Catalyst overview
Research summary
This catalyst tracks a Phase 3 data readout for VAX-31 in Infectious disease, Invasive pneumococcal disease, Vaccine. The expected timing is based on the latest available company guidance and may change.
Adult indication. 10/19/23- IND cleared. 1/5/24- First patient dosed in Ph 2 portion. 9/3/24- Topline Ph1/2 data reported. Met primary endpoints. 8/6/25- Initiate Ph3 non-inferiority study by Q4 2025, topline data in 2026. 11/04/25:- Plan to initiate adult pivotal Ph3 non-inferiority study in December 2025; topline data expected 2026. 12/08/25:- First adults dosed in OPUS Ph3. OPUS topline data Q4 2026; additional Ph3 data 2027. 01/22/26:- OPUS-2 enrolling; OPUS-3 starts Q1 2026; OPUS-1 topline Q4 2026; OPUS-2/3 data H1 2027. 02/11/26:- OPUS-3 Ph3 in previously vaccinated adults now enrolling; OPUS-1 topline Q4 2026, OPUS-2/3 data H1 2027. 02/24/26:- Adult OPUS-1/2/3 Ph3 trials underway with FDA-aligned design; OPUS-1 topline Q4 2026, OPUS-2/3 H1 2027. 03/23/26:- OPUS-1/2 fully enrolled. OPUS-1 topline Q4 2026; OPUS-2/3 results H1 2027. 05/06/26:- All adult OPUS-1/2/3 Ph3 trials fully enrolled; OPUS-1 topline Q4 2026, OPUS-2/3 data H1 2027. 08/05/26:- OPUS trials enrolled with 6,191 adults. OPUS-1 data Q4 2026, OPUS-2/3 H1 2027.
Verification
Confirm timing and program details against the company announcement or filing.