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ZGNX

Zogenix

$47.72

1.04 (2.23%)

08:11
07/08/19
07/08
08:11
07/08/19
08:11

Zogenix completes enrollment in Phase 3 trial of FINTEPLA

Zogenix announced that it has completed enrollment for, and randomized the last patient into the treatment period of, Study 1601, the Company's Phase 3 clinical trial of its lead investigational therapy, FINTEPLA, for the treatment of seizures associated with Lennox-Gastaut Syndrome, a severe and often treatment-resistant childhood-onset epilepsy. Study 1601 is a multi-national, randomized, double-blind, placebo-controlled trial of two fixed doses of FINTEPLA as adjunctive therapy for seizures in children and adults with LGS. After establishing a baseline seizure frequency for four weeks, patients are randomized into one of three treatment group for a two-week period of dose titration before being held at a fixed dose for 12 weeks of maintenance treatment. The study randomized a total of 263 patients, with approximately 87 subjects per group. The primary endpoint of the clinical trial is the change in the number of seizures that result in drops between baseline and the combined titration and maintenance periods at the 0.8 mg/kg/day dose compared to placebo. The key secondary endpoints include change in the number of drop seizures between baseline and the combined titration and maintenance periods at the 0.2 mg/kg/day dose compared to placebo, and the proportion of patients achieving a 50% reduction in drop seizures. Patients who complete the maintenance treatment period may be eligible to enter a 12-month open-label extension to evaluate the long-term safety, tolerability and effectiveness of FINTEPLA in LGS. FINTEPLA for the treatment of LGS has previously been designated as an orphan drug by both the U.S. Food and Drug Administration and the European Medicines Agency.

ZGNX Zogenix
$47.72

1.04 (2.23%)

06/27/19
PIPR
06/27/19
NO CHANGE
Target $64
PIPR
Overweight
Zogenix agreement with FDA 'best case scenario,' says Piper Jaffray
The FDA, in a "surprise turn of events," indicated that it agreed with Zogenix's plan to re-submit their Fintepla new drug application without generating new preclinical toxicity data, Piper Jaffray analyst Danielle Brill tells investors in a research note. Although breakthrough therapy status was rescinded due to the recent approvals of two other drugs for Dravet Syndrome, Brill still expects an expedited review and she estimates approval and launch by Q2 of 2020. The analyst views the news as the "best case scenario" for Zogenix. She does not expect the delay to have any meaningful impact on Fintepla's overall commercial potential and reiterates an Overweight rating on the shares with a $64 price target. The stock in afternoon trading is up 21%, or $8.24, to $47.65.
06/27/19
GUGG
06/27/19
UPGRADE
GUGG
Buy
Zogenix upgraded to Buy from Neutral at Guggenheim
06/27/19
06/27/19
UPGRADE
Target $64

Buy
Zogenix upgraded to Buy Fintepla NDA news at Guggenheim
As previously reported, Guggenheim analyst Yatin Suneja upgraded Zogenix to Buy from Neutral after speaking with management following the news on Fintepla NDA resubmission in Dravet in Q3. The analyst believes the company has a clear understanding with the FDA on potential approval pathway and views the news as the best case scenario. The company also announced the loss of breakthrough designation, which is surprising but in line with FDA policy, he notes, adding however, that it does not change his view on the approvability of the drug and thinks priority review could help with a speedy approval. Suneja also raised his price target on the shares to $64 from $40.
06/28/19
MZHO
06/28/19
NO CHANGE
Target $65
MZHO
Buy
Zogenix price target raised to $65 from $58 at Mizuho
Mizuho analyst Difei Yang raised her price target for Zogenix to $65 from $58 following the FDA's decision to allow a re-submission of the new drug application for Fintepla. The analyst believes a priority review is highly likely and views the FDA's decision as a positive. She reiterates a Buy rating on Zogenix shares.

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