Inovio Pharma (INO) Announces FDA Clinical Hold Placed on Proposed VGX-3100 Phase 3
- Wall Street again marks new highs in post-election run
- Broadcom Ltd. (AVGO) Tops Q4 EPS by 11c
- Restoration Hardware (RH) Tops Q3 EPS by 4c; Guides Well Below the Street
- Unusual 11 Mid-Day Movers 12/8: (COOL) (TLRD) (DRAM) Higher; (SHIP) (OHRP) (MLSS) Lower
- After-Hours Stock Movers 12/08: (FNSR) (AVGO) (GLPG) Higher; (XTLY) (RH) (DLTH) Lower (more...)
Find out which companies are about to raise their dividend well before the news hits the Street with StreetInsider.com's Dividend Insider Elite. Sign-up for a FREE trial here.
Inovio Pharmaceuticals, Inc. (Nasdaq: INO) announced that the U.S. Food and Drug Administration (FDA) has placed a clinical hold on its proposed phase III clinical program for VGX-3100. A clinical hold is a notification issued by the FDA to a trial sponsor to delay a proposed clinical trial or suspend an ongoing clinical trial. This study has not yet been initiated and has not enrolled or dosed subjects. Additionally, the hold does not pertain to any of Inovio’s other ongoing clinical studies.
Inovio anticipates receiving a formal letter with complete information from the FDA within 30 days. In its initial communication, the FDA has requested additional data to support the shelf-life of the newly designed and manufactured disposable parts of the CELLECTRA® 5PSP immunotherapy delivery device. Inovio is working diligently with the FDA to address its concerns and anticipates that the requested data will be available before the end of this year. Inovio estimates that the start of the phase III clinical program will be delayed until the first half of 2017 pending resolution of the FDA’s requests.
Serious News for Serious Traders! Try StreetInsider.com Premium Free!
You May Also Be Interested In
- Valeant Pharma (VRX) Announces Positive Results from IDP-118 Phase 3 as Psoriasis Treatment
- Interpace Diagnostics (IDXG) Halted on LUDP Following 196% Surge
- Northwest Biotherapeutics (NWBO) Offers Update on Phase 3 Trial Of DCVax-L for Newly Diagnosed GBM Cancer
Create E-mail Alert Related CategoriesCorporate News, FDA, Hot Corp. News, Hot FDA News, Management Comments, Trader Talk, Trading Halts
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!