This section highlights FDA-related milestones and regulatory updates for drugs developed by Edesa Biotech (EDSA).
Over the past two years, Edesa Biotech has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
EB06 and EB05. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
Select a button below to view the list of FDA events for that drug.
EB06 FDA Regulatory Events
EB06 is a drug developed by Edesa Biotech for the following indication: Moderate-To-Severe Nonsegmental Vitiligo.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- EB06
- Announced Date:
- March 26, 2026
- Indication:
- Moderate-To-Severe Nonsegmental Vitiligo
Announcement
Edesa Biotech, Inc. provided an update on preparations and reaffirmed enrollment timeline guidance for its Phase 2 clinical study of EB06 in moderate-to-severe nonsegmental vitiligo.
AI Summary
Edesa Biotech provided an update on preparations and reaffirmed its enrollment timeline guidance for the Phase 2 study of EB06 in adults with moderate-to-severe nonsegmental (generalized) vitiligo. The company said it remains on track to begin enrolling patients on the schedule it previously outlined and is finalizing operational readiness across sites.
CEO Par Nijhawan said ongoing engagement with leaders in the vitiligo community and discussions at this week’s vitiligo conference have helped refine the trial design. Feedback from key opinion leaders is being used to align study endpoints, site selection, and patient outreach with the needs of both patients and treating physicians.
The randomized, placebo-controlled Phase 2 will evaluate the safety and efficacy of intravenous EB06 versus placebo, followed by a follow-up period. Edesa noted that a well-targeted biologic could meaningfully address patients with high body surface area involvement, where effective systemic options are currently limited.
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EB05 FDA Regulatory Events
EB05 is a drug developed by Edesa Biotech for the following indication: Covid-19 with Acute Respiratory Distress Syndrome (ARDS).
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- EB05
- Announced Date:
- October 28, 2025
- Indication:
- Covid-19 with Acute Respiratory Distress Syndrome (ARDS)
Announcement
Edesa Biotech, Inc. announced positive results from a Phase 3 study evaluating the company's drug candidate paridiprubart (EB05) as a treatment for Acute Respiratory Distress Syndrome (ARDS), a life-threatening form of respiratory failure.
AI Summary
Edesa Biotech, Inc. reported positive Phase 3 results for its drug candidate paridiprubart (EB05) in treating Acute Respiratory Distress Syndrome (ARDS). In a randomized trial of 104 ventilated adults, paridiprubart plus standard care cut the 28-day death rate from 52% to 39%, a 25% relative risk reduction (p < 0.001). At 60 days, mortality fell from 59% to 46%, a 22% risk drop (p = 0.003).
The treatment also boosted clinical improvement: 41% more patients no longer needed mechanical ventilation or organ support by Day 28. All primary and secondary endpoints showed statistically significant benefits, and analyses adjusted for factors like age and baseline therapies confirmed the findings.
Safety data from over 275 participants revealed a consistent tolerability profile with no new concerns. Edesa’s CEO highlighted paridiprubart’s potential to become a new standard of care for ARDS, with ongoing evaluation in government-funded studies and support from Canada’s Strategic Innovation Fund.
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