First Berlin Equity Research has published a research update on Valneva SE (ISIN: FR0004056851). Analyst Simon Scholes reiterated his BUY rating and decreased the price target from EUR 6.60 to EUR 4.80.

Abstract
Valneva and its partner Pfizer have announced topline data from the phase 3 trial of the Lyme disease vaccine candidate, LB6V. LB6V demonstrated more than 70% efficacy in preventing Lyme disease in individuals aged five years and above and was also well tolerated with no safety concerns identified. However, the pre-determined statistical criterion (95% confidence interval lower bound >20) was missed in the first pre-specified analysis, which showed a 95% confidence interval of 15.8 to 93.5, and so the primary endpoint of the trial was not met. The wide interval indicates a higher degree of uncertainty as to the efficacy score than an interval within the predetermined criterion. The wide interval arose because fewer Lyme disease cases than expected accrued during the trial. Nevertheless, given that (1) even the lower bound indicates 15.8% superiority to placebo, (2) the second pre-specified analysis met the statistical criterion, (3) the lack of an FDA-approved Lyme disease vaccine, and (4) LB6V was well tolerated with no safety concerns, we think the FDA is still substantially more likely than not to approve the vaccine. Pfizer has indicated that it is confident in LB6V’s potential and is planning submissions to the regulatory authorities. Our previous price target of €6.60 was based on a probability estimate of 90% for LB6V approval. Following the phase 3 topline data, we lower this estimate to 67% and reduce our price target to €4.80. As the upside to our price target is still well over 25%, we maintain our Buy recommendation.