Shares of Redhill Biopharma Ltd (NASDAQ:RDHL) declined on Tuesday, reversing part of the approximately 36% advance witnessed on Monday. Market data from Benzinga Pro indicates that this pullback could represent profit-taking activity after the previous day's robust rally.
Redhill Biopharma delivered detailed updates regarding the development of RHB-102, also known as Bekinda, which is being advanced in various gastrointestinal (GI) indications. Notably, the company is pursuing accelerated approval through the U.S. Food and Drug Administration's (FDA) 505(b)(2) regulatory pathway to establish RHB-102 as a once-daily oral formulation of ondansetron aimed at mitigating GI side effects induced by GLP-1 and GIP receptor agonist therapies.
RHB-102 is a patented, bimodal oral drug that combines immediate and extended-release properties of the 5HT3 antagonist ondansetron, allowing for once-daily dosing. This formulation is strategically aligned to enhance the titration process and decrease the leading reason for early discontinuation among patients receiving GLP-1 or GIP receptor agonists. Such therapies include diabetes and weight management medications like Eli Lilly and Co.'s (NYSE:LLY) Mounjaro and Zepbound, as well as Novo Nordisk A/S' (NYSE:NVO) Ozempic and Wegovy.
In addition to gastrointestinal uses, Redhill is actively seeking FDA approval for RHB-102 in oncology supportive care, with further opportunities anticipated in managing post-operative nausea and vomiting (PONV).
Clinical Evidence and Regulatory Pathway
The potential approval of RHB-102 for oncology support, gastroenteritis, irritable bowel syndrome with diarrhea (IBS-D), and GLP-1/GIP receptor agonist therapy-associated GI side effects is supported by a substantial collection of clinical and preclinical data.
Key evidence includes outcomes from the U.S. Phase 3 GUARD gastroenteritis study and a positive Phase 2 IBS-D trial, both demonstrating attainment of primary endpoints. These results have been published in reputable medical journals, specifically JAMA Network Open and The American Journal of Gastroenterology.
Supplementary data from a pharmacokinetic (PK) comparative clinical study, along with forthcoming results from a planned Phase 2 Proof-of-Concept trial targeting GI side effects linked to GLP-1 and GIP receptor agonist therapy, will further reinforce the totality of evidence underpinning regulatory submissions in multiple gastrointestinal indications.
Market and Clinical Implications
Currently, over 2% of the American population is estimated to be using GLP-1 receptor agonist treatments. However, discontinuation rates remain high, with some sources estimating that as many as 50% of patients cease therapy within three months, largely due to gastrointestinal adverse effects.
This high rate of discontinuation represents a significant obstacle to maximizing the clinical and commercial potential of these therapies. Goldman Sachs has projected that such issues could suppress the anticipated market valuation of GLP-1 drugs by as much as $35 billion by 2030.
Addressing GI side effects effectively could therefore have meaningful clinical benefits and market implications by improving treatment adherence and outcomes.
Stock Price Movement
At the time of reporting on Tuesday, shares of Redhill Biopharma traded down 4.29% at $1.34, according to Benzinga Pro. This contrasted with their previous surge following the announcement of RHB-102 development progress.
The recent price action highlights investor reactions to ongoing clinical developments and potential market opportunities, balancing enthusiasm with cautious profit realization.
Conclusion
Redhill Biopharma's strategic focus on advancing RHB-102 through the regulatory process for multiple significant gastrointestinal indications, including mitigation of GI side effects from widely prescribed GLP-1 and GIP receptor agonists, positions the company at the intersection of important therapeutic needs and a large patient base.
While recent stock fluctuations demonstrate the volatile nature of investing in biotech developments, the company's clinical progress and potential approvals in oncology support and GI conditions remain critical factors for future market performance.