# Emcitate (tiratricol) PDUFA Event: MCT8 deficiency (Allan-Herndon-Dudley syndrome)

Canonical URL: https://biopharmsignal.com/pdufa-calendar/EGTX/emcitate-tiratricol-mct8-deficiency

Ticker: EGTX

Company: Egetis

Event date: 2026-09-28

Event type: FDA Decision

Stage: PDUFA

Result: Pending

Application type: NDA

FDA decision expected. FDA assigned a September 28, 2026 PDUFA target action date to the Emcitate NDA.

## Event Timeline

### September 28, 2026 — FDA decision expected

FDA assigned a September 28, 2026 PDUFA target action date to the Emcitate NDA.

[Egetis — NDA acceptance, Priority Review and PDUFA date](https://www.egetis.com/mfn_news/egetis-announces-fda-acceptance-and-priority-review-of-nda-for-emcitate-tiratricol-for-mct8-deficiency/)

### March 27, 2026 — FDA accepted the NDA with Priority Review

FDA accepted the filing and granted Priority Review; Egetis said no advisory committee meeting was then planned.

[Egetis — NDA acceptance and Priority Review](https://www.egetis.com/mfn_news/egetis-announces-fda-acceptance-and-priority-review-of-nda-for-emcitate-tiratricol-for-mct8-deficiency/)

### January 29, 2026 — Egetis completed the rolling NDA submission

The completed application included clinical studies, real-world evidence and the U.S. expanded-access experience in MCT8 deficiency.

[Egetis — Rolling NDA submission completed](https://www.egetis.com/mfn_news/egetis-completes-the-u-s-rolling-nda-submission-for-emcitate-tiratricol-for-treatment-of-mct8-deficiency/)

### October 23, 2025 — Egetis reached alignment with FDA on the NDA package

Following a pre-NDA meeting, Egetis said FDA agreed to a rolling submission based on the available clinical-data package.

[Egetis — Pre-NDA meeting and rolling-review plan](https://www.egetis.com/mfn_news/egetis-granted-a-rolling-nda-review-by-fda-for-emcitate-tiratricol-based-on-currently-available-clinical-data/)

## Regulatory Designations

- Priority Review FDA: [Egetis — NDA acceptance, Priority Review and PDUFA date](https://www.egetis.com/mfn_news/egetis-announces-fda-acceptance-and-priority-review-of-nda-for-emcitate-tiratricol-for-mct8-deficiency/)

- Breakthrough Therapy FDA: [Egetis — Emcitate FDA designations and NDA submission](https://www.egetis.com/mfn_news/egetis-completes-the-u-s-rolling-nda-submission-for-emcitate-tiratricol-for-treatment-of-mct8-deficiency/)

- Fast Track FDA: [Egetis — Emcitate FDA designations and NDA submission](https://www.egetis.com/mfn_news/egetis-completes-the-u-s-rolling-nda-submission-for-emcitate-tiratricol-for-treatment-of-mct8-deficiency/)

- Orphan Drug FDA: [Egetis — Emcitate FDA designations and NDA submission](https://www.egetis.com/mfn_news/egetis-completes-the-u-s-rolling-nda-submission-for-emcitate-tiratricol-for-treatment-of-mct8-deficiency/)

- Rare Pediatric Disease FDA: [Egetis — Emcitate FDA designations and NDA submission](https://www.egetis.com/mfn_news/egetis-completes-the-u-s-rolling-nda-submission-for-emcitate-tiratricol-for-treatment-of-mct8-deficiency/)

- Orphan Drug EMA: [Egetis — Emcitate regulatory designations](https://www.egetis.com/wp-content/uploads/Egetis-Corporate-Presentation-June-2026-final.pdf)

## Related Pages

- EGTX PDUFA calendar: https://biopharmsignal.com/pdufa-calendar/EGTX.md

- EGTX company profile: https://biopharmsignal.com/company/EGTX.md

- PDUFA calendar: https://biopharmsignal.com/pdufa-calendar.md