Edesa Biotech, Inc. (EDSA)

[goforthebet]

Edesa Biotech Extends COVID-19 Clinical Study to Poland
November 04, 2021

https://irdirect.net/prviewer/release_only/id/4921712

[ombowstring]

Edesa Biotech Extends COVID-19 Clinical Study to Poland

http://irdirect.net/prviewer/release_only/id/4921712

[Gulo]

I don't visit ihub much, but came back when EDSA jumped last Monday. I notice there isn't much discussion of the technical viability of the EB05 TLR4 antibody as a treatment for ARDS. So, I hought I'd post this link to an independent review in case anyone cared. In short, TLR4 is looking like a critical checkpoint in ARDS from Covid-19 (as well as other causes). Expect other biotechs to start jumpig on the bandwagon. EDSA is a couple years ahead, and if EBO5 is commercialized, it will be SOC, so it will be hard to recruit for cometing trials.
Review of TLR4 in Covid pathology:
https://www.ncbi.nlm.nih.gov/labs/pmc/articles/PMC8095161/

[puddler]

no

[madras50]

was there an offering to knock this down?

[puddler]

Sic volume here, especially with this float!

[DarkPool]

Damn

[goforthebet]

worth waiting. Nice move today. I bought a lot when nobody wanted them around 4.20 - :)

[crudeoil24]

EDSA up 64% > Edesa Biotech Announces Phase 2 Data Of Its Monoclonal Antibody In Hospitalized COVID-19 Patients; Critically Ill Patients Demonstrated A 68.5% Reduction In The Risk Of Dying When Treated With EB05 Over Standard Of Care.

[goforthebet]

Edesa Biotech Announces Positive Phase 2 Data of Its Monoclonal Antibody in Hospitalized COVID-19 Patients

https://quantisnow.com/insight/1787518?s=s

[goforthebet]

Edesa Biotech to Present at the H.C. Wainwright Global Investment Conference

https://newsfilter.io/a/c0c64af3a183f142d3d2a29abbc24881

[goforthebet]

Everyone is just talking about eb05 against ARDS but I've been doing a little Dd about eb06, too, which seems pretty promising as well. I'd love to get an update for that drug before the interim results. Eb06 is an antibody against the cxcl10 receptor and here is what I found out about cxcl10:

CXCL10 was recently identified as the cardinal chemokine playing a crucial role in COVID-19 being a chemoattractant for monocytes/macrophages, dendritic cells, NK cells, and T cells. Elevated serum levels of CXCL10 were consistently reported in patients with COVID-19, being positively correlated (together with CCL2) with increased disease severity and, more importantly with an increased risk of mortality. High levels of CXCL10 were previously reported to be associated also with the severe acute respiratory syndrome (SARS) disease progression and to the development of ARDS in preclinical models.

https://www.frontiersin.org/articles/10.3389/fimmu.2021.668507/full

apparently eb06 is in phase II, too. How come we don't know anything about that drug? It might even be possible to use eb06 as an add-on-drug for eb05, if a patient does not fully recover with eb05 only, because both drugs use different pathways to prevent the cytokine storm. Just imagine both drugs get an approval until the end of this year! Good times ahead, boys and girls



from Spottford STW

[goforthebet]

Tell me where you can find a better risk/reward anywhere on the markets right now:

1. Two drugs tacking unmet medical needs and both are multi billion dollar markets

2. both at phase 2/3

3. Nobel prize winning science

4. trials running ahead of schedule and P3 could be complete this year

5. 40% insider ownership

6. Management has a sterling track record

7. Incredibly low float

8. almost zero selling pressure

9. Valuation at approx $60m

10. funded by the Canadian gov in a non dilutive way

11. no debt


by Paddy124
$EDSA

[goforthebet]

Is Edesa Biotech Inc (EDSA) a Stock to Watch After Gaining 15.20% This Week?

Thursday, August 26, 2021 10:16 AM | InvestorsObserver Analysts

https://www.investorsobserver.com/news/stock-update/is-edesa-biotech-inc-edsa-a-stock-to-watch-after-gaining-15-20-this-week

[goforthebet]

Edesa Biotech Enrolls More Than 525 COVID-19 Patients Ahead of Schedule

Delta variant contributes to rapid enrollment amid growing scientific rationale for targeting Toll-like Receptor 4 (TLR4)
Blinded interim analysis from Phase 2/3 study expected in current quarter

TORONTO, ON / ACCESSWIRE / August 26, 2021 / Edesa Biotech, Inc. (NASDAQ:EDSA), a clinical-stage biopharmaceutical company focused on inflammatory and immune-related diseases, today provided an update on a Phase 2/3 clinical study evaluating the company's monoclonal antibody candidate as a single-dose therapy for hospitalized COVID-19 patients.

As of August 25, 2021, Edesa reported that more than 525 subjects have been randomized into the study to be treated with either Edesa's monoclonal antibody (designated EB05) plus standard of care treatment, or placebo plus standard of care. Approximately 35 of these patients have been assigned to an investigation sub-study evaluating EB05 as a rescue therapy for patients with critically severe COVID-19 symptoms, including patients who have been ventilated for more than five days or are receiving extracorporeal membrane oxygenation (ECMO) therapy.

Additionally, the company reported that all patients planned for a key interim analysis have been randomized and completed the treatment protocol. Edesa expects the analysis from third-party statisticians to be completed in the coming weeks.

The company said that the interim analysis will include data from approximately 316 subjects. The blinded comparative interim analysis of treatment data and events is expected to inform patient segmentation and associated endpoints for the final part of study. As a Phase 2/3 study, enrollment has continued during the analysis.

Dr. Par Nijhawan, MD, Chief Executive Officer of Edesa, attributed the rapid pace of enrollment to the growing scientific rationale for targeting Toll-like Receptor 4 (TLR4), the attractiveness of the single-dose treatment, the broad potential utility for the drug candidate as well as increased disease incidence in regions where Edesa's clinical sites are located.

"We have continued to see rapid enrollment in our trial this summer, especially in the southern hemisphere. With the Delta variant causing another wave of infections in North America, we are now experiencing some of the highest weekly rates of enrollment since we initiated our study," said Dr. Nijhawan. "The prevalence of the Delta variant, as well as any future variants, underscores the urgent need for therapeutics that can address the mechanisms underlying the progression to severe disease and respiratory failure."

"We anticipate being in a position to provide the interim results for our Phase 2/3 study this quarter," said Dr. Nijhawan. "On behalf of Edesa, I'd like to express our continuing gratitude to the patients, their families and healthcare workers along with the clinical site teams for enabling us to reach these key milestones."

Dr. Blair Gordon, Edesa's Vice President of Research and Development, reported that with support from the federal government, the company has now established a network of 46 clinical sites at hospitals in Canada, Colombia and the United States.

"With all the planned clinical sites trained and up-and-running, and drug product on hand, our research and development team and study partners are preparing for an efficient transition into the anticipated Phase 3 study portion of the study," he said.

EB05 is an experimental monoclonal antibody that Edesa believes could regulate the overactive and dysfunctional immune response associated with Acute Respiratory Distress Syndrome (ARDS). ARDS is the leading cause of death in COVID-19 patients. Specifically, the drug inhibits toll-like receptor 4 (TLR4) signaling - an important mediator of inflammation responsible for acute lung injury that has been shown to be activated by SARS-CoV2, SARS-CoV1 and Influenza viruses. Prior to COVID-19, ARDS accounted for 10% of intensive care unit admissions, representing more than 3 million patients globally each year.

Edesa's study of EB05 in hospitalized COVID-19 patients is being funded in part by a C$14 million grant from the Canadian Government. To date, the company has reached all clinical enrollment and project targets specified under the grant ahead of schedule.

About ARDS
Acute Respiratory Distress Syndrome is the leading cause of death in COVID-19 patients. The U.S. Centers for Disease Control (CDC) reports that 20% to 42% of hospitalized COVID-19 patients develop ARDS, which increases to 67% to 85% for patients admitted to the ICU. Mortality among patients admitted to the ICU ranges from 39% to 72% depending on the study and characteristics of patient population, according to the CDC. ARDS involves an exaggerated immune response leading to inflammation and injury to the lungs that results in edema that deprives the body of oxygen. For moderate to severe cases, there are currently few meaningful treatments, other than supplemental oxygen and mechanical ventilation, and patients suffer high mortality rates. In addition to virus-induced pneumonia, ARDS can be caused by smoke/chemical inhalation, sepsis, chest injury and other causes. Prior to COVID-19, ARDS accounted for 10% of intensive care unit admissions, representing more than 3 million patients globally each year.

About Edesa Biotech, Inc.
Edesa Biotech, Inc. (NASDAQ:EDSA) is a clinical-stage biopharmaceutical company focused on developing innovative treatments for inflammatory and immune-related diseases with clear unmet medical needs. The company's two lead product candidates, EB05 and EB01, are in later stage clinical studies. EB05 is a monoclonal antibody therapy that we are developing as a treatment for Acute Respiratory Distress Syndrome (ARDS). ARDS is a life-threatening form of respiratory failure, and the leading cause of death among COVID-19 patients. Edesa is also developing an sPLA2 inhibitor, designated as EB01, as a topical treatment for chronic allergic contact dermatitis (ACD), a common, potentially debilitating condition and occupational illness. By targeting sPLA2 with enzyme inhibitors - at the inception of inflammation rather than after inflammation has occurred - Edesa believes that drugs based on this technology could provide a powerful anti-inflammatory therapeutic strategy for treating diverse inflammatory/allergic conditions. The company is based in Markham, Ontario, Canada, with a U.S. subsidiary located in Southern California. Sign up for news alerts.

https://newsfilter.io/a/b08eb8797c8f9ee8720479a32e2b2395

[goforthebet]

Edesa Biotech: A Covid Gem Ready To Explode
Aug. 19, 2021

https://seekingalpha.com/instablog/54834147-cabin11investments/5628619-edesa-biotech-covid-gem-ready-to-explode

[goforthebet]

Corporate presentation August 2021.

https://www.edesabiotech.com/wp-content/uploads/2021/08/EdesaBiotech-EDSA-CorporatePresentation-Aug-2021.pdf

[goforthebet]

for new eyes a good point to start DD

https://temertymedicine.utoronto.ca/news/u-t-test-new-drug-covid-19-edesa-biotech

Impressive read about .DR. PAR NIJHAWAN

Dr. Par Nijhawan is a seasoned physician and entrepreneur with 20 years of experience in cross-functional roles including finance, marketing and business and drug development. Dr. Nijhawan is the Founder and CEO of Edesa Biotech. In addition, he is the Founder and Chairman of Exzell Pharma, ranked as Canada’s fastest growing company in 2019. Dr. Nijhawan was Founder and CEO of Medical Futures Inc., a specialty pharmaceutical company which he successfully sold to a public company in 2015. He also established Digestive Health Clinic, Canada’s largest provider of private endoscopy services. Dr. Nijhawan was inducted into the CHLA BD Hall of fame in 2018 and Awarded Business Development Deal of the Year 2017. Dr. Nijhawan received his MD (University of Ottawa), Internship (Yale), Residency IM (Mayo), Fellowship GI (Mayo)

https://www.prnewswire.com/news-releases/edesa-biotech-wins-chla-award-for-best-bd-deal-of-2017-and-dr-par-nijhawan-inducted-into-the-chla-hall-of-fame-675970213.html

[goforthebet]

Edesa Biotech Reports Fiscal 3rd Quarter 2021 Financial Results

https://last10k.com/sec-filings/EDSA/0001654954-21-008915.htm?utm_source=stocktwits&utm_medium=forum&utm_campaign=sentiment&utm_term=edsa

[goforthebet]

8-k

https://fintel.io/sf/us/edsa?utm_source=stocktwits.com&utm_medium=Referral&utm_campaign=filing

[goforthebet]

news from June. expanding leadership team... something must be up imo

Edesa Biotech Team Expands Leadership Team with Key Manufacturing Appointment

June 23, 2021

https://finance.yahoo.com/news/edesa-biotech-team-expands-leadership-115500482.html

[goforthebet]

chart

[goforthebet]

Edsa price target $18.00

The 1 analysts offering 12-month price forecasts for Edesa Biotech Inc have a median target of 18.00, with a high estimate of 18.00 and a low estimate of 18.00. The median estimate represents a +276.57% increase from the last price of 4.78

https://money.cnn.com/quote/forecast/forecast.html?symb=edsa

[goforthebet]

this video from the CEO is amazing.. I think with some patience this stock can go much higher

https://media.rampard.com/20210429/player.jsp?id=223

[goforthebet]

looks like not much interest in this stock. I bought some today for the long term.. let´s see what will happen

EDSA

[crudeoil24]

Edesa Biotech Gets Approval to Add Sub-Study for Covid-19 Treatment
8:02 am ET January 26, 2021 (Dow Jones) Print

By Chris Wack


Edesa Biotech Inc. said Tuesday it has received regulatory approval from the U.S. Food and Drug Administration and Health Canada to add a sub-study to its Phase 2/Phase 3 clinical trial of its investigational drug, EB05, for the treatment of Acute Respiratory Distress Syndrome.

The biopharmaceutical comapny said the sub-study would evaluate the drug as a potential rescue therapy for critically severe Covid-19 cases.

Edesa's sub-study is expected to enroll up to 100 intensive-care patients with severe Covid-19 symptoms, including patients who have been ventilated for more than five days or are receiving extracorporeal membrane oxygenation therapy. The sub-study doesn't affect the design or results of Edesa's international Phase 2/3 study.

EB05 is an experimental monoclonal antibody that Edesa believes could regulate the overactive immune response associated with ARDS. The goal of the experimental treatment is to suppress inflammation, fluid accumulation and lung injury, thereby reducing the number of patients admitted to intensive care units and intubation/ventilation procedures, and ultimately saving lives. Up to 316 patients will be enrolled in the Phase 2 part of the trial in Canada, the U.S. and Colombia. Should the antibody treatment demonstrate promising results at the Phase 2 readout, the company plans to continue with a pivotal Phase 3 study.

Edesa Biotech shares were up 80% to $9.89 in premarket trading.

[kzivann]

Yes.. just saw this.

https://irdirect.net/prviewer/release_only/id/4496637

EDSA

[BluSkies]

FDA approval?

[kzivann]

Up premarket .. ??

EDSA

[Natureboy1]

Getting some traction and News is DEFINITELY due now. Or every month for 2 years straight. This thing is known to move 200-300% premarket on news! IND and funding approval imminent. Just sayin’. Set your sell orders to reflect these statement. Don’t miss out.

[Natureboy1]

News any day now!

[DanSanTrades]

EDSA Got regulatory approval from Health Canada to conduct 2/3 phase Human trial of its COVID vaccine candidates. EDSA is in the pipeline for Health Canada funding.

EDSA applied for IND approval at USA FDA on July 30. As per the regulations, FDA would approve it within 30 days. So, it’s anytime......!!!!!
Who knows, it may be tomorrow PM.

EDSA has the history to jump 150% with any news, as not much shares are in the market.No link, heard it on stocktwits before watching the price shoot up after hours.

[slyguy8888]

Im holding

[TheFinalCD]

8.15 +40%



EDSA

[MELBENZ2020]

Go EDSA!

[dsscam]

$EDSA $20? Nice call! (Not)

[ClayTrader]

* * $EDSA Video Chart 07-30-2020 * *

Link to Video - click here to watch the technical chart video

[MELBENZ2020]

Wow. What a volume. Got in too and holding tight to my shares for tomorrow's extended play.

[$treet $inatra]

EDSA another CV19 pump&dump woohooo https://finance.yahoo.com/news/edesa-biotech-files-ind-application-114500791.html

[jr525]

I think it will go back there

[BoilerRoom]

$EDSA $20.00 coming

[BoilerRoom]

Nice catch

[pennyking130]

Thank you I’m glad I was up early to catch this

[BoilerRoom]

Nice lucky man

[pennyking130]

I was all in at 9 :)

[BoilerRoom]

$EDSA All in folks!!!! Load up!!!

[pennyking130]

I’m sorry 16

[pennyking130]

Make that 15

[TheFinalCD]

OR 13

[TheFinalCD]

The safety and tolerability of EB05 has been demonstrated in more than 120 subjects.

https://finance.yahoo.com/news/edesa-biotech-files-ind-application-114500791.html