Heron Therapeutics reported CINV franchise net product sales were $35.1 million, up 22% from the same period in 2018. Net loss for the quarter was $57.9 million, or $0.65 per share.
Heron resubmitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for HTX-011 in September 2019.
The FDA has extended the review period for the NDA for HTX-011 by up to three months, with a new PDUFA goal date of June 26, 2020.
Heron's New Drug Submission (NDS) for HTX-011 was granted Priority Review status and accepted by Health Canada in December 2019.
CINV franchise net product sales were $35.1 million, up 22% from the same period in 2018.
Heron expects 2020 net product sales for the CINV franchise of $70 million to $80 million and the CINV franchise to return to growth in 2021 and beyond.