6-K - RedHill Biopharma Ltd. (0001553846) (Filer)

6-K - RedHill Biopharma Ltd. (0001553846) (Filer)

6-K - RedHill Biopharma Ltd. (0001553846) (Filer)

6-K - RedHill Biopharma Ltd. (0001553846) (Filer)

6-K - RedHill Biopharma Ltd. (0001553846) (Filer)

6-K - RedHill Biopharma Ltd. (0001553846) (Filer)

6-K - RedHill Biopharma Ltd. (0001553846) (Filer)

6-K - RedHill Biopharma Ltd. (0001553846) (Filer)

6-K - RedHill Biopharma Ltd. (0001553846) (Filer)

6-K - RedHill Biopharma Ltd. (0001553846) (Filer)

-       Dr. Almenoff brings more than 25 years of drug development and leadership experience to the Actinium Board of Directors   -       Dr. Almenoff to join Actinium's Nominating and Corporate Governance Committee NEW YORK, Nov. 4, 2024 /PRNewswire/ -- Actinium Pharmaceuticals, Inc. (NYSE:ATNM) (Actinium or the Company), a leader in the development of Antibody Radiation Conjugates (ARCs) and other targeted radiotherapies, today announced the appointment of June Almenoff, M.D., Ph.D. to its Board of Directors. Dr. Almenoff is an accomplished biopharma executive with over 25 years of senior leadership and drug development experience. She currently serves as a Board Director and advisor to nu

RedHill has been selected to provide a presentation to further elaborate on opaganib's potential to U.S. government representatives at the Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense's (JPEO-CBRND) "Host Directed Therapeutics Industry Day" -- Based on reviews, feedback, and discussion, the judges selected for presentation those therapeutics that demonstrated capability in the prophylaxis, post-exposure prophylaxis, and the treatment of exposure to viruses, bacteria and toxins. The meeting is scheduled to take place October 29-30, 2024, at the United States Patent and Trademark Office in Alexandria, VA -- The JPEO-CBRND manages U.S. government inv

The collaboration outlines plans for multiple in vivo studies, designed to test opaganib as a potential medical countermeasure to treat phosgene inhalation injury. The collaboration aims to determine whether opaganib can advance into further definitive U.S. government-sponsored development under the FDA's Animal Rule pathway to approval Used as a chemical weapon during World War I, phosgene, a toxic, colorless chemical, is today widely used in industrial processes for the manufacture of plastics and pesticides. The U.S. Environmental Protection Agency (EPA) identified 123 sites in the United States that could potentially expose millions of people to phosgene due to plant malfunction or biote

The U.S. government's Biomedical Advanced Research and Development Authority (BARDA) selected opaganib for joint development & funding as a medical countermeasure (MCM) to treat Ebola virus disease (EBOV)--The funding advances opaganib's positive development progress to date on the expected FDA Animal Rule pathway toward potential approval as an MCM for EBOV--Recent U.S. Army-funded studies showed that opaganib delivered a statistically significant increase in survival in an in vivo EBOV model. The BARDA research and development contract provides initial funding for the collaboration, in pursuit of advancing opaganib to mitigate infection and contain EBOV outbreaks--This year marks the 10th

Medi-Cal, California's Medicaid healthcare program, and RedHill have renewed their contract to maintain Talicia's first-line position on the Medi-Cal Fee-For-Service (FFS) Contract Drug List (CDL) with no prior authorization and a $0 copay – a major benefit for approximately fifteen million Californian Medi-Cal patients -- The renewed terms reflect both parties' ongoing commitment to improving patient access and outcomes, reinforcing Talicia's role as an essential treatment option, and follow the new American College of Gastroenterology (ACG) Clinical Guideline1 for H. pylori infection, listing Talicia as an empirically prescribed first-line option -- Talicia's convenient all-in-one three-ti

New U.S. patent issued covering the identification of a novel biomarker of coronavirus pneumonia (≤60% fraction of inspired oxygen (FiO2)) prognostic for potential opaganib efficacy in treating COVID-19, valid through 204 Published post-hoc data from opaganib's Phase2/3 study showed that patients with ≤60% FiO2 levels had better outcomes after 14 days' opaganib treatment (n=117) compared to placebo (n=134), including: increased number of patients no longer requiring supplemental oxygen by day 14 of opaganib treatment (76.9% vs. 63.4%; p-value =0.033), a 62.6% reduction in intubation/mechanical ventilation (6.84% vs. 17.91%; p-value=0.012) and a clinically meaningful 62% reduction in mortalit

First new American College of Gastroenterology (ACG) Clinical Guideline[1] for H. pylori infection since Talicia's approval lists Talicia as an empirically prescribed first-line option Talicia's convenient all-in-one three times daily (TID) formulation offers a simplified patient experience, supporting high rates of eradication without needing prior resistance testing Talicia is the leading branded first-line therapy prescribed by U.S. gastroenterologists[2] for H. pylori infection, which affects approximately 35% of the U.S. adult population[3] Worldwide, around 66% of the population has H. pylori infection[4], which is classified by the World Health Organization (WHO) as a Group 1 carcinog

TEL AVIV, Israel and RALEIGH, N.C., Sept. 5, 2024 /PRNewswire/ -- RedHill Biopharma Ltd. (NASDAQ:RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today announced that it received confirmation from the Listings Qualifications Department of The Nasdaq Stock Market LLC (the "Listings Qualifications Department") that the Company had regained compliance with the minimum bid price requirement under Nasdaq Listing Rule 5550(a)(2) for continued listing on The Nasdaq Capital Market ("Nasdaq"), and is now compliant with applicable listing standards for continued Nasdaq listing. To regain compliance with Nasdaq Listing Rule 5550(a)(2), the Company was required to maintain a mi

Data, from a post hoc analysis of the randomized, placebo-controlled, double-blind phase 2/3 study of oral opaganib in COVID-19 pneumonia, showing a 62% reduction in mortality and a 21% improvement in time to room air (no longer needing supplemental oxygen), has been newly published in the peer-reviewed journal, Microorganisms The analysis, from a large sub-group of 251 hospitalized, moderately severe COVID-19 patients requiring a fraction of inspired oxygen (FiO2) up to and including 60%, also indicates that FiO2 of greater than 60% may represent a threshold level for disease severity, and may potentially be a patient selection biomarker, an important finding for future therapeutic strateg

A transformed RedHill: Numerous potential catalystsStrengthened cash balance and control over our destiny following the Termination Agreement with Movantik Acquisition Co. and others: Executing on our plan to ensure a value-driven focus, operational efficiency and financial streamlining with a low cost-baseU.S. government collaborations: Developing a promising, advancing and largely financially de-risked pipeline via U.S. government and other collaborationsAddressing substantial and underserved indications: In oncology viral pandemic preparedness, nuclear/radioprotection, and obesity/diabetesBuilding value: In the lab and in the clinic through new studies, generating new intellectual propert

-       Dr. Almenoff brings more than 25 years of drug development and leadership experience to the Actinium Board of Directors   -       Dr. Almenoff to join Actinium's Nominating and Corporate Governance Committee NEW YORK, Nov. 4, 2024 /PRNewswire/ -- Actinium Pharmaceuticals, Inc. (NYSE:ATNM) (Actinium or the Company), a leader in the development of Antibody Radiation Conjugates (ARCs) and other targeted radiotherapies, today announced the appointment of June Almenoff, M.D., Ph.D. to its Board of Directors. Dr. Almenoff is an accomplished biopharma executive with over 25 years of senior leadership and drug development experience. She currently serves as a Board Director and advisor to nu

HC Wainwright & Co. reiterated coverage of Redhill Biopharma with a rating of Buy and set a new price target of $21.00 from $23.00 previously

Cantor Fitzgerald initiated coverage of Redhill Biopharma with a rating of Overweight and set a new price target of $22.00

WBB Securities downgraded Redhill Biopharma from Strong Buy to Buy and set a new price target of $16.00 from $17.00 previously

HC Wainwright & Co. initiated coverage of Redhill Biopharma with a rating of Buy and set a new price target of $23.00

Targeting positive cash from operations to start during H2/22[1] Focus on earlier achievement of operational profitability thanks to a recently implemented comprehensive cost reduction plan, with expected operational cost savings of approximately $50 million over the next 18 months Continuous implementation of disciplined cost controls reduced Q1/22 cash used in operating activities by more than 70% to approximately $4 million, compared to approximately $15 million in Q4/21 Net revenues of $18.2 million in Q1/22; Cash balance[2] of $45 million as of March 31, 2022 Talicia® TRx up 12.8% over Q4/21 and Movantik® continues strong Q4/21 prescription performance Amendment improves key covenants i

TEL AVIV, Israel and RALEIGH, N.C., June 17, 2022 /PRNewswire/ -- RedHill Biopharma Ltd. (NASDAQ:RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today announced that it will report its first quarter 2022 financial results and operational highlights on Thursday, June 23, 2022. The Company will host a conference call and webcast on Thursday, June 23, 2022, at 8:30 a.m. EDT, during which it will present key highlights for the first quarter of 2022. The webcast including slides will be broadcast live on the Company's website, https://ir.redhillbio.com/ev

TEL AVIV, Israel and RALEIGH, N.C., March 17, 2022 /PRNewswire/ -- RedHill Biopharma Ltd. (NASDAQ:RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today reported its operational highlights and financial results for the fourth quarter and full year ended December 31, 2021. Dror Ben-Asher, RedHill's Chief Executive Officer, said: "In 2021, RedHill's team delivered record revenues against a pandemic backdrop, overall contribution of commercial operations to the company was positive for the first time in Q4/21 and positive late-stage clinical data for two novel oral COVID-19 drugs. A very strong fourth quarter for both Talicia® and Movantik®, coupled with disciplined c

TEL AVIV, Israel and RALEIGH, NC, March 10, 2022 /PRNewswire/ -- RedHill Biopharma Ltd. (NASDAQ:RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today announced that it will report its fourth quarter and full year 2021 financial results and operational highlights on Thursday, March 17, 2022.     The Company will host a conference call and webcast on Thursday, March 17, 2022, at 8:30 a.m. EDT, during which it will present key highlights for the fourth quarter and full year of 2021. The webcast including slides will be broadcast live on the Company's website, https://ir.redhillbio.com/events, and will be available for replay for 30 days.   To participate in the confer

TEL AVIV, Israel and RALEIGH, N.C., Nov. 24, 2021 /PRNewswire/ -- RedHill Biopharma Ltd. (NASDAQ:RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today announced that it will report its third quarter 2021 financial results and operational highlights on Tuesday, November 30, 2021. The Company will host a webcast on Tuesday, November 30, 2021, at 8:30 a.m. EST, during which it will present key highlights for the third quarter of 2021. The webcast including slides will be broadcast live on the Company's website, https://ir.redhillbio.com/events, and will be available for replay for 30 days.   To participate in the conference call, please dial one of the following num

62% statistically significant reduction in mortality shown for moderately severe COVID-19 patients group treated with opaganib vs. the placebo-controlled arm (7 deaths in the 117-patient opaganib arm vs. 21 deaths in the 134-patient placebo arm; nominal p-value=0.019)21% statistically significant efficacy benefit with opaganib in reaching room air by Day 14, the study primary endpoint (77% of opaganib patients vs 63.5% on placebo; nominal p-value=0.033)A median four days earlier hospital discharge for opaganib-treated patients vs. placebo (10 days for opaganib arm vs. 14 days for placebo) a cumulative saving of 524 days of hospitalization across the group by Day 42 (nominal p-value=0.0195)Th

TEL AVIV, Israel and RALEIGH, N.C., Oct. 4, 2021 /PRNewswire/ -- RedHill Biopharma Ltd. (NASDAQ:RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today reported new data from the opaganib global Phase 2/3 study in hospitalized patients with severe COVID-19 pneumonia showing that treatment with oral opaganib (ABC294640)[1] vs. the placebo-controlled arm resulted in a 62% statistically significant reduction in mortality as well as statistically significant improved outcomes in time to room air and median time to hospital discharge in a group of 251 hospitalized, moderately severe COVID-19 patients, comprising 53% of the 475 study participants.     These important new

Achieved record quarterly revenues of $21.5 million for Q2/2021, 4.5% increase from Q1/2021 despite challenging market conditions; Cash balance[1] of approximately $71.5 million as ofJune 30, 2021Record Talicia® quarterly prescription volume up more than 10%; Movantik® quarterly new prescriptions up 5.6%; Talicia and Movantik coverage expanded to 8 and 9 out of 10 commercially insured Americans, respectivelyOpaganib in final stages of selection by Quantum Leap Healthcare Collaborative and BARDA for inclusion in the I-SPY COVID-19 platform trial with funding provided by BARDANew preclinical data supports opaganib's potent inhibition of Delta COVID-19 variantTop-line results from global Phase

TEL AVIV, Israel and RALEIGH, N.C., Aug. 26, 2021 /PRNewswire/ -- RedHill Biopharma Ltd. (NASDAQ:RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today reported its financial results and operational highlights for the second quarter ended June 30, 2021. Dror Ben-Asher, RedHill's Chief Executive Officer, said: "We have achieved important progress across the board this quarter. Opaganib is one of the leading drug candidates in the race to develop an effective COVID-19 therapeutic pill. New data further supports opaganib's potent inhibition of SARS-CoV-2 variants of concern, including the rapidly spreading Delta variant. The upcoming Phase 2/3 top-line data could tell

TEL AVIV, Israel and RALEIGH, NC, Aug. 19, 2021 /PRNewswire/ -- RedHill Biopharma Ltd. (NASDAQ:RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today announced that it will report its second quarter 2021 financial results and operational highlights on Thursday, August 26, 2021. The Company will host a webcast on Thursday, August 26, 2021, at 8:30 a.m. EDT, during which it will present key highlights. The webcast including slides will be broadcast live on the Company's website, https://ir.redhillbio.com/events, and will be available for replay for 30 days.   To participate in the conference call, please dial one of the following numbers 15 minutes prior to the star

In addition, the Agreement ends all existing credit ties with the Agreement parties, removes the existing lien against Talicia® and restores control over cash collections back to RedHill.

RedHill Biopharma Ltd. (NASDAQ:RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today announced the mutual decision with Cosmo Technologies Ltd. ("Cosmo") to voluntary terminate their exclusive U.S. license agreement for Aemcolo, a treatment for traveler's diarrhea (the "License Agreement"). The License Agreement, initially dated October 17, 2019, will be officially terminated on October 8, 2024.

Gainers Nexalin Technology (NASDAQ:NXL) shares rose 55.8% to $1.62 during Tuesday's after-market session. The market value of their outstanding shares is at $12.0 million. Dynatronics (NASDAQ:DYNT) stock rose 14.74% to $0.4. The company's market cap stands at $2.1 million. Oncology Institute (NASDAQ:TOI) shares moved upwards by 10.8% to $0.45. The market value of their outstanding shares is at $33.5 million. SAB Biotherapeutics (NASDAQ:SABS) stock rose 8.94% to $2.8. The market value of their outstanding shares is at $25.8 million. Bone Biologics (NASDAQ:BBLG) shares moved upwards by 8.04% to $1.61. The company's market cap stands at $1.7 million. Virpax Pharmaceuticals (NASDAQ:VRPX) s

https://patentcenter.uspto.gov/applications/17900235/ifw/docs

RedHill Biopharma Ltd. (NASDAQ:RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today announced the issue of a new Chinese patent Notice of Allowance covering opaganib[1] as a therapyg for inhibition of single-stranded RNA virus replication (notably Ebola Disease Virus) from the Chinese National Intellectual Property Administration (CNIPA), valid through 2035 (Chinese Patent Application No.: 202110229970.9 issued April 29, 2024).