Redhill Biopharma Ltd. - RDHL STOCK NEWS

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.

RedHill Biopharma (Nasdaq: RDHL) has announced plans to implement a ratio change for its American Depositary Shares (ADSs) on August 20, 2024. The new ratio will be 1 ADS representing 10,000 ordinary shares, compared to the current 1:400 ratio. This change will effectively result in a 1-for-25 reverse ADS split.

The company's ADSs will continue trading on the Nasdaq Capital Market under the symbol 'RDHL' with a new CUSIP Number. No new ADSs will be issued, and existing ADS holders will have their holdings automatically exchanged. Fractional new ADSs will be sold, with proceeds distributed to applicable holders.

This move aims to address RedHill's non-compliance with Nasdaq's minimum bid price requirements, as notified on March 14, 2024. While the company anticipates the ADS price will increase proportionally to meet Nasdaq's requirements, there is no guarantee of this outcome.

RedHill Biopharma (Nasdaq: RDHL) has announced positive Phase 3 data for RHB-104, a triple antimicrobial therapy targeting Mycobacterium avium subspecies paratuberculosis (MAP) in Crohn's disease. The study, published in the journal Antibiotics, showed that RHB-104 plus standard of care (SoC) was 64% more effective than SoC alone. The primary endpoint of clinical remission at week 26 was achieved in 36.7% of RHB-104 patients compared to 22.4% of placebo patients (p=0.0048). The safety profile was similar to placebo. This data supports the hypothesis of a Mycobacterial basis for Crohn's disease and opens a potential new avenue for treatment. The Crohn's disease market was valued at over $13 billion in 2023.

RedHill Biopharma (Nasdaq: RDHL) has announced a significant financial restructuring through a Global Termination Agreement with Movantik Acquisition Co., Valinor Pharma, , and HCR Redhill SPV, This agreement has resulted in:

1. A $9.9 million cash influx
2. Full control over an additional $0.74 million in a restricted account
3. An increase of $12.2 million in liabilities
4. A net balance sheet reduction of $2.3 million
5. Removal of the existing lien against Talicia®
6. Restoration of control over cash collections to RedHill

This restructuring aims to strengthen RedHill's cash position, enhance cash management, and allow the company to focus on R&D and commercial activities for future growth.

RedHill Biopharma (Nasdaq: RDHL) and Cosmo Technologies have mutually agreed to terminate their exclusive U.S. license agreement for Aemcolo, a treatment for traveler's diarrhea. The initial agreement, established on October 17, 2019, will end on October 8, 2024. RedHill will cease all commercialization efforts for Aemcolo upon termination, with all rights reverting to Cosmo. Rick Scruggs, Chief Commercial Officer of RedHill, expressed gratitude for the collaboration with Cosmo.

RedHill Biopharma announced a new Chinese patent that covers the use of opaganib in combination with immune checkpoint inhibitors (ICIs) to induce an anti-cancer immune response, valid until 2040. This patent, issued by the Chinese National Intellectual Property Administration, reinforces opaganib's potential across various approved and in-development ICIs for a growing number of indications. ICIs, pivotal in cancer treatment, are projected to contribute to a global market exceeding $100 billion by 2028. Opaganib, an oral small molecule with proven safety and efficacy, is also in development for COVID-19, Ebola, and other conditions.

RedHill Biopharma announced a new Chinese patent for opaganib as a therapy for inhibition of single-stranded RNA virus replication, specifically against Ebola Virus, valid through 2035. The patent strengthens opaganib's global intellectual property portfolio, with studies indicating its effectiveness in treating Ebola and potential synergistic effects in combination with remdesivir. Opaganib, a twice-daily oral small molecule, is being developed for multiple indications, including COVID-19, acute respiratory distress syndrome, oncology, and U.S. government-sponsored countermeasures programs. It has shown safety, efficacy, resistance to viral mutations, and ease of administration, positioning it well for various scenarios including viral pandemics.