Talphera's NEPHRO Trial Hits 75% Enrollment; KDIGO Endorsement and Bigger Market Estimate Sharpen Commercial Picture
Nafamostat's inclusion in the 2026 KDIGO guideline and a 21% upward revision to CRRT procedure estimates raise the stakes for the upcoming PMA filing and potential first-half 2027 launch.
TLPH · Earnings Call · 2026-08-12
Enrollment Momentum and a Landmark Guideline
Talphera's second-quarter update was dominated by two reinforcing events: the NEPHRO CRRT study has reached 75% enrollment, and for the first time the KDIGO clinical practice guideline explicitly references nafamostat as an acceptable regional anticoagulant. “The guideline now references nafamostat as an acceptable regional anticoagulant. The only available regional anticoagulant being used in the U.S. today is citrate, yet regional citrate is not FDA approved for CRRT, and it's also complex to use and has other limitations.” — Vincent Angotti, Chief Executive Officer · 2026-08-12 This endorsement is a company-unique, genuinely new catalyst—it validates decades of ex-U.S. use and directly addresses the 75% of U.S. institutions that currently lack any regional anticoagulant protocol. The KDIGO guideline is widely referenced by nephrologists, and the management expects it to ease protocol adoption at the ~70 hospitals that account for over half of CRRT procedures. Shakil Aslam, Chief Medical Officer, reinforced the clinical consistency: “Roughly about 80% of the patients, they are within therapeutic range at the starting dose... So within half an hour, almost 100% of the patients are within therapeutic range.” — Shakil Aslam, Chief Medical Officer · 2026-08-12 This stable titration profile—compared with the “chase their tails” experience with heparin or citrate—is exactly what investigators had hoped for and is a recurring theme from prior calls, but the KDIGO validation makes it now commercially actionable. The company's keyword use citrate appears as a counterpoint: lack of citrate access is the primary driver of the unmet need.Market Expansion and Launch Readiness
The most striking number in the update is the revised market size: management's updated market research now projects “the estimated annual CRRT procedures in 2027... at approximately 200,000 in the United States. That's a 21% increase from a prior estimate of 165,000.” — Vincent Angotti, Chief Executive Officer · 2026-08-12 This is a direct updated market research that expands the market opportunity meaningfully. Combined with the KDIGO endorsement, the company believes it can capture meaningful share of the annual CRRT procedures that currently have no effective regional anticoagulant. On commercialization, management is preparing to launch at approval, with initial hiring planned after PMA submission, which is now targeted for the first half of next year. “We'll likely start the hiring once the PMA is submitted... we would likely start to hire and launch our pre-launch planning and our medical education.” — Vincent Angotti, Chief Executive Officer · 2026-08-12 The strategy is deliberately concentrated: about 70 institutions represent the majority of CRRT procedures, so the rollout will rely on account managers and peer-to-peer education rather than a traditional sales force. This medical education focus is a new, concrete step toward commercialization—a shift from the pure-clinical narrative that has dominated prior quarters. Additionally, Vince noted the potential strategic option with CorMedix, which holds a right-of-first-negotiation for 60 days post-data-readout, adding a path to accelerated commercial execution.This new guidance should further highlight to healthcare professionals that nafamostat is already standard medical practice in Japan and South Korea, where it is the most widely used method of anticoagulation during CRRT.