Ariad Pharmaceuticals, Inc. (NASDAQ:ARIA) announced the initiation of a New Drug Application (NDA) submission 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 ALK+ non-small cell lung cancer (NSCLC) who are resistant to crizotinib. 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. The Company is seeking accelerated approval for brigatinib from the FDA and plans to request a priority review of the application.
“We are ahead of our previously announced schedule for initiating the submission of our brigatinib NDA to the FDA and we are grateful to have breakthrough status from the FDA, which provides the opportunity to utilize the rolling submission process,” stated Paris Panayiotopoulos, president and chief executive officer of ARIAD. “If approved, we believe that brigatinib will become an important new medicine for ALK+ NSCLC patients who have become resistant or intolerant to prior crizotinib therapy and will offer additional hope to these patients and their families.”
ARIAD’s NDA is a rolling submission which will occur in three parts. The initial submission contains all nonclinical portions of the NDA and will be followed by submissions of the chemistry, manufacturing and controls (CMC) and clinical data. The rolling NDA submission is expected to be complete in the third quarter of 2016.
Phase 2 ALTA Results Presented at ASCO
Results from the ongoing Phase 2 ALTA trial of brigatinib reported at this year’s annual meeting of the American Society of Clinical Oncology earlier this month showed that, in patients on the 180 mg regimen (Arm B, n=110) with a median follow-up of 8.3 months (range 0.1—20.2), 54 percent achieved a confirmed objective response, the trial’s primary endpoint. In this arm, the median progression free survival (PFS) exceeded one year (12.9 months) in this post-crizotinib setting. Additionally, a confirmed intracranial objective response rate (ORR) of 67 percent (12/18) was achieved in patients with measurable brain metastases.
The most common treatment-emergent adverse events (TEAEs; ≥ 25% of all patients, [Arm B/A]), regardless of relationship to treatment, were nausea (40%/33%), diarrhea (38%/19%), cough (34%/18%), and headache (27%/28%). TEAEs, ≥ grade 3, occurring in ≥ 5 percent of all patients (Arm B/A), were increased blood creatine phosphokinase (9%/3%) and hypertension (6%/6%). (Original Source)
Shares of Ariad are up around 2% in pre-market trading. ARIA has a 1-year high of $10.07 and a 1-year low of $4.37. The stock’s 50-day moving average is $7.90 and its 200-day moving average is $6.47.
On the ratings front, Ariad has been the subject of a number of recent research reports. In a report issued on June 6, JMP analyst Michael King reiterated a Buy rating on ARIA, with a price target of $9, which implies an upside of 11.9% from current levels. Separately, on the same day, Cowen’s Chris Shibutani reiterated a Buy rating on the stock and has a price target of $10.
According to TipRanks.com, which ranks over 7,500 financial analysts and bloggers to gauge the performance of their past recommendations, Michael King and Chris Shibutani have a total average return of -6.9% and 2.8% respectively. King has a success rate of 34.6% and is ranked #3374 out of 3976 analysts, while Shibutani has a success rate of 62.5% and is ranked #1901.
The street is mostly Bullish on ARIA stock. Out of 5 analysts who cover the stock, 4 suggest a Buy rating and one recommends to Sell the stock.
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 includes Iclusig (ponatinib), Brigatinib (previously known as AP26113), and AP32788.