Shares of the thinly traded, small-cap biotech Zogenix, Inc. (NASDAQ: ZGNX) were rallying Thursday.
Zogenix, which focuses on developing rare disease therapies, said following the receipt of the minutes of a May 30 Type A meeting with the FDA, it plans to resubmit the NDA for Fintepla, its investigational asset for the treatment of seizures associated with Dravet syndrome, in the third quarter.
The Type A meeting was scheduled after the FDA issued a Refusal to File letter April 5, citing two issues: non-submission of non-clinical studies and an incorrect version of a clinical dataset within the application.
The FDA has agreed to the company's plan to resubmit the NDA without the inclusion of the new chronic toxicity studies requested by the agency. To address the second issue, Zogenix said it explained the incorrect dataset with root cause analysis.
Breakthrough Therapy Designation Rescinded
The FDA has cancelled the Breakthrough Designation for Fintelpa, as there are now two approved therapies for treating seizures associated with Dravet syndrome.
Zogenix said its candidate showed 57% more efficacy than one of the approved therapies, stiripentol.
Despite the cancellation of the breakthrough designation, the biotech said it hopes to obtain Priority Review status for its resubmitted NDA.
Zogenix shares were up 22.1% at $48.12 at the time of publication Thursday.
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