GW Pharmaceuticals (GWPH) Stock Lower After Results of First Sativex Phase 3 Trials
Shares of GW Pharmaceuticals plc (GWPH) were trading down -9.50 or -13.36 percent to $61.56 per share in this morning's premarket, after the company announced early this morning the results of the first of three its investigational product, Sativex in Phase 3 trials. The company also released an update on its development program for Epidiolex, a treatment for severe drug-resistant childhood epilepsy. GW Pharmaceuticals stock closed at $71.05 per share, up +1.44 or +2.08 percent in Wednesday's regular trading session.
This morning, GW Pharmaceuticals, along with Otsuka Pharmaceutical Development & Commercialization, Inc. announced that Sativex did not show a statistically significant difference in reducing pain versus a placebo in the treatment of cancer patients. The results of the first of three Phase 3 trials did not meet its primary endpoint.
Justin Gover, GW's Chief Executive Officer stated that, "Although we missed the primary endpoint in this trial, based upon the positive data seen in the Phase 2 program, we remain confident in the ability for Sativex to relieve cancer pain in this patient population, we have two additional pivotal Phase 3 trials ongoing which, if positive, would still allow us to submit a New Drug Application with the US FDA. We look forward to results from these two further studies later this year.
The patient population tested, consisted of patients with advanced cancer that experienced inadequate analgesia while on optimized chronic opioid therapy. Dr. Marie Fallon, Professor of Palliative Care at the University of Edinburgh said that, "Too many patients with advanced cancer do not attain adequate pain relief from an opioid regimen, or experience unacceptable opioid side effects.
In addition to the news on Sativex, GW also gave an update on the Epidiolex program for treatment resistant childhood epilepsies. The company reported that all trials were on track or ahead of schedule in the treatment of both Dravet Syndrome and Lennox-Gastaut Syndrome or LGS.
In 2014, GW received Orphan Drug Designation from the FDA for Epidiolex for the treatment of both forms of epilepsy and now expects top line data from at least one of pivotal trial in Dravet Syndrome and LGS by the end of this year.
CEO Justin Gover said that "I am pleased to confirm that all aspects of this program are advancing on time and we now expect to complete pivotal Phase 3 trials by the end of 2015. GW stock was hit hard immediately after the news release, but has managed to recover considerable ground and as of this writing. The stock is still off significantly from its closing high of $107.35 per share made on July 1st of 2014.
Other News About GW Pharmaceuticals
GW Pharmaceuticals Added to NASDAQ Biotechnology Index
GW was added to the index on December 22nd.
GW Pharmaceuticals plc Reports 2014 Q4 and Full Year Financial Results
Company reports better than expected results.
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