Last 444.80
Change Today 0.00 / 0.00%
Volume 0.0
RDHL On Other Exchanges
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Tel Aviv
As of 10:24 AM 12/25/14 All times are local (Market data is delayed by at least 15 minutes).

redhill biopharma ltd (RDHL) Snapshot

Open
$468.00
Previous Close
$455.20
Day High
$474.00
Day Low
$436.00
52 Week High
06/12/14 - $680.00
52 Week Low
11/18/14 - $295.00
Market Cap
390.9M
Average Volume 10 Days
150.2K
EPS TTM
$-0.11
Shares Outstanding
87.9M
EX-Date
--
P/E TM
--
Dividend
--
Dividend Yield
--
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. Submits BEKINDA (RHB-102) European Marketing Authorization Application for Oncology Support

RedHill Biopharma Ltd. announced that it has submitted a Marketing Authorization Application to the UK Medicines and Healthcare Products Regulatory Agency and several other member states seeking European marketing approval of RHB-102 for cancer patients suffering from chemotherapy and radiotherapy-induced nausea and vomiting. RHB-102, newly branded as BEKINDA™, is a proprietary, oral, extended-release, once-daily pill formulation of the antiemetic drug ondansetron. BEKINDA™ is targeting a considerable segment of the 5-HT3 antiemetic market, with estimated worldwide sales of approximately $940 million in 20131. The MAA was submitted to several member states under the European Mutual Recognition Procedure (MRP) with the UK as the reference European member state. The MAA submission follows a positive European Scientific Advice meeting with the UK MHRA and is supported by pharmacokinetic studies comparing BEKINDA™ to several approved regimens of Zofran® (GlaxoSmithKline), including a recently completed comparative bioavailability study with the European reference drug, Zofran® suppositories, and prior comparative bioavailability studies with oral Zofran® approved worldwide. The results of these studies support the safety and efficacy of BEKINDA™ for prevention of nausea and vomiting following chemotherapy and radiotherapy.

FDA Grants QIDP Fast-Track Designation to RedHill Biopharma Ltd.'s Phase III H. Pylori Drug RHB-105

RedHill Biopharma Ltd. announced that its Phase III Helicobacter pylori (H. pylori) eradication therapy, RHB-105, has been granted Qualified Infectious Disease Product (QIDP) designation by the U.S. FDA. The granted QIDP designation allows RedHill to benefit from Fast-Track development status with an expedited development pathway for RHB-105 and Priority Review status which provides for a shorter review time by the FDA of a future potential marketing application. If approved, RHB-105 will also receive an additional five years of U.S. market exclusivity on top of the standard exclusivity period. RHB-105 is a proprietary fixed-dose combination therapy of two antibiotics and a proton pump inhibitor (PPI) in an all-in-one oral capsule, specifically selected due to their potential for improved efficacy and superior resistance profile in eradicating H. pylori infection. RHB-105 is currently undergoing a Phase III clinical study in the U.S. for the treatment of H. pylori infection (the ERADICATE Hp study) following a successful Phase II study in Australia which demonstrated eradication rates exceeding 90% in 130 subjects.

RedHill Biopharma Ltd. Reports Unaudited Earnings Results for the Third Quarter and Nine Months Ended September 30, 2014

RedHill Biopharma Ltd. reported unaudited earnings results for the third quarter and nine months ended September 30, 2014. Operating loss for the quarter ended September 30, 2014 was approximately $5.0 million, an increase of $0.9 million, or approximately 22%, compared to an operating loss of approximately $4.1 million in the second quarter of 2014. The increase was mainly attributable to an increase in research and development expenses. Net cash used in operating activities for the quarter ended September 30, 2014 was approximately $3.8 million, a decrease of $0.4 million, or approximately 9%, compared to $4.2 million in the second quarter of 2014. The decrease was mainly attributable to advanced payments made to service providers for the Phase III study with RHB-104 in the second quarter of 2014. Total revenues were $4,000 against $3,000 a year ago. Purchase of fixed assets was $4,000 against $3,000 a year ago. Purchase of intangible assets was $1,020,000 against $200,000 a year ago. Revenues for the nine months ended September 30, 2014 were approximately $7.0 million, compared to immaterial Revenues in the nine months ended September 30, 2013. The increase resulted from an upfront payment of $7.0 million received from Salix Pharmaceuticals Inc. ("Salix") in the first quarter of 2014 for the out-licensing of RedHill's RHB-106 encapsulated bowel preparation and related rights. Operating loss for the nine months ended September 30, 2014 was approximately $5.8 million, a decrease of $1.4 million, or approximately 20%, compared to $7.3 million in the nine months ended September 30, 2013. 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 nine months ended September 30, 2014 was approximately $6.3 million, an increase of $0.3 million, or approximately 5%, compared to $6.0 million in the nine months ended September 30, 2013. The increase resulted mainly from an increase in research and development expenses. Purchase of fixed assets was $34,000 against $12,000 a year ago. Purchase of intangible assets was $1,020,000 against $200,000 a year ago.

 

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