Valneva SE (NASDAQ:VALN) shares were falling on Monday following the announcement of topline results from the Phase 3 VALOR clinical trial for its Lyme disease vaccine candidate, which did not meet the primary endpoint criteria.

The investigational 6-valent OspA-based Lyme disease vaccine candidate, developed in collaboration with Pfizer Inc. (NYSE:PFE), aims to protect against Lyme disease, a tick-borne bacterial infection, which currently has no approved vaccine.

The Phase 3 VALOR trial results showed that fewer Lyme disease cases were accrued than anticipated, and the primary endpoint was not met in the first analysis.

Secondary Analysis For Valneva Drug

However, the second analysis indicated clinically meaningful efficacy, with Pfizer expressing confidence in the vaccine’s potential and planning submissions to regulatory authorities.

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 vs. placebo (95% CI 15.8, 93.5).
  • 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 (95% CI 21.7, 93.9).

The trial involved participants aged 5 years and older, randomized to receive either the vaccine or a saline placebo.

In January, Valneva decided to voluntarily withdraw the biologics license application (BLA) and Investigational New Drug (IND) application for its chikungunya vaccine, Ixchiq, in the U.S.

Valneva Technical Indicators Highlight Ongoing Weakness

Valneva is trading 40.4% below its 20-day simple moving average (SMA) and 31.9% below its 100-day SMA, indicating considerable weakness in the short to medium term.

Over the past 12 months, shares have declined by 11.44% and are now closer to their 52-week lows than to their highs.

The RSI is at 46.62, which is considered neutral territory, while the MACD is at 0.1051, below its signal line at 0.2012, indicating bearish pressure on the stock. The combination of neutral RSI and bearish MACD suggests mixed momentum.

  • Key Resistance: $7.00
  • Key Support: $6.00

VALN Stock Price Activity: Valneva shares were down 35.27% at $6.68 at the time of publication on Monday, according to Benzinga Pro data.

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