RedHill Biopharma Ltd. (RDHL), a specialty biopharmaceutical company, has entered into an exclusive worldwide licensing agreement, excluding North America, with Liège, Belgium-based Hyloris Pharmaceuticals SA (HYL.BR) for its investigational drug RHB-102 or Bekinda.
This agreement allows Hyloris to develop and commercialize RHB-102 in various territories, with RedHill receiving an upfront payment, up to $60 million in milestone payments, and royalties on revenue.
RHB-102 is a once-daily, bimodal extended-release oral tablet formulation of Ondansetron, which is in advanced development for treating chemotherapy-induced nausea and vomiting, acute gastroenteritis, gastritis, and diarrhea-predominant irritable bowel syndrome or IBS-D.
The drug is expected to provide sustained relief from nausea and vomiting, with a potential breakthrough in oncology and post-surgical settings, where continuous symptom management is critical.
RHB-102 was found to be promising, with positive regulatory advice from the UK's Medicines and Healthcare products Regulatory Agency or MHRA signaling a clear pathway for a UK Marketing Authorization Application or MAA.
If approved, it could be the first oral, 24-hour extended-release Ondansetron for chemotherapy and radiotherapy-induced nausea and vomiting.
This agreement also follows RedHill's positive results from the U.S. Phase 2 study of RHB-102 for IBS-D and a Phase 3 study for gastroenteritis, both of which met their primary endpoints.
RDNT closed Monday's (Feb.24 2025) trading at $4.82 up by 1.26 percent. In premarket trading Tuesday the stock is down by 0.19 percent at $4.81 on the Nasdaq.
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