Redhill Biopharm Stock Price, News & Analysis

RedHill Biopharma (RDHL) has secured a key Chinese patent for RHB-107, its COVID-19 treatment candidate. The patent, granted by China National Intellectual Property Administration, covers the compound's molecular structure and its use in treating SARS-CoV-2 infections, including variants.

The company's Phase 2 study demonstrated promising results with 100% reduction in COVID-19 hospitalization (0/41 patients on RHB-107 vs 3/20 on placebo) and approximately 88% reduction in new severe COVID-19 symptoms (2.4% RHB-107 vs 20% placebo). Recovery time was notably faster at 3 days with RHB-107 compared to 8 days with placebo.

RHB-107 is an oral, once-daily, host-directed antiviral designed to act independently of viral spike protein mutations. The patent strengthens RedHill's position in the global COVID-19 therapeutic market, projected to be worth over $3 billion in 2025.

RedHill Biopharma (Nasdaq: RDHL) has received a notification from Nasdaq on April 15, 2025, indicating non-compliance with the minimum stockholders' equity requirement for continued listing. The company reported a stockholders' deficit of $4,683,000 in its 2024 Annual Report, falling below Nasdaq's required minimum of $2,500,000 in stockholders' equity.

The notification does not immediately affect RedHill's listing on the Nasdaq Capital Market or its business operations. The company has until May 30, 2025 (45 calendar days) to submit a compliance plan. If accepted, Nasdaq may grant up to 180 calendar days from the notification date to demonstrate compliance.

RedHill Biopharma (RDHL) has published positive data for opaganib in the treatment of obesity and diabetes, showing efficacy comparable to semaglutide in preclinical models. The study, published in the journal Diabetes, Metabolic Syndrome and Obesity, demonstrates that opaganib effectively suppresses weight gain and improves glucose tolerance in high-fat diet mice.

As a first-in-class oral, non-peptide therapeutic targeting sphingosine kinase-2 (SPHK2), opaganib offers potential advantages over current GLP-1 inhibitors, potentially avoiding their common side effects and administration challenges. The drug has already shown safety and tolerability data in over 470 subjects across several clinical programs.

The company is positioning opaganib as a potential disruptor in the global obesity-diabetes drugs market, which is projected to reach $100 billion by 2034. This market is currently dominated by GLP-1 inhibitors like Novo Nordisk's Ozempic and Wegovy, and Eli Lilly's Trulicity, Zepbound, and Mounjaro.

RedHill Biopharma (NASDAQ: RDHL) reported its full-year 2024 financial results, showing a 123% increase in net revenues to $8.0 million, up from $6.5 million in 2023. The company highlighted several achievements, including a global licensing deal with Hyloris Pharmaceuticals for RHB-102 worth up to $60 million in potential milestone payments and an $8 million court win against Kukbo.

Financial highlights include a 74% reduction in cash burn, with net cash used in operations dropping to $9.4M from $35.8M in 2023. The company reported a net loss of $8.3 million for 2024, compared to net income of $23.9 million in 2023. Cash balance stood at $4.8 million as of December 31, 2024.

Operational highlights include Talicia's successful performance with $9.0 million in net revenues, securing 25 million covered lives, and its launch in UAE. The company is advancing RHB-204 into Phase 2 clinical study for Crohn's Disease and initiated a Bayer-supported Phase 2 study of opaganib with darolutamide in prostate cancer.

RedHill Biopharma (NASDAQ: RDHL) has announced plans to submit a UK Marketing Authorisation Application for Talicia, its H. pylori infection treatment, using MHRA's fast-track approval process. The company expects potential UK approval by Q4/2025, leveraging its existing FDA approval as reference.

Talicia is currently the leading branded H. pylori therapy prescribed by U.S. gastroenterologists and is listed in the ACG Clinical Guideline as a first-line treatment option. The drug is the only FDA-approved all-in-one, low-dose rifabutin-based therapy designed to address H. pylori resistance to common antibiotics, demonstrating up to 90% effectiveness.

The market opportunity is significant, with H. pylori affecting approximately 40% of UK adults, 35% of U.S. adults, and over 50% of the global adult population. The infection is classified by WHO as a Group 1 carcinogen and is the strongest known risk factor for gastric cancer.

RedHill Biopharma has announced plans to advance its late-stage Crohn's disease (CD) program with a Phase 2 study of RHB-204, following successful Phase 3 results of its predecessor RHB-104. The new study will be the first to focus exclusively on MAP-positive CD patients, correlating mucosal healing with MAP infection eradication.

RHB-204, patent-protected until 2041, is an improved formulation with 40% reduced pill burden, designed to enhance tolerability and adherence. The previous RHB-104 Phase 3 study demonstrated a statistically significant 64% improvement in efficacy versus standard of care, with superior remission rates from week 16 through week 52.

The planned Phase 2 study will utilize novel endpoints and imaging techniques, with FDA guidance expected in Q2/25. The CD market is projected to grow from $13.6 billion in 2024 to $19.1 billion by 2033 across major markets. The company is actively pursuing partnerships and non-dilutive funding sources for this program.

RedHill Biopharma (NASDAQ: RDHL) presented a comprehensive business update at the Sachs' European Life Sciences CEO Forum, highlighting significant developments. The company announced an out-licensing deal with Hyloris for RHB-102, potentially worth $60 million plus royalties. Additionally, they initiated a Bayer-funded Phase 2 study of opaganib with darolutamide for advanced prostate cancer.

Notable progress with Talicia® includes: surpassing 100,000 prescriptions while maintaining its position as the #1 brand prescribed by gastroenterologists; Humana® Part D Plan coverage expansion adding 8+ million Medicare lives; inclusion as a first-line treatment option in ACG Clinical Guidelines; and FDA approval for more convenient three-times daily dosing. The company is also exploring new markets, with recent launch in UAE and ongoing evaluations for additional marketing authorizations.

RedHill Biopharma has licensed RHB-102 (Bekinda®) to Hyloris Pharmaceuticals for commercialization worldwide excluding North America. The deal includes an upfront payment and up to $60 million in potential milestone payments, plus up to mid-20s percent royalties on revenues.

RHB-102 is a once-daily, extended-release oral tablet formulation of ondansetron in development for multiple indications. The UK MHRA has provided a clear pathway for a Marketing Authorization Application, potentially making it the first oral 24-hour extended-release ondansetron for treating chemotherapy/radiotherapy-induced nausea and vomiting.

RedHill will continue development for FDA approval in the U.S., while Hyloris handles development, regulatory and commercialization activities in its territories. The global antiemetics market was valued at approximately $7.5 billion in 2023 with expected growth at 6% CAGR through 2030.

RedHill Biopharma has initiated a Phase 2 clinical study evaluating opaganib combined with Bayer's darolutamide for metastatic castrate-resistant prostate cancer (mCRPC). The 80-patient placebo-controlled study, financially supported by Bayer and Ramsay Hospital Research Foundation, will be led by Professor Lisa Horvath from Chris O'Brien Lifehouse and ANZUP.

The study will use a companion lipid biomarker test (PCPro) to select mCRPC patients with poor prognosis from standard treatment. The primary endpoint is improved 12-month radiographic progression-free survival. The research aims to overcome resistance to standard androgen receptor pathway inhibition treatment.

Prostate cancer, the second most diagnosed cancer globally with 1.5 million new cases annually and 400,000 deaths, represents a $12 billion market. The study's approach of developing therapeutic combinations with the PCPro biomarker is unique in metabolic targeting for metastatic prostate cancer.