KemPharm (KMPH) CRL a Surprise - Oppenheimer

Shares of KemPharm (NASDAQ: KMPH) were under pressure after the FDA issued a complete response letter (CRL) to the company for Apadaz. KemPharm will have to schedule an End of Review meeting with the FDA to discuss whether there is a path forward on Apadaz's abuse-deterrent labeling. Since the Agency made an amendment request last week, the CRL came as a surprise. Investors are likely assuming the worst since the FDA chose to issue a CRL rather than grant a PDUFA extension. However, KemPharm does not yet know whether the FDA considered the amendment in providing the CRL, or whether the amendment was submitted too late in the review process.

If the FDA decides that there is a path forward on Apadaz's AD labeling, the Agency will then decide on whether KMPH's resubmission would constitute a Class I vs. Class II minor or major review. A Class I resubmission would indicate a 2-month timeframe on an FDA decision after resubmission, while a Class II resubmission would involve a 6-month timeframe.

No change to Outperform rating or $11 PT.

For an analyst ratings summary and ratings history on Kempharm click here. For more ratings news on Kempharm click here.

Shares of Kempharm closed at $6.29 yesterday.

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