Redhill Biopharma

RDHL

Market cap $6.93M

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.

RHB-102 1  is a proprietary, advanced clinical-stage, once-daily, bimodal extended-release, oral tablet formulation of 5-HT3 antagonist, ondansetron, targeting oncology support, acute gastroenteritis and gastritis, IBS-D and GLP-1/GIP-associated gastrointestinal (GI) side effects -- Largey de-risked, RHB-102 development is supported by published positive U.S. Phase 3 & 2 results in gastroenteritis/gastritis and diarrhea-predominant irritable bowel syndrome (IBS-D) respectively, a positive comparative PK clinical study as part of the oncology support (CINV/RINV) program 2 , plus decades of ondansetron clinical use (>22 million annual U.S. ER prescriptions3 ) -- RHB-102 is clinically aligned, if approved, to improve titration success and reduce the #1 cause of discontinuing diabetes & weight loss therapies like Mounjaro®/Zepbound® & Ozempic®/Wegovy® -- Development planned under the accelerated FDA 505(b)(2) route of RHB-102 (Bekinda®) as a once-daily oral therapy for GLP-1/GIP receptor agonist therapy-associated GI side effects. Phase 2 Proof-of-Concept study designed, and intellectual property expanded -- >2% of Americans take GLP-1 receptor agonist drugs 4 but estimates suggest up to 50% discontinue within 3 months 5 , potentially costing an estimated $35 billion in lost market value by 20306 TEL-AVIV, Israel and RALEIGH, N.C.

Resistance to venetoclax (Venclexta® and Venclyxto®, Abbvie / Genentech), the $2.5 billion blockbuster Chronic Lymphocytic Leukemia (CLL) therapy, is emerging as a therapeutic challenge, with leukemic cells persisting over time, even with combination therapy 1 Studies show that sphingosine kinase 2 (SPHK2) is overexpressed in venetoclax-resistant cancer cells and that SPHK2 inhibition may reduce T-cell-induced activation and proliferation of venetoclax-resistant CLL cancer cells and resensitize previously resistant CLL cells2,3 New in vivo study shows adding opaganib, a potent SPHK2 inhibitor, to venetoclax reduces CLL cell (CD19⁺, CD5⁺) counts by 50% compared to controls and lowered CD3+, CD4+ and CD8+ T cell counts compared to controls with lowered PD1 expression (CD8+) 4 Data shows opaganib's venetoclax combination potential in CLL; builds on multiple preclinical studies demonstrating opaganib's therapeutic add-on potential in oncology; further clinical evaluation ongoing in a Phase 2 study of opaganib + darolutamide in advanced prostate cancer Opaganib has a safety and tolerability profile shown in more than 470 clinical trials / expanded access participants. It targets multiple oncology, virology, inflammation, diabetes and obesity indications, with several U.S. government partnerships, including BARDA funding, in place TEL-AVIV, Israel and RALEIGH, N.C.

TEL-AVIV, Israel and RALEIGH, N.C. , Dec. 1, 2025 /PRNewswire/ -- RedHill Biopharma Ltd.

RALEIGH, N.C. and TEL-AVIV, Israel , Nov. 4, 2025 /PRNewswire/ -- RedHill Biopharma Ltd.

On October 16, 2025, the Company received a Staff Determination notification from The Nasdaq Stock Market LLC regarding continued non-compliance with the minimum stockholders' equity requirements for continued listing, pursuant to Listing Rule 5550(b)(1)  Following RedHill's transaction with Cumberland Pharmaceuticals Inc., announced October 20, 2025, the Company believes that its stockholders' equity now exceeds the minimum $2.5 million requirement and that it is well positioned to maintain compliance  The Company intends to appeal Staff's determination to a Hearings Panel, pursuant to the Nasdaq Listing Rule 5800 Series and present its case. The Panel has the authority to determine whether the Company has regained compliance or to grant up to a 180-day extension to regain compliance  Submission of a hearing request will stay any delisting or suspension action of the Company's American Depositary Shares, and RedHill remains listed and traded on the Nasdaq Capital Market, pending the hearing  There can be no assurance that the Panel will grant an extension of the compliance period or that the outcome of the hearing will be favorable to the Company TEL AVIV, Israel and RALEIGH, N.C.

Cumberland to expand its gastroenterology offerings with the market-leading Helicobacter pylori therapy NASHVILLE, Tenn. , Oct. 20, 2025 /PRNewswire/ -- Cumberland Pharmaceuticals Inc. (Nasdaq: CPIX), a specialty pharmaceutical company focused on delivering high-quality products to improve patient care, announced strategic arrangements with RedHill Biopharma Ltd.

The deal aims to accelerate Talicia's entry into new Middle East markets  Under the terms of the agreement RedHill will receive $500,000 in guaranteed payments, including a $250,000 upfront payment and $250,000 in fixed payments due within 18 months, plus a minimum of $1.3 million in near-term potential milestone payments, as well as tiered royalties up to mid-teens percent on Talicia net sales  Talicia is the only FDA-approved all-in-one, low-dose rifabutin-based therapy to address H. pylori antibiotic resistance.

The New York Supreme Court has, on appeal, upheld its original summary judgment ruling in favor of RedHill The New York Supreme Court unequivocally dismissed Kukbo Co. Ltd's ("Kukbo") defense again, further ruling that RedHill had fulfilled its agreement obligations even after Kukbo's breach RedHill has been granted approximately $10 million in total awards comprised of the $8.25 million original award and a subsequent $1.82 million award for legal costs and expenses (including 9% statutory interest accrual) RALEIGH, N.C., and TEL AVIV, Israel , Sept.

Extensive strategic, financial and operational overhaul has reshaped and refocused our business; Strong progress on multiple fronts Commercial and R&D Highlights: Recruitment initiated in the Bayer-supported Phase 2 combination study of opaganib and darolutamide in advanced prostate cancer Positive U.S. Food and Drug Administration (FDA) feedback on pathway to approval for RedHill's next-generation Crohn's disease program with RHB-204 - planned to be the first ever clinical study in a defined Mycobacterium avium subspecies paratuberculosis infected (MAP-positive) Crohn's disease (CD) patient population Increased Talicia net revenues and units sold as compared to first half 2024 - achieved with significantly reduced resources Talicia U.S. formulary wins securing 8 million additional covered lives, taking the total to more than 204 million lives UK Marketing Authorization Application (MAA) for Talicia® submission imminent and expected to be in time for potential approval this year Ex-U.S. Talicia: cash inflows from first sales milestone and from royalties, majority received post–balance sheet date Up to $60 million global (ex-North America) RHB-102 out-licensing deal signed with Hyloris Pharmaceuticals Corporate and financial highlights: Gross profit doubled compared to first half 2024 59% increase in net revenues in first half of 2025 to $ 4.1  million, up from $2.6 million in first half of 2024 Enhanced financial stability with up to approximately $13.5 million available to the Company through At-the-Market ("ATM") and Any Market Purchase agreements  Cash balance of $3 million as of June 30, 2025 1 Further 19% reduction in cash burn following the previous year's 74% reduction Net cash used in operations in first half of 2025 dropped to $5 million from $6.2 million in first half of 2024  Following RedHill's approximately $8.25 million including interest New York Supreme Court summary judgment win against Kukbo (appeal to be heard this month), the Court also awarded RedHill approximately $1.82 million including interest in legal costs and expenses. RedHill also won an attachment grant in the Korean courts, preventing Kukbo asset disposal prior to enforcement TEL AVIV, Israel and RALEIGH, N.C.