MicuRx Pharmaceuticals Inc., today announced positive top-line results from the pivotal Phase 3 clinical trial in China for its lead antibacterial drug candidate contezolid (MRX-I) in adult patients with complicated skin and soft tissue infection (cSSTI). Contezolid met the primary endpoint of noninferiority compared to linezolid for the clinical cure rate at the test-of-cure visit (TOC visit, 7-14 days after the last dose of study drug), and was associated with fewer drug-related hematologic laboratory adverse events.
FOSTER CITY, Calif. & SHANGHAI--(BUSINESS WIRE)--MicuRx Pharmaceuticals, Inc. today announced the receipt of the qualified infectious disease product (QIDP) classification and grant of fast track status by the U.S. Food and Drug Administration (FDA) for contezolid (MRX-I) and its prodrug contezolid acefosamil (MRX-4) for the treatment of acute bacterial skin and skin structure infections (ABSSSI).
Amid the IPO frenzy taking place on the Nasdaq, the stock exchange in Hong Kong has quietly caught up with two applications at the end of last week — the third and fourth companies to try the route since the city opened up to pre-revenue biotechs wanting to list.