Redhill Biopharm - RDHL STOCK NEWS

RedHill Biopharma (Nasdaq: RDHL) has renewed its contract with Medi-Cal, California's Medicaid healthcare program, to maintain Talicia's first-line position on the Medi-Cal Fee-For-Service (FFS) Contract Drug List with no prior authorization and a $0 copay. This renewal, effective October 1, 2024, benefits approximately 15 million Californian Medi-Cal patients.

The agreement follows the new American College of Gastroenterology (ACG) Clinical Guideline for H. pylori infection, which lists Talicia as an empirically prescribed first-line option. Talicia's all-in-one three-times daily formulation offers a simplified patient experience, supporting high rates of H. pylori eradication without requiring prior resistance testing. It remains the most prescribed branded H. pylori therapy by U.S. gastroenterologists.

RedHill Biopharma (Nasdaq: RDHL) has announced the issuance of a new U.S. patent for opaganib, valid through 2041. The patent covers the identification of a novel biomarker of coronavirus pneumonia (≤60% fraction of inspired oxygen (FiO2)) prognostic for potential opaganib efficacy in treating COVID-19.

Post-hoc data from opaganib's Phase 2/3 study showed that patients with ≤60% FiO2 levels had better outcomes after 14 days of treatment compared to placebo, including:

• Increased number of patients no longer requiring supplemental oxygen (76.9% vs. 63.4%; p-value=0.033)
• 62.6% reduction in intubation/mechanical ventilation (6.84% vs. 17.91%; p-value=0.012)
• 62% reduction in mortality by day 42 (5.98% vs. 16.7%; p-value=0.019)

Opaganib is being developed for various indications, including oncology, viral infections, inflammatory diseases, and nuclear/radioprotection.

RedHill Biopharma (Nasdaq: RDHL) announced that its product Talicia® has been listed as a first-line choice for treating H. pylori infection in the new American College of Gastroenterology (ACG) Clinical Guideline. This is significant as it's the first update since Talicia's approval. Talicia offers a convenient all-in-one formulation taken three times daily, supporting high eradication rates without prior resistance testing.

Talicia is currently the leading branded first-line therapy prescribed by U.S. gastroenterologists for H. pylori, which affects about 35% of U.S. adults. Globally, H. pylori infects around 66% of the population and is classified as a Group 1 carcinogen by the WHO, being the strongest known risk factor for gastric cancer.

RedHill Biopharma (Nasdaq: RDHL) has successfully regained compliance with Nasdaq's minimum bid price requirement. The company received confirmation from the Nasdaq Listings Qualifications Department that it has met the necessary criteria for continued listing on The Nasdaq Capital Market. To achieve compliance, RedHill was required to maintain a minimum closing bid price of $1.00 per share for its American Depositary Shares (ADSs) for at least 10 consecutive business days. This milestone was reached on September 3, 2024, ensuring RedHill's continued presence on the Nasdaq exchange.

RedHill Biopharma (Nasdaq: RDHL) has announced the publication of data from a post-hoc analysis of its phase 2/3 study of opaganib in COVID-19 pneumonia. The analysis, published in the journal Microorganisms, showed a 62% reduction in mortality and a 21% improvement in time to room air in a subgroup of 251 hospitalized patients requiring FiO2 ≤60%. The study also suggests that FiO2 >60% may represent a threshold for disease severity and could potentially serve as a patient selection biomarker. With 30,000 Americans dead due to COVID-19 so far this year, RedHill emphasizes the continued need for effective and safe therapies. Opaganib, an orally administered drug, has demonstrated safety and efficacy profiles in various indications, including viral infections and inflammatory diseases.

RedHill Biopharma (Nasdaq: RDHL) reported its first half 2024 financial results and operational highlights. The company has transformed with a strengthened cash balance, streamlined operations, and a focus on U.S. government collaborations for developing its pipeline. Key highlights include:

- Cash balance of $8.2 million as of June 30, 2024

- Net revenues of $2.6 million for H1 2024

- Talicia maintained leadership position as the top prescribed branded H. pylori therapy in the U.S.

- Advancing opaganib and RHB-107 in U.S. government-supported programs for various indications including Ebola, COVID-19, and radiation protection

- Cost reduction measures resulted in improved operating loss and net loss compared to H1 2023

- Post-balance sheet, RedHill signed a Global Termination Agreement, receiving $9.9 million in cash and reducing net liabilities by approximately $2.3 million

RedHill Biopharma (Nasdaq: RDHL) has announced that the FDA has granted orphan-drug designation to opaganib for the treatment of neuroblastoma, a rare childhood cancer. This designation provides seven years of marketing exclusivity if approved and may offer additional benefits such as accelerated development and review times, potential grant funding, and tax credits.

Neuroblastoma accounts for up to 10% of childhood cancer cases and 15% of pediatric cancer-related deaths in the U.S. The neuroblastoma market is expected to reach nearly $1.5 billion before the mid-2030s. This is the second orphan drug designation for opaganib in oncology, following its designation for cholangiocarcinoma. Opaganib is being developed for multiple indications, including COVID-19, Ebola, and acute respiratory distress syndrome.

RedHill Biopharma has launched Talicia, the first approved low-dose rifabutin-containing combination treatment for H. pylori, in the United Arab Emirates (UAE). This launch triggers RedHill's eligibility for additional potential milestone payments, minimum sales payments, and tiered royalties up to mid-teens on net sales.

Talicia is now available by prescription to treat adults with H. pylori infection in the UAE, where 41% of the population is affected. The drug is designed to address the declining effectiveness of clarithromycin-based therapies, which have shown eradication rates as low as 32% in patients with resistant H. pylori strains.

As the leading branded first-line therapy prescribed by U.S. gastroenterologists for H. pylori treatment, Talicia's launch in the UAE represents a significant step in addressing this major public health concern and expanding RedHill's global market presence.

RedHill Biopharma (Nasdaq: RDHL) has announced positive results from multiple in vivo studies showing the impact of opaganib, a sphingosine kinase-2 (SPHK2) inhibitor, on weight gain and glucose tolerance in a high fat diet (HFD) model. The studies support the potential clinical use of opaganib for the prevention and therapy of Type 2 diabetes and other obesity-related disorders.

Opaganib's ability to modulate multiple signaling pathways through simultaneous inhibition of three sphingolipid-metabolizing enzymes in human cells provides a strong rationale for its evaluation in obesity-related disorders. The studies showed that opaganib therapy suppressed HFD-induced body weight gain, loss of glucose tolerance, and fat deposition. It also reduced weight gain and restored glucose tolerance in an already obese HFD model.

The global obesity-diabetes drugs market is projected to be worth around $100 billion by 2034, driven by GLP-1 inhibitors and SGLT2 inhibitors.