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It may be a sucker's bet...but I'm still hopeful.
RedHill to get US patent linked to bacterial infection drug
Jan. 26, 2023 8:35 AM ETRedHill Biopharma Ltd. (RDHL)
By: Ravikash, SA News Editor
RedHill Biopharma (NASDAQ:RDHL) said that the U.S. Patent and Trademark Office (USPTO) issued a notice of allowance for a patent covering RHB-204's oral fixed-dose combination, methods treating pulmonary Mycobacterium avium Complex (MAC) disease.
The patent will also cover kits comprising a supply of fixed-dose combination products for treating pulmonary MAC disease.
The company added that RHB-204 is currently undergoing a phase 3 trial in the U.S. as the first stand-alone standard of care first-line therapy for Non-tuberculosis Mycobacteria (NTM) disease caused by MAC infection.
MAC is a group of bacteria causing lung diseases.
The patent is expected to protect RHB-204 through 2041.
RedHill noted that it is advancing discussions with several prospective partners for RHB-204 in multiple territories.
RedHill Receives USPTO Notice of Allowance for a Patent Covering Phase 3-stage RHB-204 for the Treatment of NTM Disease
https://finance.yahoo.com/news/redhill-receives-uspto-notice-allowance-120000815.html
Once issued, the patent is expected to extend protection of RHB-204 to 2041
RHB-204 is currently undergoing a Phase 3 study in the U.S. as the first stand-alone standard of care first-line drug candidate for Non-tuberculosis Mycobacteria (NTM) disease caused by MAC infection
RHB-204 has received U.S. FDA Fast Track, Orphan and QIDP priority designations as well as EMA Orphan Drug designation, providing eligibility for 12 years market exclusivity in the U.S. and 10 years exclusivity in the EU
The Company is advancing discussions with several prospective partners for RHB-204 across multiple territories
TEL AVIV, Israel and RALEIGH, N.C., Jan. 26, 2023 /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) has issued a Notice of Allowance for the granting of a patent covering RHB-204's1 oral fixed-dose combination, methods for treating pulmonary Mycobacterium avium Complex (MAC) disease, and kits comprising a supply of fixed-dose combination products for treating pulmonary MAC disease. Once issued, the patent is expected to protect RHB-204 through 2041.
"Non-tuberculosis mycobacterial disease (NTM) is particularly threatening for vulnerable people with underlying lung disease or weakened immune systems, and the incidence is increasing worldwide, with up to 180,000 people in the U.S. thought to be living with NTM disease2. It is notoriously difficult to treat, requiring multiple antibiotics to be taken over a lengthy period, and with no approved first-line stand-alone therapies in the U.S., EU, and Japan, there is an urgent need for new treatment innovation," said Danielle T. Abramson, Ph.D., RedHill's SVP Global Head of Intellectual Property. "This USPTO Notice of Allowance for RHB-204 recognizes the innovation behind RHB-204's specific fixed-dose combination therapy for the treatment of NTM disease and is expected to extend protection for this innovation to 2041."
A U.S. Phase 3 study is ongoing to evaluate the efficacy and safety of RHB-204 in adults with pulmonary NTM disease caused by MAC infection (NCT04616924). The study protocol provides for 6 months co-primary endpoint of sputum culture conversion (SCC) and clinical outcome (patient-reported outcomes - PRO) in a randomized placebo-controlled design, followed by open label active treatment with RHB-204 for 12 months from conversion.
The Company is advancing discussions with several prospective partners for RHB-204 across multiple territories.
About Pulmonary Nontuberculous Mycobacteria (NTM) Infections
Pulmonary nontuberculous mycobacteria (NTM) disease is a chronic, serious, and debilitating lung disease that is becoming a significant public health concern with prevalence rising approximately 8% per year worldwide2. It is estimated that up to 180,000 people in the U.S. may be living with NTM disease, with women, the elderly, and those with underlying lung conditions or weakened immune systems at particular risk. It is caused by ubiquitous environmental bacteria, found in soil as well as natural and engineered water systems. The most common symptoms of NTM disease include loss of lung function, persistent cough, fever, weight loss, chest pain, and blood in sputum3, contributing to a reduction in quality of life. NTM infections can lead to recurring cases of bronchitis and pneumonia and can, in some cases, lead to respiratory failure4. Although rare, the incidence and prevalence of pulmonary NTM disease are increasing in many areas of the world5. There were an estimated 110,000 pulmonary NTM disease patients in the U.S. in 20176 and an estimated 28,000 in the EU. Pulmonary manifestations account for 80-90% of all NTM-associated diseases7, and approximately 80% of pulmonary NTM infections are caused by Mycobacterium avium complex (MAC)8.
Treatment of NTM infection can be difficult with guidelines recommending that MAC infection be treated with a multi-drug regimen for treatment, with at least three antimicrobials, for at least 12 months9. There is no FDA- or EMA-approved first-line standard-of-care combination therapy. Many patients fail current therapy, and more than half will have either recurring disease or a new infection after completing treatment10. Thus, new treatment options for NTM are needed.
About RHB-204
RHB-204 is a Phase 3-stage proprietary, fixed-dose oral capsule containing a combination of clarithromycin, rifabutin and clofazimine, developed for the treatment of pulmonary NTM disease caused by MAC. RHB-204 was granted FDA Fast Track and Orphan Drug Designation, in addition to QIDP Designation under the Generating Antibiotic Incentives Now Act (GAIN Act), extending U.S. post-approval U.S. market exclusivity to a potential total of 12 years. RHB-204 has additionally been granted EU Orphan Designation, providing eligibility for 10 years EU post-approval market exclusivity. RedHill is seeking protection of RHB-204, and its use in treating pulmonary MAC disease, on a global scale, providing protection until 2041.
About RedHill Biopharma
RedHill Biopharma Ltd. (Nasdaq: RDHL) is a specialty biopharmaceutical company primarily focused on gastrointestinal and infectious diseases. RedHill promotes the gastrointestinal drugs, Movantik® for opioid-induced constipation in adults11, Talicia® for the treatment of Helicobacter pylori (H. pylori) infection in adults12, and Aemcolo® for the treatment of travelers' diarrhea in adults13. RedHill's key clinical late-stage development programs include: (i) RHB-204, with an ongoing Phase 3 study for pulmonary nontuberculous mycobacteria (NTM) disease; (ii) opaganib (ABC294640), a first-in-class oral broad-acting, host-directed SK2 selective inhibitor targeting multiple indications, with potential for pandemic preparedness, with a Phase 2/3 program for hospitalized COVID-19, a Phase 2 program in oncology and a radiation protection program ongoing; (iii) RHB-107 (upamostat), an oral broad-acting, host-directed, serine protease inhibitor with potential for pandemic preparedness and is in a Phase 3-stage study as treatment for non-hospitalized symptomatic COVID-19, and targeting multiple other cancer and inflammatory gastrointestinal diseases; (iv) RHB-104, with positive results from a first Phase 3 study for Crohn's disease; and (v) RHB-102 , with positive results from a Phase 3 study for acute gastroenteritis and gastritis and positive results from a Phase 2 study for IBS-D. More information about the Company is available at www.redhillbio.com/ twitter.com/RedHillBio.
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 include, without limitation, the risk that the Company will not initiate the Phase 3 clinical study in all or part of the sites in the U.S. or will be delayed; the risk that the U.S. Phase 3 clinical study evaluating RHB-204 will not be successful or, if successful, will not suffice for regulatory marketing approval without the need for additional clinical and/or other studies; as well as risks 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 or the development of a commercial companion diagnostic for the detection of MAP; (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®, Movantik® 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 March 17, 2022. 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: R&D
1 RHB-204 is an investigational new drug, not available for commercial distribution.
2 Strollo SE, et al. The Burden of Pulmonary Nontuberculous Mycobacterial Disease in the United States. Ann Am Thorac Soc. 2015 Oct;12(10):1458-64.
3 Kim RD, et al. Pulmonary Nontuberculous Mycobacterial Disease. Prospective Study of a Distinct Preexisting Syndrome Am J Respir Crit Care Med. 2008; 178(10):1066–74.
4 The American Lung Association, 2020.
5 Winthrop KL, et al. Incidence and Prevalence of Nontuberculous Mycobacterial Lung Disease in a Large U.S. Managed Care Health Plan, 2008-2015. Ann Am Thorac Soc. 2020 Feb;17(2):178-185.
6 Foster|Rosenblatt, 2017
7 Griffith DE, et al. An official ATS/IDSA statement: diagnosis, treatment, and prevention of nontuberculous mycobacterial diseases Am J Respir Crit Care Med. 2007;175(4):367-416.
8 Prevots DR et al. Nontuberculous mycobacterial lung disease prevalence at four integrated health care delivery systems. Am J Respir Crit Care Med 2010; 182:970-76; Winthrop KL, et al. Pulmonary nontuberculous mycobacterial disease prevalence and clinical features: an emerging public health disease. Am J Respir Crit Care Med 2010; 182: 977-82
9 Daley CL, et al. Treatment of Nontuberculous Mycobacterial Pulmonary Disease: An Official ATS/ERS/ESCMID/IDSA Clinical Practice Guideline: Executive Summary. Clinical Infectious Diseases. Ciaa241, https://doi.org/10.1093/cid/ciaa241.
10 Henkle E, et al. Patient-Centered Research Priorities for Pulmonary Nontuberculous Mycobacteria (NTM) Infection. An NTM Research Consortium Workshop Report Annals of the American Thoracic Society 2016; S379-84.
11 Movantik® (naloxegol) is indicated for opioid-induced constipation (OIC). Full prescribing information see: www.movantik.com
12 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.
13 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.
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View original content:https://www.prnewswire.com/news-releases/redhill-receives-uspto-notice-of-allowance-for-a-patent-covering-phase-3-stage-rhb-204-for-the-treatment-of-ntm-disease-301731437.html
SOURCE RedHill Biopharma Ltd.
Hi Spidey, I have not taken that link
seriously, hence my LMAOx22 remark.
P.S.
See my last post at PLX
Seems to just be a rehashed news title from August 2-years ago no less, very much before pre-HRC agreement mess-up.
Mr Brandon Evans doesn't seem reliable :)
https://www.marketscreener.com/quote/stock/REDHILL-BIOPHARMA-LTD-12243230/news/RedHill-Biopharma-Cantor-Fitzgerald-Starts-Redhill-Biopharma-at-Overweight-With-22-Price-Target-36284780/
So, “Would This be Mojo Time?”
... — (Dr. Phil)
See the header in the link:
RedHill Biopharma Ltd. [RDHL] stock Initiated by Cantor Fitzgerald analyst, price target now $22
https://dbtnews.com/2023/01/04/redhill-biopharma-ltd-rdhl-stock-initiated-by-cantor-fitzgerald-analyst-price-target-now-22/
The article linked seems to say $2.75. Where do you see $22?
RedHill Biopharma Ltd. [RDHL] stock Initiated by Cantor Fitzgerald analyst, price target now $22
[LMAOX22]
By Brandon Evans -January 4, 2023
https://dbtnews.com/2023/01/04/redhill-biopharma-ltd-rdhl-stock-initiated-by-cantor-fitzgerald-analyst-price-target-now-22/
RedHill Biopharma Ltd. [NASDAQ: RDHL] surged by $0.04 during the normal trading session on Tuesday and reaching a high of $0.205 during the day while it closed the day at $0.18. The company report on January 3, 2023 that RedHill Announces Publication of Positive Phase 2 Study Results with Once-Daily Oral RHB-107 in Non-Hospitalized COVID-19.
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And this is just one of our 5 Best Growth Stocks To Own For 2023.
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Positive data from a U.S. Phase 2 study of once-daily oral RHB-107 (upamostat) in symptomatic COVID-19 published in the peer-reviewed International Journal of Infectious Diseases.
RHB-107 successfully met the primary endpoint of safety and tolerability and delivered promising efficacy results, including faster recovery from severe COVID-19 symptoms (median of 3 days to recovery vs. 8 days with placebo) and 100% reduction in hospitalization due to COVID-19.
RedHill Biopharma Ltd. stock has also gained 11.67% of its value over the past 7 days. However, RDHL stock has declined by -65.16% in the 3 months of the year. Over the past six months meanwhile, it has lost -81.36% and gained 26.16% year-on date.
The market cap for RDHL stock reached $16.06 million, with 63.84 million shares outstanding and 34.99 million shares in the current float. Compared to the average trading volume of 3.23M shares, RDHL reached a trading volume of 36218661 in the most recent trading day, which is why market watchdogs consider the stock to be active.
Here’s what leading stock market gurus have to say about RedHill Biopharma Ltd. [RDHL]:
Based on careful and fact-backed analyses by Wall Street experts, the current consensus on the target price for RDHL shares is $2.75 per share. Analysis on target price and performance of stocks is usually carefully studied by market experts, and the current Wall Street consensus on RDHL stock is a recommendation set at 1.50. This rating represents a strong Buy recommendation, on the scale from 1 to 5, where 5 would mean strong sell, 4 represents Sell, 3 is Hold, and 2 indicates Buy.
Cantor Fitzgerald have made an estimate for RedHill Biopharma Ltd. shares, keeping their opinion on the stock as Overweight, with their previous recommendation back on August 31, 2021. While these analysts kept the previous recommendation, H.C. Wainwright raised their target price to Buy. The new note on the price target was released on May 18, 2021, representing the official price target for RedHill Biopharma Ltd. stock.
The Average True Range (ATR) for RedHill Biopharma Ltd. is set at 0.03, with the Price to Sales ratio for RDHL stock in the period of the last 12 months amounting to 0.23.
RDHL stock trade performance evaluation
RedHill Biopharma Ltd. [RDHL] gain into the green zone at the end of the last week, gaining into a positive trend and gaining by 11.67. With this latest performance, RDHL shares dropped by -51.51% in over the last four-week period, additionally sinking by -81.36% over the last 6 months – not to mention a drop of -93.14% in the past year of trading.
Overbought and oversold stocks can be easily traced with the Relative Strength Index (RSI), where an RSI result of over 70 would be overbought, and any rate below 30 would indicate oversold conditions. An RSI rate of 50 would represent a neutral market momentum. The current RSI for RDHL stock in for the last two-week period is set at 31.47, with the RSI for the last a single of trading hit 42.07, and the three-weeks RSI is set at 30.04 for RedHill Biopharma Ltd. [RDHL]. The present Moving Average for the last 50 days of trading for this stock 0.3947, while it was recorded at 0.1468 for the last single week of trading, and 0.9781 for the last 200 days.
A Toast to THAT!
Tax loss selling is over. Those who sold for a loss can’t take the loss if they buy back in before 30 days. I think we will get buyers coming in over the next few weeks and we could get back over $1.00 by early February with good news. We had $17.6 million in revenues in 3rd quarter and $31 million in cash. This stock is ridiculously undervalued. Israeli tech and biotechs will be back in 2023
Sure, only 3 days
ago it was 2022.
It was $2 to $3 only 9-12 months ago. $1 only 5 months ago.
Not even 15 months, I think...
.16 cent at this rate we can get to a buck in about 15 years and I can break even at that point!!
Well, in a way it is, for a company with
a Market Cap of less than $ 16 million
that is.
It seems important.
The only news is that this relative
old news was peer-reviewed data
publication.
The fact of publication serves as an
official stamp of authentication.
Not something that would make me
leap with joy.
My feeling is that the market is over
reacting to the PR.
No, January 3, 2023 news.
Oh, Goody. Now can it get back to $1?
RedHill Announces Publication of Positive Phase 2 Study Results with Once-Daily Oral RHB-107 in Non-Hospitalized COVID-19
https://finance.yahoo.com/news/redhill-announces-publication-positive-phase-120000969.html
Positive data from a U.S. Phase 2 study of once-daily oral RHB-107 (upamostat) in symptomatic COVID-19 published in the peer-reviewed International Journal of Infectious Diseases
RHB-107 successfully met the primary endpoint of safety and tolerability and delivered promising efficacy results, including faster recovery from severe COVID-19 symptoms (median of 3 days to recovery vs. 8 days with placebo) and 100% reduction in hospitalization due to COVID-19
RHB-107, a novel, broad-acting, host-directed, once-daily oral antiviral, is expected to act independently of viral spike protein mutations including Omicron BA.5 sub-variant[1]
Inclusion of once-daily oral RHB-107 in a multinational platform trial for COVID-19 outpatients pending. Discussions for external non-dilutive funding for additional Phase 3 COVID-19 development advancing
Several collaborative projects, with government and non-government bodies, on a range of preclinical studies against other viral targets for pandemic preparedness ongoing and under discussion
TEL AVIV, Israel and RALEIGH, NC, Jan. 3, 2023 /PRNewswire/ -- RedHill Biopharma Ltd. (Nasdaq: RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today announced publication of positive data from a Phase 2 study of once-daily oral investigational RHB-107 (upamostat)[2] in non-hospitalized symptomatic COVID-19 patients, in the peer-reviewed International Journal of Infectious Diseases[3]. The study showed that RHB-107 successfully met the primary endpoint of safety and tolerability and delivered promising efficacy results, despite the small number of patients in each treatment group, including faster recovery from severe COVID-19 symptoms and 100% reduction in hospitalization due to COVID-19.
Data showed a 100% reduction in hospitalization due to COVID-19, with zero patients (0/41) on the RHB-107 arms versus 15% (3/20) hospitalized on the placebo-controlled arm (nominal p-value=0.0317). The study also showed an approx. 88% reduction in reported new severe COVID-19 symptoms after treatment initiation, with only 2.4% of the RHB-107 treated group (1/41) versus 20% (4/20) of patients in the placebo-controlled arm (nominal p-value=0.036) reporting new severe COVID-19 symptoms. Further analysis showed faster recovery from severe COVID-19 symptoms with a median of 3 days to recovery with upamostat vs. 8 days with placebo.
"It is highly satisfying to see this study, and the exciting results it produced, published in this important journal. These data, achieved despite a small overall sample size, are impressive. Showing both safety and efficacy signals, in a highly convenient once-daily oral therapy, positively positions investigational RHB-107 as a potentially very useful treatment for COVID-19 outpatients to reduce symptom severity and prevent disease progression and hospitalization," said Terry F. Plasse MD, Medical Director at RedHill. "Given the growing awareness of the limitations of existing options for early treatment of COVID-19, it is vital that we do not stop our efforts to bring new options forward – especially those in which we have already observed broad-acting, host-directed variant-agnostic abilities."
The Phase 2 multicenter, randomized, double-blind, placebo-controlled, parallel-group study with once-daily oral RHB-107 in non-hospitalized patients with symptomatic COVID-19 (NCT04723537) evaluated safety and tolerability, provided evidence for dose selection, and provided preliminary assessment of parameters to be used for efficacy evaluation in a Phase 3 study. A total of 61 patients were enrolled and randomized on a 1:1:1 basis to receive one of two dose levels of RHB-107 or a placebo control.
Advanced discussions are ongoing regarding inclusion of once-daily oral RHB-107 in a multinational platform trial for COVID-19 outpatients. Discussions for external non-dilutive funding for Phase 3 COVID-19 development, in addition to the platform study, are also advancing.
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.
Top-line results from Part A of the Phase 2/3 study (NCT04723537) evaluating treatment with RHB-107 in non-hospitalized patients with symptomatic COVID-19 early in the course of the disease, showed a 100% reduction in hospitalization due to COVID-19, with zero patients (0/41) on the RHB-107 arms versus 15% (3/20) hospitalized on the placebo-controlled arm. The study also showed an approx. 88% reduction in reported new severe COVID-19 symptoms after treatment initiation, with only one patient in the RHB-107 treated group 2.4%, (1/41) versus 20% (4/20) of patients in the placebo-controlled arm. Further analysis showed faster recovery from severe COVID-19 symptoms with a median of 3 days to recovery with upamostat vs. 8 days with placebo.
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.
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 RedHill Biopharma
RedHill Biopharma Ltd. (Nasdaq: RDHL) is a specialty biopharmaceutical company primarily focused on gastrointestinal and infectious diseases. RedHill promotes the gastrointestinal drugs, Movantik® for opioid-induced constipation in adults[4], Talicia® for the treatment of Helicobacter pylori (H. pylori) infection in adults[5], and Aemcolo® for the treatment of travelers' diarrhea in adults[6]. RedHill's key clinical late-stage development programs include: (i) RHB-204, with an ongoing Phase 3 study for pulmonary nontuberculous mycobacteria (NTM) disease; (ii) opaganib ( ABC294640), a first-in-class oral broad-acting, host-directed, SK2 selective inhibitor targeting multiple indications, including for pandemic preparedness, with a Phase 2/3 program for hospitalized COVID-19 and a Phase 2 program in oncology and a radiation protection program ongoing; (iii) RHB-107 (upamostat), an oral broad-acting, host-directed serine protease inhibitor with potential for pandemic preparedness and is in Phase 3-stage development as treatment for non-hospitalized symptomatic COVID-19, and targeting multiple other cancer and inflammatory gastrointestinal diseases; (iv) RHB-104, with positive results from a first Phase 3 study for Crohn's disease; and (v) RHB-102, with positive results from a Phase 3 study for acute gastroenteritis and gastritis and positive results from a Phase 2 study for IBS-D. More information about the Company is available at www.redhillbio.com / https://twitter.com/RedHillBio.
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 include the risk that RHB-107 will not be included in the multinational platform trial for COVID-19 outpatients, the risk that RHB-107 will not be shown to be a broad acting, host-directed candidate therapy for pandemic preparedness, the risk that a pivotal Phase 3 trial for RHB-107 will not be initiated or that such trial be successful and, even if successful, such study and results may not be sufficient for regulatory applications, including emergency use or marketing applications, and that additional COVID-19 studies may be required by regulatory authorities to support such potential applications and the use or marketing of rhb-107 for COVID-19 patients, that RHB-107 will not be effective against emerging viral variants, as well as risks and uncertainties associated with (i) the initiation, timing, progress and results of the Company's research, manufacturing, preclinical 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 preclinical 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 Movantik®, 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 and sustain 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, preclinical 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 commercial products 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 events 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 March 17, 2022. 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: R&D
[1] Preliminary data from a recent in vitro study
[2] RHB-107 (upamostat) is an investigational new drug, not available for commercial distribution in the United States.
[3] Manuscript accepted for publication and will be available on-line as soon as proofing is finalized
[4] Full prescribing information for Movantik® (naloxegol) is available at: www.Movantik.com.
[5] Full prescribing information for Talicia® (omeprazole magnesium, amoxicillin and rifabutin) is available at: www.Talicia.com.
[6] Full prescribing information for Aemcolo® (rifamycin) is available at: www.Aemcolo.com.
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View original content:https://www.prnewswire.com/news-releases/redhill-announces-publication-of-positive-phase-2-study-results-with-once-daily-oral-rhb-107-in-non-hospitalized-covid-19-301712263.html
SOURCE RedHill Biopharma Ltd.
So, do these people ever intend profitability for shareholders? or just dilute them into oblivion....
A thoughtful analysis. Might you consider writing to the CEO about this and letting him know that investors deserve far more clarity on near and intermediate term “direction” he intends to improve the current dismal situation?
Well I think we're all agreed and frustrated that RDHL is a company with great products, great pipeline but has been fantastically stupid with the HCR agreement.
I mean talk about shooting yourself in the foot. They knew the terms of the agreement and they knew what might happen if they didn't fullt comply. Now RDHL was usually later than the norm on they quarterly report publishing, so perhaps they felt a bit longer than their normal would be ok, but clearly HCR watching the general downturn in markets during covid and current inflationary situation, saw that they could just cut macro-economic level losses and get their moolah back pronto.
- Talicia, best product for H.Pylori
- Aemcolo, great option for TD
Both recognised as important therapies and for their contribution to reducing anti-biotic resistance (a huge and growing problem) with QIDP designation and years of exclusivities
Pipeline of effective Covid products as well as Crohn's new MAO treatment and potentially first real NTM treatment.
To be sitting at 17 million is a joke no matter how you slice it.
So what's the prognosis people?
Do we think HCR takes Movantik, slices off the debt?
Do we think the extra 8 million just a little boost to put them in better position when they are on the negotiating table for "Discussions regarding out-licensing of RedHill's products in multiple territories", which I assume mainly relates to Talicia?
Let's just note that in Q3,
- R&D was 1.6 million
- SG&A was 13 million (divided over mostly Movantik and Talicia I would assume)
- Net revenues was 17 million
- Operating loss was 7 million.
- Cost of revenue about 9 million
So just making assumptions here. We assume HCR takes over Movantik around year-end/ early Jan.
Then SG&A, might be reduce to 7 million with key focus on Talicia and some focus on Aemcolo?
R&D would still be about the 1.6 million mark
Cost of revenue also reduced without Movantik to about 5 million
Net Revenue: From my prior Q1 Calculations, I assumed about 4.5 million per quarter on Talicia. So perhaps with another few quarters later we might be on about 6-7 million per quarter sales now? Aemcolo has only been able to bring in US revenues relatively recently so we can't really speculate too much on that, but let's say a low 1 million per quarter. If so then Net Revenue might be about 5-6 million per quarter on Talicia and Aemcolo.
So looking at about 13 million out and 6 million in. So an operating quarterly loss still of about 7 million? In normal circumstance, it's not great but not terrible either. And operating loss should improve about 1-2 million over the next 1-2 quarters with greater Talicia and Aemcolo Rx?
I think this unclear future on the HCR debt and if HCR will accept Movantik in exchange for clearing debts is hanging over the SP. As for example HCR could not accept Movantik but require the full funds to be paid back now in cash. In the short-term disastrous as there isn't the money to pay it back, in the region of about 90 million I think. But if we can get news that HCR accepts Movantik, then while of course that is a blow to lose the main revenue generator, it will at least clear all debts and we know where we stand.
Regards this recent 8 million dilution, if the current thought was that HCR would not take Movantik, then the 8million would do little to pay back the debt. So perhaps this means HCR is generally on the track of taking Movantik?
Just blurbing thoughts out there as it's been awhile since I chimed in.
Great products, stupid management on putting themselves in this situation. Messing up your books so that you miss an important deadline causing this mess. Very disappointed in Micha which is where I feel the buck stops on the accounting books. Get paid handsomely, get the job done right and on time. 99% of every other company can do it.
Thoughts on the above in general?
Mystery to me, too...
I guess I am not sure why they need to dilute us to get the 8 million right now when they already had 30 million in cash. What was such a rush that destroying stockholder value was so important.
So, they just raised $8 Million very quickly, have multiple products, and are certainly not at risk of “ceasing operations” (as one irresponsible pseudo-analyst wrote with dubious motives).
Turn-around Time.
What region might that be?
Miracles happened in my region,
but that occured thousands of
years ago.
Nowadays, i am skeptical, but
who knows, History has been
known to repeat itself.
Sure hope so...
RedHill Biopharma Closes $8.0 Million Underwritten Public Offering
https://finance.yahoo.com/news/redhill-biopharma-closes-8-0-183600375.html
TEL AVIV, Israel and RALEIGH, N.C., Dec. 6, 2022 /PRNewswire/ -- RedHill Biopharma Ltd. (Nasdaq: RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today announced the closing of an underwritten public offering with gross proceeds to the Company of approximately $8.0 million, before deducting underwriting discounts and other expenses payable by the Company. The offering consisted of 32,000,000 units/pre-funded units consisting of (a) one American Depositary Share ("ADS") (or one pre-funded warrant to purchase one ADS in lieu thereof) and (b) one warrant to purchase one ADS (the "Warrants") at a price to the public of $0.25 per unit (or $0.249 per pre-funded unit after reducing $0.001 attributable to the exercise price of the pre-funded warrants). Each ADS represents 10 of our ordinary shares, par value NIS 0.01 per share. RedHill intends to use the net proceeds of the offering for working capital, acquisitions, and general corporate purposes.
Aegis Capital Corp. acted as the sole book-running manager for the proposed public offering.
The start of good news,
i wonder?
RedHill’s Aemcolo® Granted FDA QIDP 5-Year Exclusivity Extension
https://finance.yahoo.com/portfolio/p_4/view/view_17
RedHill Biopharma (Nasdaq: RDHL) today announced that the U.S. Food and Drug Administration’s (FDA) Exclusivity Board has granted Aemcolo® five years’ exclusivity under the Generating Antibiotic Incentives Now (GAIN) Act Qualified Infectious Disease Product (QIDP) designation, in addition to the five years’ data exclusivity granted as a new chemical entity (NCE) for the treatment of travelers’ diarrhea (TD) caused by non-invasive strains of Escherichia coli (E. coli) in adults.
· Aemcolo granted five years’ exclusivity under the FDA’s Qualified Infectious Disease Product (QIDP) designation in addition to the five years NCE data exclusivity, extending regulatory exclusivity through to 2028
· Aemcolo (rifamycin) is a non-systemic antibiotic whose delivery is targeted to the site of non-invasive Escherichia coli (E. coli) infection in the distal small bowel and colon, approved by the FDA for the treatment of Travelers’ Diarrhea caused by non-invasive strains of E. coli in adults
· Aemcolo is listed as an acute diarrhea antibiotic treatment recommendation in the Centers for Disease Control and Prevention (CDC) Yellow Book
Patricia Anderson, RedHill's Senior Vice President of Regulatory Affairs said: “Given the great concerns around maintaining effective therapeutic options for infectious diseases in the face of growing microbial resistance, Aemcolo represents an important innovation to meet significant unmet need. This FDA grant of five additional years’ exclusivity for Aemcolo under the FDA’s Generating Antibiotic Incentives Now (GAIN) Act Qualified Infectious Disease Product (QIDP) designation, in addition to the five years awarded to Aemcolo based on new chemical entity exclusivity, will protect that innovation through to 2028.”
Follow us on Twitter: @RedHillBio
Company contact:
Adi Frish
Chief Corporate & Business Development Officer
RedHill Biopharma
+972-54-6543-112
adi@redhillbio.com
Midas,
I totally agree!
Or get paid for longer.
Perhaps it sends a signal that they have no intention of “ceasing operations”? Perhaps they want to hire more scientists, expand market penetration?
RedHill Biopharma Prices $8.0 Million Underwritten Public Offering
https://finance.yahoo.com/news/redhill-biopharma-prices-8-0-140000069.html
TEL AVIV, Israel, and RALEIGH, N.C., Dec. 2, 2022 /PRNewswire/ -- RedHill Biopharma Ltd. (Nasdaq: RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today announced the pricing of an underwritten public offering with gross proceeds to the Company expected to be approximately $8.0 million, before deducting underwriting discounts and other expenses payable by the Company. The offering consists of 32,000,000 units/pre-funded units consisting of (a) one American Depositary Share ("ADS") (or one pre-funded warrant to purchase one ADS in lieu thereof) and (b) one warrant to purchase one ADS (the "Warrants") at a price to the public of $0.25 per ADS (or $0.249 per pre-funded unit after reducing $0.001 attributable to the exercise price of the pre-funded warrants). Each ADS represents 10 of our ordinary shares, par value NIS 0.01 per share. RedHill intends to use the net proceeds of the offering for working capital, acquisitions, and general corporate purposes.
The offering is expected to close on December 6, 2022, subject to the satisfaction of customary closing conditions.
Aegis Capital Corp. is acting as sole book-running manager for the proposed public offering.
They have 30 million in cash what is the point of all this dilution for 8 million dollars.
Never in my many years of investing have i
been ever so disappointed from a company
such as RDHL.
RedHill Biopharma Announces Proposed Public Offering
https://finance.yahoo.com/news/redhill-biopharma-announces-proposed-public-210100467.html
TEL AVIV, Israel and RALEIGH, N.C., Dec. 1, 2022 /PRNewswire/ -- RedHill Biopharma Ltd. (Nasdaq: RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today announced that it intends to offer and sell, subject to market and other conditions American Depositary Shares ("ADSs") (or pre-funded warrants in lieu thereof) and warrants to purchase ADSs (the "Warrants") in an underwritten public offering. Each ADS represents 10 of our ordinary shares, par value NIS 0.01 per share. The Company expects to grant the underwriter a 30-day option to purchase additional ADSs and/or Warrants at the public offering price, less the underwriting discounts and commissions. All of the securities to be sold in the offering are to be offered by RedHill.
That now looks like Malarkey...
RedHill Biopharma Announces Q3/22 Results and Operational Highlights
https://finance.yahoo.com/news/redhill-biopharma-announces-q3-22-130000638.html
Non-binding agreement in principle reached with HCR on sale of Movantik to extinguish all debt obligations, to facilitate growth
Q3/22 Net revenues of $17.6 million; Operating loss of $7.1 million; Q3/22 positive cash flow from U.S. commercial operations, before interest payments[1]; Cash balance[2] of $31.4 million as of September 30, 2022
Talicia® and Movantik® have delivered year-to-date prescription growth of 65% and 6.7%, respectively; Q4/22 data to date indicate continued growth for both products
Discussions underway regarding opaganib for nuclear radiation injury with various government agencies with expedited Animal Rule pathway expected, and potential eligibility for a medical countermeasures Priority Review Voucher; Development activities ongoing with opaganib for COVID-19 and other viral diseases for government pandemic preparedness purposes
Advanced discussions ongoing regarding inclusion of once-daily oral RHB-107 in a U.S. platform trial for COVID-19 outpatients
RHB-204 granted EU orphan drug designation providing 10 years of post-approval EU market exclusivity
TEL AVIV, Israel and RALEIGH, N.C., Nov. 29, 2022 /PRNewswire/ -- RedHill Biopharma Ltd. (Nasdaq: RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today reported its third quarter 2022 financial results and operational highlights.
Dror Ben-Asher, RedHill's Chief Executive Officer, said: "The agreement in principle to sell Movantik to HCR in return for termination of all HCR debt obligations, subject to closing, is a significant turnaround opportunity for the Company, freeing us up to expedite both organic and inorganic growth. RedHill's U.S. commercial operations achieved positive cash flow in Q3/22, before interest payments, thanks to ongoing implementation of our cost-reduction plan. Talicia and Movantik have delivered year-to-date growth of 65% and 6.7%, respectively, and Q4/22 data to date indicate continued growth for both products. Turning to R&D, we continue to press forward with our two novel, broad-acting, host-directed late clinical-stage antiviral drug candidates, opaganib and RHB-107, in line with our stated goal to advance our late clinical-stage R&D programs primarily through external non-dilutive financing. We are advancing discussions for RHB-107's inclusion in a U.S. COVID-19 outpatients platform trial. Opaganib continues to advance as well, with collaborations ongoing and under discussion for COVID-19 and other viral diseases for government pandemic preparedness purposes. Additionally, multiple discussions and activities are advancing to expedite opaganib's development as a potential homeland security nuclear medical countermeasure (MCM) via the Animal Rule, subject to further guidance from FDA, which may provide for an MCM Priority Review Voucher eligibility. We are also holding multiple partnership discussions in relation to our products and potential acquisitions of additional revenue-generating products."
Financial results for the three months ended September 30, 2022 (Unaudited)[1]
Net Revenues for the third quarter of 2022 were $17.6 million, as compared to $18.3 million in the second quarter of 2022, the difference being attributable to an increase in units sold, accompanied by increased gross-to-net allowances as the percentage of Medicare part D and Medicaid prescriptions increased.
Cost of Revenues for the third quarter of 2022 was $9.5 million, as compared to $9 million for the second quarter of 2022.
Gross Profit for the third quarter of 2022 was $8.1 million, as compared to $9.4 million for the second quarter of 2022. The decrease was primarily attributable to a $0.7 million inventory write-off, recognized in the third quarter of 2022.
Research and Development Expenses for the third quarter of 2022 were $1.6 million, as compared to $1.5 million for the second quarter of 2022.
Selling, Marketing and General and Administrative Expenses for the third quarter of 2022 were $13.6 million, as compared to $17 million for the second quarter of 2022. The decrease was mainly attributed to the successful and ongoing cost-reduction program.
Operating Loss for the third quarter of 2022 was $7.1 million, as compared to $9.2 million for the second quarter of 2022, as described above.
Financial Expenses, net, as of September 30, 2022 were $28.6 million, as compared to $4.0 million as of September 30, 2021 due to the previously disclosed notice of event of default sent by HCR in September as a result of which the Company classified the borrowing under the credit agreement with HCR as a current liability and adjusted its carrying amount to reflect all amounts owing or payable under the credit agreement as being immediately due. As noted below, the Company has reached a non-binding agreement in principle with HCR with respect to the terms of a transfer of RedHill's rights in Movantik to HCR in exchange for the extinguishment of all RedHill's obligations under the credit agreement.[4]
Net Cash Used in Operating Activities for the third quarter of 2022 was $6 million, as compared to $16.6 million for the second quarter of 2022. The decrease was attributed to ongoing cost-reduction program accompanied by changes in working capital and positive cash flow from U.S. commercial operations.
Net Cash Used in Financing Activities for the third quarter of 2022 was $5.7 million comprised primarily of payables with respect to the Movantik acquisition.
Cash Balance2 as of September 30, 2022, was $31.4 million, as compared to $43.2 million as of June 30, 2022, and $45 million as of March 31, 2022.
Q3/22 Business updates
On November 14, 2022, the Company announced that it has reached a non-binding agreement in principle with HCR with respect to the terms of a transfer of RedHill's rights in Movantik to HCR in exchange for the extinguishment of all RedHill's obligations (including all principal, interest, revenue interest, prepayment premiums and exit fees) under the Credit Agreement between RedHill's U.S. subsidiary RedHill Biopharma Inc. and HCR dated as of February 23, 2020 (as amended). RedHill would retain substantially all pre-closing assets and liabilities relating to Movantik and HCR would assume substantially all post-closing assets and liabilities. It is expected that RedHill would provide cash-generating transition services to HCR to ensure a seamless process and uninterrupted patient care. Subject to certain approvals, the definitive agreements are expected to be signed and the transaction is expected to close by year-end, but there can be no assurance that the parties will enter into definitive agreements or that the transaction will be completed.
On September 2, 2022, the Company filed a lawsuit against Kukbo Co. Ltd. ("Kukbo") in the Supreme Court of the State of New York, County of New York, Commercial Division, as a result of Kukbo's default in delivering to the Company $5.0 million under the Subscription Agreement, dated October 25, 2021, in exchange for ADSs, and a further payment of $1.5 million due under the Exclusive License Agreement, dated March 14, 2022. On November 24, 2022, the Company received a letter from Kukbo asserting that Kukbo intends to defend its case and bring a counterclaim against the Company. The Company believes in the merits of its lawsuit against Kukbo and will continue to pursue a favorable judgment. The Company notes that Kukbo did not file a response in the U.S. court within the required timeframe.
Discussions regarding out-licensing of RedHill's products in multiple territories and in-licensing of new revenue-generating products are advancing.
Q3/22 Commercial Highlights
Movantik® (naloxegol)[3]
Movantik delivered a 4.9% growth in new prescriptions in Q3/22, compared to Q3/21, representing the second highest quarterly prescribing volume for Movantik since RedHill acquired the product rights. Indications from data to date suggest further growth in Q4/22.
Movantik continues to hold a firm grip on its PAMORA class leadership position, with more than 70% market share. As market leader, Movantik is anticipated to benefit further from positive PAMORA class growth trends – up 7.0% year-over-year and up 7.6% for the three months ending September 30, 2022, as compared to the same period in the previous year.
Two new Movantik analyses, from pooled data from two Phase 3 studies, were presented at PAINWeek in September, demonstrating that Movantik (naloxegol) provides healthcare-related quality of life (HR-QOL) and clinically meaningful symptom improvements, compared to placebo, in patients with opioid-induced constipation (OIC).
Movantik retains best-in-class coverage with Preferred Status in two of the three largest Commercial PBMs and 86% Preferred Status within Medicare Part D[4].
New updated Centers for Disease Control and Prevention (CDC) guidelines, issued in November 2022, provided for increased flexibility in opioid prescribing.
Talicia® (omeprazole magnesium, amoxicillin and rifabutin)[5]
A 56.6% increase in Talicia prescriptions in Q3/22, compared to Q3/21, builds on the record quarterly prescription levels seen in Q1/22 and Q2/22 and represents 64.8% year-to-date growth in Talicia prescriptions. Indications from data to date suggest further growth in Q4/22.
Talicia is the most prescribed branded agent by gastroenterologists and is on track to become the most prescribed branded H. pylori therapy in 2023.
New Talicia data analyses were presented at Obesity Week (November 2022) and the World Gastro 2022 congress (August 2022) supporting the efficacy and safety of Talicia as empiric first-line treatment for H. pylori infection in patients regardless of obesity, body mass index (BMI) or diabetic status and demonstrating that:
A commercial PBM win improved coverage to "preferred" for up to 58.0 million lives starting July 1, 2022. As of September 2022, total Talicia coverage stood at almost 200 million American lives.
Aemcolo® (rifamycin)[6]
The first post-pandemic prescriptions for Aemcolo are beginning to be seen and the Company is planning additional commercialization initiatives focused on driving growth in the primary care segment.
Q3/22 R&D Highlights
Opaganib (ABC294640)[7] - A novel broad-acting, host-directed oral antiviral targeting COVID-19, other viruses as part of a pandemic preparedness approach, inflammatory indications, oncology and radioprotection. Updates include:
On November 14, 2022, the Company announced acceleration of opaganib's nuclear radiation protection development program, with newly published data from eight U.S. government-funded in vivo studies, and additional experiments, indicating that opaganib was associated with:
Development of opaganib as a homeland security nuclear medical countermeasure is expected to follow the Animal Rule under which human efficacy studies may not be required, and if approved, may be eligible for a medical countermeasure Priority Review Voucher. Discussions regarding further support and pathway to potential approval have been initiated with U.S. and other governments.
Other opaganib updates include:
RHB-107 (upamostat)[8] – A novel broad-acting, host-directed oral antiviral targeting COVID-19, other viruses as part of a pandemic preparedness approach, inflammatory and oncology indications. Updates include:
Pursuing RHB-107's inclusion in a COVID-19 outpatients platform trial, pre-IND submitted.
Demonstrated preliminary in vitro inhibition of Omicron BA.5 sub-variant in testing conducted by the University of Tennessee in October 2022.
Both opaganib and RHB-107 are being pursued in development programs against multiple viral targets, including influenza and Ebola (amongst others).
RHB-204 - Pulmonary Nontuberculous Mycobacteria (NTM) Disease[9]
In August 2022, the European Commission granted Orphan Drug Designation to RHB-204, which is in an ongoing U.S. Phase 3 study, for the treatment of nontuberculous mycobacteria (NTM) disease, providing 10 years of post-approval EU market exclusivity.
HAIFA, Israel, March 03, 2020 (GLOBE NEWSWIRE) -- Pluristem Therapeutics Inc. (Nasdaq:PSTI) (TASE:PSTI), a leading regenerative medicine company developing a platform of novel biological products, today announced it received a response to the proposal it submitted to the U.S. Biomedical Advanced Research and Development Authority (BARDA) for funding a study designed to demonstrate the superiority of PLX-R18 therapy versus current standard of care in the treatment of Acute Radiation Syndrome (ARS). At this time, BARDA has chosen not to move forward with the funding of the current proposal.
----------------------------------------------------------------------------------
Perhaps RDHL will succeed?
BTW, another Israeli company MDWD did succeed,
although with a different product.
RedHill Biopharma set to lose key revenue source, could 'cease operations'
https://finance.yahoo.com/m/0137db42-72e0-370a-a819-e4d6333ba475/redhill-biopharma-set-to-lose.html?utm_source=sy&utm_medium=nsyp&utm_campaign=yh&yptr=yahoo
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NCI
BARDA
U.S. Department of Defense
FDA Office of Orphan Products Development
Top-line data from the 270-patient global Phase 2/3 COVID-19 study expected Q1/2021
Top-line data from the 40-patient U.S. Phase 2 study of opaganib in severe COVID-19 expected in the coming days; this non-powered study was designed to evaluate safety and potential identification of preliminary efficacy signals in support of the global Phase 2/3 study of opaganib
(Posted 12/22/2020)
21 Ha'arba'a Street
Tel Aviv 6473921
Israel
972 3 541 3131
http://www.redhillbio.com
[1] https://www.redhillbio.com/RedHill/Templates/showpage.asp?DBID=1&LNGID=1&TMID=178&FID=1358&PID=0&IID=1899
[2] https://www.redhillbio.com/RedHill/Templates/showpage.asp?DBID=1&LNGID=1&TMID=178&FID=2432&PID=0&IID=17299
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