Monday, Viatris Inc. (VTRS) announced that the U.S. Food and Drug Administration has accepted for review the New Drug Application for MR-107A-02 for the treatment of moderate-to-severe acute pain.
The agency has assigned a PDUFA goal date of December 27, 2026.
The approval is based on data from the Phase 3 program, which includes two randomized, double-blind, placebo- and active-controlled trials - one following herniorrhaphy surgery and one following bunionectomy surgery.
In both studies, fast-acting meloxicam met primary and secondary endpoints and demonstrated a safety profile consistent with the well-characterized safety profile of this mechanism of action.
In the pre-market hours, VTRS is trading at $16.44, down 0.24 percent on the Nasdaq.
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Business News
May 15, 2026 15:25 ET Apart from the confirmation of Kevin Warsh as the next Fed chair, the main news on the economics front this week included key price data from the U.S. and the first quarter economic growth figures from major economies. Both consumer prices and producer costs have started to reflect the effect of supply shocks due to the Middle East conflict. In Europe, GDP data was in focus, while inflation data from China dominated the news flow in Asia.