Premarket Biotech Digest – JNJ Receives EU Nod, XBIT Terminates Trial, PFE Amends Protocol

Top Pick of the Day: JNJ

Johnson & Johnson (JNJ) announced receiving the approval from the regulatory authorities in the EU for its planned $30 billion takeover of Actelion. The approval has come through after the company pledged to spin-off one of the combined firm’s two insomnia pipeline programs. Actelion’s insomnia project will be transferred to a new company called Idorsia.Johnson & Johnson will not be allowed to nominate a board member to the new entity. It will also limit its stake to 10% if it is the largest shareholder.

Johnson & Johnson stock has gained over 14 percent this year so far while its 12 months gain stands at 12 percent.

Focus Ticker: LXRX

Lexicon Pharmaceuticals Inc. (LXRX) announced that its Phase 3 clinical trail, TANDEM 3 met its primary endpoint of demonstrating superiority over placebo as measured by the proportion of patients achieving HbA1C levels less than 7.0% at week 24.The study is designed to assess the efficacy of sotagliflozin for the treatment of type 1 diabetes. The results showed that there were no episodes of hypoglycemia or diabetic ketoacidosis after randomization. The company has an agreement with Sanofi, which gives the company global rights to the product, except for in Japan.
Lexicon stock is up 18 percent this year so far while its 12 years gain stands at 12 percent.

Sector News

XBiotech (XBIT) announced ending its Phase 3 clinical trial, XCITE, designed for assessing lead product candidate Xilonix for the treatment of colorectal cancer. The decision has been taken pursuant to a second planned analysis by the Independent Data Monitoring Committee which determined that it would be unlikely to show sufficient efficacy to continue.

Tesaro (TSRO) announced that it has suspended the patient recruitment in a Phase 2 clinical trial assessing niraparib for the treatment of prostate cancer being conducted by collaboration partner Janssen Biotech. The FDA approved niraparib in March for treating certain patients with epithelial, ovarian, fallopian tube or primary peritoneal cancer.