The French biotech firm Valneva announced it has formally withdrawn its Biologics License Application (BLA) and Investigational New Drug (IND) applications for its IXCHIQ Chikungunya vaccine in the United States. This action follows a suspension order by the U.S. Food and Drug Administration (FDA) and a new review prompted by a serious adverse event associated with the vaccine. The news significantly impacted Valneva’s stock performance, which dropped 7.7% to trade at $9.29 in pre-market hours.
Beyond Valneva, a range of other companies saw notable declines in pre-market trading. Rezolve AI PLC (NASDAQ:RZLV) shares fell 15% to $3.92, indicating investor retrenchment in the artificial intelligence sector’s volatility. POET Technologies Inc (NASDAQ:POET) also experienced a sharp fall, with shares down 11.2% at $7.37, pointing to continued pressure within tech-related stocks.
Additional stocks facing substantial overnight declines included Forward Industries Inc (NASDAQ:FWDI), which dropped 10.5% to $7.70 after posting gains the previous Friday; Babcock & Wilcox Enterprises Inc (NYSE:BW), down 9.9% to $7.59; and Bakkt Holdings Inc (NYSE:BKKT), losing 9.5% to $19.38 after its prior 10% rise.
Applovin Corp (NASDAQ:APP) shares took a 9.5% hit, moving down to $515.03 after a 6% loss on Friday. ALT5 Sigma Corp (NASDAQ:ALTS), which recently reported it had regained Nasdaq compliance, declined 8.9% to $2.36 despite a 7% boost on the previous trading day. HIVE Digital Technologies Ltd (NASDAQ:HIVE) shares slipped 7.7% to $3.20 amid a broader industry selloff.
The pre-market session further highlighted declines in Aeva Technologies Inc (NASDAQ:AEVA), down 6.8% to $18.01, and Bitdeer Technologies Group (NASDAQ:BTDR), which fell 6.8% to $14.75. Terrestrial Energy Inc (NASDAQ:IMSR) shares dropped 6.3% to $10.95, signaling investor caution in energy-related sectors.
Tesla Inc (NASDAQ:TSLA) experienced a more moderate decline of 2.7% to $425.75 in pre-market trading. The downward movement followed comments from Tesla CEO Elon Musk confirming that vehicles equipped with the company’s new AI4 (HW4) chip will be capable of achieving fully unsupervised autonomous driving without necessitating future hardware upgrades. This technological advancement is a key development in Tesla’s autonomous vehicle strategy and is likely to have long-term implications for the company’s market position.
NVIDIA Corp (NASDAQ:NVDA), a key player in the semiconductor space, also witnessed a 2.4% decrease to $181.77. The decline in such influential technology stocks contributed to the subdued sentiment prevailing in pre-market trading.
Overall, these price movements come amid a market environment influenced by regulatory developments, technological innovation announcements, and shifting investor sentiment, pointing toward continued volatility in equities related to technology, biotech, and energy sectors. Market participants are closely observing how recent FDA actions and corporate product capabilities announcements will impact future performance.