Teva Pharmaceutical Industries Ltd (ADR) (NYSE:TEVA) and Active Biotech announced that the patient enrollment for the pivotal Phase III CONCERTO trial has been finalized, as well as a planned sample size re-assessment analysis of the study. CONCERTO, the third Phase III trial of laquinimod in patients with relapsing-remitting multiple sclerosis (RRMS), is designed to evaluate the safety and efficacy of laquinimod (0.6mg or 1.2mg/day) with a primary endpoint of time to Confirmed Disability Progression (CDP), as measured by the Expanded Disability Status Scale (EDSS).
The sample size reassessment was included as part of the protocol to confirm that the original assumptions are in line with the study and that the sample size is adequate. Based on recent agreement with FDA, under a Special Protocol Assessment (SPA) agreement, study completion will occur when either 260 events are reached or all patients complete 24 months of study treatment (whichever occurs first). CONCERTO study results are expected to be available toward mid-2017. Regulatory submission will follow study completion.
“We are committed to realizing the full potential of laquinimod. The molecule has a unique mechanism for future treatment of MS and other neurodegenerative diseases by working directly in the Central Nervous System, showing promise to prevent brain atrophy and slow disability progression in these patients,” said Michael Hayden, M.D., Ph.D., President of Global R&D and Chief Scientific Officer at Teva.
Laquinimod is also being tested in Phase II trials for the treatment of subjects with primary progressive MS and Huntington disease; two diseases for which no approved disease modifying therapies are available. For further details on the Phase III CONCERTO study, please visit https://clinicaltrials.gov/ct2/show/NCT01707992. (Original Source)
Shares of Teva Pharmaceutical Industries closed yesterday at $59.37 . TEVA has a 1-year high of $68.75 and a 1-year low of $47.36. The stock’s 50-day moving average is $60.49 and its 200-day moving average is $59.20.
On the ratings front, Teva Pharmaceutical Industries has been the subject of a number of recent research reports. In a report issued on June 19, Maxim Group analyst Jason Kolbert maintained a Buy rating on TEVA, with a price target of $68, which implies an upside of 14.5% from current levels. Separately, on June 4, Deutsche Bank’s Gregg Gilbert maintained a Buy rating on the stock and has a price target of $73.
According to TipRanks.com, which ranks over 7,500 financial analysts and bloggers to gauge the performance of their past recommendations, Jason Kolbert and Gregg Gilbert have a total average return of 3.2% and 20.9% respectively. Kolbert has a success rate of 43.8% and is ranked #1066 out of 3632 analysts, while Gilbert has a success rate of 80.4% and is ranked #193.
The street is mostly Bullish on TEVA stock. Out of 8 analysts who cover the stock, 7 suggest a Buy rating and one recommend to Hold the stock. The 12-month average price target assigned to the stock is $73.00, which represents a potential upside of 23.0% from where the stock is currently trading.
Teva Pharmaceutical Industries Ltd develops, produces and markets generic, branded & OTC medicines. Some of its products are Copaxone, Azilect & Provigil.