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September 24, 2025 07:05 ET | Source: uniQure Inc.

uniQure Announces Positive Topline Results from Pivotal Phase I/II Study of AMT-130 in Patients with Huntington’s Disease

~ Pivotal study met primary endpoint; high-dose AMT-130 demonstrated statistically significant 75% disease slowing at 36 months as measured by cUHDRS compared to a propensity score-matched external...
April 22, 2025 06:00 ET | Source: R3 Vascular

R3 Vascular Announces First Patient Treated in ELITE-BTK Pivotal Trial for Below-the-Knee PAD Using MAGNITUDE® Drug Eluting Bioresorbable Scaffold

MOUNTAIN VIEW, Calif., April 22, 2025 (GLOBE NEWSWIRE) -- R3 Vascular Inc., a medical device company dedicated to developing and providing novel, best-in-class bioresorbable scaffolds for treating...
March 21, 2025 06:00 ET | Source: Yaqrit

Yaqrit secures NIHR grant for pivotal trials of its liver support device, DIALIVE, for patients with liver failure

NIHR grant funds pivotal trial for Yaqrit's liver support device, DIALIVE, with potential to resolve life-threatening condition and impact survival.
January 13, 2025 06:00 ET | Source: R3 Vascular

R3 Vascular Secures WCG IRB Approval and CMS Category B Medicare Coverage for the ELITE-BTK Pivotal Trial of its MAGNITUDE® Drug Eluting Next Generation Bioresorbable Scaffold for Below-the-Knee Peripheral Arterial Disease

MOUNTAIN VIEW, Calif., Jan. 13, 2025 (GLOBE NEWSWIRE) -- R3 Vascular Inc., a medical device company dedicated to developing and providing novel, best-in-class bioresorbable scaffolds for treating...
November 04, 2024 06:00 ET | Source: R3 Vascular

FDA Grants R3 Vascular IDE Approval for ELITE-BTK Pivotal Trial of its MAGNITUDE® Drug Eluting Next Generation Bioresorbable Scaffold for Below-the-Knee Peripheral Arterial Disease

MOUNTAIN VIEW, Calif., Nov. 04, 2024 (GLOBE NEWSWIRE) -- R3 Vascular Inc., a medical device company dedicated to developing and providing novel, best-in-class bioresorbable scaffolds for treating...
October 23, 2024 08:30 ET | Source: SeaStar Medical Holding Corporation

SeaStar Medical Announces that Stanford Medicine is Cleared to Actively Enroll Subjects in the Adult Acute Kidney Injury Pivotal Trial

DENVER, Oct. 23, 2024 (GLOBE NEWSWIRE) -- SeaStar Medical Holding Corporation (Nasdaq: ICU), a commercial-stage medical device company developing proprietary solutions to reduce the consequences of...
January 29, 2024 08:00 ET | Source: Arcutis Biotherapeutics, Inc.

Journal of the American Academy of Dermatology Publishes ZORYVE (roflumilast) Foam, 0.3% Results for Seborrheic Dermatitis from Pivotal Phase 3 Trial

Arcutis today announced that JAAD published positive results from the pivotal Phase 3 STRATUM trial evaluating ZORYVE (roflumilast) foam, 0.3%.
October 13, 2023 08:00 ET | Source: Arcutis Biotherapeutics, Inc.

Arcutis Presents Positive Patient-Reported Outcome Data from the Pivotal ARRECTOR Phase 3 Trial in Scalp and Body Psoriasis at European Academy of Dermatology and Venereology (EADV) Congress

Arcutis announced new data from its pivotal ARRECTOR Phase 3 trial of roflumilast foam 0.3% for treatment of adults/adolescents with scalp/body psoriasis.
September 19, 2023 07:30 ET | Source: Arcutis Biotherapeutics, Inc.

Arcutis Announces Positive Results from INTEGUMENT-PED Pivotal Phase 3 Trial of Roflumilast Cream 0.05% for the Treatment of Atopic Dermatitis in Children Ages 2 to 5

Study met the primary endpoint and all secondary endpoints, highly consistent with rapid response from the INTEGUMENT-1 and INTEGUMENT-2 pivotal trialsFor the primary endpoint, 25.4% of children...
September 12, 2023 07:30 ET | Source: Arcutis Biotherapeutics, Inc.

Arcutis Submits Roflumilast Cream 0.15% Supplemental New Drug Application to the FDA for the Treatment of Atopic Dermatitis in Adults and Children Ages 6 Years and Older

Atopic dermatitis is the most common type of eczema, affecting approximately 9.6 million children and 16.5 million adults in the United StatesIn pivotal Phase 3 trials, roflumilast cream demonstrated...