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IntelGenx's NDA Resubmission for Rizaport Gets FDA Acceptance

IntelGenx Technologies Corp. IGXT announced that the FDA has accepted the resubmission of 505(b)(2) new drug application (NDA) for Rizaport oral soluble film 10 mg, which is being developed for the treatment of acute migraine. The FDA has set an action date of Apr 1, 2019.

Shares of IntelGenx rallied 18.6% following this news on Tuesday. However, the stock has plunged 20.3% so far this year compared with the industry’s decline of 9.8%.

Rizaport is a proprietary oral thin-film formulation of rizatriptan, a 5-HT1 receptor agonist and the active drug in Merck’s MRK Maxalt.

We would like to remind investors that in March 2013, IntelGenx submitted the first NDA for Rizaport along with partner RedHill Biopharma RDHL. Both companies received a complete response letter (CRL) in exchange from the FDA. The CRL was primarily related to third-party chemistry, manufacturing and controls (CMC) as well as the packaging/labeling of the product. However, back then, the regulatory body did not raise any questions regarding Rizaport’s safety and bio-equivalence data.

Later, in November 2017, both IntelGenx and RedHill announced that they have resubmitted the 505(b)(2) NDA for Rizaport 10 mg to the FDA.

However, last December, RedHill terminated its agreement with IntelGenx for the co-development and commercialization of Rizaport. Redhill’s termination notice was due to a receipt of communication from the FDA, which requested for additional information before the full review of the candidate’s NDA resubmission. The regulatory agency asked for extra data following the NDA refiling earlier in November.

Post this round of events, IntelGenx gained exclusive worldwide rights to develop and commercialize Rizaport.

Zacks Rank & Stock to Consider

IntelGenx currently carries a Zacks Rank #4 (Sell).

A better-ranked stock in the same sector is BioSpecifics Technologies Corp BSTC, sporting a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

BioSpecifics’ earnings estimates have been revised 9.6% upward for 2018 and 16.8% for 2019 over the past 60 days. The stock has jumped 29.7% year to date.

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Merck & Co., Inc. (MRK) : Free Stock Analysis Report
 
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