VALN News & Events

Pfizer (PFE) and Valneva (VALN) announced topline results from the Phase 3 VALOR clinical trial of its investigational 6-valent OspA-based Lyme disease vaccine candidate PF-07307405 demonstrating: In the pre-specified analyses: Efficacy of 73.2% from 28 days post-dose 4 (season 2) in reducing the rate of confirmed Lyme disease cases compared to the placebo arm; Efficacy of 74.8% from 1-day post-dose 4 (season 2) in reducing the rate of confirmed Lyme disease cases compared to the placebo arm; Fewer than anticipated Lyme disease cases were accrued over the study period, and the pre-determined statistical criterion was not met in the first pre-specified analysis. Given the clinically meaningful efficacy and the fact that the 95% confidence interval lower bound was above 20 in the second pre-specified analysis, Pfizer is confident in the vaccine's potential and is planning submissions to regulatory authorities.

Elaris FlexCo announced an exclusive global license agreement with Valneva for technology related to Valneva's Clostridioides difficile vaccine candidate, VLA84. Under the agreement, Elaris obtains an exclusive global license to Valneva's antigen technology targeting Clostridioides difficile. Building on this technology, Elaris plans to advance a next-generation vaccine program incorporating additional proprietary components designed to broaden protective immune responses. The agreement strengthens Elaris' intellectual property position and supports advancement of its lead vaccine program. Elaris plans to advance the program through IND-enabling development with the goal of initiating clinical studies around 2027.

Valneva SE announced that the company has decided to voluntarily withdraw the biologics license application, BLA, and Investigational New Drug, IND, application for its chikungunya vaccine, Ixchiq, in the United States, following suspension of the license by the U.S. Food and Drug Administration, FDA, in August 2025. The Company had been awaiting further information with respect to its formal response to the vaccine license suspension. Valneva was recently informed of the FDA's further decision to now place the Investigational New Drug, IND, on clinical hold pending an investigation of a newly reported foreign Serious Adverse Event, SAE. There are currently no clinical studies involving Ixchiq that are actively vaccinating participants, and the Company intends to move forward with its planned post-marketing clinical activities, subject to further discussions with relevant regulatory authorities.