Ariad Pharmaceuticals, Inc. (NASDAQ:ARIA) announced it has completed the rolling submission of the New Drug Application (NDA) for its investigational anaplastic lymphoma kinase (ALK) inhibitor, brigatinib, to the U.S. Food and Drug Administration (FDA). ARIAD is seeking U.S. marketing approval of brigatinib for patients with metastatic ALK-positive (ALK+) non-small cell lung cancer (NSCLC) who are resistant or intolerant to crizotinib. The Company is seeking accelerated approval for brigatinib from the FDA and has requested a priority review of the application, which, if granted, would allow for approval of brigatinib eight months after the NDA submission, as opposed to 12 months for a standard review.
“Many patients with ALK-positive non-small cell lung cancer eventually develop disease progression,” said Corey Langer, M.D., director of thoracic oncology in the Abramson Cancer Center of theUniversity of Pennsylvania and a professor of Hematology-Oncology in Penn’s Perelman School of Medicine. “We are excited that the brigatinib NDA submission is now complete and are hopeful that brigatinib’s data, including the observation of complete responses and activity in the central nervous system, will provide patients and their oncologists with a new treatment option.”
ARIAD’s NDA submission includes clinical data from its Phase 1/2 and pivotal Phase 2 ALTA trials of brigatinib. Data from the ALTA trial, in which patients who had experienced disease progression on crizotinib therapy were randomized to one of two brigatinib regimens, were presented at the 2016 Meeting of the American Society of Clinical Oncology (ASCO). With a median follow-up of 8.3 months, the data show that, for patients treated with the 180 mg regimen with a seven day lead-in at 90 mg (Arm B), 54 percent achieved an investigator-assessed confirmed objective response, the trial’s primary endpoint. In this arm, the median progression free survival (PFS) exceeded one year (12.9 months). Additionally, a 67% confirmed intracranial objective response rate was achieved in patients with measurable brain metastases. The most common treatment-emergent adverse events (TEAEs; ≥ 25% of all patients in Arm B), regardless of relationship to treatment, were nausea (40%), diarrhea (38%), cough (34%), increased blood creatine phosphokinase (30%), headache (27%) and fatigue (27%). TEAEs, ≥ grade 3, occurring in ≥ 5 percent of all patients in Arm B, were increased blood creatine phosphokinase (9%), hypertension (6%) and pneumonia (5%). A subset of pulmonary adverse events with early onset (median: Day 2; range: Day 1-9) occurred in 6 percent of all patients (≥ grade 3 in 3% of patients); no such events with early onset occurred after dose escalation to 180 mg QD in Arm B.
“With the completion of the brigatinib submission this week, we are excited by its potential, if approved, to offer additional hope to patients and their families,” stated Paris Panayiotopoulos, president and chief executive officer of ARIAD. “We are thankful to the patients and physicians who participated in the clinical trials of brigatinib. We remain grateful to the FDA for granting brigatinib a breakthrough designation and the benefit of a rolling submission process, unique to the U.S. regulatory system.”
Brigatinib received Breakthrough Therapy designation from the FDA for the treatment of patients with ALK+ NSCLC whose tumors are resistant to crizotinib, and was granted orphan drug designation by the FDA for the treatment of ALK+ NSCLC. ARIAD plans to submit a Marketing Authorization Application (MAA) for brigatinib to the European Medicines Agency (EMA) in early 2017. (Original Source)
Shares of Ariad closed yesterday at $10.21, down $0.04 or -0.39%. ARIA has a 1-year high of $10.85 and a 1-year low of $4.37. The stock’s 50-day moving average is $9.01 and its 200-day moving average is $7.44.
On the ratings front, ARIA has been the subject of a number of recent research reports. In a report issued on August 22, Jefferies Co. analyst Brian Abrahams reiterated a Buy rating on ARIA. Separately, on August 16, J.P. Morgan’s Anupam Rama maintained a Hold rating on the stock and has a price target of $8.
According to TipRanks.com, which ranks over 7,500 financial analysts and bloggers to gauge the performance of their past recommendations, Brian Abrahams and Anupam Rama have a total average return of 6.5% and 0.6% respectively. Abrahams has a success rate of 59.9% and is ranked #403 out of 4129 analysts, while Rama has a success rate of 52% and is ranked #2274.
The street is mostly Bullish on ARIA stock. Out of 6 analysts who cover the stock, 3 suggest a Buy rating , 2 suggest a Hold and one recommends to Sell the stock. The 12-month average price target assigned to the stock is $10.00, which represents a slight downside potential from current levels.
ARIAD Pharmaceuticals, Inc. operates as an oncology company which engages in the discovery, development, and commercialization of small-molecule drugs for the treatment of cancer. Its products include Iclusig and Caregivers.