Heron Therapeutics (NASDAQ:HRTX) announces a successful Type A meeting with the FDA in which alignment was reached to resubmit the New Drug Application or NDA for HTX-011 in Q4.
It is used for management of postoperative pain and is the first and only extended–release local anesthetic to demonstrate in Phase 3 studies significantly reduced pain and opioid use through 72 hours compared to bupivacaine solution
“We expect to resubmit the HTX-011 NDA in the next few months and appreciate the FDA’s commitment to an expeditious review for this Breakthrough Therapy product.” says CEO and president Barry Quart, Pharm.D.
“HTX-011 has the potential to be the company’s best-selling product by a good margin. The company expects sales of approximately $70 million to $80 million in FY2020, almost all of it from CINVANTI.” says contributor Bret Jensen in his article ‘Heron Therapeutics: The Play Now‘ on Seeking Alpha.
Dive deeper in Corporate Presentation more details on HTX-011
https://seekingalpha.com/news/3612103-heron-therapeutics-cheers-fda-type-meeting-for-htxminus-011
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