Redhill Biopharma Ltd: Business description, financial summary, 3yr and interim financials, key statistics/ratios and historical ratio analysis.
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Redhill Biopharma Ltd and IntelGenx Corp receive complete response letter from FDA for RHB-103 oral film for Acute Migraines
RedHill Biopharma Ltd. and together with IntelGenx Corp:Says that they received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) regarding the New Drug Application (NDA) for RHB-103 for the treatment of acute migraines.Says RHB-103 is a proprietary oral thin film formulation of rizatriptan benzoate, a 5-HT1receptor agonist and the active drug in Merck & Co.'s Maxalt.Says a CRL is issued by the FDA's Center for Drug Evaluation and Research to inform companies that certain questions and deficiencies remain that preclude the approval of the application in its present form.Says while continuing to review the FDA's CRL, RedHill and IntelGenx believe that they can supply the requested information based on available data.Says IntelGenx and RedHill further believe that the majority of issues raised by the FDA were recently addressed in an amendment submitted by the companies to the FDA that has yet to be reviewed.Says companies will work with the FDA to address the remaining questions in the CRL and plan to submit the requested information within a few weeks.
Latest Developments for Redhill Biopharma Ltd
- Redhill Biopharma Ltd provides update on PK program in support of ongoing RHB-104 Phase III Crohn's Study
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- Redhill Biopharma Ltd Announces Positive Pre-Clinical Results for Lupus With RHB-104
- Redhill Biopharma Ltd Announces Positive Pre-Clinical Rheumatoid Arthritis Results With RHB-104
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