PDUFAApproval decision

INO-3107

Recurrent respiratory papillomatosis (RRP)

INOInovio Pharmaceuticals

Expected catalystOctober 30, 2026Company guidance: Oct 30, 2026

Catalyst overview

Event details

Drug or asset: INO-3107
Development stage: PDUFA
Event type: Approval decision
Indication: Recurrent respiratory papillomatosis (RRP)

Research signalsHigh management interest

Research summary

What is being tracked?

This catalyst tracks a PDUFA approval decision for INO-3107 in Recurrent respiratory papillomatosis (RRP). The expected timing is based on the latest available company guidance and may change.

Development notes

05/13/26:- Mid-cycle BLA review completed; PDUFA remains October 30, 2026; ASCO presentation planned. 08/12/26:- Late-cycle review and pre-licensure inspections completed. PDUFA approval decision will occur October 30, 2026.

Verification

Primary source

Confirm timing and program details against the company announcement or filing.

Open source