By Robb M. Stewart

 

IntelGenx Corp.'s shares jumped Thursday after the Canadian drug-delivery company and its partner received the U.S. Food and Drug Administration's review of the data submitted in their abbreviated new drug application for Buprenorphine Buccal Film, a generic version of an opioid used to manage chronic pain.

In morning trading, the stock was 8% higher at C$0.27, widening the year-to-date gain to 10%.

IntelGenx said co-developer Chemo Research SL received a complete response letter from the FDA, and the pair plan to contact the regulator to discuss the letter and assess the filing of a request for reconsideration of the complete response letter. Chemo Research will address the FDA's concerns in the current quarter, IntelGenx said.

Earlier this month, the company said the FDA approved its Rizafilm new drug application for the treatment of acute migraine.

 

Write to Robb M. Stewart at robb.stewart@wsj.com

 

(END) Dow Jones Newswires

April 27, 2023 10:56 ET (14:56 GMT)

Copyright (c) 2023 Dow Jones & Company, Inc.
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