Cempra (CEMP) Shares Halted Ahead of FDA AdCom on Solithromycin as CABP Treatment
- Oil steadies on doubts output cut will end global glut
- Western Digital (WDC) Raises Q2 Outlook
- Dollar edges up vs yen as traders eye ECB meeting for cues
- Foxconn says in preliminary discussions to expand U.S. operations
- Dave & Buster's Entertainment (PLAY) Tops Q3 EPS by 11c, Raises FY Revenue Guidance
News and research before you hear about it on CNBC and others. Claim your 2-week free trial to StreetInsider Premium here.
Cempra, Inc. (Nasdaq: CEMP) announced that NASDAQ has halted trading of the company's common stock.
The U.S. Food and Drug Administration's (FDA) Antimicrobial Drugs Advisory Committee (AMDAC) is meeting today to discuss the safety and efficacy of solithromycin to treat community-acquired bacterial pneumonia (CABP).
The Advisory Committee meeting is scheduled to begin at 8:30 a.m. ET and is scheduled to end at 5:00 p.m. ET. The FDA briefing materials for the meeting can be found at: http://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/Anti-InfectiveDrugsAdvisoryCommittee/ucm496389.htm.
Solithromycin was granted qualified infectious diseases product (QIDP) designation which entitled the new drug applications (NDAs) to eight month priority reviews, resulting in PDUFA dates of December 27, and December 28, 2016, respectively, for the oral and intravenous NDAs.
Serious News for Serious Traders! Try StreetInsider.com Premium Free!
You May Also Be Interested In
- Repros Therapeutics (RPRX) Updates on Hypogonadism AdCom Meeting; Panel Suggests Additional Endpoint
- Juno Therapeutics (JUNO) Presents Update of Key Data from Studies of CAR T Cell Product Candidates at ASH
- FDA Approves Genentech's Avastin Plus Chemotherapy to Treat Type of Ovarian Cancers (RHHBY)
Create E-mail Alert Related CategoriesCorporate News, FDA, Trading Halts
Related EntitiesPDUFA, AdCom
Sign up for StreetInsider Free!
Receive full access to all new and archived articles, unlimited portfolio tracking, e-mail alerts, custom newswires and RSS feeds - and more!