RedHill Biopharma Ltd. (RDHL) announced selected key milestones and regulatory updates expected in 2015.
RedHill has a deep pipeline and 2015 looks like an eventful year for RedHill with quite a few regulatory events lined up.
Among its candidates, Rizaport, for treating acute migraines, is currently under review in the EU and a response is expected by the second half of 2015. The FDA is also expected to set a new PDUFA date by the second half of 2015.
RedHill also expects top-line data from the phase III study (GUARD) on Bekinda for acute gastroenteritis and gastritis by the third/fourth quarter of 2015. Additionally, the candidate is being evaluated for chemotherapy- and radiotherapy-induced nausea and vomiting (CINV and RINV respectively). A response from the European Medicines Agency for using Bekinda for CINV and RINV is expected by the second half of 2015. The company plans to use data from Europe along with the data generated from prior studies to further support its planned submission of a New Drug Application for Bekinda for the prevention of CINV in the U.S.
RedHill is evaluating RHB-105 for H. pylori bacterial infection and top-line data from the first ongoing phase III study (the ERADICATE Hp study) in the U.S. is expected in the second quarter of 2015. We note that the candidate has been designated as Qualified Infectious Disease Product (QIDP) in the U.S.
Additionally, RedHill expects to announce timelines for an interim analysis by the independent Data Safety and Monitoring Board along with completion of the ongoing first phase III study on candidate RHB-104 for the treatment of Crohn's disease by the second quarter of 2015. Also, the company is expected to release top-line interim results from the ongoing phase IIa proof-of-concept study on RHB-104 for the treatment of multiple sclerosis in the second half of 2015.
Meanwhile, RedHill expects to initiate a clinical study on RHB-106 in partnership with Salix Pharmaceuticals, Inc. (SLXP) by the second or third quarter of 2015 as an encapsulated formulation for bowel preparation.
On the other hand, data from nonclinical studies, which the company plans to conduct on oncology candidates, Mesupron and RP-101, are expected in the second half of 2015.
Successful development and commercialization of its pipeline is important for RedHill, which currently does not have any approved product in its portfolio. Hence, we expect investor focus on pipeline updates from the company in 2015.
RedHill Biopharma currently carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the broader health care sector include Sucampo Pharmaceuticals (SCMP) and Biodel Inc. (BIOD). Both carry a Zacks Rank #1 (Strong Buy).
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