KemPharm Spikes On FDA Approval Of Apadaz

KemPharm Inc KMPH shares popped more than 25 percent Friday after the company announced the U.S. Food and Drug Administration approved Apadaz for short-term acute-pain management.

“With each of these advancements, we are significantly better positioned,” KemPharm CEO Travis Mickle said on a conference call.

Why It's Important

The FDA had rejected the Apadaz marketing application in 2016 on concerns of intranasal abuse, and KemPharm had resubmitted for review in September. Having now secured approval, the firm expects the Drug Enforcement Administration to rank Apadaz as a C-II product, a label indicating high potential for abuse.

Management confirmed it has a plan in place to scale manufacturing and has support to meet quota by the end of this year. It's also pursuing two commercialization strategies and is in active discussions for both approaches: partnership with a generic pharmaceutical manufacturer and distributor and/or partnership with a non-traditional pharmacy benefits manager agreeing to a Tier 1 or equivalent status.

At time of publication, shares were trading up 22.6 percent at $6.50.

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