Ulixacaltamide(Praxis Precision Medicines, Inc.) · Jan 29, 2027 NDA
Essential tremor — one of the most common movement disorders, causing involuntary shaking of the hands and arms that existing therapies often fail to control.
Ulixacaltamide is an oral T-type calcium channel blocker from Praxis Precision Medicines, designed to dampen the abnormal neuronal firing thought to drive tremor. Existing options — off-label primidone and beta-blockers such as propranolol — leave many patients with inadequate control or intolerable side effects. The NDA rests on the Essential3 Phase 3 program, which comprises two pivotal studies. The FDA granted Breakthrough Therapy Designation in December 2025 and is not convening an advisory committee, both signals of a relatively clear regulatory path. The PDUFA target action date is January 29, 2027. Watch whether the eventual label covers the broad essential-tremor population or a narrower responder subset.
ANKTIVA (nogapendekin alfa inbakicept-pmln) + BCG(ImmunityBio, Inc.) · Jan 6, 2027 sBLA
BCG-unresponsive non-muscle invasive bladder cancer — early-stage tumors that keep recurring after standard BCG immunotherapy stops working, where the fallback is often removal of the bladder.
Nogapendekin alfa inbakicept-pmln (ANKTIVA) is an IL-15 receptor agonist given alongside BCG to reawaken the natural-killer and T-cell response against bladder tumors. ImmunityBio's supplemental BLA seeks to extend ANKTIVA's use to BCG-unresponsive papillary disease without carcinoma in situ — patients whose alternative is often cystectomy, surgical removal of the bladder. The filing is supported by QUILT-3.032 Cohort B (n=80), which reported 12-month disease-free survival of 58.2%. The PDUFA target action date is January 6, 2027, and the roughly eight-month review window is consistent with a standard (non-priority) review. Watch whether the label cleanly carves out the papillary, CIS-negative group this submission targets.
