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RedHill Biopharma to Host Third Quarter 2021 Financial Results and Operational Highlights Webcast on November 30, 2021
https://finance.yahoo.com/news/redhill-biopharma-host-third-quarter-120000923.html
TEL AVIV, Israel and RALEIGH, N.C., Nov. 24, 2021 /PRNewswire/ -- RedHill Biopharma Ltd. (Nasdaq: RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today announced that it will report its third quarter 2021 financial results and operational highlights on Tuesday, November 30, 2021.
The Company will host a webcast on Tuesday, November 30, 2021, at 8:30 a.m. EST, during which it will present key highlights for the third quarter of 2021.
The webcast including slides will be broadcast live on the Company's website, https://ir.redhillbio.com/events, and will be available for replay for 30 days.
To participate in the conference call, please dial one of the following numbers 15 minutes prior to the start of the call: United States: +1-877-870-9135; International: +1-646-741-3167 and Israel:
+972-3-530-8845; the access code for the call is: 9753927 .
RedHill Biopharma Announces Closing of $15.5 Million Public Offering of American Depositary Shares
https://finance.yahoo.com/news/redhill-biopharma-announces-closing-15-161000809.html
TEL AVIV, Israel and RALEIGH, N.C., Nov. 23, 2021 /PRNewswire/ -- RedHill Biopharma Ltd. (Nasdaq: RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today announced the closing of the previously announced underwritten public offering of approximately 4.7 million American Depositary Shares ("ADSs") for gross proceeds of approximately $15.5 million, before deducting the underwriting discounts and commissions and other estimated offering expenses payable by RedHill. Each ADS represents ten ordinary shares, par value NIS 0.01 per share, of the Company. All of the ADSs were offered by RedHill. In addition, RedHill has granted the underwriter a 30-day option to purchase up to approximately an additional 0.7 million ADSs.
Well - they have done the ‘F them’ to us.
My 2nd worst investment by far - lesson for me is - how not to believe management, be always skeptical and book losses and run away.
Bad management never improves and expecting as such is a miracle.
HOW MANY TIMES ARE THESE SCUMBAGS GOING TO DILUTE
"S.O.B.!" Did you see today's price? Pretty soon we will be able to get RDHL for a dollar a share! I hope my other stocks do well, so I can use RDHL as a tax write-off! Damn it!!!
RedHill Biopharma Announces Pricing of $15.5 Million Public Offering of American Depositary Shares
https://finance.yahoo.com/news/redhill-biopharma-announces-pricing-15-140000358.html
TEL AVIV, Israel and RALEIGH, N.C., Nov. 19, 2021 /PRNewswire/ -- RedHill Biopharma Ltd. (Nasdaq: RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today announced the pricing of an underwritten public offering of 4.7 million American Depositary Shares ("ADSs") for gross proceeds of $15.5 million, before deducting the underwriting discounts and commissions and other estimated offering expenses payable by RedHill. Each ADS represents ten ordinary shares, par value NIS 0.01 per share, of the Company. All of the ADSs are being offered by RedHill. The closing of the offering is expected to occur on or about November 23, 2021, subject to the satisfaction of customary closing conditions. In addition, RedHill has granted the underwriter a 30-day option to purchase up to an additional 0.7 million ADSs.
Cantor Fitzgerald & Co. is acting as sole bookrunner for the offering.
The underwriter may offer the ADSs from time to time for sale in one or more transactions on the Nasdaq Global Market, in the over-the-counter market, through negotiated transactions or otherwise at market prices prevailing at the time of sale, at prices related to prevailing market prices or at negotiated prices. On November 18, 2021, the last sale price of the ADSs as reported on the Nasdaq Global Market was $3.88 per ADS.
RedHill intends to use the net proceeds of the offering to fund its commercialization activities, clinical development programs and for acquisitions and general corporate purposes.
Pfizer moves to allow cheaper COVID-19 pills sending shares of rivals lower
Nov. 16, 2021 9:04 AM ETModerna, Inc. (MRNA), AZN,BNTX,RHHBYPFE, JNJ, MRK,AVIR,RDHL,ADGI,VIR,REGN,LLY,GILD
By: Dulan Lokuwithana, SA News Editor
Established COVID-19 vaccine makers have come under pressure after Pfizer (NYSE:PFE) and a United Nations-backed public health organization announced a licensing pact to allow generic-drugmakers to produce cheaper versions of the company’s experimental COVID-19 pill.
Moderna (NASDAQ:MRNA), AstraZeneca (NASDAQ:AZN), and Pfizer’s (PFE) partner in COVID-19 vaccine development BioNTech (NASDAQ:BNTX) have lost ~1.4%, ~3.1%, and ~1.0% in the pre-market, respectively. Johnson & Johnson (NYSE:JNJ) and is trading flat.
The licensing deal by Pfizer (PFE) to enable wider access to its COVID-19 therapeutic follows a similar deal from the rival drugmaker Merck (NYSE:MRK) for its investigational pill, molnupiravir. Merck (MRK) has shed ~1.0% in early trading.
The shares of early-stage developers of oral COVID-19 therapies such as Atea Pharmaceuticals (NASDAQ:AVIR)/ Roche (OTCQX:RHHBY), RedHill Biopharma (NASDAQ:RDHL), and Adagio Therapeutics (NASDAQ:ADGI) are also expected to open lower.
Stocks to watch: Established manufacturers of COVID-19 antibody treatments such as Vir Biotechnology (NASDAQ:VIR), Regeneron (NASDAQ:REGN), Eli Lilly (NYSE:LLY) as well as Gilead (NASDAQ:GILD), which produces the intravenously administered COVID-19 therapy Remdesivir.
In terms of effectiveness, Pfizer (PFE)) and its rival Merck (MRK) have demonstrated about 89% and ~50% effectiveness for their oral COVID-19 drugs, PAXLOVID, and molnupiravir in late-stage trials, respectively.
RedHill Biopharma Ltd Announces RedHill: LPI in Part A of RHB-107 P2/3 COVID Study
https://finance.yahoo.com/news/redhill-biopharma-ltd-announces-redhill-120200532.html
RedHill Biopharma Announces Last Patient Randomized in Part A of Ongoing Phase 2/3 COVID-19 Study of Once-Daily Oral RHB-107 in Non-Hospitalized Patients
Recruitment completed for Part A of 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
Top-line results for Part A of the study, designed to evaluate safety and tolerability of RHB-107 and dose selection, expected in Q1/ 22
RHB-107 is a novel, investigational antiviral serine protease inhibitor targeting human cell factors and is expected to be effective against emerging viral variants
In parallel, data packages for opaganib, RedHill's other advanced novel oral COVID-19 drug candidate, have been submitted in the U.S., EU, UK and other territories, ahead of planned regulatory advice
TEL AVIV, ISRAEL and RALEIGH, NC / ACCESSWIRE / November 15, 2021 / RedHill Biopharma Ltd. (Nasdaq:RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today announced that the last patient has been enrolled in Part A of 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 being conducted in the U.S. and South Africa.
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 once-daily oral treatment that can be prescribed and used in the 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 to evaluate time to sustained recovery from illness as the primary endpoint and for dose selection. A total of 61 patients have been enrolled in Part A and randomized on a 1:1:1 basis to receive one of two doses of upamostat or placebo. Based on safety and tolerability results of part A, a dose for part B will be selected, and patients will be randomized 3:2 to active vs. placebo. Patients are also tested for specific viral strain. Top-line results from Part A of the study are expected in the first quarter of 2022, with Part B of the study expected to follow subsequent to discussions with regulators.
"Once again, we see a rise in COVID-19 infections in many countries across the world - and the need for effective, simple and safe oral therapies that can be used outside the hospital setting, and that can work across COVID-19 variants, is significant," said Terry F. Plasse MD, Medical Director at RedHill. "Completing randomization for Part A of the RHB-107 Phase 2/3 study is an important step forward for this elegant, once-daily novel oral pill as a potential treatment of COVID-19 in the community."
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.
In parallel, data packages for opaganib[2], RedHill's other advanced novel oral COVID-19 drug candidate - have been submitted to regulators in various territories including the U.S., EU, UK and others, ahead of planned regulatory advice. Opaganib's global Phase 2/3 study in patients hospitalized with severe COVID-19 demonstrated a 62% reduction in mortality as well as improved outcomes in time to room air and median time to hospital discharge in a sub-group of 251 moderately severe patients, comprising 54% of the study participants.
RedHill Biopharma to Present at H.C. Wainwright 7th Annual Israel Conference and German Equity Forum (EKF) 2021
https://finance.yahoo.com/news/redhill-biopharma-present-h-c-120000312.html
TEL-AVIV, Israel and RALEIGH, N.C., Nov. 9, 2021 /PRNewswire/ -- RedHill Biopharma Ltd. (Nasdaq: RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today announced that Mr. Guy Goldberg, RedHill's Chief Business Officer, will present an overview of the Company and host 1-on-1 investor meetings at the following virtual conferences in November:
H.C. Wainwright 7th Annual Israel Conference - November 15, 2021
Presentation: Monday, November 15, 2021, at 8:00 a.m. EST
Webcast: Live and on-demand for 30 days: https://www.redhillbio.com/investors
German Equity Forum (Deutsches Eigenkapital Forum, EKF) - November 22-24, 2021
Presentation: Tuesday, November 23, 2021, at 14:30 CET / 8:30 a.m. EST
Webcast: On-demand after the conference for 30 days: https://www.redhillbio.com/investors
RedHill Biopharma and South Korea's Kukbo Co. Announce a Strategic Investment of Up To $10 Million in RedHill
https://finance.yahoo.com/news/redhill-biopharma-south-koreas-kukbo-121500390.html
RedHill received the first tranche of $5 million in a private placement of restricted stock priced at $6.04 per ADS, representing a 20% premium based on the 30 trading days' volume weighted average price (VWAP) ending on the effective date
RedHill granted Kukbo a right of first offer for opaganib, RHB-107 (upamostat) and Talicia® for South Korea and other Asian territories
Opaganib's COVID-19 data packages submission process is advancing in various territories including the U.S., EU, Latin America and others, ahead of planned regulatory advice
TEL AVIV, ISRAEL and RALEIGH, NC / ACCESSWIRE / November 8, 2021 /RedHill Biopharma Ltd.(Nasdaq:RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today announced that it has entered into a strategic agreement with Kukbo Co. Ltd. (Kospi: 001140) ("Kukbo"), a South Korean corporation, for the sale of RedHill's American Depositary Shares ("ADSs") in a private placement of up to $10 million at a 20% premium to the prior 30 trading days' volume weighted average price ("VWAP").
Kukbo's strategic investment in RedHill is to be made in two tranches, with the first tranche of $5 million already paid and the second tranche of $5 million to follow within six months, subject to satisfaction of certain conditions. As part of the first tranche, RedHill is to issue 827,586 ADSs at a purchase price of $6.04, representing a 20% premium based on the VWAP of RedHill's ADS on NASDAQ over the 30 trading days ending on the effective date. All ADSs are to be issued with a 180-day transfer restriction.
In addition, under the terms of the agreement, RedHill has agreed to grant Kukbo a right of first offer, for a period of six months, for a license with respect to one or more of RedHill's late-stage clinical assets, opaganib, RHB-107 (upamostat)[1] and Talicia®, for one or more of the territories of South Korea, Japan, Indonesia, Vietnam, Thailand and Malaysia. Kukbo has the right to elect not to purchase the ADSs in the second tranche if no such license agreement is executed within six months of the closing of the first tranche.
Dror Ben-Asher, RedHill's CEOsaid: "We are rapidly advancing with opaganib's COVID-19 data package submissions to regulators in several territories including the U.S., EU and others, ahead of planned regulatory advice. We are pleased with the addition of Kukbo as a committed strategic investor and look forward to evaluating opportunities for opaganib, RHB-107 and Talicia in South Korea and other territories in Asia where large unmet medical needs exist."
"As Kukbo proceeds in its planned strategic expansion into healthcare, we believe that RedHill's opaganib, RHB-107 and Talicia, if approved, hold substantial promise in South Korea and other Asian countries and are eager to leverage our local expertise and network in those territories," said Hyun Ha, Kukbo's CEO.
Nexpedia Holdings Co., Ltd. and Network 1 Financial Securities, Inc. facilitated the introduction between the parties.
The securities to be sold in the private placement have not been registered under the Securities Act of 1933, as amended (the "Securities Act"), or any state or other applicable jurisdiction's securities laws, and may not be offered or sold in the United States absent registration or an applicable exemption from the registration requirements of the Securities Act and applicable state or other jurisdictions' securities laws.
This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any offer, solicitation, or sale of these securities in any jurisdiction in which such offer, solicitation or sale would be unlawful.
This will kill any hope for RDHL pill
Pfe ceo talked about capacity to mfr 500 million pills in 2022 - all others will need to get help to mfr - so they have clear advantage
Pfizer says antiviral pill cuts risk of severe COVID-19 by 89%
Nov 5 (Reuters) - A trial of Pfizer Inc's experimental antiviral pill for COVID-19 was stopped early after the drug was shown to cut by 89% the chances of hospitalization or death for adults at risk of developing severe disease, the company said on Friday.
The results appear to surpass those seen with Merck & Co Inc's pill molnupiravir, which was shown last month to halve the likelihood of dying or being hospitalized for COVID-19 patients also at high risk of serious illness.
Full trial data is not yet available from either company
-------------------------------------------------------------
Good news for mankind, bad news for RDHL
Great article - why are we stuck in low 5’s?
Price target of 22. When?
We ran over 10 several times - over 11 on 2/22/21
I’m looking for 22 on 2/22/22
Deuces Wild!!
Best Covid Vaccine and Pill Stocks To Invest In
https://finance.yahoo.com/news/11-best-covid-vaccine-pill-192121981.html
RedHill Biopharma Ltd. (NASDAQ:RDHL)
Number of Hedge Fund Holders: 4
In early October, RedHill Biopharma Ltd. (NASDAQ:RDHL) presented the results of a study into a new experimental drug, administered orally, for COVID-19 patients. The company, which operates from Israel, revealed that the drug reduced the risk of mortality in COVID-19 patients by up to 62% compared to a placebo. The share price of the firm jumped more than 6% after the results were announced.
In August, Cantor Fitzgerald analyst Brandon Folkes had initiated coverage of RedHill Biopharma Ltd. (NASDAQ:RDHL) stock with an Overweight rating and a price target of $22, noting that the firm was working on several interesting drugs, including two COVID-19 ones.
Among the hedge funds being tracked by Insider Monkey, New York-based investment firm ARK Investment Management is a leading shareholder in RedHill Biopharma Ltd. (NASDAQ:RDHL) with 787,469 shares worth more than $5.4 million.
RedHill Biopharma Presents New Talicia(R) and Movantik(R) Data Analyses at ACG 2021
https://finance.yahoo.com/news/redhill-biopharma-presents-talicia-r-110200370.html
Two new analyses evaluate pharmacological and clinical advantages of Talicia® as first-line
H. pylori therapy over clarithromycin-based regimens
-
Two new analyses of Movantik® data evaluate efficacy in treating extreme opioid-induced constipation with severe symptoms
-
Talicia®, an FDA approved therapy, is designed to replace clarithromycin-based regimens as first-line H. pylori eradication therapy; ACG Guideline recommends avoiding treatment with clarithromycin to eradicate H. pylori due to growing bacterial resistance
-
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
TEL-AVIV, ISRAEL and RALEIGH, NC / ACCESSWIRE / October 25, 2021 / RedHill Biopharma Ltd.(NASDAQ:RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today announced the presentation of four new analyses of Phase 3 Talicia® (omeprazole magnesium, amoxicillin and rifabutin)[1] and Movantik® (naloxegol)[2] data at the ACG 2021 Annual Scientific Meeting, taking place October 22-27, 2021.
The first Talicia analysis evaluated physician-directed therapy data, confirming high utilization of clarithromycin and low rates of H. pylori eradication. Inappropriate use of clarithromycin persists despite American College of Gastroenterology (ACG) recommendations to avoid clarithromycin when treating H. pylori patients who have a history of macrolide exposure, where local resistance rates are ≥ 15% or unknown, and/or when the patient has been previously treated with a clarithromycin-containing regimen. Utilization data based on U.S. prescriptions confirmed that clarithromycin-based regimens remain predominant, even though the majority of Americans have previously been prescribed a macrolide antibiotic[3]. The authors conclude that since Talicia does not contain clarithromycin, and resistance to amoxicillin and rifabutin is very rare, Talicia can be used first-line with minimal concern for antibiotic resistance or CYP2C19 metabolism.
The second Talicia analysis assessed gastric luminal rifabutin concentrations of three times a day rifabutin 50 mg (the dose of rifabutin within Talicia®) vs. once-daily administration of rifabutin 150 mg, and the potential impact on H. pylori eradication. The data suggest that there may be a link between sustained gastric rifabutin exposure achieved with Talicia's unique dosing and formulation and the 90% eradication rates seen in clinical studies. The findings demonstrate that rifabutin dosed once-daily as 150 mg cannot replicate both the pharmacokinetic profile and therapeutic effects of rifabutin 50 mg three-times daily (as dosed in Talicia®).
"Sustained high intragastric rifabutin concentrations explain the high clinical trial eradication rates seen with Talicia and suggest that three-times daily Talicia should be considered a first-line therapy for patients with H. pylori infection." said Dr. Colin W. Howden, MD, AGAF, FACG, Professor Emeritus, University of Tennessee Health Science Center. "Contrary to ACG guideline recommendations, many physicians continue to prescribe clarithromycin-based therapies to patients, resulting in low rates of eradication because of high rates of clarithromycin resistance."
The two Movantik posters analyzed data from patients experiencing extreme opioid-induced constipation (OIC) with severe symptoms. Both Movantik 12.5 mg and 25 mg provided rapid onset with early symptom relief and consistent, predictable and sustained efficacy in improving multiple symptoms despite high baseline symptom burden. Movantik also demonstrated a favorable safety-profile and tolerability.
The two analyses included pooled data from two large, pivotal 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.
"Chronic pain patients are already subject to considerable suffering. For up to 80% of them, this is compounded by opioid-induced constipation - with a significant number suffering from extreme OIC with severe and debilitating symptoms. Movantik demonstrated both rapid and durable symptom improvement which are highly important clinical considerations in patients with OIC" said Dr. Darren M. Brenner, MD, AGAF, Associate Professor of Medicine and Surgery at Northwestern University Feinberg School of Medicine and Director of the Gastrointestinal Physiology Laboratory and Functional Bowel Programs.
Posters Presented at ACG 2021 Annual Scientific Meeting:
Talicia:
Poster number 2029
RHB-105 Q8H Rifabutin Dosing Provides Favorable Exposure for Helicobacter pylori Eradication
Presenter: Dr. Colin W. Howden
Authors: Colin W. Howden, Salil N. Pendse, Mark A. Bush, June S. Almenoff, Kely L. Sheldon
Poster number 3083
Pitfalls of Physician-Directed Treatment of Helicobacter pylori Infection: Results from Two Phase 3 Clinical Trials and Real-World Prescribing Data
Presenter: Dr. Colin W. Howden
Authors: Colin W. Howden, Kely L. Sheldon, June S. Almenoff, William D. Chey
Movantik:
Poster number 0386
Naloxegol Accelerates Time to First Spontaneous Bowel Movement (SBM) and Complete SBM (CSBM) with Predictable Efficacy in Patients with Extreme Opioid-Induced Constipation (OIC): A Pooled Analysis of Two Phase 3 Trials
Presenter: Dr. Darren M. Brenner
Authors: William Chey, Carol B. Rockett, Jeremy Adler, Theresa Mallick-Searle, Enoch Bortey, Darren M. Brenner
Poster number 0397
Naloxegol Achieved Rapid and Sustained Improvement of Opioid-Induced Constipation (OIC) Symptoms in Patients with Extreme OIC: A Pooled Analysis of Two Pivotal Phase 3 Trials
Presenter: Dr. Darren M. Brenner
Authors: Darren M. Brenner, Carol B. Rockett, Jeremy Adler, Theresa Mallick-Searle, Enoch Bortey, William Chey
About Talicia®
Talicia® is the only rifabutin-based therapy approved for the treatment of H. pylori infection and is designed to address the high resistance of H. pylori bacteria to clarithromycin-based therapies. 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 by the ACG, FDA and the World Health Organization (WHO) in recent years.
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). In November 2019, Talicia® was approved by the U.S. FDA for the treatment of H. pylori infection in adults. 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[4] to their therapy had response rates of 90.3% in the Talicia® arm vs. 64.7% in the active comparator arm[5].
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.
About H. pylori
H. pylori is a bacterial infection that affects approximately 35%[6] 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 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 therapies[12].
As for RedHill, the insiders' purchases amounted to well under 1% of the biotech's outstanding shares. So why did the stock price jump so much? Investors love to see insider buying. It reinforces the impression that a company's board and executives are confident about the business's prospects.
RedHill plans to soon talk with regulators, including the FDA, about the next steps for its experimental COVID-19 pill, opaganib. Earlier this month, the company reported a statistically significant 62% reduction in mortality for the therapy among hospitalized patients with severe COVID-19 pneumonia.
https://www.fool.com/investing/2021/10/22/why-biontech-and-redhill-are-soaring-this-week-whi/?source=eptyholnk0000202&utm_source=yahoo-host&utm_medium=feed&utm_campaign=article
PEOPLE-THE-PILL-WORKS!!!!-62%-BETTER-CHANCE-TO-LIVE-MRK-PILL-IS-50%.
There is no hype and they do not have a partner so no clout to have same exposure as MRK
RedHill Biopharma to Present at the BIO-Europe 2021 Conference
Wed, October 20, 2021, 2:00 PM
https://finance.yahoo.com/news/redhill-biopharma-present-bio-europe-110000365.html
TEL AVIV, Israel and RALEIGH, N.C. , Oct. 20, 2021 /PRNewswire/ -- RedHill Biopharma Ltd. (Nasdaq: RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today announced that Mr. Adi Frish, RedHill's Chief Corporate & Business Development Officer, will present a corporate overview at the BIO-Europe Digital Conference, taking place October 25-28, 2021.
The presentation will be available on-demand for 30 days on the Company's website from the start of the conference: https://www.redhillbio.com/investors.
Whoa...presently up 20%...
"...a small, Israeli/U.S. upstart, RedHill Biopharma Ltd. (NASDAQ:RDHL), has quietly raced to the front of the pack for a novel COVID pill with its two-pronged oral development program..."
Thanks for the info midastouch!
David v Goliath in The Race to Develop an Oral Therapy for COVID-19
Broad agreement in the world of science can be a rarity. However, one thing that public health leaders active in the fight against COVID-19 can agree on, is the urgent need for oral, pill-based treatments that are effective at halting disease progression, can get — and keep — people out of the hospital and can reduce mortality. One key group of COVID-19 patients who are in desperate need of treatment options are those moderately severe patients in hospital who are at high risk of becoming critically ill, and for whom most drugs have so far failed to deliver.
A slew of promising drug candidates from big pharma such as Merck & Co. Inc. (NYSE:MRK), Roche Holdings AG (OTC:RHHBY), and Pfizer Inc. (NYSE:PFE) have so far either tried, and failed, to benefit this key majority group of hospitalized patients or are focused on managing much milder disease, in the outpatient setting, limited to within a few days from infection.
However, a small, Israeli/U.S. upstart, RedHill Biopharma Ltd. (NASDAQ:RDHL), has quietly raced to the front of the pack for a novel COVID pill with its two-pronged oral development program - one of which, opaganib, has just posted late-stage clinical data showing impressive mortality reduction figures in the underserved hospitalized patient population with moderately severe COVID-19.
RedHill believes this new data for its oral COVID-19 pill, opaganib, puts it ahead of some of the pharma behemoths who have struggled to show a benefit in hospitalized patients, outside of the earliest stages of disease. Moreover, opaganib, a sphingosine kinase-2 (SK2) inhibitor with a dual antiviral and anti-inflammatory action that targets human enzymes in cells in the body rather than the virus itself, has also delivered pre-clinical data demonstrating potent antiviral inhibition of SARS-CoV-2 variants, including the Beta, Gamma and Delta.
RedHill has recently reported new data from a post-hoc analysis of 251 hospitalized moderately severe COVID-19 pneumonia patients from its opaganib global Phase 2/3 study showing that treatment with opaganib versus the placebo-controlled arm resulted in a 62% reduction in mortality (nominal p-value=0.019). The new data also showed a 21% efficacy benefit with opaganib in reaching room air by Day 14, the study primary endpoint (nominal p-value=0.033), and a median four day benefit to hospital discharge for opaganib-treated patients vs. placebo (10 days for opaganib arm vs. 14 days for placebo; nominal p-value=0.0195). The moderately severe group comprised 53% of study participants requiring a Fraction of inspired Oxygen (FiO2) up to 60% at baseline (inhaled supplemental oxygen via nasal cannula or face mask).
RedHill believes that the new data makes oral opaganib a potential game-changer and, if approved, has the potential to save lives. RedHill is optimistic about opaganib for several reasons, including:
Easy to take, make and distribute oral pill formulation
A dual mechanism of action — antiviral and anti-inflammatory — acting on the viral cause and inflammatory effects of COVID-19
It inhibits a human host factor, not the virus itself, and has shown preclinically to be effective against variants including Beta, Gamma and Delta
Manufacturing scale-up capability and product stability data in place
Advanced clinical development with previous positive U.S. Phase 2 trial data and encouraging compassionate use in Israel and Switzerland
Good safety based on extensive database from additional oncology studies
RedHill promotes 3 U.S. Food and Drug Administration approved drugs with its experienced U.S. sales team and has built an advanced R&D pipeline of proprietary late-stage clinical development drug candidates.
For more information on RedHill Biopharmaceutical, go to www.redhillbio.com.
Disclaimer: This content has been provided pursuant to a commercial agreement under which RedHill Biopharma paid a fee to the publisher.
5.31+0.44 (+9.10%)
As of 11:31AM EDT. Market open.
Volume 1,068,836
Avg. Volume 997,649
Finally a positive price increase,
probably due to:
Atea Pharma's COVID-19 treatment fails to meet study goal; shares plunge
The company is developing the oral drug, AT-527, in partnership with
Roche (ROG.S) and both the companies are collaborating on multiple
studies of the drug for the treatment of COVID-19.
https://ih.advfn.com/p.php?pid=nmona&article=86316085
RedHill Biopharma Announces Insider Buying
https://finance.yahoo.com/news/redhill-biopharma-announces-insider-buying-110200802.html
TEL-AVIV, ISRAEL and RALEIGH, NC / ACCESSWIRE / October 18, 2021 / RedHill Biopharma Ltd. (Nasdaq: RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today announced that members of its board of directors and senior management, including the Company's Chairman & CEO, CFO, Chief Commercial Officer, Chief Business Officer and Chief Corporate & Business Development Officer, collectively purchased approximately 180,000 American Depositary Shares (ADSs) of RedHill between mid-September and October 15, 2021 in open-market transactions.
A very frustrating situation,
ain't no doubt about it!
I'm hoping Redhill releases some bad news! Maybe that will raise the share price!!
RedHill Biopharma Announces New U.S. Patent Covering Talicia for H. pylori Infection Through 2034
https://finance.yahoo.com/news/redhill-biopharma-announces-u-patent-110000906.html
- The patent is directed to the Talicia® formulation and pharmaceutical kits for use in the treatment of H. pylori infection
- The new patent, valid through 2034, will be the fifth patent listed in the FDA Orange Book for Talicia
- Talicia is designed as a first-line option to address the high resistance of H. pylori bacteria to historical standard-of-care therapies
- H. pylori bacterial infection is a Group 1 carcinogen and the strongest risk factor for gastric cancer; H. pylori affects approximately 35% of the U.S. population
TEL AVIV, Israel and RALEIGH, N.C., Oct. 12, 2021 /PRNewswire/ -- RedHill Biopharma Ltd. (Nasdaq: RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today announced the granting of U.S. Patent No. 11,135,172 covering Talicia, its U.S. approved medicine indicated for the treatment of H. pylori infection in adults. This patent reinforces the protection for Talicia through 2034, and the Company plans to list this patent in the FDA's Approved Drug Products with Therapeutic Equivalence Evaluations, or Orange Book.
"Talicia's unique all-in-one capsule comprising a proton pump inhibitor and two antibiotics was approved by the U.S. FDA in November 2019 for the treatment of H. pylori infection in adults. Once listed, we will have five Orange-Book listed patents protecting Talicia," said Danielle T. Abramson, PhD., SVP, Global Head of Intellectual Property. "We continue to build an expansive international patent portfolio to protect this innovative formulation, which addresses increasing concerns of resistance related to clarithromycin and metronidazole and which supports ease of adherence and compliance by patients, provides a favorable tolerability and safety profile and is positioned to become the new first-line standard-of-care."
RedHill Biopharma shares rise after new U.S. patent for H. pylori infection treatment Talicia
Oct. 12, 2021 7:40 AM ETRedHill Biopharma Ltd. (RDHL)
By: Aakash Babu, SA News Editor
RedHill Biopharma (NASDAQ:RDHL) announces that the company has been granted a new U.S. patent covering Talicia, an approved medicine indicated for the treatment of H. pylori infection in adults.
The new patent reinforces the protection for Talicia through 2034, and the company plans to list the patent in the FDA's Approved Drug Products with Therapeutic Equivalence Evaluations, or Orange Book.
Talicia's all-in-one capsule comprising a proton pump inhibitor and two antibiotics was approved by the U.S. FDA in November 2019 for the treatment of H. pylori infection in adults.
These Are the Stocks to Watch as COVID-19 Enters Its Next Phase
https://time.com/6105697/stocks-covid-vaccines/
OCTOBER 9, 2021 12:54 PM EDT
The first pill to treat Covid-19 is on its way and vaccine producers are rolling out booster shots in wealthy countries. For investors, the next stage of the pandemic means a tougher landscape for stockpicking.
The success of Merck & Co.’s oral antiviral treatment in a clinical trial has shifted the momentum in the stock market, weighing on shares of the companies that developed the most effective vaccines, Moderna Inc. and the duo of Pfizer Inc. and BioNTech SE.
Nineteen months into the pandemic, a successful rollout of a Covid-19 pill could quicken and broaden the world’s recovery, opening up a plethora of investment opportunities in stock markets.
What a Tattered Pillow Taught Me About Grieving
Here are some stocks seen by traders as possible winners and losers:
Pill Makers
Dozens of companies around the globe have said they’re trying to do what Merck appears to have succeeded at: Develop an easily administered treatment that reduces the risk of serious illness or death for people infected with coronavirus. For most of them, the effort has come to nothing, and after brief share spikes, their stocks have fallen back.
Among the bigger companies still working on antivirals are Pfizer, Shionogi & Co. and Roche Holding AG with partner Atea Pharmaceuticals Inc. All plan to publish results from late-stage clinical trials by the end of the year. Shionogi’s pill could be a $2 billion drug, the Japanese company said Friday.
A tiny Israeli biotech, RedHill Biopharma Ltd., said Oct. 4 its experimental oral therapy showed promise in helping hospitalized patients. The study consisted of only 251 people; weeks earlier RedHill had said the drug failed to show an effect in a broader group of patients. The company is discussing next steps with regulators.
“The Covid pills are really a complement to the vaccines,” said Shane Oliver, head of investment strategy at AMP Capital Investors Ltd. in Sydney. They could reduce demand for costlier treatments such as intravenous medicines, he added.
Another tiny company, Synairgen Plc of the U.K., was one of the last year’s investor favorites, soaring 2,520% on optimism for its inhaled treatment for Covid-19. The stock has fallen 2% this year. It too expects late-stage trial data by year’s end.
Vaccines
The possible arrival of Merck’s molnupiravir pill, coupled with the prospect that the pandemic will wane further, already is weighing on the valuations of jab makers.
Moderna’s share price has almost tripled in 2021 after surging 434% last year. The stock’s inclusion in the S&P 500 in July further propelled it to a record and sent it soaring past analysts’ price targets.
Still, it’s now priced at 11 times estimated earnings, down from 147 times in July 2020. The recent selloff finally brought the stock back in line with analysts’ 12-month projections for the first time in more than four months.
The share price of Pfizer’s German partner BioNTech is even cheaper at 5.9 times earnings, despite tripling this year.
“Vaccines remain the primary prevention measure and largest market opportunity,” Morgan Stanley analyst Matthew Harrison wrote in a note dated Oct. 5.
Still, it’s unclear how big that market will be: Harrison’s forecast for annual coronavirus vaccine sales over the long term ranges from $3 billion to $30 billion. He has equal-weight ratings on Pfizer and Moderna.
The vaccine leaders may also lose market share if new inoculations from Sanofi, Novavax Inc. or Valneva SE succeed and if mix-and-match boosting appears to be effective. The U.S. FDA is reviewing results of a study of adults who received booster doses of different vaccines than their original shots.
Pfizer and BioNTech are seeking U.S. approval for use of their shots on children ages 5-11, while Moderna is testing its shot in kids as well.
In Asia, watch firms such as Shanghai Fosun Pharmaceutical Group Co., which has a deal to distribute BioNTech and Pfizer’s vaccine in greater China, and South Korea’s SK Bioscience Co., a local production partner for AstraZeneca Plc.
Intravenous Treatments
The convenience of a pill for Covid could take market share from expensive infusions that need to be done in a clinic, namely the monoclonal antibody treatments from Eli Lilly & Co., Regeneron Pharmaceuticals Inc., Gilead Sciences Inc., GlaxoSmithKline Plc and partner Vir Biotechnology Inc.
New oral antivirals “could open up a broader population to Covid-19 treatments in a true outpatient setting,” wrote Goldman Sachs Group Inc. analyst Chris Shibutani in an Oct. 1 research note.
Covid Testing
The continuing vaccination and a possible therapeutic may also curb the need for Covid testing kits.
“Less hospitalizations as a result of Covid (which will surely be aided by molnupiravir and similar treatments) will result in a dialed-back pandemic response, which should then result in less demand for asymptomatic testing — especially for rapid testing,” said Tycho Peterson, an analyst at JPMorgan Chase & Co.
Goldman analysts are more pessimistic, saying the market for rapid Covid tests will “collapse” in 2022 to less than $200 million outside of symptomatic and PCR testing. Companies making those quick diagnostics, known as antigen tests, namely Qiagen NV, DiaSorin SpA and Abbott Laboratories, have all slumped from their recent peaks in September.
Quidel Corp., Orasure Technologies Inc. and Abbott will be in focus in the U.S. Sugentech Inc., Biolidics Ltd., Metropolis Heathcare Ltd., Thyrocare Technologies Ltd. and Dr Lal PathLabs Ltd. are on traders’ radar in Asia.
Other stocks to watch include lab operator Eurofins Scientific SE and suppliers of lab equipment such as Fluidigm Corp., Sartorius AG, Sartorius Stedim Biotech and Tecan Group AG.
–With assistance from Morwenna Coniam and Michael Msika.
A rush to buy Covid pills
At least four countries in the Asia-Pacific region announced agreements with the drug maker Merck to purchase a pill that the pharmaceutical company says could halve the risk of hospitalization and death from Covid-19.
Australia, Malaysia, Singapore and South Korea have all announced agreements to buy supplies of molnupiravir, the Covid treatment pill, even though their regulatory agencies have yet to approve the drug. Thailand and Taiwan are also reported to be in talks to purchase supplies of the pill.
The announcements came less than a week after the pill’s manufacturer released results from clinical trials that showed its effectiveness. The countries are the first to agree to buy the pill other than the U.S., which purchased enough pills for 1.7 million treatments for $1.2 billion in June.
Treatment: Merck’s pill, the first oral antiviral drug that can be taken at home, is expected to help limit future coronavirus outbreaks and to reduce the need for costly hospital stays.
Redhill says EUA (Emergency Use Authorization) for Covid therapeutic pill in process. Says results are better than Mercks.
5.09+0.40 (+8.45%)
As of 11:07AM EDT. Market open.
Going places (finally?)
Nice Nroadcast!
Great news! Why aren’t we much higher?
We invite you to join RedHill Biopharma (RDHL) tomorrow, October 7, 2021, at 8:30 a.m. EDT for a webcast during which we will present the additional analysis of the Phase 2/3 study results and answer questions.
The webcast including slides will be broadcast live on the Company's website, https://www.redhillbio.com/investors/events-and-presentations/default.aspx, and will be available for replay for 30 days.
To participate in the conference call, please dial one of the following numbers 15 minutes prior to the start of the call: United States: +1-877-870-9135; International: +1 646-741-3167 and Israel: +972-3-530-8845; the access code for the call is: 4785122.
Follow us on Twitter: @RedHillBio
Company contact:
Adi Frish
Chief Corporate & Business Development Officer
RedHill Biopharma
+972-54-6543-112
adi@redhillbio.com
RedHill Biopharma falls 4% amid H. pylori drug Talicia addition to California's Medi-Cal
Oct. 06, 2021 10:23 AM ETRedHill Biopharma Ltd. (RDHL)
By: Ravikash, SA News Editor1 Comment
RedHill Biopharma (RDHL -3.6%) said California's Medicaid Health Care program Medi-Cal added Talicia to its Contract Drug List (CDL) for H. pylori treatment, with no prior authorization required, effective Oct. 1.
"Medi-Cal's addition of Talicia with no prior authorization required is an important step in Talicia's continuing growth and we are pleased that it will be made available to Medi-Cal's 2 million FFS lives," said RedHill CFO Rick Scruggs.
"There is growing recognition of the need to employ effective, first-line therapy against H. pylori infections that does not rely on clarithromycin and that patients can tolerate well and adhere to over 14 days of therapy. Talicia meets those criteria," added Scruggs.
Hopefully some BP will take interest
with Opanagib and take it under their
'wings' in this or other manner in order
to further develop/commercialize the pill,
after all, the results so far looks quite
promising.
I am still optimistic that not all is lost
in the Opaganib front!
RedHill Biopharma's Talicia® added to Medi-Cal Contract Drug List with No Prior Authorization Requirements
https://finance.yahoo.com/news/redhill-biopharmas-talicia-added-medi-110000903.html
Addition of Talicia® by Medi-Cal Fee-For-Service (FFS) Contract Drug List (CDL) with no prior authorization is an important expansion of coverage for California patients and continues to increase Talicia's overall unrestricted coverage
Coverage commenced for two million patients in Medi-Cal's FFS plan on October 1st, 2021
Talicia® is the first and only FDA-approved rifabutin-based therapy for H. pylori infection, designed as a first-line option to address the high resistance of H. pylori bacteria to standard-of-care therapies
H. pylori bacterial infection is a Group 1 carcinogen and the strongest risk factor for gastric cancer; H. pylori affects approximately 35% of the U.S. population
TEL-AVIV, Israel and RALEIGH, N.C., Oct. 6, 2021 /PRNewswire/ -- RedHill Biopharma Ltd. (Nasdaq: RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today announced that Medi-Cal - California's Medicaid Health Care program covering two million patients - has added Talicia® (omeprazole magnesium, amoxicillin and rifabutin)[1] to its Contract Drug List (CDL) for H. pylori treatment, with no prior authorization required, effective October 1, 2021.
Coverage for Talicia commenced for two million patients in Medi-Cal's California FFS plan on October 1, 2021.
"Medi-Cal's addition of Talicia with no prior authorization required is an important step in Talicia's continuing growth and we are pleased that it will be made available to Medi-Cal's 2 million FFS lives," said Rick Scruggs, RedHill's Chief Commercial Officer. "There is growing recognition of the need to employ effective, first-line therapy against H. pylori infections that does not rely on clarithromycin and that patients can tolerate well and adhere to over 14 days of therapy. Talicia meets those criteria."
RDHL-ALSO-ONLY-10-DAYS-OUT-OF-HOSPITAL-COMPARED-TO-14 DAYS
RDHL-ALSO-ONLY-10-DAYS-OUT-OF-HOSPITAL-COMPARED-TO-14 DAYS
MRK-ONLY-50%-AND-IT-WAS-ALL-OVER-THE-NEWS-RDHL-62%-DECREASE-IN-DEATHS-MODERATE-SEVERE-COVID.
Why RedHill Biopharma Blasted 12% Higher Today
The company's Opaganib might have a promising future, after all.
https://finance.yahoo.com/m/56c0d9ef-2986-389d-855c-7f11353c6eed/why-redhill-biopharma-blasted.html?source=eptyholnk0000202&utm_source=yahoo-host&utm_medium=feed&utm_campaign=article&yptr=yahoo
Eric Volkman
(TMFVolkman)
Oct 4, 2021 at 5:46PM
Author Bio
What happened
RedHill Biopharma (NASDAQ:RDHL) was a standout stock on a gloomy Monday for the market. The biotech's shares rose by just under 12% on positive and not entirely expected news about its top pipeline drug.
So what
Monday morning, RedHill announced that its opaganib produced a 62% statistically significant reduction in mortality in hospitalized individuals with severe COVID-19 pneumonia. This was according to new data from a global phase 2/3 study.
This surprised more than a few investors and observers of the biotech, as preliminary top-line data released from the study last month wasn't nearly as heartening. That data showed that opaganib didn't meet its primary endpoint of having a sufficient number of patients breathing without being administered oxygen.
Opaganib is an oral medication currently being studied for a number of indications. Besides COVID-19 pneumonia, it could potentially be used to treat certain cancers, in addition to inflammatory and gastrointestinal difficulties.
"These new findings support the potential for opaganib's use in hospitalized, moderately severe COVID-19 patients -- a key group of patients that are at high risk of disease progression, morbidity and mortality, and who may benefit from opaganib's combined antiviral and anti-inflammatory activities," RedHill quoted its medical director Mark Levitt as saying.
Now what
While there's still much investigational work to be done with opaganib, this fresh news is quite encouraging -- particularly considering that the delta variant is still wreaking havoc on the world's collective health.
RedHill clearly sees much potential in its pipeline drug. Levitt added that, "We are excited about this promising and robust dataset. We are not aware of any other novel oral pill-based therapy that has shown a similar magnitude of difference in the mortality outcomes of hospitalized patients who are at this moderately severe stage of disease."
RedHill Biopharma says its oral COVID-19 therapy cut risk of death by 62% in study
Oct. 04, 2021 8:34 AM ETRedHill Biopharma Ltd. (RDHL)Veeva Systems Inc. (VEEV)
By: Dulan Lokuwithana, SA News Editor
RedHill Biopharma (NASDAQ:RDHL) is trading ~6.2% higher in the pre-market after the company said that in a Phase 2/3 study, its experimental oral COVID-19 therapy opaganib compared to placebo led to a 62% decline in mortality in hospitalized patients with severe COVID-19 pneumonia.
Per the new data disclosed from an analysis of 251 patients, there were seven deaths among 117 patients who received opaganib compared to 21 deaths in the placebo arm consisting of 134 patients indicating a statistical significance of the result with a nominal p-value of 0.019.
Meanwhile, 77% of opaganib-treated patients reached room air by Day 14 compared to 63.5% for placebo (nominal p-value= 0.033).
In addition, those who were treated with opaganib left the hospital early with a median time to discharge of 10 days compared to 14 days for the placebo arm (nominal p-value=0.0195).
The overall adverse events were balanced between the two groups of the study, and no new safety signals were found, the company said.
A conference call is scheduled for Oct. 07 at 8:30 a.m. EDT to present additional data from the Phase 2/3 study.
Veeva Systems (NYSE:VEEV) and Bioforum have partnered with RedHill Biopharma (RDHL) for a global Phase 2/3 study designed to evaluate opaganib in patients hospitalized with severe COVID-19 pneumonia.
RedHill Biopharma Reports Further Analysis of Phase 2/3 Data Including a 62% Reduction in Mortality with Oral Opaganib in Moderately Severe COVID-19 Patients
https://finance.yahoo.com/news/redhill-biopharma-reports-further-analysis-120000369.html
62% statistically significant reduction in mortality shown for moderately severe COVID-19 patients group treated with opaganib vs. the placebo-controlled arm (7 deaths in the 117-patient opaganib arm vs. 21 deaths in the 134-patient placebo arm; nominal p-value=0.019)
21% statistically significant efficacy benefit with opaganib in reaching room air by Day 14, the study primary endpoint (77% of opaganib patients vs 63.5% on placebo; nominal p-value=0.033)
A median four days earlier hospital discharge for opaganib-treated patients vs. placebo (10 days for opaganib arm vs. 14 days for placebo) a cumulative saving of 524 days of hospitalization across the group by Day 42 (nominal p-value=0.0195)
The moderately severe group comprised 53% of study participants requiring a Fraction of inspired Oxygen (FiO2) up to 60% at baseline (inhaled supplemental oxygen via nasal cannula or face mask)
Data indicates a potential meaningful benefit with opaganib for these hospitalized, moderately severe COVID-19 patients - a group at high risk of disease progression, morbidity and mortality; the data also supports opaganib's potential use in earlier stages of COVID-19 disease, consistent with opaganib's U.S Phase 2 study results and the demonstrated potent antiviral inhibition of SARS-CoV-2 variants
RedHill will hold a webcast on Thursday, October 7, 2021, at 08:30 am EDT to further discuss these additional analyses
TEL AVIV, Israel and RALEIGH, N.C., Oct. 4, 2021 /PRNewswire/ -- RedHill Biopharma Ltd. (Nasdaq: RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today reported new data from the opaganib global Phase 2/3 study in hospitalized patients with severe COVID-19 pneumonia showing that treatment with oral opaganib (ABC294640)[1] vs. the placebo-controlled arm resulted in a 62% statistically significant reduction in mortality as well as statistically significant improved outcomes in time to room air and median time to hospital discharge in a group of 251 hospitalized, moderately severe COVID-19 patients, comprising 53% of the 475 study participants.
These important new results are from a post-hoc analysis of data from the 251 study participants requiring a Fraction of inspired Oxygen (FiO2) up to 60% at baseline. Patients with FiO2 ≤ 60% are still considered to be severely affected and typically require oxygen supplementation via a nasal cannula or face mask.
"These new findings support the potential for opaganib's use in hospitalized, moderately severe COVID-19 patients - a key group of patients that are at high risk of disease progression, morbidity and mortality, and who may benefit from opaganib's combined antiviral and anti-inflammatory activities," said Mark L. Levitt, MD, Ph.D., Medical Director at RedHill. "The results provide a strong rationale for opaganib's potential efficacy in hospitalized patients in need of oxygen supplementation up to 60% FiO2, a large proportion of hospitalized COVID-19 patients. The Phase 2/3 study results are also consistent with opaganib's earlier U.S Phase 2 study results and the demonstrated potent antiviral inhibition of SARS-CoV-2 variants in human bronchial epithelial cells, providing further support for its potential in earlier stages of disease where viral load is higher."
"We are excited about this promising and robust dataset. We are not aware of any other novel oral pill-based therapy that has shown a similar magnitude of difference in the mortality outcomes of hospitalized patients who are at this moderately severe stage of disease. The data indicates opaganib's potential to provide an effective option, in an easy to take and distribute pill-form, to help prevent patient deterioration and mortality," said Dror Ben-Asher, RedHill's CEO. "Pinpointing the most relevant target patient population is particularly challenging with novel drugs, novel mechanisms of action and a previously unknown disease. This trial and these data have given us a clear indication of which groups of patients are likely to benefit the most from opaganib."
Analyses of the FiO2 up to 60% patient subset from the opaganib Phase 2/3 study (n=251), the approximate median for FiO2 levels in the study, who were treated with either opaganib or placebo in addition to standard-of-care (including dexamethasone and/or remdesivir) demonstrate consistent benefit across endpoints, in this subset of hospitalized moderately severe patients. Given the post-hoc characteristics of this subset, statistical inferences of significance cannot be formally attributed (nominal values presented). The Company also conducted a Sensitivity Analysis to account for missing data interpretability[2]:
Mortality: Opaganib treatment resulted in a statistically significant 62% reduction in mortality (7/117 patients treated with opaganib vs. 21/134 for placebo; nominal p-value=0.019, Relative Risk 2.6) (Sensitivity Analysis: 5/117 vs. 16/134, 64% efficacy benefit; nominal p-value=0.033, Relative Risk - 2.8).
A detailed analysis of baseline risk factors and their potential impact on the mortality outcome in the sensitivity analysis group has also been undertaken, showing that the benefit is robustly maintained irrespective of the subgroups/risk factors, confirming that the positive outcome observed is due to opaganib.
Reaching Room Air by Day 14 (primary endpoint of the study): 77% of opaganib-treated patients reached room air by Day 14 vs. 63.5% for placebo – an efficacy benefit of 21% with opaganib (nominal p-value= 0.033).
Median time to discharge: Patients treated with opaganib showed median time of 10 days to discharge vs. 14 days for the placebo arm, resulting in a saving of four days hospitalization per opaganib patient and saving a total of 524 cumulative days of hospitalization across the group by Day 42, nominal p-value=0.0195
Safety: Overall adverse events were balanced between the opaganib and placebo groups, suggesting good safety, with no new safety signals emerging, further supporting potential use in this patient population and earlier stage populations. [3]
The multi-center, randomized, double-blind, parallel-arm, placebo-controlled global 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 new data of the sub-group analysis follows the Company's previously announced top-line results of the Phase 2/3 study. Analysis of the top-line data is still ongoing, including further analysis of the potential for increased benefit of treatment with opaganib in patients at earlier stages of disease. RedHill intends to discuss the study outcomes with regulators, including U.S. FDA and U.S. government agencies, as well as other regulators and governments and international agencies, to help determine next steps.
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 and is expected to be effective against emerging viral variants, having already preclinically demonstrated strong inhibition against variants of concern, including Delta.
Webcast and Conference Call Information:
The Company will host a webcast on Thursday, October 7, 2021, at 8:30 a.m. EDT, during which it will present the additional analysis of the Phase 2/3 study results and answer questions.
The webcast including slides will be broadcast live on the Company's website, https://www.redhillbio.com/investors/events-and-presentations/default.aspx, and will be available for replay for 30 days.
To participate in the conference call, please dial one of the following numbers 15 minutes prior to the start of the call: United States: +1-877-870-9135; International: +1 646-741-3167 and Israel: +972-3-530-8845; the access code for the call is: 4785122.
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, submitted for peer review and 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[4].
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.
The top-line results from the Company's Phase 2/3 study with opaganib are preliminary in nature. The Company intends to further examine the data from this study in greater detail, along with all the information gathered during this study, including all safety, and secondary outcome measures. Such analysis may result in findings which are new or inconsistent with the top-line data disclosed in this release. As such, investors should not rely on the analyses reported in this release as the final definitive results of the study.
Fortunately i had some gains that will
be offset by my significant sale losses.
Did you book losses as well during the liquidation?
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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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