EDSA News & Events

Edesa Biotech announced additional data from a Phase 3 study of paridiprubart. The results represent a broader, 278-patient population, which includes both previously reported 104 patients requiring invasive mechanical ventilation as well as 174 non-IMV patients. Across this full population, the company's first-in-class anti-TLR4 antibody demonstrated a statistically significant reduction in 28-day mortality. Treatment benefits were consistent across severity groups and in patients with serious comorbidities. The primary endpoint was achieved for the full treatment population of 278 randomized subjects. Paridiprubart reduced adjusted 28-day mortality to 24% from 33%, a 27% relative reduction in the risk of death. In addition, subjects receiving paridiprubart demonstrated a higher relative rate of clinical improvement by Day 28. Paridiprubart or placebo were provided in addition to standard of care treatments. In an exploratory analysis of a milder population of 174 randomized patients who did not meet the study's IMV-based inclusion criteria, paridiprubart + SOC reduced adjusted 28-day mortality to 15% from 23%, a 35% relative reduction in the risk of death. Edesa also reported that exploratory analyses across a patient population of up to 108 randomized subjects consistently demonstrated reduced adjusted mortality for paridiprubart + SOC vs. placebo + SOC at 28 days in subjects with clinically important comorbidities: Acute Kidney Injury: 35% relative reduction; Sepsis: 36% relative reductionl Pneumonia: 30% relative reduction. Overall rates of adverse events, serious adverse events, infections and treatment discontinuations were low and similar between the paridiprubart and placebo groups. The safety profile was consistent with prior clinical exposures, with more than 400 patients now having received paridiprubart. Based in part on these results, Edesa has filed provisional patent applications with the United States Patent and Trademark Office covering the use of paridiprubart in the treatment of sepsis, acute kidney injury and pneumonia. The company's core composition-of-matter patents extend into the 2030s.

"Manufacturing plans for our upcoming vitiligo study are on schedule, and we are advancing the EB06 program toward regulatory readiness and launch," said Par Nijhawan, MD, Chief Executive Officer of Edesa. "In parallel, we are utilizing positive Phase 3 data to explore accelerated commercialization pathways as well as potential broader strategic opportunities for paridiprubart." Edesa's Chief Financial Officer Peter Weiler reported that financial results for the first quarter reflected the continuation of trends from the preceding period, including the ramp up in activities for the company's vitiligo drug development program as well as the completion of the Phase 3 clinical study of paridiprubart. "Management remains disciplined in deploying resources and executing in line with our plans. Going forward, we anticipate that research expenditures will generally track activity in our EB06 program, including the manufacturing of clinical drug supplies. We continue to evaluate opportunities to achieve our clinical objectives more efficiently, such as establishing investigational sites across multiple jurisdictions to provide greater cost and operational flexibility."

The major averages had a down day as markets enter the final full trading week of 2025, with investors responding to recent rally attempts and bouts of tech selloff pressure.Last week's mixed performance and rotation suggests investors are beginning to weigh earnings fundamentals more heavily than lofty growth multiples. Treasury yields have moved sideways after recent volatility, and risk appetite seems to be stabilizing, but only tentatively, as incoming economic indicators and central-bank decisions in both the U.S. and Europe remain key catalysts.Gold prices were fractionally higher as the commodity once again reaches for record highs, while oil finished lower.Get caught up quickly on the top news and calls moving stocks with these five Top Five lists.1. STOCK NEWS:Intelis in discussions to acquire SambaNova for $1.6B,ServiceNowis close to a $7B deal for Armis,CencoraOneOncology from TPGfor $6BiRobotentered into ato be acquired by PiceaLuminarinitiatedand agreed to sell its photonics business to Quantum Computingfor $110M2. WALL STREET CALLS:Texas Instrumentsto Sell from Buy at Goldman SachsAkamaito Overweight from Underweight at KeyBancAdobeto Underweight at KeyBancServiceNowto Underweight at KeyBancGoldman SachsLas Vegas Sands, Marriottand Hiltonto Buy as the firm adjusted ratings in the gaming and lodging group as part of its 2026 outlook3. AROUND THE WEB:Xeroxis working on a debt financing that would use its IP as collateral,A collaboration between Matteland Microsoft-backedOpenAI won't emerge this year,Nvidiahas told some Chinese clients that it is evaluating adding production capacity for its H200 AI chips after orders exceeded its output levels,TPGhas exited most of its $600M stake in Anastasia Beverly Hills as part of a debt restructuring,U.S. District Judge George Wu in California ruled Live Nationand its subsidiary Ticketmaster must face a class action for allegedly overcharging its customers for events at major venues across the country,4. MOVERS:Kyverna Therapeuticsincreases after announcing data from itsImmunomegains after announcing its RINGSIDE trial metZIMhigher in New York after announcingto vote 'FOR' all eight of the company's director nomineesCritical Metalsfalls afterfrom its 2024 drilling program at the Tanbreez Rare Earth ProjectZillowand CoStarlower as Google5. EARNINGS/GUIDANCE:Quipt Home Medical, with CEO Gregory Crawford commenting, "Our fiscal 2025 performance underscores both the durability of our model and the accelerating momentum"Highway Holdings, with EPS and revenue lower year-over-yearOcean PowerreportedEdesa Biotechreported, with EPS missing consensusEnWave, with EPS and revenue higher year-over-yearINDEXES:The Dow fell 41.49, or 0.09%, to 48,416.56, the Nasdaq lost 137.76, or 0.59%, to 23,057.41, and the S&P 500 declined 10.90, or 0.16%, to 6,816.51.

The major averages were lower near noon as markets enter the final full trading week of 2025, with investors responding to recent rally attempts and bouts of tech selloff pressure. Of note, certain AI stocks, including Broadcom and Oracle, were weighing down the broader market.Last week's mixed performance and rotation suggests investors are beginning to weigh earnings fundamentals more heavily than lofty growth multiples. Treasury yields have moved sideways after recent volatility, and risk appetite seems to be stabilizing, but only tentatively, as incoming economic indicators and central-bank decisions in both the U.S. and Europe remain key catalysts.Looking to commodities, gold prices were fractionally higher as the "safe haven" asset once again reaches for record highs. Oil was over 1% lower.Get caught up quickly on the top news and calls moving stocks with these five Top Five lists.1. STOCK NEWS:Intelis in discussions to acquire SambaNova for $1.6B,ServiceNowis close to a $7B deal for Armis,CencoraOneOncology from TPGfor $6BiRobotentered into ato be acquired by PiceaLuminarinitiatedand agreed to sell its photonics business to Quantum Computingfor $110M2. WALL STREET CALLS:Texas Instrumentsto Sell from Buy at Goldman SachsAkamaito Overweight from Underweight at KeyBancAdobeto Underweight at KeyBancServiceNowto Underweight at KeyBancGoldman SachsLas Vegas Sands, Marriottand Hiltonto Buy as the firm adjusted ratings in the gaming and lodging group as part of its 2026 outlook3. AROUND THE WEB:Nvidiahas told some Chinese clients that it is evaluating adding production capacity for its H200 AI chips after orders exceeded its output levels,Coca-Colais holding last-ditch discussions with TDR Capital as it attempts to salvage its proposed sale of Costa Coffee,JPMorgan (JPM) advised on and financed a $7.4B deal for Korea Zinc to build the largest zinc smelter in the U.S., aligning with the bank's national security funding strategy,TPGhas exited most of its $600M stake in Anastasia Beverly Hills as part of a debt restructuring,U.S. District Judge George Wu in California ruled Live Nationand its subsidiary Ticketmaster must face a class action for allegedly overcharging its customers for events at major venues across the country,4. MOVERS:Kyverna Therapeuticsincreases after announcing data from itsImmunomegains after announcing its RINGSIDE trial metZIMhigher in New York after announcingshareholders to vote 'FOR' all eight of the company's director nomineesCritical Metalsfalls afterfrom its 2024 drilling program at the Tanbreez Rare Earth ProjectRocket Lablower afterfor JAXA5. EARNINGS/GUIDANCE:Quipt Home Medical, with CEO Gregory Crawford commenting, "Our fiscal 2025 performance underscores both the durability of our model and the accelerating momentum"Highway Holdings, with EPS and revenue lower year-over-yearOcean PowerEdesa Biotech, with EPS missing consensusEnWave (NWVCF), with EPS and revenue higher year-over-yearINDEXES:Near midday, the Dow was down 0.13%, or 64.76, to 48,393.29, the Nasdaq was down 0.29%, or 67.88, to 23,127.30, and the S&P 500 was down 0.06%, or 3.90, to 6,823.51.