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As of 10:24 AM 08/28/14 All times are local (Market data is delayed by at least 15 minutes).

redhill biopharma ltd (RDHL) Snapshot

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$509.00
Previous Close
$509.00
Day High
$509.00
Day Low
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52 Week High
06/12/14 - $680.00
52 Week Low
12/12/13 - $323.00
Market Cap
440.0M
Average Volume 10 Days
144.8K
EPS TTM
$-0.10
Shares Outstanding
87.8M
EX-Date
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Current Stock Chart for REDHILL BIOPHARMA LTD (RDHL)

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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.

8 Employees
Last Reported Date: 02/25/14
Founded in 2009

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redhill biopharma ltd (RDHL) Key Developments

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.

Redhill Biopharma Ltd. Signs Binding Option Agreement with Resprotect GmbH to Buy Oncology Drug Candidate RP101

RedHill Biopharma Ltd. signed a binding exclusive option agreement to buy oncology drug candidate RP101 from RESprotect GmbH. Under the agreement, RedHill has the option to acquire the worldwide exclusive rights to RP101 for all indications (other than to the pancreatic cancer indication in South Korea). RedHill has agreed to pay RESprotect for a one year option, with an option to extend. During the option period, RedHill may conduct development activities with RP101. If RedHill elects to exercise the option, it will acquire the exclusive rights to RP101 for $100,000, and potential milestone payments and tiered royalties. RP101 is an orally administered, patent-protected small molecule that binds to Hsp27, a chaperone protein that is found in abnormally high levels in cancer cells, and inhibits its activity. RP101 has been granted Orphan Drug designation for the adjunct treatment of pancreatic cancer by the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA).

RedHill Biopharma Ltd. Reports Audited Earnings Results for the Second Quarter and Six Months Ended June 30, 2014

RedHill Biopharma Ltd. reported audited earnings results for the second quarter and six months ended June 30, 2014. For the quarter, the company’s revenues for the quarter ended June 30, 2014 were immaterial compared to approximately $7.0 million in the first quarter of 2014. Operating Loss for the quarter ended June 30, 2014 was approximately $4.114 million, compared to an operating profit of approximately $3.3 million in the first quarter of 2014, and operating loss of $2.526 million for the quarter ended June 30, 2013. The transition from operating profit to operating loss resulted from the $7.0 million upfront payment from the Salix licensing transaction received in the first quarter of 2014. Comprehensive loss was $4.524 million or $0.05 per basic and diluted share against $2.512 million or $0.04 per basic and diluted share a year ago. Net cash used in operating activities for the quarter ended June 30, 2014 was approximately $4.164 million, compared to net cash resulting from operating activities of $1.7 million in the first quarter of 2014, net cash used in operating activities of $2.118 million a year ago. The decrease was mainly due to revenues from the Salix licensing transaction received in the first quarter of 2014. Net cash used in operating activities for the six months ended June 30, 2014 was approximately $2.488 million, a decrease of $1.4 million, or approximately 36%, compared to $3.876 million in the six months ended June 30, 2013. The decrease was mainly due to revenues from the Salix transaction received in the first quarter of 2014 and an increase in prepaid expenses paid mainly to research and development service providers. For the six months, the company’s revenues for the six months ended June 30, 2014 were approximately $7.0 million compared to immaterial revenues in the six months ended June 30, 2013. The differences in both periods resulted from an upfront payment of $7.0 million from Salix Pharmaceuticals Inc. for the out-licensing of the company's RHB-106 encapsulated bowel preparation and related rights in the first quarter of 2014. Operating Loss for the six months ended June 30, 2014 was approximately $0.822 million, a decrease of $3.7 million, or approximately 82%, compared to $4.543 million in the six months ended June 30, 2013. The decrease was mainly due to revenues from the Salix licensing transaction received in the first quarter of 2014. Comprehensive loss was $1.147 million or $0.01 per basic and diluted share against $4.489 million or $0.07 per basic and diluted share a year ago. Net cash used in operating activities for the six months ended June 30, 2014 was approximately $2.488 million, a decrease of $1.4 million, or approximately 36%, compared to $3.876 million in the six months ended June 30, 2013. The decrease was mainly due to revenues from the Salix transaction received in the first quarter of 2014 and an increase in prepaid expenses paid mainly to research and development service providers. Purchase of fixed assets was $0.005 million against $0.007 million a year ago.

 

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