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PR Newswire (Tue, 8:30AM)
PR Newswire (Thu, 8:20AM)
Oramed Submits Phase 2a Protocol to FDA for the Treatment of Type 1 Diabetes with its Oral Insulin CapsulePR Newswire (Feb 10, 2014)
PR Newswire (Jan 30, 2014)
at CNBC.com (Jan 28, 2014)
at CNBC.com (Dec 26, 2013)
at MarketWatch.com (Dec 26, 2013)
PR Newswire (Dec 24, 2013)
ORMP vs. ETF Alternatives
Wednesday, Feb 2612:11 PM
Wednesday, Feb 2612:11 PM| 3 Comments
- Buy the dip in Oramed (ORMP)? No way, says the NY Observer's Duff McDonald
- "Look at the R&D that has gone into ORMD 0801; you might think you’re looking at a typo," he writes, noting Oramed has spent a total of just $12M in R&D on its insulin pill since 2002. As comparison, Novo Nordisk - the world's largest producer of insulin and working on its own pill for years - spent $635M in Q4 alone.
- Giving the nimble Oramed the benefit of the doubt, McDonald turns to the management team. The company's director of R&D - Dr. Ehud Arbit, former chief neurosurgeon at Sloan-Kettering - was twice accused of operating on the wrong side of patients' brains, and was dismissed from Sloan Kettering in 1995. The CEO Nadav Kidron? He's the 39-year-old son of chief scientific officer Miriam Kidron. "I just went for the ride to do the business side," he said recently. Ride indeed, says McDonald, noting the large automobile-related expenses the company is incurring despite losses of more than $20M since inception and no revenues in sight.
- Finding little proprietary about the pill, McDonald finds a $250 investment in equipment and easy-to-get ingredients in enough to make it himself.
- McDonald also takes aim at SA's bullish-on-Oramed Sharon Di Stefano and her background in the penny stock brokerage business.
- The stock is ahead 3.8% on the session, but off about $1.50 since the article hit.
Monday, Feb 103:29 PM
Monday, Feb 103:29 PM| Comment!
- Oramed Pharmaceuticals (ORMP +13.9%) says it delivered to the FDA the protocol for phase 2a testing of its oral insulin capsule treating both Type 1 and Type 2 diabetes.
- The protocol was submitted under ORMP's existing investigational new drug application for its ORMD-0801 drug candidate; the double-blind, placebo controlled study, expected to start next month, will be carried out over seven days at an in-patient facility with 24 Type 1 diabetic patients.
Wednesday, Feb 59:15 AM
Wednesday, Feb 58:51 AM
Wednesday, Feb 58:51 AM| 5 Comments
- Seeking Alpha author Sharon de Stefano jumps to Oramed's (ORMP +6.7%) defense after the tongue lashing the company received from Adam Feuerstein over Phase IIa trial results sent its shares into a tailspin.
- Feuerstein focused on a chart which showed what appeared to be high rates of adverse events.
- However, de Stefano accuses Feuerstein of not distinguishing between the levels of those events, and implies that he doesn't know what he's talking about. "Clinical data is often difficult for physicians to interpret, much less laymen, and jumping to inaccurate conclusions is not uncommon," de Stefano writes.
- The side effects in the Oramed study were dizziness, nausea, constipation and headaches, which are "of little concern to the FDA in a diabetes study," says de Stefano.
Tuesday, Feb 412:46 PM
Monday, Feb 312:51 PM|Monday, Feb 312:51 PM| 1 Comment
Monday, Feb 310:13 AM
Monday, Feb 310:13 AM| 12 Comments
- Oramed's (ORMP) shares are -9% after The Street's Adam Feuerstein criticizes the results of a Phase IIa trial of the company's ORMD-0801 insulin capsule for the treatment of Type 2 diabetes.
- Oramed said last week that the capsule met all its primary and secondary endpoints, and that it is safe and well tolerated, although it didn't provide any data.
- However, Feuerstein has found a slide which shows that "adverse events were reported by 40% of type 2 diabetics treated with the high dose of ORMD-0801." The rate was 30% in the low-dose group and 50% in the placebo group.
- Feuerstein charges that Oramed's "handling of the ORMD-0801 data smacks more of stock promotion than credible drug development."
Thursday, Jan 309:10 AM|Thursday, Jan 309:10 AM| 1 Comment
Thursday, Jan 307:16 AM
Thursday, Jan 307:16 AM| 3 Comments
- Oramed's (ORMP) oral insulin capsule for the treatment of Type 2 diabetes met all primary and secondary endpoints in a Phase 2a trial of 30 patients.
- Oramed now plans to begin Phase 2b testing later later in the year.
- In the near term, the company intends to start a Phase 2a study of the capsule for treating Type 1 diabetes.
- Shares are +4%, although the Twitterati is none too pleased at the notable lack of detail in Oramed's PR. The company plans to present the full results of the latest trial at a conference in the future.
Tuesday, Jan 289:10 AM
Monday, Jan 2712:46 PM
Wednesday, Jan 1512:45 PM
Tuesday, Jan 144:37 PM
Thursday, Jan 99:11 AM|Thursday, Jan 99:11 AM| 3 Comments
Wednesday, Jan 812:46 PM
Wednesday, Jan 811:02 AM
Wednesday, Jan 811:02 AM| Comment!
- Aegis figures now is a good time to hike the price target on Oramed Pharmaceuticals (ORMP +20.1%) to $30 from $25 as "positive proof-of-concept data has been generated in animals for both ORMD-0801 [and] ORMD-0901."
- Here's analyst Ram Selvaraju, commenting: "Positive Phase 2b data [in ORMD-0801] could set the scene for a transformative licensing transaction or an acquisition by an established diabetes focused firm like AstraZeneca (AZN), Novartis (NVS), Novo Nordisk (NVO), or Sanofi (SNY)."
- The shares are up 222% since the company reported successful results with its oral insulin capsule last month.