Insys Therapeutics (NASDAQ: INSY) reported Q3 EPS of $0.63, $0.34 better than the analyst estimate of $0.29. Revenue for the quarter came in at $58.3 million versus the consensus estimate of $57.1 million.

Subsequent Events Pipeline Developments

• Insys received DEA approval to manufacture synthetically its CBD and was granted a quota to produce 15kg of CBD in 2014. The company expects a larger quota in 2015 for its continued clinical studies.
• Insys received a Refusal to File Letter from the FDA for its proprietary Dronabinol Oral Solution because it provided an incomplete pediatric study plan in its NDA submission. The Company subsequently submitted the pediatric study plan to the FDA. The Company intends to discuss the plan with the FDA, and to resubmit the NDA to the FDA thereafter.
• Insys filed an IND for its buprenorphine/naloxone for opioid dependence sublingual spray candidate in October 2014. This IND was cleared by the FDA in early November.
• Insys remains on track to file INDs for ondansetron sublingual spray to treat nausea and vomiting and CBD to treat Lennox-Gastaut Syndrome and Dravet Syndrome in the fourth quarter of 2014.

For earnings history and earnings-related data on Insys Therapeutics (INSY) click here.