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Talphera Announces Achievement of 17 Patient Enrollment Milestone in NEPHRO CRRT Pivotal Trial
Prnewswire· 2025-08-25 12:30
Core Insights - Talphera, Inc. has achieved a significant milestone in its NEPHRO CRRT clinical trial by enrolling 17 out of the planned 70 patients, which is approximately 25% of the total enrollment target [1][2] - The company is on track to complete the study by the end of 2025, supported by an accelerated recruitment rate from new clinical sites [1][2] Enrollment Progress - The NEPHRO CRRT trial has seen an increase in enrollment, with 17 patients now participating, up from 15 just a week prior [2] - Over 90% of the enrolled patients are coming from newly targeted clinical sites, indicating a successful re-launch of the study [2] Study Design and Objectives - The NEPHRO CRRT Study is a prospective, double-blinded trial conducted in up to 14 U.S. hospital intensive care units, focusing on 70 adult patients who cannot tolerate heparin or are at risk for bleeding [3] - The primary endpoint is the mean post-filter activated clotting time using Niyad versus placebo over the first 24 hours, with key secondary endpoints including filter lifespan and dialysis efficacy [3] Product Information - Niyad is a lyophilized formulation of nafamostat, a synthetic serine protease inhibitor with anticoagulant and anti-inflammatory properties, currently under investigation as an anticoagulant for extracorporeal circuits [4][5] - The product has received Breakthrough Device Designation from the FDA, highlighting its potential significance in medical applications [5] Company Overview - Talphera, Inc. specializes in developing and commercializing innovative therapies for medically supervised settings, with a focus on products like Niyad [5]
Talphera to Host Second Quarter Financial Results and Corporate Update Call and Webcast on Thursday, August 14, 2025
Prnewswire· 2025-08-07 20:35
Core Viewpoint - Talphera, Inc. is set to release its second quarter 2025 financial results on August 14, 2025, followed by a live webcast and conference call to discuss the results and provide a business update [1]. Group 1: Financial Results Announcement - The financial results for the second quarter of 2025 will be released after market close on August 14, 2025 [1]. - A live webcast and conference call will take place at 4:30 p.m. Eastern Time/1:30 p.m. Pacific Time on the same day [1]. Group 2: Webcast and Conference Call Details - The webcast can be accessed through the Investors section of Talphera's website, and a replay will be available for 90 days post-event [2]. - Investors can participate in the conference call by dialing specific numbers for North American and international callers, with a conference ID provided [3]. Group 3: Company Overview - Talphera, Inc. is a specialty pharmaceutical company focused on developing innovative therapies for medically supervised settings [4]. - The company's lead product candidate, Niyad™, is a lyophilized formulation of nafamostat, currently studied as an anticoagulant and has received Breakthrough Device Designation from the FDA [4].