Leerink Affirms Aurinia Pharma (AUPH) at 'Outperform' Following Voclosporin; Says Pipeline Remains Promising
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Leerink reiterates Aurinia Pharmaceuticals (Nasdaq: AUPH) at Outperform with a price target of $7 after the company announced that in addition to voclosporin (23.7 mg BID) achieving its primary endpoint of Complete Remission (CR) at 24 weeks, both doses of voclosporin when added to the current standard of care of Mycophenolate Mofetil (MMF) and a forced oral corticosteroid taper have met all 24-week pre-specified secondary endpoints vs the control group.
Analyst Joseph P. Schwartz commented today,
This morning Aurinia Pharmaceuticals hosted an event to discuss add'l data supporting that Voclosporin has been shown to be safe and effective throughout its clinical development. The event highlighted that Voclosporin achieved all pre-specified secondary endpoints in the phase 2b AURA-LV study of lupus nephritis (LN) and that the pattern of patient deaths highlights the burden of this disease rather than reason for concern regarding Voclosporin's regulatory approval. This update provides incremental support of the strong topline efficacy data reported last month.
There are two crucial outstanding questions that investors are waiting to hear addressed: 1) whether AUPH will enroll patients in their Ph 3 trial from areas with similarly compromised access to healthcare and 2) how many additional trials, of what size and duration, are necessary before filing for Voclosporin approval is prudent. Mgmt. noted that they will aim to minimize enrolling patients at the greatest risk of near-term death in subsequent trials but also that showing efficacy and safety in a representative Asian patient population is critical for garnering approval and rapid uptake in the Japanese market. Regarding trial sizing and duration, the breadth of likely outcomes we foresee are that AUPH will run 1-2 additional trials with either 24 or 48 week endpoints but we await further guidance from the company.
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