Aegis Capital Starts Zogenix, Inc. (ZGNX) at Buy; Positive on Dravet Syndrome Possibilities
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Aegis Capital starts Zogenix (Nasdaq: ZGNX) with a Buy rating and $28 price taget.
The analst Difei Yang noted the following wi today's initation:
- ZX-008 and the unmet need in patients with Dravet Syndrome. ZX-008 is a potential therapy geared towards addressing the unmet needs for caregivers affected by and patients living with Dravet Syndrome (DS) and to serve as a treatment alternative to improve their daily functioning and health related quality of life (HRQoL). Currently in clinical development, the pivotal phase III trials for ZX-008 are undergoing enrollment in North America and Europe and serve as potential catalytic events for the company in 2Q17. We believe ZX-008 has the potential of proving better efficacy in DS patients vs. GW Pharma's ( GWPH, non-rated) cannabidiol which had reported positive Phase III readouts earlier in the year.
- ZX-008 Phase III studies 1501 and 1502 updates. The 1501 and 1502 trials, which have identical designs, are enrolling patients in North America and Western Europe respectively. The 1501 Phase III clinical trial was initiated back in January 2016, while the 1502 clinical trial was initiated in June 2016, with both trials expecting to readout top-line data in 2Q17. In terms of clinical site activation, 1501 currently has ~71% of total sites open (17 of 24) and enrolling, however the site activation comes at a slower pace than previously expected and the delays are already built into the current expected readout date, which was initially anticipated in 1Q17. On the other hand, 1502 currently has 52% of sites open and is experiencing enrollment at a pace in line with managementfs expectations. Management affirmed earlier guidance that if 1501 and 1502 studies are positive, the company is on track to file a NDA in 4Q17.
- Lennox-Gastaut syndrome Phase II trial. The open label investigator-initiated Phase II study of ZX008 with a read-out expected in 4Q16. Lennox-Gastaut syndrome (LGS) is a disorder characterized by severe epilepsy that starts in children slightly older than in. Given the timing, it's likely that the phase II trial data will be folded into the abstract posters set to be presented by Zogenix at the American Epilepsy Conference.
- Near term catalysts. Events on the near-term horizon in our focus include: 1) Interim data from the on-going phase 2 for ZX-008 in Lennox-Gastaut syndrome anticipated in 4Q16; 2) Presentations at the American Epilepsy Conference on December 2nd . 6th 2016; 3) Top-line data from phase III trials 1501 and 1502 for ZX-008 are anticipated in 2Q17; And 4) ZX-008 NDA and MAA submission for DS in 4Q17.
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