Tandem Diabetes Care TNDM
Tandem Diabetes Care (Nasdaq: TNDM) is an endocrine/women's health drug developer. Its lead program, Mobi tubeless capability, is in Phase 3 for Type 1 and Type 2 diabetes (insulin delivery). Its next catalyst on record is Mobi tubeless capability: 510(k) FDA decision (application submitted Q2 2026) (date not stated).
Upcoming catalysts
No catalyst is dated to the next 30 days or to an FDA action date.
Next further out: Mobi tubeless capability — 510(k) FDA decision (application submitted Q2 2026) (date not stated). 1 catalyst on record beyond the next 30 days; subscribers see each with its filing sentence.
Pipeline
| Program | Indication | Modality | Stage |
|---|---|---|---|
| t:slim X2 with Control-IQ+ | Type 1 diabetes (ages 2+), pregnancy with T1D, Type 2 diabetes (ages 18+) | device-combination | Approved |
| Tandem Mobi with Control-IQ+ | Type 1 and Type 2 diabetes | device-combination | Approved |
| Mobi tubeless capability (extended-wear infusion site) | Type 1 and Type 2 diabetes | device-combination | Phase 3 |
| Next-generation Mobi patch pump (Sigi technology) | Type 1 and Type 2 diabetes | device-combination | Pre-clinical |
| Extended-wear infusion set technology | Type 1 and Type 2 diabetes | device-combination | Pre-clinical |
| Dual glucose-ketone sensor compatibility | Type 1 diabetes | device-combination | Pre-clinical |
| Fully closed loop algorithm (next-generation AID) | Type 1 and Type 2 diabetes | device-combination | Pre-clinical |
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.