Redhill Biopharma Ltd (NASDAQ:RDHL) stock is trading lower on Tuesday, possibly on profit-taking after the stock rallied roughly 36% on Monday, as per data from Benzinga Pro.
On Monday, RedHill Biopharma shared development progress for RHB-102 (Bekinda) in multiple gastrointestinal (GI) indications, including its development, via the accelerated FDA 505(b)(2) route, as a once-daily oral ondansetron therapy for GLP-1/GIP receptor agonist therapy-associated GI side effects.
RHB-102 is a patent-protected bimodal, immediate and extended-release, once-daily oral formulation of 5HT3 antagonist, ondansetron.
It is clinically aligned to improve titration success and reduce the #1 cause for early discontinuation of GLP-1/GIP-based diabetes & weight loss therapies like Eli Lilly and Co.’s (NYSE:LLY) Mounjaro/Zepbound and Novo Nordisk A/S’ (NYSE:NVO) Ozempic/Wegovy.
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RedHill further announced that it is currently pursuing potential U.S. FDA approval of RHB-102 for oncology support, with additional potential for use in post-operative nausea and vomiting (PONV).
What Is The Impact Of RHB-102?
An extensive body of clinical and non-clinical data will be available to support potential FDA approval of RHB-102 for oncology support, as well as gastroenteritis, IBS-D, and GLP-1/GIP receptor agonist therapy-associated GI side effects.
These data include results from the RHB-102 U.S. Phase 3 GUARD gastroenteritis study and the positive Phase 2 IBS-D study, with both studies meeting their primary endpoints, which were published in JAMA Network Open and The American Journal of Gastroenterology, respectively.
In addition, data from a comparative PK clinical study, plus any additional outcomes from the planned Phase 2 Proof-of-Concept study in GLP-1/GIP receptor agonist therapy-associated GI side effects, will add to the weight of evidence in support of potential approval in multiple GI indications.
More than 2% of Americans take GLP-1 receptor agonists, but some estimates suggest up to 50% of patients discontinue GLP-1 within 3 months.
GI side-effect-driven discontinuation is considered a key contributor to reductions in forecasted GLP-1 market valuations, which, according to Goldman Sachs, could be reduced by an estimated $35 billion by 2030.
RDHL Price Action: Redhill Biopharma shares were down 4.29% at $1.34 at the time of publication on Tuesday, according to Benzinga Pro data.
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