IntelGenx Shares Rise After FDA Complete Response Letter for Buprenorphine Buccal Film
April 27 2023 - 11:11AM
Dow Jones News
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)
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