XBIT Expands XCITE, COLL To Face FDA Panel, BCRX Plunges On Study Results Delay

(RTTNews) - BioCryst Pharmaceuticals Inc. (BCRX) now expects final results from a phase I healthy volunteer study of BCX7353, which is being developed for the treatment of hereditary angioedema, in the fourth quarter. The results were initially expected to be announced this quarter, and the delay is due to the addition of a 14 day treatment cohort to the study.

A clinical trial of orally-administered Avoralstat, formerly known as BCX4161, in patients with hereditary angioedema, dubbed OPuS-2, is underway, and results are expected at the end of 2015.

Last May, BioCryst announced positive results from a proof of concept phase 2a clinical trial of orally-administered Avoralstat in patients with hereditary angioedema, dubbed OPuS-1. The trial met the primary efficacy endpoint, several secondary endpoints and all other objectives established for the trial.

BCRX plunged 23.62% on Friday to close the day's trading at $10.90.

Collegium Pharmaceutical Inc.'s (COLL) New Drug Application for Xtampza ER, an abuse-deterrent, extended-release, oral formulation of oxycodone, for the management of chronic pain is scheduled to reviewed by an FDA panel on September 11, 2015.

The FDA's final decision on Xtampza ER is set for October 12, 2015.

Collegium's shares went public on the NASDAQ as recently as May 7, 2015, priced at $12 each.

COLL closed Friday's trading at $17.01, down 10.33%.

XBiotech (XBIT) has expanded its pivotal phase III study of its investigational cancer drug Xilonix for treatment of metastatic colorectal cancer into Europe, with Poland being the first recruitment site outside the U.S.

The study, dubbed XCITE, which currently has about 98 sites in the United States, will bring on line more than 80 sites across Eastern and Western Europe, and will continue to expand to include nearly 200 clinical sites across 20 countries worldwide.

According to the company, total enrollment in the XCITE study will consist of 600 patients, and enrollment is expected to be completed by the end of 2016.

XBIT closed Friday's trading at $13.87, down 4.93%.