KemPharm Inc (NASDAQ:KMPH) shares were down 5.41% to $6.29 on Monday and have fallen by an additional 30.05% to $4.40 in after-hours trading. The company received a complete response letter (CRL) from the U.S. Food and Drug Administration (FDA) regarding its new drug application (NDA) for Apadaz.
Apadaz is an immediate release combination of KemPharm Inc drugs for the treatment of acute moderate to moderately severe pain. It is designed to be an abuse-deterrent opioid product that offers equivalent efficacy to the existing standard-of-care and it won’t release its hydrocodone component until it is metabolized in the GI tract following oral administration.
However, the FDA has issued the CRL to notify the company that the review cycle is complete but that the application is not ready for approval in its present form. The CRL also indicated guidance that describes all specific deficiencies that the FDA has identified in the application.
After last week’s amendment request, a Complete Response Letter from the FDA was received for the Apadaz NDA,” said President and CEO of KemPharm Travis Mickle, Ph.D. “We are currently evaluating the points raised in the CRL and intend to request an End of Review meeting with the Agency to determine the pathway forward for Apadaz.”
KemPharm Inc is a clinical-stage specialty pharmaceutical company engaged in the discovery and development of prodrugs, using its Ligand Activated Therapy platform technology. KemPharm is still in the middle of reviewing the details and conditions disclosed in the CRL and has yet to set a meeting with the FDA for additional discussions.
Until then, KemPharm Inc shares could be in for more losses as investors price in these delays to regulatory approval for Apadaz. Reports have shown that majority of panelists concluded that the drug should get a green light but 18 out of 20 concluded that the drug can be labelled as abuse-deterrent.
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