Redhill Biopharm Stock Price, News & Analysis

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.

RedHill Biopharma (Nasdaq: RDHL) announced that the National Institutes of Health's Radiation and Nuclear Countermeasures Program has selected opaganib for testing as a potential treatment for Acute Radiation Syndrome (ARS). This collaboration aims to validate opaganib's efficacy in pre-clinical animal models under the RNCP contract. Following recent FDA guidance on the Animal Rule for opaganib, the company expects the collaboration to enhance its development program, potentially leading to FDA approval for use in radiological emergencies. Opaganib is an oral pill with a five-year shelf-life, designed for easy administration during such incidents.

RedHill Biopharma has announced a positive outcome from its pre-Marketing Authorisation Application (MAA) meeting with the UK Medicines & Healthcare products Regulatory Agency (MHRA) for its drug RHB-102 (BEKINDA). The drug aims to manage nausea and vomiting induced by chemotherapy and radiotherapy (CINV/RINV). The MAA submission is expected in the second half of 2023. If approved, RHB-102 could be the first oral 24-hour extended-release 5-HT3 antiemetic in the UK, addressing a significant market need, given that 70-80% of patients undergoing chemotherapy experience these symptoms. The global market for CINV/RINV is projected to exceed $10 billion by 2031.

RedHill Biopharma announced that the UK MHRA has given a positive opinion on RHB-102 (Bekinda) for treatment of chemotherapy and radiotherapy-induced nausea and vomiting (CINV/RINV). This feedback supports the planned submission of a UK Marketing Authorisation Application in the second half of 2023. If approved, RHB-102 could be the first oral 24-hour extended-release 5-HT3 antiemetic drug in the UK for CINV/RINV. The global market for CINV/RINV treatments is projected to exceed $10 billion by 2031, with significant growth expected in the UK.