Skip to content

Heron Therapeutics cheers FDA Type A meeting for HTX-011

September 8, 2020

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

From → Uncategorized

Leave a Comment

Leave a Reply

Fill in your details below or click an icon to log in: Logo

You are commenting using your account. Log Out /  Change )

Google photo

You are commenting using your Google account. Log Out /  Change )

Twitter picture

You are commenting using your Twitter account. Log Out /  Change )

Facebook photo

You are commenting using your Facebook account. Log Out /  Change )

Connecting to %s

%d bloggers like this: