FDA Approves Roivant's Lisraya, First Oral Drug for Dermatomyositis
ROIV has more than doubled off its 52-week low of $11.85.
Summary
The FDA approved Lisraya, the first oral treatment for dermatomyositis in adults. This is a major regulatory win for Roivant, opening a new market with no oral competition. The approval follows a strong Q1 with $3.9B cash and a $950M Moderna settlement, giving the company ample resources to launch. Insider selling has been heavy recently, but this approval could shift sentiment. Watch for launch pricing and initial prescription data.
At the time of this announcement, ROIV was trading at $37.28 on NASDAQ in the Life Sciences sector, with a market capitalization of approximately $26.9B. The 52-week trading range was $11.85 to $37.97. This news item was assessed with positive market sentiment and an importance score of 9 out of 10. Source: Reuters.