FDA Issues Complete Response For Arena's Lorcaserin

On 10/23, Arena Pharmaceuticals

announced the FDA issued a complete response letter (

) for lorcaserin, citing several reasons for delaying the drug's approval. The CRL focused on lorcaserin's potential cancer risk and modest clinical efficacy, requesting additional preclinical data and ph.III BLOOM-DM results, minimally. Oppenheimer believes there is meaningful risk the FDA will eventually request additional clinical trials in order to address concer ns regarding lorcaserin's benefit/risk profile. Following an unfavorable FDA panel outcome in September, the CRL comes as no surprise, and we expect modest additional downside in ARNA. However, it believes ARNA faces considerable challenges, given likely prolonged lorcaserin timelines and minimal near-term pipeline news. ARNA is trading higher at $1.70, up 4%