Biopharma Transcript

Beta Bionics, Inc. BBNX

Nasdaq · endocrine/women's health · device-combination · EDGAR · Updated Oct 24, 2026

Beta Bionics, Inc. (Nasdaq: BBNX) is an endocrine/women's health medical device company. Its next catalyst on record is Mint patch pump: 510(k) clearance and full commercialization (Q2 2027).

Upcoming catalysts

No catalyst is dated to the next 30 days or to an FDA action date.

Next further out: Mint patch pump — 510(k) clearance and full commercialization (Q2 2027). 3 catalysts on record beyond the next 30 days; subscribers see each with its filing sentence.

Pipeline

ProgramIndicationModalityStage
iLet Bionic Pancreas (T2D indication expansion, pivotal trial)type 2 diabetesdevice-combinationNA_NON_THERAPEUTIC
Mint tubeless patch pumpinsulin-requiring diabetesdevice-combinationNA_NON_THERAPEUTIC
Bihormonal iLet (insulin + glucagon)diabetes / hypoglycemia protectiondevice-combinationNA_NON_THERAPEUTIC

Recent results and decisions

  1. Sep 15, 2026
    submitted 510(k) application for the 3D Intelligence algorithm submitted to FDA; company expects US commercialization as iLet 3D by end of 2026 and Mint 3D in Q1 2027.510(k) application submitted to FDA Expect to commercialize in the U.S. by the end of 2026 as iLet 3D Filing
  2. Sep 15, 2026
    started Pivotal trial enrollment was initiated in July 2026 (device program; specific trial not named in the supplied text).Pivotal trial enrollment initiated in July 2026 Filing

For subscribers

See plansOpen in the tracker

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