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Fortunately i had some gains that will
be offset by my significant sale losses.
Did you book losses as well during the liquidation?
RedHill Biopharma Announces Settlement of Movantik® Patent Litigation with Aurobindo
https://finance.yahoo.com/news/redhill-biopharma-announces-settlement-movantik-110000120.html
The settlement agreement with Aurobindo brings closure to all presently pending Movantik® patent litigation brought pursuant to The Drug Price Competition and Patent Term Restoration Act (the Hatch-Waxman Act)
The earliest licensed entry date of any generic naloxegol in the U.S. is October 1, 2030
TEL AVIV, Israel and RALEIGH, N.C., Sept. 23, 2021 /PRNewswire/ -- RedHill Biopharma Ltd. (Nasdaq: RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today announced that RedHill Biopharma Inc., AstraZeneca AB and AstraZeneca Pharmaceuticals LP ("AstraZeneca") and Nektar Therapeutics have entered into a settlement and license agreement with Aurobindo Pharma USA, Inc. resolving their patent litigation in the U.S. in response to Aurobindo's Abbreviated New Drug Application ("ANDA") seeking approval by the US. Food and Drug Administration ("FDA") to market a generic version of Movantik® (naloxegol).
RedHill acquired from AstraZeneca in April 2020 the global rights to Movantik, excluding Europe and Canada.
Under the terms of the settlement agreement, Aurobindo may not sell a generic version of Movantik in the U.S. until April 1, 2031 (subject to U.S. FDA approval) or earlier under certain circumstances.
The parties to the settlement agreement have also agreed to file a stipulation and order of dismissal with the U.S. District Court for the District of Delaware which will conclude this litigation with respect to Aurobindo. As required by law, the parties will submit the settlement agreement to the U.S. Federal Trade Commission and the U.S. Department of Justice for review. Upon entry of the stipulation and order of dismissal, this settlement agreement will conclude all Hatch-Waxman Act patent litigation brought to date against ANDA filers prior to the expiration of the patents listed in the Orange Book.
RDHL was my biggest holding at
a point of time, now it is 5th due
to liquidating 50% of shares and
of course due to sp deterioration.
Obviously, if people knew and sold then it is illegal insider trading. Maybe we should have known that bad news was coming. Long term it still looks good. I’m hanging in there
Time to buy???
THESE-SCUMBAGS-KNEW.-THEY-KEPT-PUMPING-OUT-BS-PR'S.-WHILE-THEY-DILUTED-ALL-ALONG.THEY-SHOULD-CHOKE-ON-THEIR-BULLSHIIT.
Why RedHill Biopharma Stock Is Getting Crushed Today
A clinical failure is sending shareholders to the exits this morning.
https://www.fool.com/investing/2021/09/14/why-redhill-biopharma-stock-is-getting-crushed-tod/?source=eptyholnk0000202&utm_source=yahoo-host&utm_medium=feed&utm_campaign=article
George Budwell
(Tmfgbudwell)
Sep 14, 2021 at 12:02PM
Author Bio
What happened
Shares of the specialty biopharmaceutical company RedHill Biopharma (NASDAQ:RDHL) are down by an eye-popping 33% as of 10:53 a.m. EDT Tuesday morning. The drugmaker's stock is tanking today in response to the performance of opaganib, a sphingosine kinase-2 selective inhibitor, which failed to hit its primary endpoint in a phase 2/3 trial as a treatment for hospitalized patients with severe COVID-19 pneumonia.
Interestingly, the market appears to have anticipated this clinical failure, as evinced by RedHill's steady decline over the course of the past week. The company's stock, in fact, has now shed almost half of its value since Sept. 8.
So what
While opaganib's COVID-19 indication probably wasn't going to be a huge moneymaker for RedHill (analysts expected roughly $200 million to $300 million at the peak from this indication), this sizable market may have had enough juice to transform the company into a profitable operation perhaps as soon as next year. What's important to understand is that Wall Street currently expects RedHill to be cash-flow negative until at least 2023 despite having three gastroenterology-focused medicines on the market.
Now what
Is RedHill's stock worth picking up on this latest pullback? There is a lot to like about this small-cap pharma stock, especially at these bargain-basement levels. RedHill's gastroenterology franchise -- consisting of Talicia for Helicobacter pylori infection, Movantik for opioid-induced constipation in adults, and Aemcolo for travelers' diarrhea in adults -- could garner sales in excess of $1 billion before the end of the decade. That's an enormous potential revenue stream for a healthcare company with a market cap of less than $250 million.
All told, RedHill's stock is likely to take a while to turn into a consistent winner. But there is enough latent value hidden within this tiny drugmaker to merit a deeper dive by healthcare investors with a long-term outlook.
Obviously somebody knew the results
Obviously somebody knew the results
Well - my tea leaves reading was not wrong - a new trial announcement while waiting for results from another trial is never a good sign.
RedHill Biopharma says trial for COVID-19 therapy did not meet endpoint
Sep. 14, 2021 8:32 AM ETRedHill Biopharma Ltd. (RDHL)
By: Dulan Lokuwithana, SA News Editor
Announcing preliminary topline data from a global Phase 2/3 study, RedHill Biopharma (NASDAQ:RDHL) said the study for opaganib (ABC294640) in patients hospitalized with severe COVID-19 pneumonia did not reach its primary endpoint.
However, without statistical significance, the study efficacy endpoints showed favorable trends for opaganib arm compared to placebo across multiple endpoints, including the primary endpoint, the company added.
The adverse events were balanced across both arms of the study, and topline safety data indicated a good tolerability profile for opaganib.
The analysis of topline data is ongoing, and RedHill Biopharma (RDHL) intends to discuss the results with the FDA and other overseas regulators for a potential path forward.
“While we are disappointed with the data not reaching statistical significance, we do see a trend that needs to be investigated that opaganib may provide benefit to patients earlier in the course of the disease,” CEO Dror Ben Asher noted.
Well - my tea leaves reading was not wrong - a new trial announcement while waiting for results from another trial is never a good sign.
I expected it to drop to $5 but it is much lower. A bad company
RedHill Biopharma Reports Top-Line Data from Opaganib Phase 2/3 Study in Severe COVID-19 Patients
https://finance.yahoo.com/news/redhill-biopharma-reports-top-line-121500779.html
While preliminary top-line data of the study efficacy endpoints showed consistent trends in favor of the opaganib arm, the study endpoints did not achieve statistical significance
Analysis of the top-line data is ongoing, including regarding the potential for increased benefit of opaganib in patients at earlier stages of the disease on low flow oxygen support
Top-line safety data shows good tolerability with balanced adverse events between the study arms
Additional data will be presented upon further analysis and will be discussed with U.S. and non-U.S. regulators to help determine next steps
RedHill plans to hold a conference call to discuss the results in greater detail following further data analysis
TEL AVIV, Israel and RALEIGH, NC, Sept. 14, 2021 /PRNewswire/ -- RedHill Biopharma Ltd. (Nasdaq: RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today announced preliminary top-line data from the 475-patient global Phase 2/3 study with opaganib (ABC294640)[1] in hospitalized patients with severe COVID-19 pneumonia.
Preliminary top-line data showed that the study did not meet its primary endpoint. Analysis of the study efficacy endpoints did show trends in favor of the opaganib arm vs. placebo across multiple endpoints, including the primary endpoint, despite not achieving statistical significance.
Top-line safety data showed good tolerability of opaganib, with balanced adverse events between the study arms. These findings, together with preliminary analysis pointing to increased benefit in a subset of patients requiring less oxygen, could support the potential utilization of opaganib in earlier stages of the disease and are in line with the previously announced results from the U.S. Phase 2 study and the previously observed antiviral activity of opaganib.
"We would like to thank the patients, physicians and supporting medical staff who took part in this important study. While we are disappointed with the data not reaching statistical significance, we do see a trend that needs to be investigated that opaganib may provide benefit to patients earlier in the course of the disease. This correlates with what we know about opaganib's strong antiviral mechanism and effect against variants, as well as its mechanism of action and previously announced results from the Phase 2 U.S. study with opaganib," said Dror Ben Asher, RedHill CEO. "In parallel, we continue to make progress with our Phase 2/3 study with another novel, orally-administered drug candidate, RHB-107 (upamostat) in non-hospitalized symptomatic COVID-19 patients, with the recent approval of the study in South Africa and its expansion within the United States. We are determined to continue our efforts to advance potential treatments to address COVID-19 and its overwhelming impact worldwide."
The multi-center, randomized, double-blind, parallel-arm, placebo-controlled Phase 2/3 study enrolled 475 subjects with severe COVID-19 pneumonia requiring hospitalization and treatment with supplemental oxygen. Subjects were randomized at a 1:1 ratio to receive either opaganib or placebo, on top of standard-of-care therapy. The primary endpoint of the study is the proportion of patients breathing room air without oxygen support by Day 14.
Analysis of the top-line data is ongoing, including an analysis of the potential for increased benefit of treatment with opaganib in patients at earlier stages of disease. RedHill intends to discuss the data with regulators, including U.S. FDA and foreign regulators, to help determine next steps.
The top-line results from the Company's Phase 2/3 study with opaganib are preliminary in nature, as they are based solely on top-line information provided to the Company by an independent third-party contractor. The Company intends to examine the data from this study in greater detail, along with all of the information gathered during this study, including all safety, and secondary outcome measures. Such analysis may result in findings inconsistent with the top-line data disclosed in this release. As such, investors should not rely on the top-line results reported in this release as the final definitive results of the study.
Opaganib is a novel small molecule investigational drug in oral pill form. Opaganib has a unique dual antiviral and anti-inflammatory mechanism of action that acts on the viral cause and inflammatory effect of COVID-19. It is believed to exert its antiviral effect by selectively inhibiting SK2, a key enzyme produced in human cells that may be recruited by the virus to support its replication.
About Opaganib (ABC294640)
Opaganib, a new chemical entity, is a proprietary, first-in-class, orally-administered, sphingosine kinase-2 (SK2) selective inhibitor, with dual anti-inflammatory and antiviral activity. Opaganib is host-targeted and is expected to be effective against emerging viral variants, having already demonstrated strong inhibition against variants of concern, including Delta. Opaganib has also shown anticancer activity and positive preclinical results in renal fibrosis, and also has the potential to target multiple oncology, viral, inflammatory, and gastrointestinal indications.
Opaganib previously delivered positive U.S. Phase 2 data in patients with severe COVID-19, recently published in medRxiv.
Opaganib has also received Orphan Drug designation from the U.S. FDA for the treatment of cholangiocarcinoma and is being evaluated in a Phase 2a study in advanced cholangiocarcinoma and in a Phase 2 study in prostate cancer. Based on a preliminary review of partial unaudited data, the ongoing study in prostate cancer has met its primary endpoint. Patient accrual, treatment and analysis in this study are ongoing.
Opaganib demonstrated potent antiviral activity against SARS-CoV-2, the virus that causes COVID-19, inhibiting viral replication of all SARS-CoV-2 variants tested to date in an in vitro model of human lung bronchial tissue. Additionally, preclinical in vivo studies have demonstrated opaganib's potential to ameliorate inflammatory lung disorders, such as pneumonia, have demonstrated opaganib's potential to decrease renal fibrosis and have shown decreased fatality rates from influenza virus infection and amelioration of Pseudomonas aeruginosa-induced lung injury by reducing the levels of IL-6 and TNF-alpha in bronchoalveolar lavage fluids[2].
The ongoing clinical studies with opaganib are registered on www.ClinicalTrials.gov, a web-based service by the U.S. National Institute of Health, which provides public access to information on publicly and privately supported clinical studies.
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, Movantik® for opioid-induced constipation in adults[3], Talicia® for the treatment of Helicobacter pylori (H. pylori) infection in adults[4], and Aemcolo® for the treatment of travelers' diarrhea in adults[5]. RedHill's key clinical late-stage development programs include: (i) RHB-204, with an ongoing Phase 3 study for pulmonary nontuberculous mycobacteria (NTM) disease; (ii) opaganib (ABC294640), a first-in-class oral SK2 selective inhibitor targeting multiple indications with a Phase 2/3 program for COVID-19 and Phase 2 studies for prostate cancer and cholangiocarcinoma ongoing; (iii) RHB-107 (upamostat), an oral serine protease inhibitor in a U.S. Phase 2/3 study as treatment for symptomatic COVID-19, and targeting multiple other cancer and inflammatory gastrointestinal diseases; (iv) RHB-104, with positive results from a first Phase 3 study for Crohn's disease; (v) RHB-102 , with positive results from a Phase 3 study for acute gastroenteritis and gastritis and positive results from a Phase 2 study for IBS-D; and (vi) RHB-106, an encapsulated bowel preparation. More information about the Company is available at www.redhillbio.com / https://twitter.com/RedHillBio.
the fact that new trial announced means
the old trial is not as successful.
I hope they have some good news
else this will go to $5
SO-IN-8-MONTHS-WE-HAD-2-VACCINES-FROM-SCRATCH.-READY-FOR-APPROVAL.-THIS-MED-WAS-THERE-ALREADY-AND-IT-IS-NOW-19-MOTHS-AND-WE-STILL-DON'T-KNOW-THE-F IN RESULTS-OF-A-F IN TRIAL YET. LET THAT SINK IN FOR A MINUTE.
Look at the drop today - the fact that new trial announced means the old trial is not as successful.
I hope they have some good news else this will go to $5
In parallel RedHill's leading oral COVID-19 therapeutic, opaganib, is being evaluated
in a global Phase 2/3 study in 475 patients hospitalized with severe COVID-19,
with top-line results upcoming
RedHill Biopharma Accelerates Ongoing U.S. Phase 2/3 COVID-19 Study of Once-Daily Oral RHB-107 in Non-Hospitalized Patients with South African Approval
https://finance.yahoo.com/news/redhill-biopharma-accelerates-ongoing-u-110000066.html
The South African Health Products Regulatory Authority (SAHPRA) has approved the Phase 2/3 study of once-daily orally-administered RHB-107 (upamostat) for patients with symptomatic COVID-19 who do not require hospital care
Number of U.S. sites for the study has also been expanded
RHB-107, a novel antiviral serine protease inhibitor targeting human cell factors, is expected to be effective against emerging viral variants
RHB-107 is being developed as a potential treatment with a simple once-daily oral pill in the early course of COVID-19
In parallel RedHill's leading oral COVID-19 therapeutic, opaganib, is being evaluated in a global Phase 2/3 study in 475 patients hospitalized with severe COVID-19, with top-line results upcoming
TEL AVIV, Israel and RALEIGH, N.C., Sept. 13, 2021 /PRNewswire/ -- RedHill Biopharma Ltd. (Nasdaq: RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today announced that South Africa has joined the U.S. in approving the Phase 2/3 study with novel, once-daily, orally-administered pill RHB-107 (upamostat)[1] for non-hospitalized patients with symptomatic COVID-19. The study is already ongoing in the U.S., with expansion of study sites underway to further accelerate recruitment.
RHB-107 is a novel antiviral drug candidate 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 has demonstrated strong inhibition of SARS-CoV-2 viral replication in an in vitro human bronchial epithelial cell model. RHB-107 has a strong clinical safety and biodistribution profile, demonstrated in previous clinical studies, including several Phase 1 and Phase 2 studies in different indications, in approximately 200 patients.
"South Africa continues to face an onslaught of COVID-19 that is claiming many lives and causing significant distress to the healthcare system. South Africa, along with the U.S. and rest of the world, urgently need the ability to easily and effectively treat COVID-19 and its variants, both inside and outside the hospital setting," said Terry F. Plasse MD, Medical Director at RedHill. "As clearly highlighted recently by the Director of NIAID, it is important to be able to treat patients early in the course of the disease to prevent progression to more severe symptoms. The approval of this study in South Africa, along with the expansion of study sites in the U.S., are aimed at accelerating our efforts to bring RedHill's two novel, oral compounds that cover the spectrum of COVID-19 disease severity, RHB-107 and opaganib, to patients across the world."
The Phase 2/3 study (NCT04723527) with RHB-107 is aimed at evaluating treatment in patients with symptomatic COVID-19 early in the course of the disease, with a simple once-daily oral treatment that can be prescribed and used in the largest, non-hospitalized, patient population. The study is a 2-part, multicenter, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the safety and efficacy of RHB-107. The study is designed for dose selection and to evaluate time to sustained recovery from illness as the primary endpoint. Patients are also tested for specific viral strain.
In parallel, top-line results are upcoming from the opaganib[2] global 475-patient Phase 2/3 study in patients hospitalized with severe COVID-19 - RedHill's other advanced COVID-19 oral drug candidate.
About RHB-107 (upamostat)
RHB-107 is a proprietary, first-in-class, orally-administered antiviral, that targets human serine proteases involved in preparing the spike protein for viral entry into target cells. RHB-107 targets human cell factors involved in preparing the spike protein for viral entry into target cells and is therefore expected to be effective against emerging viral variants with mutations in the spike protein. RHB-107 is being evaluated in a Phase 2/3 study for treatment of patients with symptomatic COVID-19 who do not require inpatient care. In addition, RHB-107 has potential in several indications in oncology, inflammatory and gastrointestinal disease. RHB-107 has undergone several Phase 1 studies and two Phase 2 studies, demonstrating its clinical safety profile in approximately 200 patients. 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.
A very frustrating situation, no doubt
about it. I am still with high hopes,
and no, i don't think anybody knows
the results.
Last 3 day drop seems to indicate that the results are not that good.
THEY-ARE-PROBABLY-TRYING-TO-DILUTE-THE-SHIIT-OUT-OF-THIS-BEFORE-THEY-GIVE-THE-RESULTS. TWO MONTHS DURING A PANDEMIC IS DISGUSTING.
TWO-FING-MONTHS-TO-FIGURE-OUT-THE-FING-RESULTS-OF-A-TRIAL.-THEY-ALREADY-KNOW-THE-KIDNEY-SHIT-BUT-THEY-DON'T KNOW THE REST. TOTAL ASSHOOOLES
I wonder how will RDHL hold should
Opaganib prove a HUGE success?
Will the pattern be similar?
Time will tell!
As expected this stock gave up all the gains. No sustaining power
Daily volume of 2-3 average 3 months
volume indeed speaks volumes!
More exposure, much more interest.
Indeed, although every now and then we find out Opangib is a pill for every maladie, today for the kidneys.
It is fun to keep waiting for the results
Recent research has shown that after acute kidney injury, which we know can be a result of COVID-19 infection, the kidneys often fail to repair themselves properly and that sphingosine kinase-2 (SK2), which is inhibited by opaganib, is part of this process. These findings provide further support for the extensive work we are doing with opaganib in COVID-19. With the upcoming readout, we expect to learn more about kidney outcomes from hospitalized COVID-19 patients treated with opaganib in our global Phase 2/3 study."
Opaganib's global 475-patient Phase 2/3 study in hospitalized patients with COVID-19 has completed its treatment and follow up phase, and study top-line results are upcoming.
RedHill Biopharma's Opaganib Demonstrates Significant Decrease of Kidney Fibrosis
https://finance.yahoo.com/news/redhill-biopharmas-opaganib-demonstrates-significant-110200501.html
COVID-19 and long COVID patients are at increased risk of developing kidney damage
-
Opaganib significantly decreased kidney fibrosis in a preclinical in vivo model
-
Renal fibrosis is a progressive process which occurs in patients with chronic kidney disease (CKD) and can ultimately lead to end-stage renal failure
-
Opaganib is a novel, late clinical-stage oral pill drug candidate with dual anti-inflammatory and antiviral activity and has already demonstrated strong inhibition against variants of concern, including Delta
-
The global 475-patient Phase 2/3 study with opaganib oral pill in hospitalized COVID-19 patients has completed treatment and follow up phase, with top-line results upcoming
TEL AVIV, ISRAEL and RALEIGH, NC / ACCESSWIRE / September 7, 2021 / RedHill Biopharma Ltd. (NASDAQ:RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today announced results of a new preclinical study demonstrating opaganib's (ABC294640)[1] efficacy in significantly decreasing renal fibrosis in a unilateral ureteral obstruction-induced renal interstitial fibrosis model. Reports suggest that over 20% of hospitalized COVID-19 patients experience acute renal failure[2].
Kidney fibrosis generally leads to loss of tissue function and subsequent organ failure, with high mortality rate. New therapeutic small molecules to modulate fibrosis are urgently needed. The aim of the in vivo efficacy study was to verify the effect of opaganib on kidney inflammation and fibrosis in a unilateral ureteral obstruction (UUO) model - a well characterized model for renal fibrosis. Results from the study showed that opaganib significantly decreased renal fibrosis.
"A final, common pathway in chronic kidney disease is fibrosis, the formation of internal scar tissue, which can cause devastating effects and can ultimately lead to end-stage kidney failure. This new preclinical data, demonstrating opaganib's ability to decrease kidney fibrosis, along with its observed anti-inflammatory properties, positions opaganib as a potential novel therapy for the millions of patients suffering from chronic kidney disease and potentially extends to COVID-19 patients with Acute Kidney Injury (AKI) who are at risk of developing renal fibrosis," said Reza Fathi, PhD., RedHill's Senior VP, R&D. "Kidney injury and its associated progression to fibrosis is an important facet in both the acute phase of COVID-19 and in long COVID. Recent research has shown that after acute kidney injury, which we know can be a result of COVID-19 infection, the kidneys often fail to repair themselves properly and that sphingosine kinase-2 (SK2), which is inhibited by opaganib, is part of this process. These findings provide further support for the extensive work we are doing with opaganib in COVID-19. With the upcoming readout, we expect to learn more about kidney outcomes from hospitalized COVID-19 patients treated with opaganib in our global Phase 2/3 study."
Renal fibrosis, a common outcome of chronic kidney disease (CKD), is characterized by an excessive accumulation and deposition of extracellular matrix (ECM) components and fibrous tissue. Renal fibrosis may ultimately lead to end-stage renal failure, a devastating disorder that requires dialysis or kidney transplantation. CKD is a very common disease, affecting 15% of U.S. adults[3].
Recent studies have found that patients infected with SARS-CoV-2 are at increased risk of developing kidney damage, as well as chronic and end-stage kidney disease., associated with morbidity and mortality in these patients. Findings have suggested that beyond the acute phase of the disease, COVID-19 survivors, even those who did not require hospitalization, exhibit an increased risk of developing major adverse kidney disease such as CKD. In addition, data suggests that approximately 10% of people infected with COVID-19 may experience long COVID (post-acute sequalae), potentially involving acute kidney-related outcomes[4].
Opaganib, a leading novel small molecule investigational oral pill in development for the treatment of COVID-19, is a unique host targeted, dual antiviral and anti-inflammatory drug that acts on the cause and effect of COVID-19. It is believed to exert its antiviral effect by selectively inhibiting SK2, a key enzyme produced in human cells that may be recruited by the virus to support its replication. Opaganib's global 475-patient Phase 2/3 study in hospitalized patients with COVID-19 has completed its treatment and follow up phase, and study top-line results are upcoming.
Evaluations of blinded blended intubation and mortality rates from the Phase 2/3 study have been encouraging compared to reported rates of mortality from large platform studies such as RECOVERY, and other studies in similar patient populations[5]. Furthermore, the opaganib Phase 2/3 study has also passed four Data Safety Monitoring Board reviews, as well as a futility review, extending the total opaganib safety database to more than 460 patients and healthy subjects. Opaganib previously delivered positive U.S. Phase 2 data in patients with severe COVID-19, has been recently published in medRxiv. Additionally, encouraging use of opaganib under compassionate use exemption has been experienced in Israel and Switzerland.
About Opaganib (ABC294640)
Opaganib, a new chemical entity, is a proprietary, first-in-class, orally-administered, sphingosine kinase-2 (SK2) selective inhibitor, with dual anti-inflammatory and antiviral activity. Opaganib is host-targeted and is expected to be effective against emerging viral variants, having already demonstrated strong inhibition against variants of concern, including Delta. Opaganib has also shown anticancer activity and positive preclinical results in renal fibrosis, and also has the potential to target multiple oncology, viral, inflammatory, and gastrointestinal indications.
Opaganib is being evaluated as a treatment for COVID-19 pneumonia in a global Phase 2/3 study that has completed patient treatment and follow-up, with top-line results upcoming. Opaganib previously delivered positive U.S. Phase 2 data in patients with severe COVID-19, recently published in medRxiv.
Opaganib has also received Orphan Drug designation from the U.S. FDA for the treatment of cholangiocarcinoma and is being evaluated in a Phase 2a study in advanced cholangiocarcinoma and in a Phase 2 study in prostate cancer. Based on a preliminary review of partial unaudited data, the ongoing study in prostate cancer has met its primary endpoint. Patient accrual, treatment and analysis in this study are ongoing.
Opaganib demonstrated potent antiviral activity against SARS-CoV-2, the virus that causes COVID-19, inhibiting viral replication in an in vitro model of human lung bronchial tissue. Additionally, preclinical in vivo studies have demonstrated opaganib's potential to ameliorate inflammatory lung disorders, such as pneumonia, and have shown decreased fatality rates from influenza virus infection and amelioration of Pseudomonas aeruginosa-induced lung injury by reducing the levels of IL-6 and TNF-alpha in bronchoalveolar lavage fluids[6].
The ongoing clinical studies with opaganib are registered on www.ClinicalTrials.gov, a web-based service by the U.S. National Institute of Health, which provides public access to information on publicly and privately supported clinical studies.
RedHill Biopharma Presents Three New Analyses of Movantik Data at PAINWeek 2021
https://finance.yahoo.com/news/redhill-biopharma-presents-three-analyses-100000757.html
[url]- Two new analyses of Movantik® (naloxegol) data evaluated the safety and efficacy of Movantik in a subgroup of patients aged ≥ 65 years
- Analysis of Movantik effects on rapid and sustained improvement of both spontaneous and complete spontaneous bowel movements in the Movantik group vs. placebo were evaluated across high and low opioid dosages
- Movantik is the U.S. market-leading oral peripherally acting mu-opioid receptor antagonist (PAMORA), approved to treat opioid-induced constipation in adults with chronic non-cancer pain[/url][tag]insert-text-here[/tag]
TEL AVIV, Israel and RALEIGH, N.C., Sept. 7, 2021 /PRNewswire/ -- RedHill Biopharma Ltd. (Nasdaq: RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today announced presentation at PAINWeek 2021 of three new analyses of Movantik® (naloxegol) Phase 3 study data demonstrating rapid onset of action and sustained and predictable improvement of key symptoms associated with opioid-induced constipation (OIC) in both a subgroup of patients aged ≥ 65 and across both low and high dose opioid therapy.
Two of the posters are dedicated to the subgroup of patients aged ≥ 65, with Movantik achieving significantly better response rates vs. placebo, with rapid onset of action and a higher proportion of subjects achieving spontaneous bowel movement (SBM) and complete spontaneous bowel movement (CSBM) over the first 48 hours of treatment. Additional presented data also shows that naloxegol delivers similar rapid and sustained symptom improvement for patients, irrespective of the opioid dose they are prescribed, including at doses lower than 100 mg of morphine equivalent. The authors conclude that even with lower doses of morphine equivalent, clinicians should be diligent about treating these patients because they still are susceptible to OIC.
The three analyses included pooled data from two large, robust, identically designed Phase 3 studies of Movantik (Kodiak 4 and Kodiak 5; NCT01309841/NCT01323790), involving 891 treated patients across two doses (12.5 mg and 25 mg), compared to a total of 446 patients in the placebo arms.
"With up to 90% of older patients receiving opioids to help cope with chronic pain, and up to 86% of them suffering from symptoms of OIC, these new analyses are particularly important in helping these patients achieve satisfactory control of their pain without the added burden of OIC. Older patients tend to be more susceptible to OIC due to comorbidities, polypharmacy, and reduced physical activity, and it is vital that they have access to therapies such as Movantik, that are shown to be effective in this challenging patient group." said Dr. Lynn Webster, Pain Researcher and Clinician and Senior Fellow at the Center of U.S. Policy.
"There has been a shift in clinical practice to try to reduce doses of opioids used to treat chronic pain. However, low dose opioid therapy can prove to be equally troublesome in terms of treatment-related constipation as higher doses and it is important that physicians are diligent in monitoring for signs of OIC," said Dr. June Almenoff, MD, Ph.D., RedHill's Chief Scientific Officer. "This new analysis showing Movantik's efficacy irrespective of opioid dose is equally important in supporting the clinical shift to low dose opioid therapy through the management of OIC which can be expected in between 40-80% of patients taking chronic opioid therapy[1]."
New Movantik (Naloxegol) Analyses Presented at PAINWeek 2021:
Poster 1 (poster number 55):
Naloxegol Provided Rapid Onset of Time to First Spontaneous Bowel Movement (SBM), Complete SBM and Predictable Efficacy in Older Adults (Age ≥ 65 Yrs): A Pooled Analysis of Two Phase 3 Studies
Authors: Lynn Webster, Charles Argoff, Charles H. McLeskey, Carol B. Rockett, Enoch Bortey, Theresa Mallick-Searle, Martin Hale
Poster 2 (poster number 59):
Naloxegol Provided Rapid and Sustained Improvement of Opioid-Induced Constipation (OIC)
Symptoms in Older Adults Age ≥ 65 Yrs: A Pooled Analysis of Two Phase 3 Studies
Authors: Martin Hale, Charles Argoff, Charles H. McLeskey, Carol B. Rockett, Enoch Bortey, Theresa Mallick-Searle, Lynn Webster
Poster 3 (poster number 30):
Naloxegol Provides Rapid and Sustained Improvement of Opioid-Induced Constipation (OIC)
Symptoms Irrespective of Opioid Dose: A Pooled Analysis of Two Phase 3 Studies
Authors: Jeffrey Gudin, Jeremy A. Adler, June Almenoff, Carol B. Rockett, Enoch Bortey, Richard Rauck, Lynn Webster
YES AND AT THAT TIME THEY SAID RESULTS IN THE COMING WEEKS. ITS UP TO 2 MONTHS, NOT THE COMING WEEKS.. AND AS THEY DICK AROUND PEOPLE ARE DIEING.
The company issued PR on 19th Jul - we are entering into 8th week. This is sufficient time for topline results. They may not have sub-group analysis.
If the topline results are good then they will try to get them out as soon as possible without sub-group analysis.
———-
/ July 19, 2021 / RedHill Biopharma Ltd. (NASDAQ:RDHL) ('RedHill' or the 'Company'), a specialty pharma company that is a leader in the development of novel oral therapies for COVID-19, today announced that all treatment and follow-up has now been completed in the 475-patient global Phase 2/3 study with opaganib (ABC294640) [1] in patients hospitalized with severe COVID-19 pneumonia (NCT04467840).
I think the topline results could
come next week
RDHL market cap is $484 million
This is a company with 3 products on market - not making profit but supporting the sales staff and other expenses.
If the results come good - it can easily double and still have market cap less than $ 1 Billion
Once it is declared as Covid play - a market cap of $2-3 B is norm. So there are good possibility - fingers crossed
I think the topline results could come next week
Perhaps after announcing positive phase
2/3 Opaganib, just maybe then, will
RDHL hold $10 for 10 days in a row!
Serious: I am pretty confident that
if the results will be by amazing
flying colours, sp will shoot up by
100% minimum.
And if the announcement will be coupled
with a distribution agreement with BP,
price will appreciate even more.
I would love it to stay above $10 for 10 days in a row then only we can say it is moving up - even then it is on shaky ground but it is 1st step
Indeed so, very unlike eg ORMP!
This stock can never keep the gains - not a fighter - gives back the gains very easily
SA Capital Partners LLP Increases Stock Holdings in RedHill Biopharma Ltd. (NASDAQ:RDHL)
Posted by Max Byerly on Sep 3rd, 2021
https://www.tickerreport.com/banking-finance/7841425/gsa-capital-partners-llp-increases-stock-holdings-in-redhill-biopharma-ltd-nasdaqrdhl.html
RedHill Biopharma logoGSA Capital Partners LLP lifted its position in RedHill Biopharma Ltd. (NASDAQ:RDHL) by 350.5% during the second quarter, according to the company in its most recent Form 13F filing with the Securities and Exchange Commission. The institutional investor owned 81,778 shares of the biotechnology company’s stock after buying an additional 63,627 shares during the quarter. GSA Capital Partners LLP owned approximately 0.18% of RedHill Biopharma worth $563,000 at the end of the most recent quarter.
Other institutional investors have also recently made changes to their positions in the company. Great Point Partners LLC purchased a new stake in RedHill Biopharma in the first quarter valued at approximately $5,163,000. ARK Investment Management LLC raised its stake in RedHill Biopharma by 365.2% in the first quarter. ARK Investment Management LLC now owns 775,698 shares of the biotechnology company’s stock valued at $5,678,000 after purchasing an additional 608,949 shares in the last quarter. DAFNA Capital Management LLC purchased a new stake in RedHill Biopharma in the first quarter valued at approximately $3,337,000. Ibex Investors LLC raised its stake in RedHill Biopharma by 17.1% in the first quarter. Ibex Investors LLC now owns 2,216,793 shares of the biotechnology company’s stock valued at $16,227,000 after purchasing an additional 324,200 shares in the last quarter. Finally, Psagot Investment House Ltd. purchased a new stake in RedHill Biopharma in the first quarter valued at approximately $1,402,000. 19.96% of the stock is currently owned by hedge funds and other institutional investors.
RDHL has been the topic of a number of recent analyst reports. BTIG Research reaffirmed a “buy” rating and issued a $26.00 target price on shares of RedHill Biopharma in a research note on Monday, May 31st. Cantor Fitzgerald started coverage on shares of RedHill Biopharma in a research note on Tuesday. They issued an “overweight” rating and a $22.00 target price on the stock. Roth Capital reiterated a “buy” rating on shares of RedHill Biopharma in a research report on Tuesday, June 1st. HC Wainwright reiterated a “buy” rating and set a $23.00 price target on shares of RedHill Biopharma in a research report on Monday. Finally, Zacks Investment Research cut shares of RedHill Biopharma from a “hold” rating to a “sell” rating in a research report on Wednesday. One analyst has rated the stock with a sell rating and six have given a buy rating to the stock. Based on data from MarketBeat, RedHill Biopharma has an average rating of “Buy” and a consensus target price of $20.17.
so how many shares did they sell today
RedHill Biopharma to Present at H.C. Wainwright Annual Global Investment and Cantor Global Healthcare Conferences
Thu, September 2, 2021, 5:00 PM
https://finance.yahoo.com/news/redhill-biopharma-present-h-c-140000858.html
TEL AVIV, Israel and RALEIGH, NC, Sept. 2, 2021 /PRNewswire/ -- RedHill Biopharma Ltd. (Nasdaq: RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today announced that it will present at the following virtual conferences in September:
H.C. Wainwright 23rd Annual Global Investment Conference (September 13-15, 2021)
Presentation: Available from Monday, September 13, 2021, 7:00 a.m. EDT
Speaker: Guy Goldberg, Chief Business Officer
Cantor Global Healthcare Conference (September 27-30, 2021)
Fireside chat: will be broadcast live on Thursday, September 30, 2021, 8:40 a.m. EDT and available for replay
Moderator: Brandon Folkes, CFA, Director, Equity Research – Healthcare, Biopharma
Speaker: Guy Goldberg, Chief Business Officer
The webcasts will be available for 30 days on the Company's website under the Investors page: www.redhillbio.com.
With the new variants coming every day - the Covid management strategy will change
1. People will try to find vaccines that create antibodies based on non-spike proteins as those parts of Covid virus do not change.
RDHL is one that is really driving that approach. So they need to start the trial and that will make this as an official Covid play
2. Develop Therapeutics to address the cases and avoid hospitalization and deaths
MRK -PFE -PFE are upfront in the efforts
The 475 patient results which may come next week is very key - that may trigger substantial up movement and 50% down movement
Pfizer, Merck test oral COVID-19 therapeutics; Oral vaccine on the way?
Sep. 02, 2021 5:57 AM ETMRK, MRNA...By: Yoel Minkoff, SA News Editor
(I am completely pissed off RDHL not included )
#msg-165741013 (although I am invested in ORMP too)
Oral drugs that combat COVID-19 are garnering interest from drugmakers and countries alike, as the coronavirus battle moves beyond jabs and syringes. Pfizer (NYSE:PFE) and Merck (NYSE:MRK) have both announced the start of trials to test oral antiviral medications that target the disease. The race to develop an easy-to-administer treatment comes amid growing interest in the market for coronavirus therapeutics as the threat of COVID-19 sticks around for the foreseeable future.
Pfizer's latest mid-to-late-stage trial will enroll 1,140 non-hospitalized adults diagnosed with coronavirus infection who are not at risk of severe illness. They'll be given Pfizer's pill, known as PF-07321332, as well as a low dose of ritonavir, which is widely used in combination with HIV treatments.
Merck's trial will study experimental drug molnupiravir for the prevention of COVID-19 among adults who live in the same household as a person with a symptomatic coronavirus infection.
Over in Israel: The country announced in July that it would be the first in the world to test an oral COVID-19 vaccine developed by Oramed Pharmaceuticals (NASDAQ:ORMP). The first trial will involve 24 unvaccinated volunteers, each taking one or two pills, before moving on to larger Phase 3 trials if successful. The vaccine should be "much more resistant to Covid-19 variants," according to Oramed CEO Nadav Kidron, since it trains the immune system against three viral proteins instead of the single protein targeted by Pfizer and Moderna's (NASDAQ:MRNA) shots.
]HC Wainwright Reiterates “Buy” Rating for RedHill Biopharma (NASDAQ:RDHL)
https://zolmax.com/investing/hc-wainwright-reiterates-buy-rating-for-redhill-biopharma-nasdaqrdhl/6235817.html
Posted by John Perry on Sep 1st, 2021
RedHill Biopharma logoRedHill Biopharma (NASDAQ:RDHL)‘s stock had its “buy” rating reissued by analysts at HC Wainwright in a research report issued on Monday, TipRanks reports. They presently have a $23.00 price objective on the biotechnology company’s stock. HC Wainwright’s price target points to a potential upside of 127.72% from the stock’s previous close.
Several institutional investors and hedge funds have recently made changes to their positions in the company. Ibex Investors LLC boosted its stake in shares of RedHill Biopharma by 17.1% during the first quarter. Ibex Investors LLC now owns 2,216,793 shares of the biotechnology company’s stock worth $16,227,000 after buying an additional 324,200 shares during the period. Disciplined Growth Investors Inc. MN boosted its stake in shares of RedHill Biopharma by 8.1% during the second quarter. Disciplined Growth Investors Inc. MN now owns 1,976,476 shares of the biotechnology company’s stock worth $13,598,000 after buying an additional 147,889 shares during the period. ARK Investment Management LLC lifted its position in RedHill Biopharma by 1.5% in the second quarter. ARK Investment Management LLC now owns 787,469 shares of the biotechnology company’s stock valued at $5,418,000 after purchasing an additional 11,771 shares during the period. Great Point Partners LLC acquired a new stake in RedHill Biopharma in the first quarter valued at about $5,163,000. Finally, DAFNA Capital Management LLC acquired a new stake in RedHill Biopharma in the first quarter valued at about $3,337,000. Institutional investors and hedge funds own 19.96% of the company’s stock.
There is no doubt, RDHL has become
a Gorilla stock as the volume proves!
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NCI
BARDA
U.S. Department of Defense
FDA Office of Orphan Products Development
Top-line data from the 270-patient global Phase 2/3 COVID-19 study expected Q1/2021
Top-line data from the 40-patient U.S. Phase 2 study of opaganib in severe COVID-19 expected in the coming days; this non-powered study was designed to evaluate safety and potential identification of preliminary efficacy signals in support of the global Phase 2/3 study of opaganib
(Posted 12/22/2020)
21 Ha'arba'a Street
Tel Aviv 6473921
Israel
972 3 541 3131
http://www.redhillbio.com
[1] https://www.redhillbio.com/RedHill/Templates/showpage.asp?DBID=1&LNGID=1&TMID=178&FID=1358&PID=0&IID=1899
[2] https://www.redhillbio.com/RedHill/Templates/showpage.asp?DBID=1&LNGID=1&TMID=178&FID=2432&PID=0&IID=17299
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