Beta Bionics, Inc. BBNX
Beta Bionics, Inc. (Nasdaq: BBNX) is an endocrine/women's health medical device company. Its next catalyst on record is Next-generation Fully-Closed Loop Algorithm: Pivotal trial initiation (Q4 2026).
Upcoming catalysts
No catalyst is dated to the next 30 days or to an FDA action date.
Next further out: Next-generation Fully-Closed Loop Algorithm — Pivotal trial initiation (Q4 2026). 4 catalysts on record beyond the next 30 days; subscribers see each with its filing sentence.
Pipeline
| Program | Indication | Modality | Stage |
|---|---|---|---|
| iLet Automated Insulin Delivery System | Type 1 Diabetes (patients six and older) | device-combination | Approved |
| Mint Patch Pump | Type 1 Diabetes (assumed) | device-combination | Approved |
| iLet for Type 2 Diabetes | Type 2 Diabetes (adults) | device-combination | Phase 3 |
| Next-generation Fully-Closed Loop (FCL) Algorithm | Type 1 and Type 2 Diabetes (adults) | device-combination | Phase 3 |
| Bihormonal iLet System (insulin + glucagon) | Diabetes (Type 1 and Type 2) | device-combination | Phase 2 |
Recent results and decisions
- Sep 15, 2026submitted 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 - Sep 15, 2026started 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
- Cash runway against each catalyst, with the company's own runway statement
- Track record: every Phase 3 readout, FDA decision and guidance slip since 2014
- Expected move for each dated catalyst, from comparable past events
- Phase 2 evidence behind each Phase 3 readout
- Companies on the same target or class
- Full catalyst list with filing sentences, deals, registered trials, Excel export
Other phase 3 endocrine/women's health companies
The free Monday brief
Last week's readouts and FDA decisions and the dated catalysts in the week ahead, each with its filing sentence.