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Be the first with the news that moves the market- IntelGenx Technologies (TSXV:IGX) has failed to get US approval for its new Versafilm drug
- The company previously resubmitted the drug in October last year, after addressing issues raised by the US Food and Drug Administration’s (FDA) previous rejection
- The drug dissolves on the tongue and could possibly treat acute migraines
- The company intends to meet with the FDA to clarify the next steps forward
- IntelGenx Technologies (IGX) is down 58.54 per cent, with shares trading for C$0.17 and a market cap of $18.2 million
IntelGenx Technologies (TSXV:IGX) has seen its market share more than halve after it failed to get US approval for a new drug.
The company had previously hoped that the US Food and Drug Administration would approve its new drug delivery product for the treatment of acute migraines.
This is the second time that the FDA has rejected the product. The company previously resubmitted the drug in October last year, after addressing issues raised by the FDA’s initial findings.
The drug uses the company’s Versafilm technology. Versafilm is a small, thin edible sheet, about the size of a stamp. The patient places it on their tongue and allows the sheet to dissolve, delivering the drug into the patient’s system.
The company had paired this technology with the drug rizatriptan, which treats migraines when taken early enough.
However, the US FDA released its report today, stating that the product did not meet the standards required for approval. It remains unclear what the specific reasons for denial were.
IntelGenx CEO, Dr. Horst G. Zerbe,was candid about the decision’s impact on the company.
“Obviously, we are surprised and disappointed. We are committed to addressing the concerns raised by the FDA.
“To that end, we will request a meeting with the Agency as soon as reasonably possible, to discuss the scope of the comments, to obtain clarification, and determine next steps,” he said.
The company has a commercialisation agreement with Gensco Pharma for distribution in the US. IntelGenx has not commented on whether the FDA’s decision will impact this agreement moving forward.
IntelGenx Technologies (IGX) is down 58.54 per cent, with shares trading for C$0.17 at 2:42pm EST.
