Welcome to our dedicated page for Redhill Biopharma Ltd. news (Ticker: RDHL), a resource for investors and traders seeking the latest updates and insights on Redhill Biopharma Ltd. stock.
RedHill Biopharma Ltd. (NASDAQ: RDHL) is a specialty biopharmaceutical company centered on gastrointestinal and infectious diseases. The company is headquartered in Israel and operates internationally, with teams in the U.S., Canada, and Europe. RedHill's primary focus is the development and commercialization of late-stage clinical therapeutics and patented reformulations of existing drugs.
Core Business and Products
RedHill's flagship commercial products in the U.S. include Talicia® (omeprazole, amoxicillin, and rifabutin) for treating Helicobacter pylori (H. pylori) infection in adults, and Aemcolo® (rifamycin) for treating travelers' diarrhea. Talicia® is unique as the only FDA-approved rifabutin-containing therapy optimized for H. pylori eradication, addressing the rising concern of antibiotic resistance.
Key Development Programs
- Opaganib (ABC294640): A first-in-class oral SPHK2 inhibitor with applications in pandemic preparedness, oncology, and radioprotection. It is undergoing trials for multiple indications including Acute Radiation Syndrome (ARS) and COVID-19, and has shown promising results in pre-clinical studies against Ebola.
- RHB-107 (upamostat): An oral broad-acting, host-directed serine protease inhibitor targeting non-hospitalized symptomatic COVID-19, supported by U.S. Department of Defense funding in a 300-patient Phase 2 trial. It also shows potential for cancer and inflammatory gastrointestinal diseases.
- RHB-102: A novel therapy for chemotherapy and radiotherapy-induced nausea and vomiting, with positive Phase 3 results for acute gastroenteritis.
- RHB-104: Demonstrated efficacy in a Phase 3 study for Crohn's disease.
- RHB-204: In Phase 3 development for pulmonary nontuberculous mycobacteria (NTM) disease.
Recent Achievements
Recent publications highlight Opaganib's efficacy in enhancing long-term survival in radiation exposure models, and its selection by the U.S. NIH for the Radiation and Nuclear Countermeasures Program. Additionally, the company secured a new U.S. patent for Talicia®, extending its protection until 2034, and obtained a new Chinese patent for Opaganib in combination with immune checkpoint inhibitors, valid through 2040.
Financial Performance
For the year ending December 31, 2023, RedHill reported net revenues of $6.5 million, primarily from Talicia®, with a gross profit of $3.1 million. The company has reduced its liabilities significantly following the divestiture of Movantik, and its financial health is bolstered by ongoing U.S. government funding for key R&D programs.
Strategic Direction
RedHill is focused on leveraging its solid pipeline and partnerships to address unmet medical needs in gastrointestinal and infectious diseases. The company is strategically positioned to benefit from growing geopolitical and health threats, aiming to provide innovative solutions in challenging healthcare environments.
RedHill Biopharma (Nasdaq: RDHL) announced its compliance with Nasdaq Listing Rule 5450(a)(1) on April 11, 2023, after maintaining a minimum bid price of $1.00 for ten consecutive trading days, achieving this on April 5, 2023. Previously, on October 12, 2022, RedHill was notified of non-compliance due to its American Depositary Shares (ADSs) closing below the $1.00 requirement. This recent compliance confirms its eligibility for continued listing on Nasdaq, which is crucial for maintaining investor confidence and market access.
RedHill is focused on gastrointestinal and infectious diseases, promoting drugs such as Talicia® and Aemcolo®. Ongoing late-stage clinical developments include studies for RHB-204 and RHB-107, targeting various health conditions.
The report titled "Global Royalty Rate Trends in Pharma and Biotech Dealmaking 2010-2023" has been released by ResearchAndMarkets.com. This comprehensive report offers insights into partnering deals in the pharmaceutical and biotechnology sectors, including details on technology licensed, royalty rates, license fees, and other payments. It covers all disclosed deals since 2010, providing essential data for prospective dealmakers. Key chapters analyze royalty rate trends, the structure of royalty clauses, and leading companies in the field. The report aims to equip readers with the necessary tools for effective negotiations and due diligence in licensing agreements.
On April 3, 2023, RedHill Biopharma (Nasdaq: RDHL) announced the closure of a registered direct offering, raising $6 million. The offering included 1,500,000 American Depositary Shares (ADSs) and series A and B warrants, with respective exercise prices of $4.75 and $4.00. The proceeds will be utilized for general working capital, acquisitions, and research and development. Additionally, existing warrants for 330,106 ADSs were amended to lower the exercise price to $4.75. H.C. Wainwright & Co. was the exclusive placement agent for this offering.
The Non-Cystic Fibrosis Bronchiectasis (NCFB) market is projected to grow significantly from USD 3.4 billion in 2022, driven by increased awareness and diagnosis of the condition. Current estimates indicate around 9.3 million diagnosed cases across the 7MM and China. Prominent companies, including AstraZeneca and CSL Behring, are developing innovative therapies, with several promising drugs in the pipeline, such as Brensocatib and Colistimethate sodium. Despite rising disease prevalence and improved diagnostic techniques, challenges remain, including a lack of standardized treatment guidelines and insufficient evidence for many interventions.
RedHill Biopharma (NASDAQ: RDHL) announced a definitive agreement for a registered direct offering of 1,500,000 American Depositary Shares (ADSs) at $4.00 each, expected to generate gross proceeds of $6 million. The offering includes series A and B warrants to purchase additional ADSs. The proceeds are earmarked for general working capital, acquisitions, research and development, and corporate purposes. The offering is expected to close on April 3, 2023. Additionally, existing warrants for 330,106 ADSs will be amended to reduce the exercise price to $4.75.
RedHill Biopharma has launched a pioneering warranty program for its Talicia H. pylori therapy, committing to reimburse out-of-pocket costs for patients who complete a 14-day treatment but do not achieve infection eradication. This initiative, applicable to both insured and non-insured patients, aims to enhance access to Talicia, which boasts a cure rate exceeding 90% in adherent populations. The program marks a first in community settings and seeks to address rising resistance to traditional therapies. Notably, Talicia is the leading prescribed option among U.S. gastroenterologists, indicating strong market positioning.
RedHill Biopharma (Nasdaq: RDHL) announced a change in the ratio of its American Depositary Shares (ADSs) to ordinary shares, shifting from 1:10 to 1:400. This is akin to a one-for-forty reverse split and will take effect on or about March 23, 2023. The Bank of New York Mellon will manage the conversion for ADS holders, with no action required on their part. This change aims to increase the ADS price and help meet Nasdaq's minimum bid price requirements, following a notification received on October 18, 2022. However, there is no guarantee that the anticipated price increase will occur.
RedHill Biopharma Ltd. (Nasdaq: RDHL) announced a private placement agreement with a single investor for a $6 million convertible promissory note. This issuance will convert into American Depositary Shares (ADS) and comes with warrants, potentially enhancing the company's capital structure. The funding will be disbursed in three tranches of $2 million, $1 million, and $3 million, with the first tranche available at closing. RedHill plans to use the proceeds for general working capital, acquisitions, and research and development. The warrants will have an exercise price of $0.21 and a three-year term.
RedHill Biopharma (Nasdaq: RDHL) has announced that its drug opaganib has been selected by the NIH's Radiation and Nuclear Countermeasures Program (RNCP) for testing as a potential treatment for Acute Radiation Syndrome (ARS). This collaboration aims to expedite the development of opaganib, a novel oral medication that may mitigate radiation damage. Following FDA guidance, the RNCP will validate opaganib's efficacy in preclinical animal models. Opaganib's mechanism involves reducing inflammatory damage and protecting hematopoietic stem cells from radiation exposure. The ongoing partnership could lead to its stockpiling for emergency use if approved.
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