Oramed Pharmaceuticals Inc.NASDAQ
Tue, Jun. 21, 10:00 AM
- Oramed Pharmaceuticals (ORMP +2.3%) earns a $6.5M milestone payment from Hefei Tianhui Incubator of Technologies Co. Ltd. (HTIT) triggered by the successful results from a Phase 2b clinical trial assessing Oramed's oral insulin capsule, ORMD-0801, in type 2 diabetics.
- Per a 2015 agreement, HTIT has exclusive commercialization rights to ORMD-0801 in China, Hong Kong and Macau.
- Recent SA articles: Pro & Con
- Previously: Oramed inks $50M marketing deal for oral insulin capsule in China; shares up 19% premarket (Nov. 30, 2015)
- Previously: Oramed's oral insulin capsule successful in mid-stage study in type 2 diabetics; shares up 17% premarket (May 18)
Wed, May 18, 11:32 AM
- Key points from this morning's call hosted by Oramed Pharmaceuticals (ORMP -7.5%) regarding its announcement of successful results in a Phase 2b clinical trial assessing lead product candidate ORMD-0801, its oral insulin capsule, in type 2 diabetics:
- ORMD-0801 will advance to Phase 3. Strategic partners sought.
- Pooled data combined 16 mg and 24 mg dose cohorts. Awaiting results from various additional glucose measures, including continuous monitoring. Will be shared as soon as feasible. Primary endpoint is what's important. Secondary endpoints only exploratory? Hemoglobin A1c levels: need three-month data, only have one-month at present. No specific timelines given. Meeting with FDA will be scheduled as soon as possible.
- Results from individual doses may be shared at a later time, but study was based on pooled data so not a priority at this point.
- Co. believes oral insulin may enable treatment earlier in T2D.
- One case of hypoglycemia in placebo group, one in the pooled group.
- Current cash position: ~$36M. $10M - 15M in new capital expected in near term. More $ needed for Phase 3.
- Investors are getting less enthused about the data. Shares have reversed and are now down 5%.
Wed, May 18, 9:15 AM
Wed, May 18, 7:42 AM
- A Phase 2b clinical trial assessing Oramed Pharmaceuticals' (NASDAQ:ORMP) oral insulin capsule, ORMD-0801, in type 2 diabetics met its primary endpoint of a statistically valid reduction of weighted mean night-time glucose versus placebo.
- The U.S.-based randomized, double-blind, placebo-controlled study in 180 adult type 2 diabetics showed a statistically significant decrease of 6.47% in pooled night-time average glucose compared to control (p=0.0268).
- No drug-related serious adverse events were observed.
- The company plans to present more comprehensive data at a future time. Management will host a conference call this morning at 11:00 am ET to discuss the results.
- Shares are up 17% premarket on robust volume.
Mon, May 16, 12:51 PM
Fri, May 13, 12:45 PM
Thu, May 12, 3:51 PM
- Shareholders in thinly traded nano cap Oramed Pharmaceuticals (ORMP -19.8%) are having their optimism tested today. Shares are down on 15x surge in volume ahead of next week's announcement of results from a Phase 2b clinical trial assessing ORMD-0801, its oral insulin capsule, in type 2 diabetics. Sell-offs like this don't bode well.
- Previously: Oramed says results from mid-stage study of oral insulin capsule due in two weeks (May 4)
Thu, May 12, 12:50 PM
Wed, May 4, 10:27 AM
- In a regulatory filing, thinly traded micro cap Oramed Pharmaceuticals (ORMP +1.2%) discloses that results from its Phase 2b clinical trial assessing lead product candidate ORMD-0801, its oral insulin capsule, in 180 type 2 diabetics will be announced in about two weeks.
- ORMD-0801 is based on the company's Protein Oral Delivery (POD) technology, designed to protect orally-delivered proteins from enzymatic activity within the GI tract in order to enhance their absorption across the intestinal wall.
- This is yet another binary event for biotech investors. If successful, the price will rocket skyward. If not, look out below. Investors appear to expect good news considering the 50% appreciation in share price since March.
- Previously: Oramed completes mid-stage study of oral insulin capsule (April 5)
Tue, Apr. 5, 10:46 AM
- Oramed Pharmaceuticals (ORMP -0.3%) announces that all follow-up visits have been completed in the Phase 2b clinical trial assessing its oral insulin capsule, ORMD-0801, in 180 type 2 diabetics. Top-line results should be available later this quarter.
- An orally administered insulin has the potential to redefine the diabetes treatment paradigm. ORMD-0801 is based on the company's Protein Oral Delivery (POD) technology, designed to protect orally-delivered proteins from enzymatic activity within the GI tract in order to enhance their absorption across the intestinal wall.
- Read now $50 Million Plus Royalties Deal Indicates Bright Future For Oramed's Oral Insulin
Mon, Jan. 25, 12:41 PM
Dec. 28, 2015, 4:50 PM
- Oramed Pharmaceuticals (NASDAQ:ORMP) enters into a Securities Purchase Agreement with Hefei Tianhui Incubation of Technologies Co., Ltd. (HTIT) under which the company will sell 1,155,367 shares of common stock to HTIT for ~$10.39 per share.
- Separately, the company and HTIT inked an Amended and Restated Technology License Agreement to replace the original November 30 contract, although the material terms remain unchanged. Oramed will receive its upfront payment of $3M next month.
- Previously: Oramed inks $50M marketing deal for oral insulin capsule in China; shares up 19% premarket (Nov. 30)
Nov. 30, 2015, 12:49 PM
Nov. 30, 2015, 9:27 AM
- Thinly traded nano cap Oramed (NASDAQ:ORMP) is up 19% premarket on increased volume in response to its announcement that it has signed a licensing agreement with Hefei Tianhui Incubator of Technologies Co. (HTIT) valued as much as $50M for exclusive marketing rights to its oral insulin capsule, ORMD-0801, for the territory of China, Hong Kong and Macau.
- Under the terms of the agreement, Oramed will receive an upfront payment of $3M, $8M in near-term payments and milestones and a 10% royalty on net sales. In addition, Oramed will issue HTIT 1,155,469 restricted shares of common stock at ~$10.39 per share ($12M total).
- Previously: Oramed Pharma up 9% premarket on pending $50M deal (July 7)
Nov. 30, 2015, 9:26 AM
Sep. 24, 2015, 12:40 PM