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Nice coverage...looking forward to more general public awareness for ABML.
Thank you for posting the link....
3BB
Excellent!
We have a .10 1,000 share trade this morning.
We are starting a new baseline of support.
I grabbed another 100000k shares.
A few highlights...
A treatment that successfully allows patients the ability to be discharged earlier than with SOC is most certainly a plus and worthy of EUA consideration. When you look at compounding hospital stays, 1 -3 days fewer allows for other incoming, sick patients to get treatment faster and be discharged earlier. Additionally, this "snow ball" effect is worthy of strong consideration; along with the fact that the financial impact of spending even 1 day less, let alone, 3 fewer days in ICU/hospital is extraordinary. Additionally, this can help our healthcare system to not be as overwhelmed with COVID 19 and return to other important surgical needs. JMHO.
Among the secondary efficacy endpoints evaluated in patients treated with High Flow Nasal Cannula therapy and with Mechanical Ventilation, there were six of 8 comparisons, all favoring ZYESAMI, resulting in at least a three-day median difference in hospital stay.
The study has not yet determined results for the stated primary endpoint of recovery from respiratory failure and the secondary endpoint data reported today should not create an expectation that the primary endpoint will be met overall or for any subgroup.
We will also report on day 60 survival.
The hospitalization data further suggest that patients treated at an earlier stage of illness (i.e. those who can be managed with HFNC) may have a better response to treatment.
Dial in VF
Conference call starts in few minutes.....on now.
To participate in the conference call, dial +1 866-373-3402 (Toll-Free) or +1 201-689-7825 (International), shortly before 9:00 a.m. EST. The webcast can also be accessed directly at https://lnkd.in/dFvkEfF
Good morning! Start your engines...we have NEWS.
https://finance.yahoo.com/news/neurorx-reports-initial-phase-2b-131300609.html
NeuroRx reports Initial Phase 2b/3 Study Results Demonstrating Significant Benefit of ZYESAMI™ (aviptadil) in Reducing Hospital Stay among Patients with Respiratory Failure due to Critical COVID-19
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Tue, February 9, 2021, 7:13 AM
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BRPA
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BRPAU
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If Authorized for Use, ZYESAMI™ Would be First Treatment Specifically for Critically Ill Patients with Respiratory Failure
RADNOR, Pa., Feb. 9, 2021 /PRNewswire/ -- NeuroRx, Inc. today reported preliminary results from their Phase 2b/3 trial of ZYESAMI™ (aviptadil, previously RLF-100) performed in collaboration with Relief Therapeutics Holdings, AG (SIX:RLF; OTCQB:RLFTF) in patients with respiratory failure due to Critical COVID-19. The study showed that patients who were treated with the maximal standard of care plus ZYESAMI were discharged sooner from the hospital compared to those treated with placebo plus maximal standard of care (SOC). If authorized for use, ZYESAMI would be the first drug indicated specifically for COVID-19 patients who are critically ill with respiratory failure.
(PRNewsfoto/NeuroRx)
(PRNewsfoto/NeuroRx)
Jonathan Javitt, M.D., M.P.H., CEO of NeuroRx, said: "We are greatly encouraged by these preliminary findings and believe they are indicative of a biologic effect of aviptadil in hastening recovery from Critical COVID-19. We expect to discuss with the Food and Drug Administration and other regulatory authorities the submission of an Emergency Use Authorization (EUA) so that ZYESAMI can be available for treating this population that is at immediate risk of death and for which there is no approved therapy."
With the improvement in survival since the start of the pandemic, differences in patient survival were not seen at day 28, and patients are now being followed through day 60. The study has not identified an overall difference in the stated primary endpoint of recovery from respiratory failure from summary data. However, investigators are in the process of confirming the timing of each case of recovery from medical records, following which the study's investigators' committee will review each case prior to patient-level unblinding of this endpoint. Those data are expected within a few weeks and will provide further insight into the benefits of ZYESAMI. A blinded substudy of radiographic improvement is similarly underway.
Among the secondary efficacy endpoints evaluated in patients treated with High Flow Nasal Cannula (HFNC) therapy and with Mechanical Ventilation, ZYESAMI showed an advantage in 15 of 16 comparisons and demonstrated a 40% or better advantage (hazard ratio <0.7). The likelihood of this magnitude of advantage being seen by chance alone is about 1 in 2,000 (P=.0005). This difference includes at least a five-day median reduction in hospital stay. (P=.043). The largest difference observed was among those treated with HFNC who experienced a median of 11 fewer days in hospital (15 vs. 26).
Dr. Javitt said: "The data provide preliminary support for ZYESAMI as a drug that may help get critically-ill patients home to their families sooner. The hospitalization data further suggest that patients treated at an earlier stage of illness (i.e., those who can be managed with HFNC) may have a better response to treatment. We have launched a phase 2/3 trial to explore ZYESAMI's inhaled use in patients who are not yet in respiratory failure.
"Further study of ZYESAMI's role in critical COVID-19 will be conducted under the BARDA and DOD Medical Countermeasures-funded I-SPY trial.
Dr. Javitt added: "To our knowledge this is the first demonstration of clinically and statistically-significant benefit by any therapeutic agent in patients with COVID-19 respiratory failure in a randomized, double blind, prospective trial. Other COVID-19 therapeutics have demonstrated clinical advantage in patients with non-critical COVID-19 (ordinal scale 4 and 5) but have not demonstrated benefit in those with Critical COVID-19 (ordinal scale 6 and 7). Steroids have demonstrated benefit in open label studies. However, no randomized controlled trial to date has shown efficacy when patients are in respiratory failure and require High Flow Nasal Cannula, Non-invasive ventilation, or Mechanical Ventilation to maintain blood oxygenation. ZYESAMI, if authorized, would be the first drug for such critically ill patients. Of note, the patients who received either drug or placebo in this trial also received all approved and standard of care treatments including Remdesivir, anti-cytokine drugs, steroids, and anticoagulants."
Dr. Javitt added: "We are forever indebted to the study coordinators, nurses, respiratory therapists, and doctors who carried out this study in the midst of a public health calamity that so far has claimed the lives of nearly half a million Americans and millions worldwide. Our study teams kept the effort going despite contracting COVID themselves, losing family members, and dealing with an unimaginable daily reality.
The data were generated in multicenter clinical trial whose subjects were COVID-19 patients with respiratory failure being treated with the maximal standard of care that included anti-coagulants, steroids, convalescent plasma and antiviral drugs. The primary endpoint was the resolution of respiratory failure within 28 days after treatment started. The secondary endpoints were patient survival, time to ICU discharge, time to hospital discharge, time to return to NIAID score of 6-8, and safety.
A total of 203 patients were screened and consented to participate in the study; 136 were given ZYESAMI. while 67 received the standard of care. All patients were evaluated through Day 28 with planned long-term follow-up through day 60. A total of 138 patients (91 ZYESAMI, 47 SOC) survived through Day 28. Ninety-six patients (65 ZYESAMI, 31 SOC) were discharged from the hospital by Day 28. Data analysis per protocol is ongoing.
The study, conducted in 10 medical centers, also showed the safety of the drug when administered by intravenous infusion in the ICU. No unexpected side effects identified. The most common side effects of ZYESAMI in the clinical trial were mild to moderate diarrhea (seen in 30% of ZYESAMI-treated vs. 1.5% of placebo-treated patients) and systemic hypotension (low blood pressure) seen in 31 ZYESAMI-treated patients vs. 25 placebo patients. There were two deaths in the study related to hypotension, both of which occurred more than a week after treatment. One patient was in the ZYESAMI group, and the other was in the placebo group. All potentially serious adverse effects were investigated by a board-certified critical care physician together with site investigators, and none was deemed drug-related.
Conference Call Information
NeuroRx will host a conference call and webcast on February 9, 2021 at 9:00 a.m. EST to discuss study results. To participate in the conference call, dial +1 866-373-3402 (Toll-Free) or +1 201-689-7825 (International), shortly before 9:00 a.m. EST. The webcast can also be accessed directly at https://78449.themediaframe.com/dataconf/productusers/nrx/mediaframe/43588/indexl.html.
About VIP in COVID-19
Vasoactive Intestinal Polypeptide (VIP) was first discovered by the late Dr. Sami Said in 1970. Although first identified in the intestinal tract, VIP is now known to be produced throughout the body and to be primarily concentrated in the lungs. VIP has been shown in more than 100 peer-reviewed studies to have potent anti-inflammatory/anti-cytokine activity in animal models of respiratory distress, acute lung injury, and inflammation. Most importantly, 70% of the VIP in the body is bound to a rare cell in the lung, the alveolar type II cell (ATII), that is critical to transmission of oxygen to the body.
COVID-19-related respiratory failure is caused by selective infection of the ATII cell by the SARS-CoV-2 virus. They are vulnerable because of their (ACE2) surface receptors, which serve as the route of entry for the virus. These specialized cells manufacture surfactant that coats the lung and is essential for oxygen exchange. Loss of surfactant causes collapse of the air sacs (alveolae) in the lung and results in respiratory failure.
VIP is shown to block Coronavirus replication in the ATII cell, block cytokine synthesis, block viral-induced cell death (cytopathy), and upregulate surfactant production. To our knowledge, other than ZYESAMI™, no currently proposed treatments for COVID-19 specifically target these vulnerable Type II cells.
About NeuroRx, Inc.
NeuroRx draws upon more than 100 years of collective drug development experience from senior executives of AstraZeneca, Eli Lilly, Novartis, Pfizer, and PPD. In addition to its work on Aviptadil, NeuroRx has been awarded Breakthrough Therapy Designation and a Special Protocol Agreement to develop NRX-101 in suicidal bipolar depression and is currently in Phase 3 trials. Its executive team is led by Prof. Jonathan C. Javitt, MD, MPH, who has served as a health advisor to four Presidential administrations and worked on paradigm-changing drug development projects for Merck, Allergan, Pharmacia, Pfizer, Novartis, and Mannkind, together with Robert Besthof, MIM, who served as the Global Vice President (Commercial) for Pfizer's Neuroscience and Pain Division. The Company recently announced a plan to merge with Big Rock Partners Acquisition Corp (NASDAQ:BRPA) ("Big Rock"), following which it is expected to trade on the NASDAQ as NRXP.
Cautionary Note Regarding Forward Looking Statements
Statements contained in this press release that are not historical facts may be forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Forward-looking statements generally relate to future events or the Company's future financial or operating performance. In some cases, you can identify forward-looking statements because they contain words such as "may," "will," "should," "expects," "plans," "anticipates," "could," "intends," "target," "projects," "contemplates," "believes," "estimates," "predicts," "potential" or "continue" or the negative of these words or other similar terms or expressions that concern the Company's expectations, strategy, plans or intentions. Such forward-looking statements may relate to, among other things, the outcome of any discussions or applications for the future use of ZYESAMI. Such forward-looking statements do not constitute guarantees of future performance and are subject to a variety of risks and uncertainties. The Company does not undertake any obligation to update forward-looking statements as a result of new information, future events or developments or otherwise.
Additional Information and Where to Find It
This document relates to a proposed Business Combination and related transactions (the "Transactions") between the Company and Big Rock Partners Acquisition Corp. ("BRPA"). This document does not constitute an offer to sell or exchange, or the solicitation of an offer to buy or exchange, any securities, nor shall there be any sale of securities in any jurisdiction in which such offer, sale or exchange would be unlawful prior to registration or qualification under the securities laws of any such jurisdiction. BRPA has filed a registration statement on Form S-4 ("Registration Statement"), which includes a preliminary proxy statement for the solicitation of the approval of BRPA's stockholders, a preliminary prospectus for the offer and sale of BRPA's securities in the transaction and a preliminary consent solicitation statement of the Company, and other relevant documents with the SEC. The proxy statement/prospectus/consent solicitation statement will be mailed to stockholders of the Company and BRPA as of a record date to be established for voting on the proposed business combination. INVESTORS AND SECURITY HOLDERS OF THE COMPANY AND BRPA ARE URGED TO READ THE REGISTRATION STATEMENT, PROXY STATEMENT/PROSPECTUS/CONSENT SOLICITATION STATEMENT AND OTHER RELEVANT DOCUMENTS THAT WILL BE FILED WITH THE SEC CAREFULLY AND IN THEIR ENTIRETY WHEN THEY BECOME AVAILABLE BECAUSE THEY WILL CONTAIN IMPORTANT INFORMATION ABOUT THE PROPOSED TRANSACTIONS. Investors and security holders will be able to obtain free copies of the registration statement, proxy statement, prospectus and other documents containing important information about the Company and BRPA once such documents are filed with the SEC, through the website maintained by the SEC at http://www.sec.gov. In addition, copies of the documents filed with the SEC by BRPA can be obtained free of charge on BRPA's website at www.bigrockpartners.com or by directing a written request to BRPA at 2645 N. Federal Highway, Suite 230 Delray Beach, FL 33483.
Participants in the Solicitation
The Company, BRPA and their respective directors and executive officers, under SEC rules, may be deemed to be participants in the solicitation of proxies of BRPA's stockholders in connection with the proposed Transactions. Investors and securityholders may obtain more detailed information regarding the names and interests in the proposed Transactions of the Company's and BRPA's respective directors and officers in BRPA's filings with the SEC, including the proxy statement/consent solicitation statement/prospectus statement. You may obtain a free copy of these documents as described in the preceding paragraph.
MEDIA CONTACT
NeuroRx (United States):
David Schull
Russo Partners, LLC
david.schull@russopartnersllc.com
858-717-2310
INVESTOR RELATIONS
NeuroRx (United States)
Brian Korb
Solebury Trout
bkorb@troutgroup.com
917-653-5122
Thought this point was worth reiterating....
Brilacidin and COVID-19
Brilacidin is one of the few drugs targeting COVID-19 that has been tested in human trials (a total of 8) for other clinical indications, providing established safety and efficacy data on over 460 subjects, thereby potentially enabling it to rapidly help address the novel coronavirus crisis. Laboratory testing at independent laboratories supports Brilacidin’s antiviral ability to safely and potently inhibit SARS-CoV-2. In a human lung cell line, Brilacidin achieved a Selectivity Index of 426. A molecular screening study of 11,552 compounds also supports Brilacidin as a promising novel coronavirus treatment. Brilacidin anti-viral research to date has been limited to laboratory-based experiments. Additional pre-clinical and clinical data support Brilacidin’s inhibition of IL-6, IL-1ß, TNF-a and other pro-inflammatory cytokines and chemokines, which have been identified as central drivers in the worsening prognoses of hospitalized COVID-19 patients. Brilacidin’s robust antimicrobial properties might also help to fight secondary bacterial infections, which can co-present in up to 20 percent of COVID-19 patients. Collectively, these data support Brilacidin as a unique 3 in 1 combination—antiviral, immuno/anti-inflammatory, and antimicrobial—COVID-19 therapeutic candidate. A preprint supporting Brilacidin’s COVID-19 treatment potential can be downloaded on bioRxiv.org at the link below.
Brilacidin, a COVID-19 Drug Candidate, Exhibits Potent In Vitro Antiviral Activity Against SARS-CoV-2
https://www.biorxiv.org/content/10.1101/2020.10.29.352450v1.full
Study Design
Go to sections
Study Type : Interventional (Clinical Trial)
Actual Enrollment : 196 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Multicenter trial, initially conducted at a single center with a safety/futility assessment following enrollment of 30 patients, expanded to 196 total patients at 12 study sites
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Randomized, placebo-controlled trial with identical drug and placebo infusion bags
Primary Purpose: Treatment
Official Title: ZYESAMI (Aviptadil) for the Treatment of Critical COVID-19 With Respiratory Failure
Actual Study Start Date : May 15, 2020
Estimated Primary Completion Date : January 21, 2021
Estimated Study Completion Date : February 28, 2021
Resource links provided by the National Library of Medicine
Nice post JB...love all the warren buffet quotes.
Nice post JB
Revive Therapeutics Files Business Acquisition Report
5:38 PM ET 2/8/21 | GlobeNewswire
Revive Therapeutics Files Business Acquisition Report
TORONTO, Feb. 08, 2021 (GLOBE NEWSWIRE) -- Revive Therapeutics Ltd. ("Revive" or the "Company") (CSE:RVV) (USA: RVVTF), announces that it has filed a Form 51-102F4 Business Acquisition Report (BAR) pursuant to National Instrument 51-102 Continuous Disclosure Obligations in connection with its acquisition of Psilocin Pharma Corp. on March 5, 2020. The BAR has been filed as a result of a review conducted by staff at the Ontario Securities Commission in connection with the Company's recently filed preliminary short form prospectus dated January 26, 2021.
Hi JB...Couldn’t agree more!
Afternoon VF.
You seem really hard to please.
Nothing ever goes straight up....but you know that.
You definitely keep things interesting!
Vanilla have you tried calling IR directly yourself? Seems you might be able to ask your questions and get perspective of what's going on.
Nice post Lily
Something very nice is happening here. Glad to be part of the experience.
Holding my shares for the long haul. The best to all longs.
Enjoy the weekend!
3BB
Good morning. Apparently this stock is a Caveat Emptor security...so cross and bones...can't buy via ETRADE.
Any thoughts?
Good morning Dane....Hope you are feeling much better. Take care, rest up and go IPIX....Happy Friday!
https://finance.yahoo.com/news/wpd-pharmaceuticals-licensor-announces-100-123000433.html
WPD Pharmaceuticals’ Licensor Announces 100% Survival Achieved in Osteosarcoma Lung Metastases Animal Model of Annamycin Drug
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Moleculin Biotech, Inc.
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About Moleculin Biotech, Inc.
Moleculin Biotech, Inc., a clinical-stage pharmaceutical company, focuses on the development of oncology drug candidates. Its lead drug candidate is Annamycin that is in Phase 1/2 studies for the treatment of relapsed or refractory acute...Yahoo Finance
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Potentially significant therapeutic benefit against metastatic, Annamycin shown to reach "sanctuary sites" of cancer
VANCOUVER, British Columbia, Feb. 05, 2021 (GLOBE NEWSWIRE) -- WPD Pharmaceuticals Inc. (CSE: WBIO)(FSE: 8SV1) (the “Company” or “WPD”) a clinical-stage pharmaceutical company, is pleased to announce that that Moleculin Biotech Inc. (NASDAQ:MBRX) (“Moleculin”), the company that sublicenses the compound Annamycin to WPD for 29 countries mainly in Europe, announced that a preclinical study in animals demonstrated a potentially significant therapeutic benefit of Annamycin against metastatic osteosarcoma. The Moleculin press release of February 2, 2020 states, “This appears to be the result of the high cytotoxic potential of Annamycin previously demonstrated in vitro against sarcoma cells in combination with its high uptake by the lungs where the tumors in this study are localized. Computerized tomography (CT) scans demonstrated that animals treated with Annamycin exhibited significant suppression of tumor growth and not a single death was observed in the treated animals, whereas significant tumor burden contributed to the rapid death of 90% of untreated animals. While the study continues, as of day 130, the survival rate for animals treated with Annamycin was 100%, compared with only 10% for untreated animals.
Osteosarcoma is among a class of tumors that initiate in the bone of patients, with bone-related sarcomas representing the second most common form of sarcoma after soft tissue sarcoma. While many bone sarcomas can be addressed through surgical removal, it is estimated that as many as 40% of bone sarcomas will eventually metastasize to the lungs, where treatment can become more problematic. Researchers have more recently referred to the lungs and certain other vital organs as "sanctuary sites" for cancer where tumors can develop out of reach from conventional chemotherapies.
Once metastasized to the lungs, if tumors cannot be surgically removed, the primary chemotherapy regimen is the anthracycline doxorubicin (also known as Adriamycin). While 10% to 30% of patients with sarcoma lung metastases may initially respond to doxorubicin, most will relapse leaving the majority of these patients without an alternative chemotherapy. Moleculin recently announced findings from its sponsored research showing that doxorubicin has a limited ability to accumulate in the lungs of animals, which may help explain its limited efficacy in this sanctuary site. Treatment options are further limited because of the inherent cardiotoxicity of currently approved anthracyclines, including doxorubicin, which limits the amount of anthracycline that can be given to patients.
Good morning....all shares LOCKED UP.
Happy Friday!
3BB
"Yes...major "high-fives" to KarinCA"....AMEN!!
Nice post Dane...
PJ always enjoy your posts...thank you for the contributions.
Major "high-fives" to KarinCA. Hope you are well. PM when you get a spare moment.
3
Ditto..."True that!"
Hello IPIX Longs...just now able to tap in to the day's action. What a fabulous Thursday...week all the way around. Looking forward to tomorrow and the upcoming next few weeks. Feeling really good about this position. Not selling any....holding tight for the long haul.
Good luck to all longs. Shorts play your game if you so choose!
All the best!
3BB
Absolutely...I will look deeper in to the opportunities. I appreciate you patience with me and the nod to your sticky.
Thank you!
3BB
very good assertion. I think we have enough good news coming down the pike that we should have a win/win for all. I don't trade in and out, so my portfolio is never impacted by stagnation.
Best to you!
3BB
awww okay! Thank you....I appreciate the info. I have a modest position too. I guess I'll sit on and hold while longer.
Thanks and have a great week!
3
What am I missing...no volume to speak of so how can anyone sell and make $ if no ones buying?
Aso, does anyone know what the link between RNWF and HPST is?
TIA
3BB
Good morning! Who’s the 50,000 share block at .281?
Hello all. Nice pull together of situation Coop.
Excellent perspective....thank you Trow
Thank you for all of this wonderfully solid dd.
Agree. Thank you for all you do Sello!
My alert/news hit my inbox at 8:14am 1/29
Decent close for the week. Looking forward to the next 30-60 days. Slow and steady rise....