FDA at last gives thumbs up for Heron's Sustol

10 August 2016

US specialty biotech group Heron Therapeutics (Nasdaq: HRTX) says it has received US Food and Drug Administration approval for its Sustol (granisetron) extended-release injection.

The news was welcomed by investors, as Heron has previously received two complete response letters from the FDA regarding filings for Sustol. The company’s shares rose as much as 26% in Wednesday pre-market trade, and were still up 6.9% at $2.23 mid-morning.

Sustol is a serotonin-3 (5-HT3) receptor antagonist 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.

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