Redhill Biopharm Stock Price, News & Analysis

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.

RedHill Biopharma (Nasdaq: RDHL) announced two significant developments for its H. pylori treatment Talicia®. First, Humana's Part D Plan now covers Talicia, providing access to over 8 million additional Medicare beneficiaries without requiring prior therapeutic steps or authorization, effective January 1, 2025.

Additionally, new data published in The Journal of Clinical Pharmacology supports Talicia's FDA-approved label change to a more convenient three-times daily (TID) dosing schedule with meals. The study demonstrated pharmacokinetic equivalence between the new TID regimen and the previous every 8-hour (Q8H) dosing schedule.

Talicia continues to be the most prescribed branded H. pylori therapy by U.S. gastroenterologists and is listed as a first-line treatment option in the updated American College of Gastroenterology Clinical Guideline.

RedHill Biopharma (Nasdaq: RDHL) announced positive results from new in vivo studies of opaganib for treating gastrointestinal acute radiation syndrome (GI-ARS). The studies were conducted under the U.S. government's Radiation and Nuclear Countermeasures Program (RNCP) contract and confirmed opaganib's protective activity.

The company is in discussions with the National Institute of Allergy and Infectious Diseases (NIAID) regarding the next development phase following the FDA's Animal Rule pathway. Opaganib, an oral small molecule with a five-year shelf-life, is being developed as a potential medical countermeasure for GI-ARS, for which there are currently no approved therapies.

RedHill Biopharma has been awarded approximately $8 million plus costs in a summary judgment by the New York Supreme Court in its legal proceedings against Kukbo Co. The amount consists of $6.5 million plus interest of approximately $1.5 million. The case involves Kukbo's failure to make agreed payments to RedHill under a Subscription Agreement from October 25, 2021, and an Exclusive License Agreement from March 14, 2022. The Court dismissed all of Kukbo's counterclaims. Kukbo retains the right to seek an appeal of the judgment.

RedHill Biopharma (Nasdaq: RDHL) has been selected to present its drug opaganib at the JPEO-CBRND's 'Host Directed Therapeutics Industry Day' on October 29-30, 2024, in Alexandria, VA. The selection was based on the drug's demonstrated capabilities in prophylaxis and treatment of exposure to viruses, bacteria, and toxins.

The JPEO-CBRND, which manages U.S. government investments in chemical, biological, radiological, and nuclear defense equipment and medical countermeasures, will host the presentation. Opaganib, a novel host-directed oral drug, is being developed for various applications including oncology, viral infections, inflammatory diseases, and chemical/nuclear protection, with multiple ongoing U.S. government collaborations.