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Redhill Biopharma Ltd. - RDHL STOCK NEWS

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.

News

RedHill Biopharma Regains Compliance with Nasdaq Minimum Bid Price Requirement

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RedHill Biopharma Ltd. (Nasdaq: RDHL) has announced that it has regained compliance with the minimum bid price requirement under Nasdaq Listing Rule 5450(a)(1) for continued Nasdaq listing. The company maintained a minimum closing bid price of $1.00 or more for at least 10 consecutive trading days, achieving compliance on December 8, 2023. This comes after previously receiving notification that the bid price for the American Depositary Shares (ADSs) had closed below the minimum $1.00 per share requirement for continued listing.
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RedHill Announces New, Non-Dilutive External Funding of Entire RHB-107 COVID-19 300-Patient Phase 2 Study

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RedHill Biopharma Ltd. (RDHL) announces new non-dilutive external funding of approximately $4.8M to cover the RHB-107 arm of the ACESO PROTECT adaptive platform trial for early COVID-19 outpatient treatment. The Phase 2 RHB-107 arm has received FDA clearance to start and is estimated to be completed by the end of 2024. RHB-107 showed a 100% reduction in hospitalization due to COVID-19 in a U.S. Phase 2 study, with a 88% reduction in new severe COVID-19 symptoms and a faster recovery period. The study will compare investigational products to control in non-hospitalized adult SARS-CoV-2 infected participants with at least two moderate-severe symptoms at baseline.
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RedHill Biopharma Announces FDA Grant of 5-Year U.S. Market Exclusivity for Talicia® with IP Protection Running to 2034

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RedHill Biopharma Ltd. (RDHL) has announced that the U.S. FDA has granted five years' market exclusivity for Talicia under the Generating Antibiotic Incentives Now (GAIN) Act Qualified Infectious Disease Product (QIDP) designation, in addition to three years' exclusivity granted for the approval of Talicia under section 505(b)(2). Talicia is protected by its broad intellectual property suite to 2034. Talicia is the leading branded first-line therapy prescribed by U.S. gastroenterologists for the eradication of H. pylori, a bacterial infection that affects approximately 35% of the U.S. adult population.
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RedHill Biopharma Announces the Transfer of its Listing to The Nasdaq Capital Market

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RedHill Biopharma Ltd. (Nasdaq: RDHL) has received approval from Nasdaq to transfer the listing of the American Depositary Shares (ADSs) to the Nasdaq Capital Market. The transfer will take place on November 15, 2023, with trading unaffected and continuing under the same ticker symbol of 'RDHL.' The transfer follows a delisting notification due to non-compliance with the minimum Market Value of Publicly Held Shares (MVPHS) requirement.
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RedHill and U.S. Army Announce Opaganib's Ebola Virus Disease Survival Benefit in U.S. Army-Funded In-Vivo Study

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RedHill Biopharma's oral opaganib shows statistically significant increase in survival time in a U.S. Army-funded Ebola virus study, making it the first host-directed molecule to show activity in Ebola virus disease. Opaganib has also demonstrated antiviral benefit in late-stage clinical studies of COVID-19 patients. Promising potential for treating infectious viral diseases.
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RedHill Biopharma Announces Receipt of Nasdaq Notification Regarding Minimum Bid Price Deficiency

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RedHill Biopharma received a letter from Nasdaq indicating that its bid price for ADSs closed below the minimum $1.00 per share requirement for continued listing. The company has 180 days to regain compliance. If not, it may be eligible for an additional 180-day period. RedHill also received a notification for not complying with the minimum market value of publicly held shares requirement.
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RedHill Announces FDA sNDA Approval for Talicia®

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FDA approves sNDA for Talicia, changing dosing to a simplified TID regimen, improving patient adherence
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RedHill Announces New USPTO Notice of Patent Allowance for Opaganib and EU Patent Grant for RHB-102 (BEKINDA®)

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USPTO issues Notice of Allowance for new opaganib patent for Ebola treatment, providing protection until Oct 2035. European Patent Office grants new RHB-102 patent for nausea, vomiting, and diarrhea treatment, protection until Mar 2035.
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RedHill Biopharma Provides H1/23 Financial Results and Operational Highlights

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RedHill Biopharma reports H1/23 Talicia net revenues of $5.1 million and cash balance of $16.3 million as of June 30, 2023
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RedHill Biopharma Announces Talicia Approved in the United Arab Emirates and First Commercial Order Outside the U.S.

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RedHill's partner, Gaelan Medical, has received marketing approval from the UAE Ministry of Health for Talicia, a rifabutin-containing all-in-one oral capsule to treat H. pylori. Talicia is the leading first-line therapy prescribed by U.S. gastroenterologists for H. pylori eradication. The approval makes Talicia the first rifabutin-containing combination product for H. pylori in the UAE.
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FAQ

What is the current stock price of Redhill Biopharma Ltd. (RDHL)?

The current stock price of Redhill Biopharma Ltd. (RDHL) is $6.5 as of December 20, 2024.

What is the market cap of Redhill Biopharma Ltd. (RDHL)?

The market cap of Redhill Biopharma Ltd. (RDHL) is approximately 8.1M.

What does RedHill Biopharma Ltd. specialize in?

RedHill Biopharma specializes in the development and commercialization of therapeutics for gastrointestinal and infectious diseases.

What are RedHill's main commercial products?

RedHill's main commercial products are Talicia® for Helicobacter pylori infection and Aemcolo® for travelers' diarrhea.

What is Opaganib, and what are its potential uses?

Opaganib is an investigational drug targeting SPHK2 with potential uses in pandemic preparedness, oncology, and radioprotection.

What stage is RHB-107 currently in?

RHB-107 is in late-stage development, specifically a 300-patient Phase 2 adaptive platform trial for non-hospitalized symptomatic COVID-19.

What recent achievements has RedHill Biopharma accomplished?

Recent achievements include new patents for Talicia® and Opaganib and successful pre-clinical study results for Opaganib's use against Ebola and radiation exposure.

How is RedHill Biopharma's financial performance?

For the year ending December 31, 2023, RedHill reported net revenues of $6.5 million and a gross profit of $3.1 million, with a significant reduction in liabilities.

What is the strategic direction of RedHill Biopharma?

RedHill is focusing on leveraging its robust pipeline and strategic partnerships to address unmet medical needs in gastrointestinal and infectious diseases.

Who are RedHill Biopharma's development partners?

RedHill collaborates with various entities including the U.S. National Institutes of Health and the U.S. Department of Defense for its development programs.

What is the significance of RedHill's new patents?

The new patents enhance RedHill's intellectual property portfolio, providing extended protection for its key products and potential new treatments.

Where can more information about RedHill Biopharma be found?

More information can be found on the company's website at www.redhillbio.com and their Twitter page at twitter.com/RedHillBio.

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Redhill Biopharma Ltd.

Nasdaq:RDHL

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8.08M
1.28M
5.9%
0.53%
Drug Manufacturers - Specialty & Generic
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Tel Aviv