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TEL AVIV, Israel and RALEIGH, N.C. - In a strategic move to expand its product portfolio, Hyloris Pharmaceuticals SA has entered into a licensing agreement with RedHill Biopharma (NASDAQ:RDHL) Ltd. (market cap: $6.69M) for the global development and commercialization of RHB-102, known as Bekinda®, excluding North America. This deal could potentially be worth up to $60 million in milestone payments, in addition to royalties on sales. According to InvestingPro data, RedHill’s analysts are forecasting significant sales growth of 219% for FY2024, suggesting strong commercial potential for its pipeline.
Under the agreement announced today, Hyloris will make an upfront payment to RedHill and is committed to handling all development, regulatory, and commercialization activities for RHB-102 in the agreed territories. RedHill retains the rights to continue developing the drug for FDA approval in the United States. While RedHill’s stock has faced challenges, trading near its 52-week low of $4.71, InvestingPro analysis reveals 18 additional key insights about the company’s potential. Get access to the complete RedHill Biopharma Pro Research Report, part of InvestingPro’s coverage of 1,400+ US stocks.
RHB-102 is a once-daily, extended-release oral tablet of ondansetron, designed to treat nausea and vomiting associated with chemotherapy, radiotherapy, and certain gastrointestinal conditions. The drug is currently in advanced development stages for various indications, including acute gastroenteritis and diarrhea-predominant irritable bowel syndrome (IBS-D).
The agreement follows positive feedback from the UK’s Medicines and Healthcare products Regulatory Agency (MHRA), outlining a clear path for a Marketing Authorization Application in the UK. If approved, RHB-102 could become the first oral 24-hour extended-release ondansetron for chemotherapy and radiotherapy-induced nausea and vomiting (CINV/RINV).
The global antiemetics drugs market, valued at approximately $7.5 billion in 2023, is expected to grow at a 6% CAGR through 2030. This growth potential, coupled with the recent successful completion of Phase 2 and Phase 3 studies in the United States for RHB-102, positions both RedHill and Hyloris favorably in a growing market. InvestingPro data shows analysts maintain a strong buy consensus on RedHill, with expectations of profitability in the current year despite recent challenges in cash flow metrics.
The collaboration between Hyloris and RedHill is indicative of the companies’ shared vision for RHB-102’s potential to provide sustained relief from nausea and vomiting in outpatient settings. This partnership is part of RedHill’s broader strategy to advance its R&D pipeline, which includes a range of late-stage development programs for gastrointestinal diseases, infectious diseases, and oncology.
The information reported is based on a press release statement.
In other recent news, RedHill Biopharma reported a decline in net revenues for Q1 2022, dropping to $18.2 million from $22.1 million in the previous quarter. Despite this, the company maintained a gross profit of $10.2 million with a 56% margin. RedHill has been actively reducing its R&D expenses, which decreased significantly from $5.9 million to $3.1 million, as part of a broader cost optimization strategy. The company is targeting positive cash flow from operations in the second half of 2022 and has plans to achieve $50 million in savings over the next 18 months. RedHill’s focus on operational efficiency is underscored by a reduction in operating cash use by over 70% to approximately $4 million. Additionally, the company is exploring potential acquisitions of revenue-generating products and seeking external funding for its R&D programs. Analyst firms have not recently issued upgrades or downgrades for RedHill Biopharma, but the company continues to navigate challenges in the biotech sector with strategic cost-cutting measures.
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