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What: Shares of the developmental-stage biotech Heron Therapeutics (NASDAQ:HRTX) rose by over 45% today after the company announced that its lead product candidate, Sustol, met the primary endpoint of delaying chemotherapy-induced nausea and vomiting following administration of highly emetogenic chemotherapy (HEC) agents in a late-stage study dubbed "MAGIC". Per the press release, the company said Sustol was also generally well-tolerated in the study.
So what: Heron has already tried to gain approval for Sustol with the Food and Drug Administration twice before, only to receive the dreaded Complete Response Letter on both occasions. While analysts have noted that the FDA's reluctance to approve the drug previously stemmed primarily from manufacturing issues that have since been resolved, it's important to keep in mind that Sustol has been in clinical development at this point for over a decade. In short, there is no guarantee that this latest clinical success will translate into a regulatory approval, especially in light of Sustol's lengthy developmental history.
Now what: Heron plans on resubmitting Sustol's New Drug Application to the FDA by mid-year. That means a formal review should be concluded around the end of the first-quarter of 2016. Over the next few weeks, though, investors should probably brace themselves for a secondary offering to help fund the drug's commercial launch, if approved. That's why you might want to shy away from trying to catch this high flying biotech today.
George Budwell has no position in any stocks mentioned. The Motley Fool has no position in any of the stocks mentioned. Try any of our Foolish newsletter services free for 30 days. We Fools may not all hold the same opinions, but we all believe that considering a diverse range of insights makes us better investors. The Motley Fool has a disclosure policy.