# JOENJA (leniolisib) PDUFA Event: Activated phosphoinositide 3-kinase delta syndrome

Canonical URL: https://biopharmsignal.com/pdufa-calendar/PHAR/joenja-leniolisib-pediatric-apds-review-2

Ticker: PHAR

Company: Pharming Group

Event date: 2026-10-24

Event type: FDA Decision

Stage: PDUFA

Result: Pending

Application type: sNDA

Review cycle: 2

FDA decision expected. FDA assigned an October 24, 2026 PDUFA target action date to the resubmitted pediatric sNDA.

## Event Timeline

### October 24, 2026 — FDA decision expected

FDA assigned an October 24, 2026 PDUFA target action date to the resubmitted pediatric sNDA.

[Pharming — Resubmission acceptance and PDUFA date](https://www.pharming.com/our-news/pharming-announces-u-s-fda-acceptance-of-snda-resubmission-for-joenja)

### June 4, 2026 — FDA accepted the sNDA resubmission

The resubmission seeks approval of 40 mg and 50 mg twice-daily dosing for children aged 4 to 11 years weighing at least 27 kg and includes additional production-batch analytical data requested by FDA.

[Pharming — Resubmission acceptance](https://www.pharming.com/our-news/pharming-announces-u-s-fda-acceptance-of-snda-resubmission-for-joenja)

### March 26, 2026 — Pharming held a Type A meeting with FDA

The meeting followed the first-cycle CRL and informed the scope of the pediatric sNDA resubmission.

[Pharming — Resubmission acceptance and regulatory history](https://www.pharming.com/our-news/pharming-announces-u-s-fda-acceptance-of-snda-resubmission-for-joenja)

### January 30, 2026 — FDA issued a Complete Response Letter in the first review cycle

FDA requested additional pediatric pharmacokinetic information for lower-weight groups and additional data and clarification regarding a production-batch testing method.

[Pharming — Complete Response Letter](https://www.pharming.com/our-news/pharming-group-receives-complete-response-letter-us-fda-snda-joenja-leniolisib-children)

### October 1, 2025 — FDA accepted the original pediatric sNDA with Priority Review

FDA accepted the initial application for children aged 4 to 11 years and assigned a January 31, 2026 PDUFA goal date.

[Pharming — Initial pediatric sNDA acceptance](https://www.pharming.com/sites/default/files/imce/Press%20releases/Pharming%20announces%20U.S.%20FDA%20Priority%20Review%20for%20pediatric%20indication%20for%20leniolisib_EN_01OCT25.pdf)

### December 11, 2024 — Positive pediatric Phase 3 topline data were reported

The open-label study showed improvements in lymphadenopathy and naïve B-cell measures across the dose levels studied in children aged 4 to 11 years.

[Pharming — Positive pediatric study results](https://www.pharming.com/our-news/pharming-announces-positive-topline-data-in-pediatric-clinical-trial-of-leniolisib)

## Regulatory Designations

- Priority Review FDA: [Pharming — Initial pediatric sNDA acceptance and Priority Review](https://www.pharming.com/sites/default/files/imce/Press%20releases/Pharming%20announces%20U.S.%20FDA%20Priority%20Review%20for%20pediatric%20indication%20for%20leniolisib_EN_01OCT25.pdf)

- Orphan Drug FDA: [Pharming — Annual report and leniolisib regulatory designations](https://www.pharming.com/files/ar22-pdf-040423-final.pdf)

- Orphan Drug EMA: [Pharming — European Commission Orphan Drug designation](https://www.pharming.com/our-news/pharming-receives-orphan-drug-designation-from-the-european-commission-for-leniolisib-for-the-treatment-of-act)

## Related Pages

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

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

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

## Related News

- 2026-08-13 — Pharming announces commercial launch of Joenja (leniolisib) in Japan for adult and pediatric patients with APDS aged 4 and older: https://biopharmsignal.com/news/PHAR/pharming-announces-commercial-launch-of-joenja-leniolisib-in-japan-for-adult-and-15d022ed.md

- 2026-08-04 — Pharming Group to participate in Canaccord Genuity 46th Annual Growth Conference: https://biopharmsignal.com/news/PHAR/pharming-group-to-participate-in-canaccord-genuity-46th-annual-growth-conference-89bea5c1.md

- 2026-07-30 — Pharming reports second quarter and first half 2026 financial results and revises year-end guidance; strong Joenja momentum and near-term clinical readouts to support broader therapeutic use: https://biopharmsignal.com/news/PHAR/pharming-reports-second-quarter-and-first-half-2026-financial-results-and-revise-5218552c.md

- 2026-07-16 — Pharming Group to report second quarter and first half 2026 financial results and provide business update on July 30: https://biopharmsignal.com/news/PHAR/pharming-group-to-report-second-quarter-and-first-half-2026-financial-results-an-f222ee56.md

- 2026-06-04 — Pharming announces U.S. FDA acceptance of sNDA resubmission for Joenja® (leniolisib) to treat children aged 4 to 11 years with APDS: https://biopharmsignal.com/news/PHAR/pharming-announces-u-s-fda-acceptance-of-snda-resubmission-for-joenja-leniolisib-5cf3429e.md