Talphera (TLPH) presented at the H.C. Wainwright 28th Annual Global Investment Conference on September 14, 2026, with CEO Vince Angotti and CMO Dr. Shakil Aslam outlining advances for nafamostat mesylate, an anticoagulant under investigation for continuous renal replacement therapy in acute care settings.
The pivotal NEPHRO study, which evaluates nafamostat for anticoagulation during CRRT, reported 75% enrollment as of the conference and is on track to finish enrollment before the end of 2024. The FDA reduced the planned sample size from 166 to 70 patients, yet the trial maintains more than 90% statistical power under conservative effect assumptions and a 20% dropout rate. The primary endpoint is activated clotting time at 24 hours, with dose titration targeted within 15 minutes; over 95% of data are collected within the first 72 hours, and topline results are expected four to five weeks after the final patient is enrolled.
Regulatory milestones include an FDA breakthrough designation that grants a six‑month review clock upon filing. Talphera plans to submit a premarket approval application within three months of receiving final study data, targeting product approval and commercial launch in the second half of 2025. The company identified three near‑term catalysts: pivotal study readout, PMA filing, and potential approval/launch.
Market analysis, based on McKesson Compile data, estimates pre‑COVID U.S. CRRT procedures at 100,000 to 165,000 annually, with post‑COVID growth of 5% to 6% per year. Current practice shows roughly one‑third of ICU physicians using no anticoagulation, a median filter lifespan of 12 to 14 hours, and about half of filters clotting within the first 12 to 24 hours. Heparin is used as rescue therapy in about 40% of cases, while citrate—though not FDA approved—holds approximately 27% market share despite complex monitoring requirements.
The 2026 KDIGO guideline update moved nafamostat from a previously listed "available agent" to a recommended "alternative to citrate" for CRRT anticoagulation, citing two published studies (50‑ and 70‑patient trials) that showed fewer clotting events and filter changes. On the day of the conference, Talphera’s stock closed at $1.24, traded up to $1.2554 in after‑hours (+1.24%), gave a six‑month return of 56%, and carries analyst price targets between $3.00 and $3.50, with a market capitalization of $63.84 million.
