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So what is their next play sit around and do nothing then do another offerining in about three months?
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.
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.
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.
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.
One step forward, two steps back!
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.
They never ever cease to amaze me you just knew they were gong to destroy everythign with an offering. They are so predictable.
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........
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
1.1500 +0.0700 (+6.4815%)
Pre-Market: 08:33AM EST
Momentum Continues!
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 – especially clarithromycin – 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 pylori–Induced inflammatory response in the development of gastric cancer. J Cell Biochem 2013;114.3:491-497.
[9] NIH – 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®
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.
This price movement has to be more than just earnings announcements, please make it be so.
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?
1.1799+0.2884 (+32.3500%)
As of 01:39PM EST. Market open.
This huge uptick due to a patent?
1.1100 +0.2185 (+24.5093%)
Pre-Market-05:06AM EST
Even Better!
$RDHL 1.0700 +0.1785 (+20.0224%)
Pre-Market: 05:06AM EST
I smell good news!
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.
1.5600 +0.07 (+4.70%)
Pre-Market: 08:42AM EST
Hopefully sp will hold and increase today!
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.
And volume is looking good so far…
1.5900+0.1200 (+8.1633%)
As of 10:24AM EST. Market open.
Thank You. Happy Holidays
and GLTU.
Thanks, hopefully you were able to enjoy the holiday season. Good luck to everyone there.
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.
“The SEC requires that companies report ?their quarterly earnings on Form 10-Q no later than ?35 days from the end of its fiscal quarter.”
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.
1.4800+0.2000 (+15.6250%)
As of 01:19PM EST. Market open.
HOD
It is very odd but that has to be the case of they would released by now.
Next leg much higher. Break 1.68. Off to races.
A reply today to my request of yesterday:
Entire float gobbled. Squeeze imminent
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.
q3 has been over for 2.5 months everyone else on the planet has already reported.
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.
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 “robust synergistic effect” when individually combined with the antiviral drug remdesivir, also known as Veklury. The company said the combinations showed “significantly improved viral inhibition” without increasing toxicity.
The combination of opaganib and remdesivir exhibited the greatest synergistic effect, according to the statement.
“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,” 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.
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 solutions—therapeutics, vaccines, diagnostics, and information—that benefit both military personnel and civilians. USAMRIID is a subordinate laboratory of the U.S. Army Medical Research and Development Command.
I have NOT asked to be informed privately,
rather that RDHL announces publicly the Q3
results.
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 “everyone”.
Upon my 3rd request over the last 2 weeks, this was the reply:
They were telling you they had not yet publicly announced…?
I did not request non public information.
This was my 3rd request for RDHL to
announce Q3 results.
Mind you, RDHL according to sec rules
results should be published one or two weeks
after the last month of each quarter.
Q4 is over in less than 2 weeks time, hence i
guess results for fiscal 2023 will be published
somewhere around 2025?
Ha!
They have to reply like that; otherwise they would be giving individuals non-public information. You might then be trading on non-public information, at some advantage over other investors.
1.3068+0.1668 (+14.6316%)
As of 01:04PM EST. Market open.
Getting better ....
1.2750+0.1350 (+11.8421%)
As of 12:29PM EST. Market open.
Nice uptick on relative robust volume.
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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)
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[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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02-07-2021
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