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Redhill Biopharma Ltd

Redhill Biopharma Ltd (RDHL)

0.5652
-0.0508
(-8.25%)
Closed March 01 04:00PM
0.56
-0.0052
(-0.92%)
After Hours: 07:37PM

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RDHL News

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RDHL Discussion

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midastouch017 midastouch017 2 days ago
0.6200+0.0781 (+14.4123%)
As of 10:40AM EST. Market open.
Sparks of optimism?
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midastouch017 midastouch017 2 weeks ago
..... A lot of blah blah. What we need is FDA approval
for any of these indications or perhaps better still, a
military pile up stock contract such as MDWD has.
MediWound Announces an Additional $10 Million Award from BARDAFunding to support emergency stockpiling replenishment, pediatric indication submission, and expanded access treatment protocol extension

https://www.biospace.com/article/releases/mediwound-announces-an-additional-10-million-award-from-bardafunding-to-support-emergency-stockpiling-replenishment-pediatric-indication-submission-and-expanded-access-treatment-protocol-extension/
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midastouch017 midastouch017 2 weeks ago
RedHill's Opaganib Protects Against Radiation-Induced Lung Inflammation and Fibrosis - New Publication

https://finance.yahoo.com/news/redhills-opaganib-protects-against-radiation-120000115.html
Performance Outlookyahoo plus badge

The data, published in the International Journal of Molecular Sciences, demonstrate that opaganib significantly improved long-term survival in an in vivo model of lung damage following exposure to ionizing radiation

Opaganib is the first selective sphingosine kinase-2 (SPHK2) inhibitor investigational drug targeting sphingolipid metabolism for the treatment of radiation-induced inflammation

Opaganib, a novel oral, small molecule pill with a five-year shelf-life, is easy to administer and distribute, supporting potential central government stockpiling for use as radioprotection therapy in mass casualty radiological or nuclear incidents, if approved by the FDA

Opaganib is being tested as a potential treatment for Acute Radiation Syndrome (ARS) following selection by the U.S government National Institutes of Health's (NIH) Radiation and Nuclear Countermeasures Program (RNCP) for its radiation medical countermeasures Product Development Program

Opaganib is being developed for multiple additional indications, including COVID-19, acute respiratory distress syndrome (ARDS), filoviruses (including Ebola) and oncology

TEL AVIV, Israel and RALEIGH, N.C., Feb. 20, 2024 /PRNewswire/ -- RedHill Biopharma Ltd. (Nasdaq: RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today announced a new publication of data from multiple experiments in the International Journal of Molecular Sciences1. The published data shows that opaganib2 protects against radiation-induced lung inflammation and fibrosis in an in vivo mouse model of lung damage following exposure to ionizing radiation, demonstrating its potential use as a medical countermeasure against nuclear irradiation and in cancer radiotherapy.

Radiation-induced inflammation is known to occur in two phases โ€“ in an initial inflammatory response immediately after irradiation and in a delayed response that can occur weeks later. As such, one of the experiments looked specifically at longer-term survival with two treatment windows: 1-3 days post-radiation and 31-45 days post-radiation. The opaganib group treated both during the initial and delayed phases of inflammation demonstrated a highly statistically significant improvement in survival at Day 180 (60% survival compared with 10% for controls, p=0.008). Thus, treating with opaganib during both initial and delayed phases of inflammation provided the greatest improvement in survival.

"The data, when looked at collectively across multiple experiments, demonstrate that opaganib significantly improved long-term survival associated with reduced lung fibrosis, suppression of granulocyte infiltration, and reduced expression of IL-6 and TNFa in an in vivo model of lung damage following exposure to ionizing radiation," said Dr. Lynn W. Maines, lead author of the publication and VP of Research at Apogee Biotechnology Corporation, RedHill's development partner for opaganib. "These data further demonstrate that sphingolipid metabolism is a critical regulator of fibrogenesis, and specifically show that opaganib suppresses radiation-induced pulmonary inflammation and fibrosis."

Opaganib is being tested as a potential treatment for Acute Radiation Syndrome (ARS), following selection by the U.S government National Institutes of Health's (NIH) Radiation and Nuclear Countermeasures Program (RNCP) for its radiation medical countermeasures Product Development Program. Opaganib was also recently selected for inclusion into the BARDA/NIH Chemical Countermeasures screening program for Sulfur Mustard exposure. Opaganib, a novel, oral, small molecule pill with a five-year shelf-life, is easy to administer and distribute, supporting potential central government stockpiling for use as a medical countermeasure in the event of mass casualty nuclear radiation incidents or Sulfur Mustard attack, if approved by the U.S. Food and Drug Administration (FDA).

About Lung Inflammation, Fibrosis and Acute Radiation Syndrome (ARS)

ARS, sometimes known as radiation toxicity or radiation sickness, is generally rare; however, public health emergencies, such as a nuclear power plant accident or detonation of a nuclear device, could affect large numbers of people. ARS is an acute illness caused by irradiation of the body by a high dose of penetrating radiation in a short period of time. Much of the damage caused by ARS is caused by inflammation secondary to the direct effects of ionizing radiation itself. The inflammation can occur throughout the body, but specifically, inflammation in the lungs can cause the tissue around the air sacs of the lungs (alveoli) to become damaged, thickened, and scarred โ€“ this is known as pulmonary fibrosis. As the lungs scar and stiffen, breathing becomes more difficult, and the amount of oxygen entering the blood system becomes reduced.

Current treatments for ARS are supportive care, including blood transfusions, antibiotics, etc., as well as the availability of four approved products (three growth factors to address neutropenia and one to mitigate thrombocytopenia*). However, other radiation-induced clinical manifestations that have been observed in natural history studies and remain unaddressed with the current treatments include GI-ARS, cutaneous injury, and late effects in the lung, heart, and kidneys. Opaganib, an SPHK2 inhibitor, may offer a new therapeutic approach to mitigate both hematopoietic-ARS and GI-ARS. It has also been reported in the literature that inhibition of SPHK2 promotes the viability and robustness of hematopoietic stem cells, even in the face of radiation damage, supporting increased survival.

* The agents are filgrastim, PEGylated filgrastim and romiplostim (Neupogen®, Neulasta® and Nplate®, all Amgen Inc., NasdaqGS: AMGN), sargramostim (Leukine®, Partner Therapeutics Inc.).

About Opaganib (ABC294640)

Opaganib, a proprietary investigational host-directed and potentially broad-acting drug, is a first-in-class, orally administered sphingosine kinase-2 (SPHK2) selective inhibitor with anticancer, anti-inflammatory and antiviral activity, targeting multiple potential diseases, including gastrointestinal acute radiation syndrome (GI-ARS), COVID-19, other viruses as part of pandemic preparedness, and cholangiocarcinoma (bile duct cancer).

Opaganib's host-directed action is thought to work through the inhibition of multiple pathways, the induction of autophagy and apoptosis, and disruption of viral replication, through simultaneous inhibition of three sphingolipid-metabolizing enzymes in human cells (SPHK2, DES1 and GCS).

Opaganib was selected by the U.S. government's Radiation and Nuclear Countermeasures Program (RNCP), led by the National Institute of Allergy and Infectious Diseases, part of the National Institutes of Health, for the nuclear medical countermeasures product development pipeline as a potential treatment for Acute Radiation Syndrome (ARS).

Opaganib has demonstrated antiviral activity against SARS-CoV-2, multiple variants, and several other viruses, such as Influenza A. Opaganib also recently demonstrated a distinct synergistic effect when combined individually with remdesivir (Veklury®, Gilead Sciences Inc., Nasdaq: GILD), significantly improving potency while maintaining cell viability, in a U.S. Army-funded and conducted in vitro Ebola virus study.

Being host-targeted, and based on data accumulated to date, opaganib is expected to maintain effect against emerging viral variants. In prespecified analyses of Phase 2/3 clinical data in hospitalized patients with moderate to severe COVID-19, oral opaganib demonstrated improved viral RNA clearance, faster time to recovery and significant mortality reduction in key patient subpopulations versus placebo on top of standard of care. Opaganib has demonstrated its safety and tolerability profile in more than 470 people in multiple clinical studies and expanded access use. Data from the opaganib global Phase 2/3 study was published in medRxiv.

Opaganib has received Orphan Drug designation from the FDA for the treatment of cholangiocarcinoma and has undergone studies in advanced cholangiocarcinoma (Phase 2a) and prostate cancer. Opaganib also has a Phase 1 chemoradiotherapy study protocol ready for FDA-IND submission.

Opaganib has also shown positive preclinical results in renal fibrosis, and has the potential to target multiple oncology, radioprotection, viral, inflammatory, and gastrointestinal indications.
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midastouch017 midastouch017 2 weeks ago
I thought it was insiders buy,
hence my comment.
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seve333 seve333 2 weeks ago
Why is it a vote of confidence?
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midastouch017 midastouch017 3 weeks ago
RedHill Biopharma files to sell 10.6M ADS for holders

Feb. 09, 2024 4:29 PM ETRedHill Biopharma Ltd. (RDHL) Stock
By: Jaskiran Singh, SA News Editor

RedHill Biopharma (NASDAQ:RDHL) Friday filed a prospectus related to
the proposed resale of 10.6M ADS, with each of the ADS representing 400 shares,
by selling stockholders.
This prospectus is not an offer to sell these securities.
SEC Filing
A Vote of Confidence!
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seve333 seve333 1 month ago
So what is their next play sit around and do nothing then do another offerining in about three months?
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seve333 seve333 1 month ago
I simply do not see a path forward for this company it is alot of talk and zero results. They claim to have this great drug but yet release no earnings which leads me to believe the sales suck. They keep bleeding money yet layoff no staff. It honestly almost feels like simple ponzi scheme to a certain extent.. The only real way to make money on this thing is to buy like at .60 cents and wait for a positive PR release and sell right after it runs up. They do not bring in nerly enough money to avoid future offerenings and it is clear nobody wants to partner with them.
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midastouch017 midastouch017 1 month ago
With so much disappointment, you
would be doing the right move.
Myself, i guess i am something
of a masochist, hence will still
hang on.
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seve333 seve333 1 month ago
At this point I think I am about done with this thing and will just move on. The last runup gave me some hope but I should have known better nothign is ever going to change with this company. I guess time to takee the loss and move on.
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midastouch017 midastouch017 1 month ago
So Sad!
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seve333 seve333 1 month ago
People thought this last runup was finally the end of this but nope. Same old same old with RDHL any good news is crushed with offernings. I am have tempted to just give up on this thing at this point.
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Scrapiron Scrapiron 1 month ago
One step forward, two steps back!
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seve333 seve333 1 month ago
Do not hold your breath seems we simply cannot have good things with this company it is simply offering after offering. Clearly sales are not that great.
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seve333 seve333 1 month ago
They never ever cease to amaze me you just knew they were gong to destroy everythign with an offering. They are so predictable.
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surf1944 surf1944 1 month ago
https://stockcharts.com/h-sc/ui?s=rdhl&p=D&yr=0&mn=6&dy=0&id=p38090673899

https://www.barchart.com/stocks/quotes/rdhl/technical-chart?plot=CANDLE&volume=total&data=DO&density=M&pricesOn=1&asPctChange=0&logscale=1&indicators=BBANDS(20,2);SMA(13);PTP(50);ADX(14);SMA(50);SMACD(12,26,9);RSI(14,100);ACCUM;STOSL(14,3)&sym=CNNA&grid=1&height=500&studyheight=100

https://www.barchart.com/stocks/quotes/rdhl/opinion

https://finance.yahoo.com/quote/rdhl/

Still has a huge open gap at .31 to fill........
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TheFinalCD TheFinalCD 1 month ago
RedHill Biopharma Announces $8 Million Registered Direct Offering

https://ih.advfn.com/stock-market/NASDAQ/redhill-biopharma-RDHL/stock-news/93139168/form-6-k-report-of-foreign-issuer-rules-13a-16
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midastouch017 midastouch017 1 month ago
1.1500 +0.0700 (+6.4815%)
Pre-Market: 08:33AM EST
Momentum Continues!
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midastouch017 midastouch017 1 month ago
RedHill Announces New USPTO Patent Grant for Talicia® for H. pylori Treatment Through 2042

https://finance.yahoo.com/news/redhill-announces-uspto-patent-grant-110000416.html

USPTO issues new patent covering Talicia[1] as a method for eradicating H. pylori regardless of patient Body Mass Index (BMI)[2], supporting Talicia protection until May 2042

The patent is supported by previously published pooled data from two Phase 3 studies showing Talicia's efficacy was unaffected by presence of elevated BMI[3]

The U.S. FDA recently granted five years' market exclusivity for Talicia under the Generating Antibiotic Incentives Now (GAIN) Act Qualified Infectious Disease Product (QIDP) designation, additional to the three years' exclusivity granted for the approval of Talicia under section 505(b)(2)

Talicia is the leading branded first-line therapy prescribed by U.S. gastroenterologists[4] for eradication of H. pylori - a bacterial infection that affects approximately 35% of the U.S. adult population[5]

TEL AVIV, Israel and RALEIGH, N.C., Jan. 25, 2024 /PRNewswire/ -- RedHill Biopharma Ltd. (Nasdaq: RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today announced that the U.S. Patent and Trademark Office (USPTO) issued a new patent, U.S. Patent No. 11,878,011, covering Talicia as a method for eradicating Helicobacter pylori (H. pylori) regardless of patient Body Mass Index (BMI). This new patent is expected to provide protection for Talicia until May 2042.

"Rates of obesity continue to rise in the U.S., with over 70% of the population being overweight or obese[6], and published data have shown that obesity has been associated with failure of clarithromycin-based therapies for the treatment of H. pylori infection. This patent acknowledges the novelty of the data demonstrating Talicia's ability to remain effective regardless of patient BMI, awarding this clinically important innovation with expected patent protection for Talicia until May 2042" said Gilead Raday, RedHill's Chief Operating Officer, and Head of R&D.

About H. pylori infection
H. pylori is a bacterial infection that affects approximately 35% of the U.S. population, with an estimated two million patients treated annually[7]. Worldwide, more than 50% of the population has H. pylori infection, which is classified by the World Health Organization (WHO) as a Group 1 carcinogen. It remains the strongest known risk factor for gastric cancer[8] and a major risk factor for peptic ulcer disease[9] and gastric mucosa-associated lymphoid tissue (MALT) lymphoma[10]. More than 27,000 Americans are diagnosed with gastric cancer annually[11]. Eradication of H. pylori is becoming increasingly difficult, with current therapies failing in approximately 25-40% of patients who remain H. pylori-positive due to high resistance of H. pylori to antibiotics โ€“ especially clarithromycin โ€“ which is still commonly used in standard combination therapies5.

About Talicia
Talicia is a novel, fixed-dose, all-in-one oral capsule combination of two antibiotics (amoxicillin and rifabutin) and a proton pump inhibitor (PPI) (omeprazole), approved by the U.S. Food and Drug Administration (FDA) for the treatment of H. pylori infection in adults.

Talicia is the only low-dose rifabutin-based therapy approved for the treatment of H. pylori infection and is designed to address H. pylori's high resistance to other antibiotics. The high rates of H. pylori resistance to clarithromycin have led to significant rates of treatment failure with clarithromycin-based therapies and are a strong public health concern, as highlighted American College of Gastroenterology, the FDA and the WHO in recent years.

In the pivotal Phase 3 study, Talicia demonstrated 84% eradication of H. pylori infection in the intent-to-treat (ITT) group vs. 58% in the active comparator arm (p<0.0001). Minimal to zero resistance to rifabutin, a key component of Talicia, was detected in RedHill's pivotal Phase 3 study. Further, in an analysis of data from this study, it was observed that subjects who were confirmed adherent[12] to their therapy had response rates of 90.3% in the Talicia arm vs. 64.7% in the active comparator arm[13]. To reduce the development of drug-resistant bacteria and maintain the effectiveness of Talicia and other antibacterial drugs, Talicia should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria.

Talicia is eligible for a total of eight years of U.S. market exclusivity under its Qualified Infectious Disease Product (QIDP) designation and is also covered by U.S. patents which extend patent protection until 2034 with additional patents and applications pending and granted in various territories worldwide.

TALICIA: IMPORTANT SAFETY INFORMATION

Tell your healthcare provider about all of the medicines you take, including prescription or non-prescription medications or herbal supplements before starting Talicia. Talicia may affect the way other medicines work, and other medicines may affect the way Talicia works. Do not start any new medications while taking Talicia without first speaking with your healthcare provider.

You should not take Talicia if you are known to be sensitive to any of the components of Talicia (omeprazole, amoxicillin, rifabutin), penicillins, proton pump inhibitors or rifamycins.

You should not take Talicia if you are taking rilpivirine-containing products, delavirdine or voriconazole.

Before you take Talicia, tell your healthcare provider about all of your medical conditions, including if you:

Are pregnant or plan to become pregnant. Talicia may harm your unborn baby. Tell your healthcare provider if you become pregnant or think you may be pregnant during your treatment with Talicia.

Have severe kidney disease or liver disease.

When taking Talicia, do not crush or chew capsules. Do not take Talicia with alcohol.

Call your healthcare provider immediately if while taking Talicia you develop:

New rash or other skin changes, muscle or joint pains, swelling of any area of the body, severe flu-like symptoms, difficulty breathing, fever, blood in your urine, increased or decreased urination, drowsiness, confusion, nausea, vomiting, ongoing stomach pain, bloody diarrhea, or if diarrhea continues after therapy is completed, weight gain or changes in your eyesight.

What are the common side effects of Talicia?

The most common side effects of Talicia are diarrhea, headache, nausea, stomach pain, rash, indigestion, mouth or throat pain, vomiting, and vaginal yeast infection. Call your healthcare professional for medical advice about side effects.

Tell your healthcare provider if you experience tiredness, weakness, achiness, headaches, dizziness, depression, increased sensitivity to light, or pain when taking a deep breath.

Talicia may reduce the effectiveness of oral or other forms of hormonal birth-control. You should use an additional non-hormonal highly effective method of birth control while taking Talicia.

You may experience a brown-orange discoloration of your urine or tears while taking Talicia.

The information here is not comprehensive. Talk to your healthcare provider to learn more.

APPROVED USE FOR TALICIA

TALICIA is indicated for the treatment of Helicobacter pylori infection in adults.

Click here for the full Prescribing Information for TALICIA.

You are encouraged to report Adverse Reactions to RedHill Biopharma Inc. at 1-833-ADRHILL (1-833-237-4455) or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

About RedHill Biopharma

RedHill Biopharma Ltd. (Nasdaq: RDHL) is a specialty biopharmaceutical company primarily focused on gastrointestinal and infectious diseases. RedHill promotes the gastrointestinal drugs Talicia®, for the treatment of Helicobacter pylori (H. pylori) infection in adults[14], and Aemcolo®, for the treatment of travelers' diarrhea in adults[15]. RedHill's key clinical late-stage development programs include: (i) opaganib (ABC294640), a first-in-class oral broad-acting, host-directed SPHK2 selective inhibitor with potential for pandemic preparedness, targeting multiple indications with a U.S. government collaboration for development for Acute Radiation Syndrome (ARS), a Phase 2/3 program for hospitalized COVID-19, and a Phase 2 program in oncology; (ii) RHB-107 (upamostat), an oral broad-acting, host-directed, serine protease inhibitor with potential for pandemic preparedness is in late-stage development as a treatment for non-hospitalized symptomatic COVID-19, with non-dilutive external funding covering the entirety of the RHB-107 arm of the 300-patient Phase 2 adaptive platform trial, and is also targeting multiple other cancer and inflammatory gastrointestinal diseases; (iii) RHB-102, with potential UK submission for chemotherapy and radiotherapy induced nausea and vomiting, positive results from a Phase 3 study for acute gastroenteritis and gastritis and positive results from a Phase 2 study for IBS-D; (iv) RHB-104, with positive results from a first Phase 3 study for Crohn's disease; and (v) RHB-204, a Phase 3-stage program for pulmonary nontuberculous mycobacteria (NTM) disease.

More information about the Company is available at: www.redhillbio.com / twitter.com/RedHillBio.

Forward Looking Statements

This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements may be preceded by the words "intends," "may," "will," "plans," "expects," "anticipates," "projects," "predicts," "estimates," "aims," "believes," "hopes," "potential" or similar words. Forward-looking statements are based on certain assumptions and are subject to various known and unknown risks and uncertainties, many of which are beyond the Company's control and cannot be predicted or quantified, and consequently, actual results may differ materially from those expressed or implied by such forward-looking statements. Such risks and uncertainties, including without limitation, the risk that the Company will not comply with the listing requirements of the Nasdaq Capital Market ("Nasdaq") to remain listed for trading on Nasdaq; the risk that the addition of new revenue generating products or out-licensing transactions will not occur; the risk that the Company will not succeed to expand Talicia's reach to additional ex-U.S. territories; as well as other risk and uncertainties associated with (i) the initiation, timing, progress and results of the Company's research, manufacturing, pre-clinical studies, clinical trials, and other therapeutic candidate development efforts, and the timing of the commercial launch of its commercial products and ones it may acquire or develop in the future; (ii) the Company's ability to advance its therapeutic candidates into clinical trials or to successfully complete its pre-clinical studies or clinical trials; (iii) the extent and number and type of additional studies that the Company may be required to conduct and the Company's receipt of regulatory approvals for its therapeutic candidates, and the timing of other regulatory filings, approvals and feedback; (iv) the manufacturing, clinical development, commercialization, and market acceptance of the Company's therapeutic candidates and Talicia®; (v) the Company's ability to successfully commercialize and promote Talicia® and Aemcolo®; (vi) the Company's ability to establish and maintain corporate collaborations; (vii) the Company's ability to acquire products approved for marketing in the U.S. that achieve commercial success and build its own marketing and commercialization capabilities; (viii) the interpretation of the properties and characteristics of the Company's therapeutic candidates and the results obtained with its therapeutic candidates in research, pre-clinical studies or clinical trials; (ix) the implementation of the Company's business model, strategic plans for its business and therapeutic candidates; (x) the scope of protection the Company is able to establish and maintain for intellectual property rights covering its therapeutic candidates and its ability to operate its business without infringing the intellectual property rights of others; (xi) parties from whom the Company licenses its intellectual property defaulting in their obligations to the Company; (xii) estimates of the Company's expenses, future revenues, capital requirements and needs for additional financing; (xiii) the effect of patients suffering adverse experiences using investigative drugs under the Company's Expanded Access Program; and (xiv) competition from other companies and technologies within the Company's industry. More detailed information about the Company and the risk factors that may affect the realization of forward-looking statements is set forth in the Company's filings with the Securities and Exchange Commission (SEC), including the Company's Annual Report on Form 20-F filed with the SEC on April 28, 2023. All forward-looking statements included in this press release are made only as of the date of this press release. The Company assumes no obligation to update any written or oral forward-looking statement, whether as a result of new information, future events or otherwise unless required by law.

Company contact:
Adi Frish
Chief Corporate & Business Development Officer
RedHill Biopharma
+972-54-6543-112
adi@redhillbio.com

Category: Commercial

[1] Talicia® (omeprazole magnesium, amoxicillin and rifabutin) is indicated for the treatment of H. pylori infection in adults. For full prescribing information see: www.Talicia.com.
[2] Body mass index (BMI) is a measure of body fat based on height and weight that applies to adult men and women. It is calculated by taking a person's weight in kilograms (or pounds) and dividing it by the square of height in meters (or feet). A high BMI can indicate high body fatness.
[3] https://www.redhillus.com/ObesityWeek/2022/RHB-105PBPKObesity/Portenier
[4] IQVIA XPO Data on file
[5] Hooi JKY et al. Global Prevalence of Helicobacter pylori Infection: Systematic Review and Meta-Analysis. Gastroenterology 2017; 153:420-429.
[6] CDC. Adult Obesity Facts. May 17, 2022. Division of Nutrition, Physical Activity, and Obesity.
[7] IQVIA Custom Study for RedHill Biopharma, 2019
[8] Lamb A et al. Role of the Helicobacter pyloriโ€“Induced inflammatory response in the development of gastric cancer. J Cell Biochem 2013;114.3:491-497.
[9] NIH โ€“ Helicobacter pylori and Cancer, September 2013.
[10] Hu Q et al. Gastric mucosa-associated lymphoid tissue lymphoma and Helicobacter pylori infection: a review of current diagnosis and management. Biomarker research 2016;4.1:15.
[11] National Cancer Institute, Surveillance, Epidemiology, and End Results Program (SEER).
[12] Defined as the PK population which included those subjects in the ITT population who had demonstrated presence of any component of investigational drug at visit 3 (approx. day 13) or had undetected levels drawn >250 hours after the last dose.
[13] The pivotal Phase 3 study with Talicia® demonstrated 84% eradication of H. pylori infection with Talicia® vs. 58% in the active comparator arm (ITT analysis, p<0.0001).
[14] Talicia® (omeprazole magnesium, amoxicillin and rifabutin) is indicated for the treatment of H. pylori infection in adults. For full prescribing information see: www.Talicia.com.
[15] Aemcolo® (rifamycin) is indicated for the treatment of travelers' diarrhea caused by noninvasive strains of Escherichia coli in adults. For full prescribing information see: www.aemcolo.com.

Cision
Cision
View original content:https://www.prnewswire.com/news-releases/redhill-announces-new-uspto-patent-grant-for-talicia-for-h-pylori-treatment-through-2042-302044556.html

SOURCE RedHill Biopharma Ltd.


GlobeNewswire
Gamida Cell to Present at the 2024 Tandem Meetings of ASTCT® and CIBMTR®
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midastouch017 midastouch017 1 month ago
I hope that full year results are to be published soon, and results will be positive, or else the company will announce a stockpiling contract.
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mmbo mmbo 1 month ago
This price movement has to be more than just earnings announcements, please make it be so.
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midastouch017 midastouch017 1 month ago
1.0800+0.1885 (+21.14%)
At close: January 24 04:00PM EST
1.1399 +0.06 (+5.55%)
After hours: 08:00PM EST
All due to a patent grant?
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midastouch017 midastouch017 1 month ago
1.1799+0.2884 (+32.3500%)
As of 01:39PM EST. Market open.
This huge uptick due to a patent?
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midastouch017 midastouch017 1 month ago
1.1100 +0.2185 (+24.5093%)
Pre-Market-05:06AM EST
Even Better!
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midastouch017 midastouch017 1 month ago
$RDHL 1.0700 +0.1785 (+20.0224%)
Pre-Market: 05:06AM EST
I smell good news!
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midastouch017 midastouch017 2 months ago
earning could come out at anytime and we would not know until that day.
I concur.
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seve333 seve333 2 months ago
No I am just saying they will not preannouce a date with a time and conference call. So earning could come out at anytime and we would not know until that day.
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midastouch017 midastouch017 2 months ago
1.5600 +0.07 (+4.70%)
Pre-Market: 08:42AM EST
Hopefully sp will hold and increase today!
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midastouch017 midastouch017 2 months ago
unlike most normal american companies they do not do conference calls
A quite irritating modus operandi, i fully agree, but as long as
earnings are good, i do not really care (although i approached
RDHL 3 times already the past 2 weeks in regards earning date)
I remain cautiously optimistic!
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seve333 seve333 2 months ago
Would certainly make sense but unlike most normal american companies they do not do conference calls, etc so they never issue an kind of press release stating when earnings are coming.
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mmbo mmbo 2 months ago
And volume is looking good so farโ€ฆ
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midastouch017 midastouch017 2 months ago
1.5900+0.1200 (+8.1633%)
As of 10:24AM EST. Market open.
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midastouch017 midastouch017 2 months ago
Thank You. Happy Holidays
and GLTU.
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mmbo mmbo 2 months ago
Thanks, hopefully you were able to enjoy the holiday season. Good luck to everyone there.
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midastouch017 midastouch017 2 months ago
You've probably read my #msg-173475660
My guess is that RDHL obtained Sec permission
to report twice annually, hence my opinion that
the anual report will be issued by Jan/Feb 2024.
Notwithstanding perhaps some partnership is in
the works, if so it would probably be for Talicia.
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mmbo mmbo 2 months ago
โ€œThe SEC requires that companies report ?their quarterly earnings on Form 10-Q no later than ?35 days from the end of its fiscal quarter.โ€

Is a significantly late quarterly earnings report perhaps suggest some progress in a product marketing partnership?
I doubt the company is in serious negotiations for a sale, however anything is possible, I suppose.

Thanks in advance Midas.
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midastouch017 midastouch017 2 months ago
1.4800+0.2000 (+15.6250%)
As of 01:19PM EST. Market open.
HOD
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seve333 seve333 2 months ago
It is very odd but that has to be the case of they would released by now.
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tbonaces80 tbonaces80 2 months ago
Next leg much higher. Break 1.68. Off to races.
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midastouch017 midastouch017 2 months ago
A reply today to my request of yesterday:

RedHill continues to report its financial statements according to SEC regulations
Best,
That's it. Last time for me to bother asking.
By now i am pretty confident RDHL will report full year 2023
around end Jan/Feb 2024.
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tbonaces80 tbonaces80 2 months ago
Entire float gobbled. Squeeze imminent
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tbonaces80 tbonaces80 2 months ago
Get ready
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midastouch017 midastouch017 2 months ago
RDHL has reported H1/23 Financial Results at August 17, 2023.
No Q2 were released, so perhaps RDHL intends to release
full 2023 results? (sometime in Feb 2024?)
I wonder.
In the meantime nice positive news today.
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seve333 seve333 2 months ago
q3 has been over for 2.5 months everyone else on the planet has already reported.
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seve333 seve333 2 months ago
What are they hiding? I will say I am surprised the price is holding up after the shorts had hammered it back to a buck I was getting worried again.
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midastouch017 midastouch017 2 months ago
RedHill shares rally 20% on positive data for two antiviral drugs

Dec. 20, 2023 11:06 AM ETRedHill Biopharma Ltd. (RDHL) Stock

By: Val Brickates Kennedy, SA News Editor

RedHill Biopharma (NASDAQ:RDHL) shares rallied 20% in morning trading Wednesday after the company reported encouraging results from a laboratory study of its drug candidates opaganib and RHB-107, also known as upamostat, in the treatment of ebola.

The Israeli biotech company said the study, which was funded by the US Army, showed the drugs demonstrated โ€œrobust synergistic effectโ€ when individually combined with the antiviral drug remdesivir, also known as Veklury. The company said the combinations showed โ€œsignificantly improved viral inhibitionโ€ without increasing toxicity.

The combination of opaganib and remdesivir exhibited the greatest synergistic effect, according to the statement.

โ€œThe results suggest that opaganib and upamostat may have potential or use in combination with direct antiviral agents, such as remdesivir, to improve treatment outcome, increasing efficacy while maintaining safety,โ€ said Jefferey Kugelman of the US Army Medical Research institute of Infectious Diseases, in the statement.

RedHill added that a US government-backed Phase 2 study of RHB-107 in the treatment of early COVID-19 is set to enroll its first patient in the coming weeks. The study is expected to be completed by the end of 2024.
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midastouch017 midastouch017 2 months ago
Twice daily administered opaganib has previously demonstrated benefit in late-stage clinical studies of patients hospitalized with moderate to severe COVID-19 and was selected by the NIH Radiation and Nuclear Countermeasures Program (RNCP) for Acute Radiation Syndrome development.
A stockpiling contract is soon to be announced?
IMO.
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midastouch017 midastouch017 2 months ago
RedHill and U.S. Army Announce Opaganib and RHB-107 Combinations with Remdesivir Show Distinct Synergistic Effect Against Ebola

https://finance.yahoo.com/news/redhill-u-army-announce-opaganib-134500031.html

Investigational drugs opaganib and RHB-107 (upamostat) demonstrate distinct synergistic effect when combined individually with remdesivir, significantly improving potency while maintaining cell viability, in a new U.S. Army-funded and conducted in vitro Ebola virus study

Opaganib and RHB-107 are both novel, oral, host-directed, small molecule investigational drugs that are easy to administer and distribute, with demonstrated activity against multiple viral targets, including COVID-19, and are expected to be effective against emerging viral variants

Opaganib is believed to be the first host-directed molecule to show activity in Ebola virus disease, having recently delivered a statistically significant increase in survival time in a separate U.S. Army-funded in vivo Ebola virus study. RHB-107 was recently accepted for inclusion in the ACESO PROTECT adaptive platform trial for early COVID-19 outpatient treatment

TEL-AVIV, Israel and RALEIGH, N.C., Dec. 20, 2023 /PRNewswire/ -- RedHill Biopharma Ltd. (Nasdaq: RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today announced that its two novel, oral host-directed investigational drugs, opaganib[1] and RHB-107 (upamostat)[2], demonstrated robust synergistic effect when combined individually with remdesivir (Veklury®)[3], significantly improving viral inhibition while maintaining cell viability, in a new U.S. Army-funded and conducted Ebola virus in vitro study.

"These encouraging in vitro results for opaganib and RHB-107 show a distinct synergy in terms of viral inhibition while maintaining cell viability (i.e., not increasing toxicity), when either is added to remdesivir, with opaganib showing the greatest synergistic effect in combination with remdesivir," said Jeffrey Kugelman, Ph.D., Major(P), US Army MSC, Branch Chief Synthetic Biology & Surveillance, Molecular Biology Division, U.S. Army Medical Research Institute of Infectious Diseases (USAMRIID), who led the bioinformatics analysis of the study. "The results suggest that opaganib and upamostat may have potential or use in combination with direct antiviral agents, such as remdesivir, to improve treatment outcome, increasing efficacy while maintaining safety."

"Opaganib is believed to be the first host-directed molecule to show activity in Ebola virus disease, and these results add to a recent U.S. Army Ebola virus study in which opaganib delivered a statistically significant increase in mice survival time in vivo," said Reza Fathi, Ph.D., RedHill's SVP R&D. "Opaganib and RHB-107 are both novel, oral, host-directed, small molecule investigational drugs with demonstrated activity against multiple viral targets, including COVID-19, and are expected to be effective against emerging viral variants. This, together with their growing safety and tolerability databases, presents a compelling hypothesis for further study of their potential in treating Ebola virus."

Utilizing a checkerboard design to test the study compounds in combination, the study cell lines were pretreated and then infected with Ebola virus. The cells were fixed, washed and subjected to immunofluorescence staining using a virus-specific antibody. The raw data for the combination was analyzed to determine synergistic, additivity or antagonistic effects on viral inhibition while taking into account cell viability.

Twice daily administered opaganib has previously demonstrated benefit in late-stage clinical studies of patients hospitalized with moderate to severe COVID-19 and was selected by the NIH Radiation and Nuclear Countermeasures Program (RNCP) for Acute Radiation Syndrome development.

RHB-107 successfully met its U.S. Phase 2 study primary endpoint of safety and tolerability and delivered promising efficacy results, including marked reduction in hospitalization due to COVID-19. RHB-107 was recently accepted for inclusion in the ACESO PROTECT adaptive platform trial for early COVID-19 outpatient treatment. The 300-patient PROTECT Phase 2 RHB-107 arm, fully funded by non-dilutive external funding sources including the U.S. government[4], has received FDA clearance to start, with the first patient expected to be enrolled in the coming weeks. The study is being conducted in the U.S., Thailand, Ivory Coast, South Africa and Uganda, and is estimated to be completed by end of 2024.

About Ebola virus disease:
According to the Centers for Disease Control and Prevention, Ebola disease is a rare and often deadly illness, caused by infection by one of a group of four viruses, known as ebolaviruses, that are found primarily in sub-Saharan Africa and are known as: Zaire, Sudan, Taï Forest (formerly Côte d'Ivoire) and Bundibugyo. Transmission of the disease is mostly through contact with an infected animal (bat or nonhuman primate), or a sick or dead person infected with an ebolavirus. The course of the illness typically progresses from "dry" symptoms initially (such as fever, aches and pains, and fatigue), and then progresses to "wet" symptoms (such as diarrhea, vomiting and unexplained hemorrhaging, bleeding or bruising) as the person becomes sicker. There are currently only two FDA-approved therapies to treat EVD caused by the Ebola virus, species Zaire ebolavirus, in adults and children; Inmazeb™, a combination of three monoclonal antibodies and Ebanga™, a single monoclonal antibody. Both are intravenously infused direct acting monoclonal antibody antivirals that bind to glycoproteins on the Ebola virus's surface to prevent the virus from entering a person's cells. There is an urgent need for host-directed small molecule therapies that may be effective against multiple strains of ebolavirus, less likely to be impacted by viral mutation, and that are easy to store, distribute and administer, especially in areas where healthcare services and infrastructures may be sub-optimal.

About Opaganib (ABC294640)
Opaganib, a proprietary investigational host-directed and potentially broad-acting drug, is a first-in-class, orally administered sphingosine kinase-2 (SPHK2) selective inhibitor with anticancer, anti-inflammatory and antiviral activity, targeting multiple potential diseases, including gastrointestinal acute radiation syndrome (GI-ARS), COVID-19, other viruses as part of pandemic preparedness, and cholangiocarcinoma (bile duct cancer).

Opaganib's host-directed action is thought to work through the inhibition of multiple pathways, the induction of autophagy and apoptosis, and disruption of viral replication, through simultaneous inhibition of three sphingolipid-metabolizing enzymes in human cells (SPHK2, DES1 and GCS).

Opaganib was selected by the U.S. government's Radiation and Nuclear Countermeasures Program (RNCP), led by the National Institute of Allergy and Infectious Diseases, part of the National Institutes of Health, for the nuclear medical countermeasures product development pipeline as a potential treatment for Acute Radiation Syndrome (ARS).

Opaganib has received Orphan Drug designation from the FDA for the treatment of cholangiocarcinoma and has undergone studies in advanced cholangiocarcinoma (Phase 2a) and prostate cancer. Opaganib also has a Phase 1 chemoradiotherapy study protocol ready for FDA-IND submission.

Opaganib has demonstrated antiviral activity against SARS-CoV-2, multiple variants, and several other viruses, such as Influenza A. Being host-targeted, and based on data accumulated to date, opaganib is expected to maintain effect against emerging viral variants. In prespecified analyses of Phase 2/3 clinical data in hospitalized patients with moderate to severe COVID-19, oral opaganib demonstrated improved viral RNA clearance, faster time to recovery and significant mortality reduction in key patient subpopulations versus placebo on top of standard of care. Data from the opaganib global Phase 2/3 study has been submitted for peer review and recently published in medRxiv.

Opaganib has also shown positive preclinical results in renal fibrosis, and has the potential to target multiple oncology, radioprotection, viral, inflammatory, and gastrointestinal indications.

About RHB-107 (upamostat)
RHB-107 is a proprietary, first-in-class, once-daily orally administered investigational antiviral, that targets human serine proteases involved in preparing the spike protein for viral entry into target cells. Because it is host-cell targeted, RHB-107 is expected to also be effective against emerging viral variants with mutations in the spike protein. RHB-107 is well tolerated; in the initial COVID-19 study, among 41 patients only one reported a drug-related adverse reaction (a mild, self-limited, rash).

In addition, RHB-107 inhibits several proteases targeting cancer and inflammatory gastrointestinal disease. RHB-107 has undergone several Phase 1 studies and two Phase 2 studies, demonstrating its clinical safety profile in approximately 200 patients[5].

RedHill acquired the exclusive worldwide rights to RHB-107, excluding China, Hong Kong, Taiwan and Macao, from Germany's Heidelberg Pharmaceuticals (FSE: HPHA) (formerly WILEX AG) for all indications.

About USAMRIID
Since 1969, USAMRIID has served as the U.S. Department of Defense's lead laboratory for medical biological defense research. The core mission is to protect the warfighter from biological threats, while also investigating disease outbreaks and threats to public health. Research conducted at USAMRIID leads to medical solutionsโ€”therapeutics, vaccines, diagnostics, and informationโ€”that benefit both military personnel and civilians. USAMRIID is a subordinate laboratory of the U.S. Army Medical Research and Development Command.
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midastouch017 midastouch017 2 months ago
I have NOT asked to be informed privately,
rather that RDHL announces publicly the Q3
results.
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carusso carusso 2 months ago
I hear ya; was just suggesting the date of earnings could in itself be considered tradable info, so they will make that info available to the public by an announcement, and they cannot let those who contact them by phone or email or message, know that date before they announce it to โ€œeveryoneโ€.
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