform diabetes treatment with oral solutions.