Immunovant Shares Fall After Lupus Drug Fails to Meet Primary Endpoint

Shares of Immunovant (NASDAQ: IMVT) fell sharply in pre-market trading after the company announced it was halting development of its drug candidate, imeroprubart (IMVT-1402), for the treatment of cutaneous lupus erythematosus (CLE).

The stock slid 6.1% to $35.00 per share before the market open following the news.

Disappointing Trial Results

The decision to discontinue the program was based on results from a proof-of-concept study that failed to meet its primary endpoint. The randomized, double-blind, placebo-controlled trial involving 57 adult patients did not show a statistically significant change from baseline in the Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI-A) score at Week 12.

According to the company, the results fell short of an internal threshold required to justify further development. While Immunovant noted numerical trends that favored the drug over placebo on several secondary endpoints, the failure on the key measure and competitive dynamics in the CLE field led to the program's termination.

Impact on Pipeline and Market

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Immunovant emphasized that the safety and tolerability profile of imeroprubart remained consistent with previous studies. The company also confirmed that development timelines for its other programs are not affected by this decision.

IMVT-1402 remains in development for several other indications, including:

• Graves’ disease
• Rheumatoid arthritis
• Myasthenia gravis
• Sjögren’s disease

The negative clinical trial news also impacted shares of Immunovant's parent company, Roivant Sciences (NASDAQ: ROIV), which holds a majority stake and saw its stock decline in sympathy during pre-market hours.