The FDA notified the company of its decision regarding the drug Apadaz via a complete response letter. These letters usually outline concerns and conditions that must be addressed before gaining regulatory approval.
KemPharm, headquartered in East Setauket, N.Y., plans to evaluate the points of concern in the letter. The drugmaker intends to request a meeting with the FDA to discuss the best way to move forward with the drug’s development.
After news of FDA’s denial, KemPharm’s stock fell more than 30 percent. Company shares closed at $6.29 on Monday.
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