Last 475.40
Change Today -11.50 / -2.36%
Volume 132.0K
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Tel Aviv
As of 10:24 AM 09/22/14 All times are local (Market data is delayed by at least 15 minutes).

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redhill biopharma ltd (RDHL) Details

RedHill Biopharma Ltd. is an Israeli biopharmaceutical company focused primarily on the development and acquisition of late clinical-stage, proprietary drugs for the treatment of inflammatory and gastrointestinal diseases, including gastrointestinal cancers. Its pipeline of proprietary products includes: RHB-104, an oral combination therapy for the treatment of Crohn's disease, with an ongoing Phase III study; RHB-105, an oral combination therapy for Helicobacter pylori infection, with an ongoing Phase III study; and RHB-102, a once-daily oral pill formulation of ondansetron for the prevention of nausea and vomiting in advanced stages of development for multiple indications. In addition, the company’s product pipeline includes RHB-106, an encapsulated formulation for bowel preparation licensed to Salix Pharmaceuticals, Ltd.; MESUPRON, a Phase II-stage uPA inhibitor, administered by oral capsule, targeting gastrointestinal and other solid tumor cancers; RP101, a Phase II-stage Hsp27 inhibitor, administered by oral tablet, targeting pancreatic and other gastrointestinal cancers; RHB-103, an oral thin film formulation of rizatriptan for acute migraines with a U.S. NDA under FDA review; and RHB-101, a once-daily oral pill formulation of the cardio drug carvedilol. RedHill Biopharma Ltd. was founded in 2009 and is based in Tel Aviv, Israel.

Founded in 2009

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RedHill Biopharma Ltd. Presents at Gelbart Kahana Biomed Conference, Sep-04-2014 08:30 AM

RedHill Biopharma Ltd. Presents at Gelbart Kahana Biomed Conference, Sep-04-2014 08:30 AM. Venue: Hilton Tel-Aviv, 205 HAYARKON ST., Tel-Aviv, Israel.

RedHill Biopharma Initiates Phase III Study of RHB-102 for Gastroenteritis

RedHill Biopharma Ltd. announced that it is initiating a Phase III clinical study designed to evaluate the safety and efficacy of RHB-102 in patients suffering from acute gastroenteritis, an inflammation of the gastrointestinal tract which causes, among other symptoms, nausea and vomiting. RHB-102 is a proprietary, oral, extended-release, once-daily formulation of the antiemetic drug ondansetron. Acute gastroenteritis is an inflammation of the mucus membranes of the gastrointestinal tract, most commonly caused by a viral infection. Symptoms of gastroenteritis include nausea, vomiting, diarrhea and abdominal pain. With over 179 million cases annually in the U.S. alone, the worldwide potential market could exceed $650 million annually. The randomized, double-blind, placebo-controlled, parallel group Phase III study will be conducted in up to 10 clinical sites in the U.S. and is expected to enroll 320 adults and children over the age of 12 who suffer from acute gastroenteritis. Patients will be randomized to receive either RHB-102 or a placebo. The primary endpoint for the study is the absence of vomiting from 30 minutes after the first dose through the discharge from the emergency department. Secondary endpoints include frequency of vomiting, severity and time to resolution of nausea, and time to resumption of normal activities. Top-line results from the RHB-102 Phase III GUARD study are expected during the second half of 2015. Following prior discussions with the U.S. Food and Drug Administration (FDA) and the UK Medicines and Healthcare Products Regulatory Agency (MHRA), the GUARD study is intended to support potential future submissions of marketing applications in both the U.S. and Europe for this indication. If approved for marketing by the FDA, RHB-102 could become the first-ever 5-HT3 antiemetic drug indicated for the treatment of acute gastroenteritis. Ondansetron, a 5-HT3 antagonist and the active pharmaceutical ingredient in RHB-102, has been approved in the U.S. and Europe, in oral immediate release and non-oral forms, for the prevention and treatment of chemotherapy and radiotherapy-induced nausea and vomiting. No formulation of ondansetron or any other 5-HT3 antagonist has been approved by the FDA for the treatment of gastroenteritis. RHB-102 is a proprietary, extended-release (24 hours), oral pill formulation of ondansetron. In parallel to the Phase III study for gastroenteritis, RedHill is pursuing marketing approval of RHB-102 for the indications of chemotherapy-induced and radiotherapy-induced nausea and vomiting ("CINV" and "RINV" respectively) in the U.S. and Europe. Following a positive European scientific advice meeting with the UK's MHRA, and a successful comparative bioavailability study comparing RHB-102 to a European reference drug, RedHill plans to submit a European Marketing Authorization Application for RHB-102 by October 2014 for the indications of CINV and RINV prevention. RedHill has also held a pre-New Drug Application (pre-NDA) meeting with the FDA regarding the development of RHB-102 for CINV and RINV prevention in the U.S. Following the pre-NDA meeting and in light of the FDA's feedback, RedHill provided the FDA with additional information and is currently awaiting the FDA's response.

RedHill Biopharma Ltd. Provides an Update on the Ongoing RHB-105 Phase III ERADICATE Hp Study

RedHill Biopharma Ltd. provided an update on the ongoing RHB-105 Phase III ERADICATE Hp study. In order to enhance statistical powering and expedite recruitment, RedHill is expanding the study to include, respectively, additional subjects and clinical sites. The company further announced that, based on prior discussions, the U.S. Food and Drug Administration (FDA) has authorized RedHill to pursue a new, distinct and broader indication with RHB-105, a proprietary fixed-dose combination therapy of two antibiotics and a proton pump inhibitor (PPI) in an all-in-one oral capsule for the first line treatment of Helicobacter pylori (H. pylori) infection. The ongoing Phase III ERADICATE Hp study follows a successful Phase II study in Australia with 130 subjects, as well as a successful PK study conducted in 2013. As part of an amendment to the ongoing RHB-105 Phase III ERADICATE Hp study protocol, currently being reviewed by FDA, RedHill has increased the number of subjects to be enrolled from 90 to 120. RedHill believes that the increased number of subjects, as well as other amendments to the study protocol, should improve the study's statistical powering and reduce the potential impact of non-compliant subjects in meeting the study's primary endpoint of H. pylori eradication. RedHill is also increasing the total number of clinical sites from 8 to 12 in order to expedite recruitment. In light of the changes to the study protocol, top-line data from the study is currently expected in the first half of 2015. Following prior discussions with the FDA, RedHill has received authorization from the FDA to pursue a new and significantly broader indication with RHB-105. While current standard treatments for H. pylori are typically indicated to treat patients with active or recent history of ulcers, RedHill's RHB-105 new intended indication will target H. pylori infection as a first line treatment regardless of ulcer status. If approved, RHB-105 may be the first H. pylori eradication therapy to pursue this broader indication, which would significantly expand the potential patient population for the drug. The ERADICATE Hp randomized, double-blind, placebo-controlled Phase III study is designed to evaluate the safety and efficacy of RHB-105 for the treatment of H. pylori infection in non-investigated dyspepsia subjects with confirmed H. pylori infection. Subjects in the study are randomized to receive either RHB-105 or a placebo for a period of 14 days and are assessed for the study's primary endpoint of eradication of H. pylori infection 28 to 35 days after completion of treatment. Current standard of care combination therapies for H. pylori infection have increasingly high failure rates due to growing antibiotic resistance of H. pylori. RHB-105 is a novel combination of two antibiotics with a proton pump inhibitor, specifically selected due to their potential for improved efficacy and superior resistance profile in eradicating H. pylori infection. In addition to a potential increase in efficacy, RHB-105's new and proprietary all-in-one oral capsule formulation offers a convenient treatment regimen, potentially improving patient compliance and convenience. A Phase II study conducted in Australia with the RHB-105 active agents demonstrated an eradication rate greater than 90% in 130 patients who had previously failed at least one course of standard of care therapy for H. pylori infection.


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