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. (NASDAQ: ORMP) is a pioneering pharmaceutical company focused on the development and commercialization of innovative oral drug delivery systems. Headquartered in the United States and Israel, Oramed aims to revolutionize the treatment of various diseases by transforming injectable therapies into oral formulations.
Oramed's flagship product, an orally ingestible insulin capsule known as ORMD-0801, is currently in Phase 2 clinical trials under the supervision of the U.S. Food and Drug Administration (FDA). This product holds significant promise for improving the quality of life for diabetes patients by eliminating the need for daily insulin injections.
The company’s proprietary Protein Oral Delivery (POD™) technology is designed to protect therapeutic proteins like insulin from the harsh conditions of the gastrointestinal tract, ensuring their effective delivery and absorption in the body. This platform technology opens up possibilities for the oral administration of a wide range of therapeutic proteins and peptides.
Oramed recently announced a strategic partnership with Hefei Tianhui Biotech Co., Ltd. (HTIT) to establish a joint venture aimed at the global commercialization of Oramed's oral insulin and POD™ pipeline. This collaboration leverages HTIT's advanced manufacturing capabilities, which include a state-of-the-art facility in Hefei, China. The initial phase of the partnership includes a $70 million investment from HTIT and a $20 million investment from Oramed, the latter consisting of both cash and shares of common stock.
Additionally, Oramed has entered a securities agreement with Scilex Holding Company, securing an 18-month Senior Secured Promissory Note valued at approximately $101.9 million. This agreement includes an interest rate of SOFR plus 8.5% and offers Oramed new warrants for up to 13 million shares of Scilex common stock.
Oramed is also branching into topical treatments through its acquisition of PeriTech Pharma Ltd.’s innovative film-forming technology. This includes over-the-counter treatments for hemorrhoids and other dermatological conditions. Oramed has secured an exclusive licensing agreement with an international consumer and pharmaceutical group, promising future royalties based on net sales.
With a robust pipeline and strategic partnerships, Oramed is well-positioned to advance its mission of improving patient care and increasing shareholder value through groundbreaking oral drug delivery solutions.
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.
Oramed Pharmaceuticals Inc. (Nasdaq: ORMP) announced that CEO Nadav Kidron will present a company overview at the H.C. Wainwright Global Life Sciences Conference, taking place virtually on March 9-10, 2021. The presentation will be available on demand starting March 9 at 7:00 AM ET. Oramed is known for its innovative oral drug delivery systems, particularly its candidate ORMD-0801, aimed at revolutionizing diabetes treatment as a potential oral insulin capsule. The company, founded in 2006, is also developing an oral GLP-1 analog capsule, ORMD-0901.
Oramed Pharmaceuticals has provided a shareholder update highlighting its pivotal Phase 3 oral insulin trial (ORMD-0801) for type 2 diabetes, which is now enrolling patients across multiple U.S. sites. The company has initiated a Phase 2 study for nonalcoholic steatohepatitis (NASH) and plans to begin studies for oral GLP-1 and leptin later in 2021. With a strong financial position, Oramed is in discussions with potential partners to advance its innovative oral delivery technology for diabetes treatment.
Oramed Pharmaceuticals Inc. (Nasdaq: ORMP) has commenced the randomization of patients for its Phase 3 study of the oral insulin capsule, ORMD-0801, aimed at treating type 2 diabetes. The trial, ORA-D-013-1, is recruiting 675 patients across 75 clinical sites in the U.S. to compare ORMD-0801's efficacy against placebo in improving glycemic control. CEO Nadav Kidron emphasized the significance of this FDA-approved study as a global first for oral insulin. Results will be analyzed after the six-month treatment period, focusing on changes in A1c and fasting plasma glucose levels.
FAQ
What is the current stock price of Oramed Pharmaceuticals (ORMP)?
What is the market cap of Oramed Pharmaceuticals (ORMP)?
What is Oramed Pharmaceuticals Inc.'s primary focus?
What is ORMD-0801?
What is the significance of Oramed's POD™ technology?
Who are Oramed's strategic partners?
What recent financial agreements has Oramed entered into?
What is the purpose of the joint venture with HTIT?
What is Oramed's recent acquisition related to dermatological treatments?
How is Oramed expanding its market presence?
What are the potential benefits of Oramed's oral insulin capsule?
Where is Oramed Pharmaceuticals Inc. headquartered?
