Cempra (CEMP) Shares Halted Ahead of FDA AdCom on Solithromycin as CABP Treatment
- Wall Street falls as investors ready for Trump's inauguration
- IBM (IBM) Tops Q4 EPS by 13c, FY17 EPS Guidance Beats Consensus
- American Express (AXP) Misses Q4 EPS by 7c, FY17 EPS Guidance Tops Views at Mid-Poinit
- Skyworks Solutions (SWKS) Tops Q1 EPS by 3c, Offers Q2 Guidance, Announces Buyback
- After-Hours Stock Movers 01/19: (SWKS) (QRVO) (NVAX) Higher; (AFMD) (SGYP) (IBM) Lower (more...)
Get access to the best calls on Wall Street with StreetInsider.com's Ratings Insider Elite. Get your Free Trial 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
- Western Union (WU) Admits Anti-Money Laundering and Consumer Fraud Violations, Forfeits $586M in Settlement
- Eli Lilly & Co. (LLY), Incyte (INCY) Announce FDA Extends Review Period for Baricitinib
- Novavax (NVAX) Initiates Phase 2 Trial of RSV F Vaccine in Older Adults
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!