Phase 2Data readout

QTORIN Rapamycin

Angiokeratomas

PVLAPalvella Therapeutics

Expected catalystDecember 31, 2027Company guidance: Dec 31, 2027

Catalyst overview

Event details

Drug or asset: QTORIN Rapamycin
Development stage: Phase 2
Event type: Data readout
Indication: Angiokeratomas

Research signalsHigh management interest

Research summary

What is being tracked?

This catalyst tracks a Phase 2 data readout for QTORIN Rapamycin in Angiokeratomas. The expected timing is based on the latest available company guidance and may change.

Development notes

9/24/25- Initiate Ph2 trial in H2 2026. Meet with the FDA in H1 2026 to discuss trial design. 11/11/25:- Development in clinically significant angiokeratomas reiterated; FDA meeting H1 2026 and Ph2 initiation H2 2026 remain planned. 12/16/25:- FDA granted Fast Track for angiokeratomas. FDA meeting H1 2026 and Ph2 initiation H2 2026 reiterated. 03/31/26:- FDA feedback supports ~10–20 patient Ph2; trial initiation accelerated to Q2 2026 from prior H2 2026. 05/04/26:- First patients dosed in LOTU Ph2 trial. Topline results expected H2 2027. 05/07/26:- LOTU Ph2 dosing and H2 2027 topline expectations reiterated. 08/04/26:- LOTU dosing and H2 2027 topline results were reiterated.

Verification

Primary source

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

Open source

What is being tracked?

This catalyst tracks a Phase 2 data readout for QTORIN Rapamycin in Angiokeratomas. The expected timing is based on the latest available company guidance and may change.