Flamel Technologies (FLML): Sodium Oxybate Getting Back On Track - Needham
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Leerink Partners analyst, Jason Gerberry reiterated his Outperform rating on shares of Flamel Technologies (NASDAQ: FLML) after the company highlighted that the pivotal Phase 3 study (REST-ON) for the company's once-nightly sodium oxybate (similar to JAZZ’s Xyrem) commenced after a several month delay.
At the event, mgmt emphasized 3 key features it believes will differentiate m-SXB:
1) once-nightly dosing vs. Xyrem's twice-nightly dosing.
2) tamper-resistant packaging - FLML plans to package m-SXB in child resistant packaging and emphasized QD dosing mitigates the issue of having an unattended dose on the pts nightstand
3) tolerability benefit - mgmt believes less water consumed with QD dosed product could cut down on the frequency of nocturnal enuresis (bed wetting).
Key upcoming events for FLML include: (1) possible update on Xyrem 2.0 by end-2016, per JAZZ; (2) Xyrem patent updates over the next 12 months.
No change to the price target of $16.
Shares of Flamel Technologies closed at $13.36 yesterday.
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