New User:

Forgot your password?

Stock Market & Financial Investment News

News Breaks
January 27, 2014
08:04 EDTHRTXHeron sees one-quarter delay to timeline for Sustol NDA resubmission
Heron Therapeutics announced an approximate one-quarter delay to the company’s timeline for the resubmission of the new drug application for Sustol to the U.S. Food and Drug Administration, the company’s product candidate for chemotherapy-induced nausea and vomiting. The company received notice last week from the supplier of the syringes used for Sustol injections that the production order of syringes manufactured for Heron, and scheduled to be used in the validation of the commercial manufacturing process for Sustol required for resubmission of the NDA, will be delayed due to equipment failure of an in-process quality control check. The equipment failure is not specific to Sustol or Heron, and remedial efforts are underway. “While the timing of our resubmission will be impacted by this delay, we expect it to have minimal impact on our projected timing of the launch of Sustol,” said Barry D. Quart, PharmD, CEO. “Subject to the FDA’s review and approval of the Sustol NDA, we project being in a position to launch Sustol in early 2015, which presents more optimal timing than potentially launching into the late 2014 holiday season.”
News For HRTX From The Last 14 Days
Sign up for a free trial to see the rest of the stories you've been missing.
March 20, 2015
10:00 EDTHRTXOn The Fly: Analyst Initiation Summary
Subscribe for More Information
07:32 EDTHRTXHeron Therapeutics resumed with a Buy at Jefferies
Subscribe for More Information
March 19, 2015
09:20 EDTHRTXOn The Fly: Pre-market Movers
Subscribe for More Information
08:06 EDTHRTXHeron: Anesthetic effects of HTX-011 persisted through 96 hours in Phase 1 trial
Subscribe for More Information
March 13, 2015
08:04 EDTHRTXHeron Therapeutics reports Q4 EPS (71c), consensus (79c)
Subscribe for More Information

Sign up for a free trial to see the rest of the stories you've been missing.

I agree to the disclaimer & terms of use