Ariad Pharmaceuticals, Inc. (NASDAQ:ARIA) announced that it has achieved full enrollment in the pivotal Phase 2 ALTA trial of its investigational anaplastic lymphoma kinase (ALK) inhibitor, brigatinib. This registration study enrolled approximately 220 patients at approximately 75 sites in North America, Europe and Asia.
“We are proud to have completed patient enrollment in the ALTA trial in the timeframe we established at the outset,” stated Timothy P. Clackson, president of research and development and chief scientific officer of ARIAD. “We expect data from this trial to form the basis for an NDA filing of brigatinib in patients with refractory non-small cell lung cancer in the third quarter of next year.”
The ALTA (ALK in Lung Cancer Trial of AP26113) trial is designed to determine the safety and efficacy of brigatinib (previously known as AP26113) in refractory non-small cell lung cancer (NSCLC) patients who test positive for the ALK oncogene (ALK+) and who have been treated with and progressed on their most recent crizotinib therapy. The primary endpoint of the trial is objective response rate (ORR) as measured by RECIST criteria. Brigatinib received Breakthrough Therapy designation from the U.S. Food and Drug Administration in 2014.
Median time on treatment for patients in the ALTA trial is less than 4 months, and follow-up data are limited at this time. As a result, ARIAD now expects that first data from the trial will be submitted for presentation at theAmerican Society of Clinical Oncology (ASCO) annual meeting in 2016. Presenting data at ASCO will also align more closely with the anticipated filing for marketing approval of brigatinib in the U.S. in the third quarter of 2016.
A randomized front-line clinical trial of brigatinib is expected begin in early 2016. This Phase 3 trial will compare brigatinib to crizotinib in approximately 300 patients with ALK+ NSCLC, who have not received prior ALK inhibitors. (Original Source)
Shares of Ariad Pharmaceuticals closed yesterday at $8.02. ARIA has a 1-year high of $10.07 and a 1-year low of $4.90. The stock’s 50-day moving average is $7.70 and its 200-day moving average is $8.38.
On the ratings front, Ariad has been the subject of a number of recent research reports. In a report issued on August 5, J.P. Morgan analyst Cory Kasimov maintained a Hold rating on ARIA, with a price target of $9, which implies an upside of 12.2% from current levels. Separately, on June 3, William Blair’s Tim Lugo reiterated a Buy rating on the stock and has a price target of $11.
According to TipRanks.com, which ranks over 7,500 financial analysts and bloggers to gauge the performance of their past recommendations, Cory Kasimov and Tim Lugo have a total average return of 7.4% and -3.6% respectively. Kasimov has a success rate of 56.3% and is ranked #419 out of 3757 analysts, while Lugo has a success rate of 43.2% and is ranked #3151.
ARIAD Pharmaceuticals Inc is an oncology company. The Company is engaged in transforming the lives of cancer patients with breakthrough medicines. It commercializes & develops products and product candidates including Iclusig, Brigatinib, and AP32788.