Edesa Biotech Inc

Edesa Biotech, Inc. is a biopharmaceutical company, which focuses on acquiring, developing, and commercializing clinical stage drugs for inflammatory and immune-related diseases with clear unmet medical needs. Its product candidate, EB01 is a non-steroidal, anti-inflammatory treatment for chronic allergic contact dermatitis, a common, potentially debilitating condition and occupational illness. The company was founded on June 12, 2007 and is headquartered in Markham, Canada.

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Edesa Biotech, Inc. is a biopharmaceutical company, which focuses on acquiring, developing, and commercializing clinical stage drugs for inflammatory and immune-related diseases. Its clinical studies include EB05 for Acute Respiratory Distress Syndrome (ARDS), EB07 for systemic sclerosis (SSc), EB01 for chronic Allergic Contact Dermatitis (ACD), EB02 for hemorrhoids, and EB06 for vitiligo. The company was founded by Pardeep Nijhawan on June 12, 2007 and is headquartered in Markham, Canada.

TORONTO, ON / ACCESSWIRE / June 15, 2023 / Edesa Biotech, Inc. (NASDAQ:EDSA), a clinical-stage biopharmaceutical company focused on inflammatory and immune-related diseases, announced today the assignment of the name "daniluromer" for its first-in-class anti-inflammatory drug candidate. Daniluromer is a non-steroidal anti-inflammatory compound that inhibits secretory phospholipase 2 (sPLA2) pro-inflammatory enzymes.

Edesa Biotech Anti-Inflammatory Drug Candidate Assigned Name

TORONTO, ON / ACCESSWIRE / May 11, 2023 / Edesa Biotech, Inc. (Nasdaq:EDSA), a clinical-stage biopharmaceutical company focused on inflammatory and immune-related diseases, today reported financial results for the three and six months ended March 31, 2023 and provided an update on its business. During the fiscal second quarter, the company achieved two regulatory milestones, including an agreement with the U.S. Food and Drug Administration on the primary endpoint of a pivotal Phase 3 study of Edesa's ARDS (acute respiratory distress syndrome) drug candidate EB05 (paridiprubart) in critical-care patients hospitalized with SARS-CoV2 infections, and an authorization by Canadian regulators for a Phase 2 clinical study of Edesa's EB06 monoclonal antibody candidate as a treatment for vitiligo.

Edesa Biotech Reports Fiscal 2nd Quarter 2023 Results

TORONTO, ON / ACCESSWIRE / April 20, 2023 / Edesa Biotech, Inc. (NASDAQ:EDSA), a clinical-stage biopharmaceutical company focused on inflammatory and immune-related diseases, announced today that the company will join a Canadian delegation of officials and industry participating in Swiss Biotech Day on April 24-25, 2023 in Basel, Switzerland. Attendees who are interested in meeting with the company can utilize the conference scheduling system or contact Edesa directly via email at investors@edesabiotech.com.

Edesa Biotech to Participate in Swiss Biotech Day

International name assignment is a key step in Edesa's development and commercialization plans TORONTO, ON / ACCESSWIRE / April 4, 2023 / Edesa Biotech, Inc. (NASDAQ:EDSA), a clinical-stage biopharmaceutical company focused on inflammatory and immune-related diseases, today announced the World Health Organization (WHO) has adopted the international nonproprietary name "paridiprubart" for the company's monoclonal antibody candidate, EB05. Paridiprubart (EB05) is currently being evaluated in an international Phase 3 study in hospitalized Covid-19 patients with Acute Respiratory Distress Syndrome (ARDS), a severe form of respiratory failure.

The WHO and USAN Adopt Generic Name for Edesa's ARDS Drug Candidate

TORONTO, ON / ACCESSWIRE / March 23, 2023 / Edesa Biotech, Inc. (NASDAQ:EDSA), a clinical-stage biopharmaceutical company focused on inflammatory and immune-related diseases, announced today that the company will participate in a Fireside Chat and host one-on-one meetings at the H.C. Wainwright Autoimmune & Inflammatory Disease Virtual Conference on March 30, 2023.

Edesa Biotech to Participate in HC Wainwright Autoimmune & Inflammatory Disease Conference

TORONTO, ON / ACCESSWIRE / March 16, 2023 / Edesa Biotech, Inc. announced today that the company has been selected to present clinical trial data from a Phase 2B multi-dose study of its EB01 drug candidate at a Late Breaking Abstract session of the American Academy of Dermatology Association (AAD) annual meeting being held March 17-21, 2023. The presentation will detail the statistically significant topline results achieved by 1.0% EB01 cream in moderate-to-severe chronic allergic contact dermatitis (ACD) subjects, as well as data from other dose concentrations and safety data.

Edesa Biotech to Present Favorable Dermatitis Drug Results at American Academy of Dermatology Association Annual Meeting

28-day survival will be evaluated in ARDS patients hospitalized with Covid-19 Updated protocol approved by study's ethics committee Company exploring pathways for treating general ARDS patients TORONTO, ON / ACCESSWIRE / March 15, 2023 / Edesa Biotech, Inc. (NASDAQ:EDSA), a clinical-stage biopharmaceutical company focused on inflammatory and immune-related diseases, today reported that the company and the U.S. Food and Drug Administration (FDA) have agreed on the primary endpoint and population for a pivotal Phase 3 study evaluating Edesa's monoclonal antibody candidate, EB05, as a therapy for hospitalized patients with a severe form of respiratory failure. The FDA recently granted the program Fast Track designation.

Edesa Biotech and FDA Agree on Primary Endpoint for Phase 3 ARDS Drug Study

TORONTO, ON / ACCESSWIRE / February 10, 2023 / Edesa Biotech, Inc. (NASDAQ:EDSA), a clinical-stage biopharmaceutical company focused on inflammatory and immune-related diseases, today reported financial results for the three months ended December 31, 2022 and provided an update on its business. During the fiscal first quarter, the U.S. Food and Drug Administration (FDA) granted Fast Track designation for Edesa's drug candidate, EB05, which the company is developing for Acute Respiratory Distress Syndrome (ARDS), a severe form of respiratory failure.

Edesa Biotech Reports Fiscal 1st Quarter 2023 Results

Company's biologic drug candidate targets a key pathway involved in the progression and maintenance of depigmentation. TORONTO, ON / ACCESSWIRE / February 1, 2023 / Edesa Biotech, Inc. (Nasdaq:EDSA), a clinical-stage biopharmaceutical company focused on inflammatory and immune-related diseases, today announced that it has received approval from Health Canada for a Phase 2 clinical study of the company's EB06 monoclonal antibody candidate as a treatment for vitiligo.

Edesa Biotech Receives Regulatory Approval for Phase 2 Vitiligo Study

Study successfully identified lowest effective dose 1.0% formulation reached primary endpoint with statistical significance Company preparing for End of Phase 2 meeting with FDA following full analysis TORONTO, ON / ACCESSWIRE / January 17, 2023 / Edesa Biotech, Inc. (NASDAQ:EDSA), a clinical-stage biopharmaceutical company focused on inflammatory and immune-related diseases, today announced preliminary, topline results from a Phase 2b clinical study evaluating multiple concentrations of the company's drug candidate, EB01, as a monotherapy for moderate-to-severe chronic Allergic Contact Dermatitis (ACD). The double-blind, placebo-controlled trial evaluated the safety and efficacy of EB01 in approximately 200 subjects, who were treated for 28 days with either EB01 cream (2.0%, 1.0% or 0.2%) or a placebo/vehicle cream.

Edesa Biotech Reports Topline Phase 2b Results for Dermatology Drug

Fast Track improves the speed and frequency of communication with FDA, potentially leading to earlier drug approval and access by patients. TORONTO, ON / ACCESSWIRE / December 20, 2022 / Edesa Biotech, Inc. (Nasdaq:EDSA), a clinical-stage biopharmaceutical company focused on inflammatory and immune-related diseases, has received Fast Track designation from the U.S. Food and Drug Administration for its monoclonal antibody candidate, EB05.

FDA Grants Fast Track to Edesa Biotech's ARDS Drug Candidate

TORONTO, ON / ACCESSWIRE / December 16, 2022 / Edesa Biotech, Inc. (NASDAQ:EDSA), a clinical-stage biopharmaceutical company focused on inflammatory and immune-related diseases, today reported financial results for the fiscal year ended September 30, 2022 and provided an update on its business. During the fiscal year, Edesa reported positive final results from the Phase 2 part of a Phase 2/3 study of its monoclonal antibody in Covid-19 patients with Acute Respiratory Distress Syndrome (ARDS).

Edesa Biotech Reports Fiscal Year 2022 Results

TORONTO, ON / ACCESSWIRE / December 2, 2022 / Edesa Biotech, Inc. (NASDAQ:EDSA), a clinical-stage biopharmaceutical company focused on inflammatory and immune-related diseases, announced today that Dr. Par Nijhawan, Chief Executive Officer, will participate in a panel discussion and host one-on-one meetings at the Cantor Fitzgerald Medical Dermatology, Opthalmology & Medtech Conference. The panel discussion is scheduled to take place on Thursday, December 8, 2022 at 10:00 am ET, and is open to those who are registered to attend the event.

Edesa Biotech to Participate in the 2022 Cantor Fitzgerald Dermatology Conference

TORONTO, ON / ACCESSWIRE / November 3, 2022 / Edesa Biotech, Inc. (NASDAQ:EDSA) (the "Company" or "Edesa"), a clinical-stage biopharmaceutical company focused on inflammatory and immune-related diseases, today announced the closing a private placement directly with investors priced at-the-market under the rules of the Nasdaq Stock Market of 2,691,337 common shares, 12-month warrants to purchase up to an aggregate of 1,345,665 common shares and 3-year warrants to purchase up to an aggregate of 1,345,665 common shares. Officers and directors of the Company purchased approximately $0.5 million of the securities sold in the offering.

Edesa Biotech Announces Closing of $3.0 Million Private Placement Priced At-the-Market

Amid a soft opening performance for the major equity indices, Edesa Biotech (NASDAQ: EDSA ) shot up 7% against the prior session before dipping into negative territory during the afternoon session. The biopharmaceutical company, which specializes in inflammatory and immune-related diseases, announced positive Phase 2 results for its monoclonal antibody candidate targeting respiratory symptoms.

What Is Going on With Edesa Biotech (EDSA) Stock Today?

Mortality reduction in critically ill subjects at 28 days revised favorably, statistically significant EB05 demonstrated an 84% reduction in the risk of dying when compared to placebo Clinical Study Report submitted to FDA TORONTO, ON / ACCESSWIRE / September 30, 2022 / Edesa Biotech, Inc. (Nasdaq:EDSA), a clinical-stage biopharmaceutical company focused on inflammatory and immune-related diseases, announced final results from the Phase 2 portion of its ongoing Phase 2/Phase 3 clinical study. The study is evaluating the company's monoclonal antibody candidate, EB05, as a single-dose treatment for hospitalized patients with or at risk of developing Covid-19 induced Acute Respiratory Distress Syndrome (ARDS).

Edesa Biotech Reports Statistically Significant Mortality Reductions in Phase 2 ARDS Drug Study

TORONTO, ON / ACCESSWIRE / September 8, 2022 / Edesa Biotech, Inc. (NASDAQ:EDSA), a clinical-stage biopharmaceutical company focused on inflammatory and immune-related diseases, announced today that Par Nijhawan, MD, Chief Executive Officer, will present at the H.C. Wainwright Global Investment Conference being held in New York, NY on September 12-14, 2022.

Edesa Biotech to Present at Upcoming H.C. Wainwright Investor Conference

Primary Endpoint To Be Reached Within 30 Days, With Topline Data Available by End of Year Company Evaluating Partnership and Out-Licensing Opportunities Outside North America for Its First-in-Class, Anti-Inflammatory Drug Candidate TORONTO, ON / ACCESSWIRE / September 7, 2022 / Edesa Biotech, Inc. (NASDAQ:EDSA), a clinical-stage biopharmaceutical company focused on inflammatory and immune-related diseases, today announced that patient recruitment has been completed for a Phase 2b clinical study evaluating the company's drug candidate, designated EB01, as a monotherapy for moderate-to-severe chronic Allergic Contact Dermatitis (ACD). EB01 represents a potentially new class of non-steroidal, anti-inflammatory treatment for this often-debilitating occupational disease.

Edesa Biotech Reports Phase 2b Study Reaches Full Enrollment

Phase 3 ARDS drug study in hospitalized Covid-19 patients expanded Company reaffirms guidance on completion of Phase 2b dermatology drug study TORONTO, ON / ACCESSWIRE / August 12, 2022 / Edesa Biotech, Inc. (NASDAQ:EDSA), a clinical-stage biopharmaceutical company focused on inflammatory and immune-related diseases, today reported financial results for the three and nine months ended June 30, 2022 and provided an update on its business. During the quarter, the company expanded an international Phase 3 study of its critical care drug candidate in hospitalized Covid-19 patients with Acute Respiratory Distress Syndrome (ARDS).

Edesa Biotech Reports Fiscal 3rd Quarter 2022 Results

TORONTO, ON / ACCESSWIRE / August 3, 2022 / Edesa Biotech, Inc. (NASDAQ:EDSA), a clinical-stage biopharmaceutical company focused on inflammatory and immune-related diseases, announced today that its executive management will participate in the upcoming BTIG Biotechnology Conference being held in New York, NY on August 8-9, 2022. The hybrid event will be held both virtually and in-person.

Edesa Biotech to Participate at the Upcoming BTIG Biotech Conference

TORONTO, ON / ACCESSWIRE / July 11, 2022 / Edesa Biotech, Inc. (Nasdaq:EDSA), a clinical-stage biopharmaceutical company focused on inflammatory and immune-related diseases, announced today that Par Nijhawan, MD, Chief Executive Officer, will present at the 2nd Annual ARDS Drug Development Summit being held July 13-15, 2022 in Boston, Mass. Dr. Nijhawan's presentation is scheduled for 8:25 am ET on July 14, 2022.

Edesa Biotech to Present at ARDS Drug Development Summit

TORONTO, ON / ACCESSWIRE / May 24, 2022 / Edesa Biotech, Inc. (Nasdaq:EDSA), a clinical-stage biopharmaceutical company focused on inflammatory and immune-related diseases, today announced that the company has initiated enrollment for a second cohort of patients for the Phase 3 part of a Phase 2/3 study of the company's critical care drug candidate, designated EB05. Edesa is currently evaluating EB05, a monoclonal antibody, in critically ill patients with Covid-19-induced Acute Respiratory Distress Syndrome (ARDS), a severe respiratory illness that can result in long ICU stays and high mortality rates.

Edesa Biotech Adds Mechanically Ventilated Patients to Phase 3 ARDS Study

TORONTO, ON / ACCESSWIRE / May 19, 2022 / Edesa Biotech, Inc. (NASDAQ:EDSA), a clinical-stage biopharmaceutical company focused on inflammatory and immune-related diseases, announced today that Par Nijhawan, MD, Chief Executive Officer, will present virtually at the H.C. Wainwright Global Investment Conference being held May 23-26, 2022.

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

TORONTO, ON / ACCESSWIRE / May 13, 2022 / Edesa Biotech, Inc. (NASDAQ:EDSA), a clinical-stage biopharmaceutical company focused on inflammatory and immune-related diseases, today reported financial results for the three and six months ended March 31, 2022 and provided an update on its business. For its critical care drug candidate, Edesa reported during the quarter that more than 25% of the subjects have been randomized for the Phase 3 part of the company's clinical study in critically ill Covid-19 patients with Acute Respiratory Distress Syndrome (ARDS).

Edesa Biotech Reports Fiscal 2nd Quarter 2022 Results

Completion of enrollment is anticipated by calendar fourth quarter for the Phase 2b study of Edesa's potentially first-in-class, anti-inflammatory drug TORONTO, ON / ACCESSWIRE / April 28, 2022 / Edesa Biotech, Inc. (NASDAQ:EDSA), a clinical-stage biopharmaceutical company focused on inflammatory and immune-related diseases, today announced that patient recruitment for a Phase 2b clinical study evaluating the company's drug candidate, designated EB01, as a monotherapy for chronic allergic contact dermatitis (ACD) has been enrolling ahead of schedule. Based on the current pace of recruitment, which had previously been impacted by pandemic-related shutdowns, the company anticipates completing enrollment of all 210 planned subjects by the fourth calendar quarter of 2022, with initial topline data available as early as the first calendar quarter of 2023.

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