NewcelX Ltd. NCEL
NewcelX Ltd. (Nasdaq: NCEL) is a cardio-renal-metabolic drug developer. Its lead program, NCEL-101, is in Pre-clinical for Type 1 diabetes (and potentially insulin-dependent type 2 diabetes). Its next catalyst on record is NCEL-101: IND submission for NCEL-101 plus tegoprubart Phase 1/2a trial (date not stated).
Upcoming catalysts
No catalyst is dated to the next 30 days or to an FDA action date.
Next further out: NCEL-101 — IND submission for NCEL-101 plus tegoprubart Phase 1/2a trial (date not stated). 1 catalyst on record beyond the next 30 days; subscribers see each with its filing sentence.
Pipeline
| Program | Indication | Modality | Stage |
|---|---|---|---|
| AstroRx (cryopreserved astrocytes) | ALS | cell therapy | Phase 2 |
| NCEL-101 (enriched pancreatic islet cells; with Eledon tegoprubart) | Type 1 diabetes | cell therapy | Pre-clinical |
| DOXA platform small molecules | unclear | small molecule | Pre-clinical |
Recent results and decisions
- Sep 18, 2026n/a FDA Type B pre-IND meeting (held July 1, 2026) gave positive feedback and consensus on regulatory path, preclinical data and proposed Phase 1/2a design for NCEL-101 with Eledon's tegoprubart.
The FDA provided positive feedback and consensus on the regulatory pathway, preclinical data, and proposed Phase 1/2a clinical trial design, providing a clear roadmap toward the submission of an Investigational New Drug (IND) application.
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 pre-clinical cardio-renal-metabolic 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.