Regeneron’s baloncibart shows Phase 2 promise in POTS

Regeneron reported positive Phase 2 results for baloncibart, an investigational NPR1-blocking antibody, in adults with postural orthostatic tachycardia syndrome (POTS). The data were announced Nov. 12, 2026, and presented at the American Autonomic Society’s annual meeting.

In the 82-person PINNACLE trial, a single 450 mg dose reduced the heart-rate increase from lying to standing versus placebo by 11.4 beats per minute on Day 8 and 7.4 bpm on Day 29. The 150 mg dose showed a Day 8 reduction, but the effect was not sustained at Day 29.

At Day 29, the 450 mg dose also improved reported orthostatic symptoms and physical functioning versus placebo. The trial’s activity-of-daily-living measure did not show a statistically clear improvement.

Treatment was generally described as well tolerated; most adverse events were mild or moderate. Adverse events were reported in 67.9% of the 450 mg group versus 48.1% of the placebo group, and two serious events occurred across the baloncibart groups.

Regeneron plans to begin a potentially pivotal Phase 3 trial in the first half of 2027. The Phase 2 study was small and no formal hypothesis testing was prespecified, so larger trials will be needed to confirm benefit and assess safety.