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Note 1 - Business
 3 Months Ended
Mar. 31, 2019
Notes to Financial Statements  
Business Description and Basis of Presentation [Text Block]
1.
     Business
 
We are a commercial-stage biotechnology company focused on improving the lives of patients by developing best-in-class treatments to address some of the most important unmet patient needs. We are developing novel, patient-focused solutions that apply our innovative science and technologies to already-approved pharmacological agents for patients suffering from cancer or pain.
 
On
August 9, 2016,
our
first
commercial product, SUSTOL (granisetron) extended-release injection (“SUSTOL”), was approved by the U.S. Food and Drug Administration (“FDA”). SUSTOL is indicated in combination with other antiemetics in adults for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of moderately emetogenic chemotherapy (MEC) or anthracycline and cyclophosphamide (AC) combination chemotherapy regimens. SUSTOL is an extended-release, injectable
5
-hydroxytryptamine type
3
receptor antagonist that utilizes Heron’s proprietary Biochronomer drug delivery technology (“Biochronomer Technology”) to maintain therapeutic levels of granisetron for
≥5
days. We commenced commercial sales of SUSTOL in the U.S. in
October 2016.
 
On
November 9, 2017,
our
second
commercial product, CINVANTI (aprepitant) injectable emulsion (“CINVANTI”), was approved by the FDA. CINVANTI, in combination with other antiemetic agents, is indicated in adults for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of highly emetogenic cancer chemotherapy (HEC) including high-dose cisplatin and nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy (MEC). CINVANTI is an intravenous (“IV”) formulation of aprepitant, a substance P/neurokinin-
1
(
“NK1”
) receptor antagonist. CINVANTI is the only IV formulation of an
NK1
receptor antagonist indicated for the prevention of acute and delayed nausea and vomiting associated with HEC and nausea and vomiting associated with MEC that is free of polysorbate
80
or any other synthetic surfactant. We commenced commercial sales of CINVANTI in the U.S. in
January 2018.
On
February 26, 2019,
we announced that the FDA approved our supplemental New Drug Application (“sNDA”) for CINVANTI, for IV use, which expanded the administration of CINVANTI beyond the already approved administration method (a
30
-minute IV infusion) to include a
2
-minute IV injection.
 
HTX-
011,
which utilizes Heron’s proprietary Biochronomer Technology, is an investigational, long-acting, extended-release formulation of the local anesthetic bupivacaine in a fixed-dose combination with the anti-inflammatory meloxicam for postoperative pain management. By delivering sustained levels of both a potent anesthetic and a local anti-inflammatory agent directly to the site of tissue injury, HTX-
011
was designed to deliver superior pain relief while reducing the need for systemically administered pain medications such as opioids, which carry the risk of harmful side effects, abuse and addiction. HTX-
011
has been shown to reduce pain significantly better than placebo or bupivacaine alone in
five
diverse surgical models: hernia repair, abdominoplasty, bunionectomy, total knee arthroplasty and breast augmentation. HTX-
011
was granted Fast Track designation from the FDA in the
fourth
quarter of
2017
and Breakthrough Therapy designation in the
second
quarter of
2018.
We submitted a New Drug Application (“NDA”) to the FDA for HTX-
011
in
October
of
2018
and received Priority Review designation in
December
of
2018.
A Complete Response Letter (“CRL”) was received from the FDA regarding the NDA for HTX-
011
on
April 30, 2019.
The CRL stated that the FDA was unable to approve the NDA in its present form based on the need for additional Chemistry, Manufacturing and Controls (“CMC”) and non-clinical information. Based on the complete review of the NDA, the FDA did
not
identify any clinical safety or efficacy issues, and there was
no
requirement for further clinical studies or data analyses. In
April 2019,
we announced that the Marketing Authorisation Application (“MAA”) for HTX-
011
was validated by the European Medicines Agency (“EMA”). Validation of the MAA confirms that the submission is complete and starts the EMA's Centralised Procedure. The EMA granted eligibility to the Centralised Procedure for HTX-
011
based on it meeting the criteria of a medicinal product constituting a significant scientific innovation. The Centralised Procedure allows applicants to receive a marketing authorisation that is valid throughout the European Union. An opinion from the EMA Committee for Medicinal Products for Human Use (CHMP) is anticipated in the
first
half of
2020.
 
HTX-
034,
our next generation product candidate for postoperative pain management, is in development for postoperative pain via local application. Based on the positive results of preclinical studies in which HTX-
034
demonstrated significant pain reduction for
seven
days, we have initiated formal development of this next-generation postoperative pain management product candidate.
 
As of
March 31, 2019
we had
$289.2
million in cash, cash equivalents and short-term investments. We have incurred significant operating losses and negative cash flows from operations. Management believes that cash, cash equivalents and short-term investments as of
March 31, 2019
will be sufficient to fund operations for at least
one
year from the date this Quarterly Report on Form
10
-Q is filed with the U.S. Securities and Exchange Commission (“SEC”).