=Ariad Pharm (ARIA) reported earnings on Thur 28 Jul 2016 (b/o)

Ariad Pharm beats by $0.70, beats on revs  :

• Reports Q2 (Jun) earnings of $0.59 per share, $0.70 better than the single analyst estimate of ($0.11); revenues rose 133.0% year/year to $68.13 mln vs the $62.11 mln Capital IQ Consensus.
• As of June 30, 2016, cash, cash equivalents and marketable securities totaled $278.5 million, compared to $168.3 million at March 31, 2016 and $242.3 million at December 31, 2015.
• Iclusig
  • ARIAD has submitted the four-year PACE data to the FDA and other health authorities as a label supplement, with an FDA action date in the fourth quarter of this year. Patient enrollment is ongoing in the OPTIC and OPTIC-2L clinical trials in patients with resistant CP-CML. Otsuka Pharmaceutical Co., Ltd. (Otsuka) submitted a new drug application (:NDA) to the Japanese Pharmaceuticals and Medical Devices Agency (:PMDA) seeking approval for Iclusig for the treatment of resistant or intolerant chronic myeloid leukemia (:CML) and Philadelphia-chromosome positive acute lymphoblastic leukemia (Ph+ALL). This marketing application was submitted in early 2016, with an anticipated action date in third quarter 2016, and reimbursement and launch expected in late 2016 or early 2017.
• Brigatinib
  • ARIAD initiated the New Drug Application (:NDA) submission for brigatinib to the FDA for patients with ALK+ non-small cell lung cancer (:NSCLC) who are resistant to crizotinib. The Company will be seeking accelerated approval for brigatinib from the FDA and plans to request a priority review of the application. We anticipate completion of the rolling submission in the third quarter of this year.
  • The ALTA 1L randomized, front-line clinical trial of brigatinib opened to patient enrollment in early April and patient enrollment is underway. This global, Phase 3 trial is designed to compare brigatinib and crizotinib in patients with ALK+ NSCLC who have not received prior ALK inhibitors. Full enrollment is expected in 2018.