Welcome to our dedicated page for Oramed Pharmaceuticals news (Ticker: ORMP), a resource for investors and traders seeking the latest updates and insights on Oramed Pharmaceuticals stock.
Oramed Pharmaceuticals Inc. (ORMP) generates news at the intersection of clinical-stage drug development, oral delivery technology, and strategic healthcare investments. The company describes itself as a platform technology pioneer in oral delivery solutions for drugs currently delivered via injection, centered on its Protein Oral Delivery (POD™) technology and a refined oral insulin program.
News about Oramed often covers clinical and strategic milestones for its oral insulin and POD™ platform, including updates on trial design, analysis of Phase 2 and Phase 3 data, and plans for U.S.-based clinical studies. Company letters to shareholders and press releases provide context on how Oramed is advancing its oral insulin program independently and how it evaluates high-responder subgroups in its clinical data.
Another major source of headlines is Oramed’s investment and partnership activity across the biomedical and medical technology landscape. Releases have detailed structured financings and royalty arrangements with Scilex Holding Company, a substantial equity investment and strategic collaboration with Alpha Tau Medical Ltd., and positions in companies such as BioXcel Therapeutics Inc. and Pelthos Therapeutics Inc. These updates often discuss repayments, warrant structures, royalty interests, and unrealized gains.
Recent news also highlights transformative corporate transactions, such as the announced transfer of Oramed’s POD™ technology to Lifeward Ltd. in exchange for a significant beneficial ownership interest and participation in a revenue-generating medical robotics business. Additional items include stock repurchase programs, cash dividend declarations, and the adoption of a Rights Agreement involving common stock purchase rights.
Investors and followers of ORMP news can use this page to review Oramed’s press releases, shareholder letters, and transaction announcements in one place, tracking developments in its oral drug delivery platform, strategic investments, and corporate actions over time.
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.
Oramed Pharmaceuticals (Nasdaq: ORMP) announced positive outcomes from its Phase 2 clinical trial (ORA-D-N02) for ORMD-0801, an oral insulin candidate targeting Type 2 diabetes patients with NASH. The trial achieved its primary endpoint, showing no serious adverse events. Key secondary endpoints demonstrated a reduction in liver fat, stiffness, and lipids. With 32 patients enrolled, 30 completed the trial, indicating a promising safety profile and potential efficacy. The global NASH treatment market is projected to reach $84 billion by 2029, highlighting the commercial potential of ORMD-0801.
Oramed Pharmaceuticals has signed an exclusive distribution agreement with Medicox for its oral insulin candidate, ORMD-0801, in South Korea, pending regulatory approval. This deal includes potential developmental milestones totaling up to $18 million, with $2 million already received. Oramed will also earn up to 15% royalties on gross sales. With 1 in 7 Koreans over 30 diagnosed with diabetes, the agreement taps into a significant market potential, and ORMD-0801 aims to be the first commercial oral insulin capsule. Top-line results from ongoing Phase 3 studies are expected in January 2023.
Oramed Pharmaceuticals reported its Q3 2022 financial results, highlighting important milestones in its clinical trials, including positive Phase 2 NASH data and initial results from a Phase 1 oral Covid-19 vaccine trial. As of September 30, 2022, the company had approximately $160 million in cash and investments, positioning it well for future developments. Research and development expenses decreased by 12% year-over-year to $5.35 million, while general and administrative expenses rose by 60% to $3.06 million. The loss per share decreased by 14% to $0.18.
Oramed Pharmaceuticals (Nasdaq: ORMP) announced a webinar on November 17, 2022, at 11:00 a.m. EST, to present safety and efficacy data from its Phase 2 trial of ORMD-0801 for reducing liver fat in Type 2 Diabetes patients with NASH. The session will feature key opinion leaders, including Dr. Yaron Ilan and Dr. Joel Neutel, discussing the need for effective NASH treatment. Registered participants can access the live and archived presentations on Oramed's website.
Oramed Pharmaceuticals' subsidiary, Oravax Medical, announced positive preliminary data from its Phase 1 trial for an oral Covid-19 vaccine. The trial met both safety and immunogenicity endpoints, showing a significant antibody response in the majority of patients. No safety issues were reported. The oral vaccine utilizes a triple antigen VLP design that targets crucial SARS-CoV-2 proteins, aiming for a protective response against existing and emerging strains. This proof-of-concept trial involves 24 healthy volunteers, with results expected over a 24-week monitoring period.
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