Roivant Halts CLE Program After IMVT-1402 Misses Primary Endpoint
ROIV has more than doubled off its 52-week low of $14.5.
Summary
Roivant's IMVT-1402 failed its proof-of-concept study in cutaneous lupus erythematosus, missing the Week 12 primary endpoint. The company is stopping development in CLE, removing a potential indication from the pipeline. Numerical trends favored the drug but were insufficient for statistical significance. Focus now shifts to other autoimmune indications including Graves', RA, MG, CIDP, and Sjogren's. This follows a strong Q1 with $3.9B cash and recent FDA approval of Lisraya, but this clinical miss narrows the near-term pipeline and removes a revenue option. Roivant shares slipped as Immunovant faced the trial setback.
At the time of this announcement, ROIV was trading at $37.74 on NASDAQ in the Life Sciences sector, with a market capitalization of approximately $27.6B. The 52-week trading range was $14.50 to $42.50. This news item was assessed with negative market sentiment and an importance score of 8 out of 10. Source: Wiseek News.