Intercept Pharmaceuticals Inc (NASDAQ:ICPT) declined 5.95% to end last trading session at $156.08. The company on Dec. 17, 2015 announced that the U.S. Food and Drug Administration (FDA) has extended the Prescription Drug User Fee Act (PDUFA) date for its Priority Review of obeticholic acid (OCA) in primary biliary cirrhosis, recently renamed primary biliary cholangitis (PBC). In response to an information request from the FDA, additional clinical data analyses have been submitted. To provide time for a full review of the submission, the original PDUFA date of February 29, 2016 has been extended by three months, resulting in a new PDUFA date of May 29, 2016. The FDA has also notified Intercept of a planned advisory committee meeting date of April 7, 2016.
Intercept is seeking approval of OCA for the treatment of PBC in combination with ursodeoxycholic acid (UDCA) in adults with an inadequate response to UDCA or as monotherapy in adults unable to tolerate UDCA.
Esperion Therapeutics Inc (NASDAQ:ESPR) plunged 5.84% to finish last trading session at $22.58. The company on November 05, 2015 provided ETC-1002 (bempedoic acid) development program updates and financial results for the third quarter ended September 30, 2015.
As of September 30, 2015, cash and cash equivalents and investment securities available-for-sale totaled $302.4 million compared with $141.6 million at December 31, 2014.
Research and development expenses were $7.2 million for the third quarter of 2015 and $21.8 million for the nine months ended September 30, 2015, compared to $7.2 million and $19.1 million for the comparable periods in 2014. The increase in research and development expenses was primarily related to the further clinical development of ETC-1002.
Esperion had a net loss of $12.8 million for the third quarter of 2015 and $36.7 million for the nine months ended September 30, 2015, compared to $9.8 million and $26.9 million for the comparable periods in 2014.
BioDelivery Sciences International, Inc. (NASDAQ:BDSI) decreased 5.07% to complete last trading session at $4.87. The company on December 18, 2015 provided an update on its development pipeline and announced plans for an R&D day in early 2016.
BDSI has initiated its multi-center, randomized, double-blind, placebo controlled study to assess the efficacy and safety of Clonidine Topical Gel in the treatment of pain associated with painful diabetic neuropathy. The study design incorporates significant learnings from two previously conducted studies and involves tightened and additional inclusion criteria to improve assay sensitivity, reduce bias, and ensure compliance with enrollment criteria. BDSI expects the first patient to be enrolled shortly with study recruitment expected to be completed before the end of 2016.