Blog Coverage ARIAD Pharma Announces US FDA Approval for NDA Filing for Lung Cancer Medicine

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LONDON, UK / ACCESSWIRE / November 1, 2016 / Active Wall St. blog coverage looks at the headline from Ariad Pharmaceuticals Inc. (NASDAQ: ARIA) (“ARIAD”) as the company announced on October 31st, 2016, that the U.S. Food and Drug Administration (FDA) has accepted for review the New Drug Application (NDA) for ARIAD’s investigational oral anaplastic lymphoma kinase (ALK) inhibitor, brigatinib, in patients with metastatic ALK-positive (ALK+) non-small cell lung cancer (NSCLC) who have progressed on crizotinib. Register with us now for your free membership and blog access at: http://www.activewallst.com/register/.

ARIAD Pharma is anticipated to report earnings today on November, 01st, 2016. One of Ariad Pharma’s competitors within the Biological Products (No Diagnostic Substances) space, Gilead Sciences, Inc. (NASDAQ: GILD), is also estimated to post its fiscal quarter ending September 2016 results on November 01st, 2016. AWS will be initiating a research report on Gilead Sciences in the coming days.

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ARIAD, headquartered in Cambridge, Massachusetts announced that the FDA granted ARIAD’s request for Priority Review and has set an action date of April 29, 2017, under the Prescription Drug User Fee Act (PDUFA).

What is Brigatinib?

Brigatinib is an investigational, targeted cancer medicine discovered by ARIAD. The medicine is in development for the treatment of patients with anaplastic lymphoma kinase positive (ALK+) NSCLC. The global Phase 2 ALTA trial, in patients with locally advanced or metastatic ALK+ NSCLC who were previously treated with crizotinib, is the primary basis for brigatinib’s initial regulatory review. ARIAD has also initiated the Phase 3 ALTA 1L trial to assess the efficacy and safety of brigatinib in comparison to crizotinib in patients with locally advanced or metastatic ALK+ NSCLC who have not received prior treatment with an ALK inhibitor.

ALK+ NSCLC

NSCLC is the most common form of lung cancer, accounting for approximately 85% of the estimated 228,190 new cases of lung cancer diagnosed each year in the United States, according to the American Cancer Society. Anaplastic lymphoma kinase (ALK) was first identified as a chromosomal rearrangement in anaplastic large-cell lymphoma (ALCL). Genetic studies indicate that chromosomal rearrangements in ALK are key drivers in a subset of NSCLC patients as well.

The Approval Process

ARIAD’s NDA submission includes clinical data from its Phase 1/2 and pivotal Phase 2 ALTA trials of brigatinib. The company stated that the FDA’s Priority Review status accelerates the review time from 10 months to a goal of six months post the filing of the application. Brigatinib received Breakthrough Therapy designation from the FDA in October 2014 for the treatment of patients with ALK+ NSCLC whose tumours are resistant to crizotinib, and was granted orphan drug designation by the FDA for the treatment of ALK-positive, ROS1-positive, and EGFR-positive NSCLC in May 2016. ARIAD plans to submit a Marketing Authorization Application (MAA) for brigatinib to the European Medicines Agency (EMA) in early 2017.

“The FDA acceptance of our application is an important milestone in our on-going efforts to discover, develop and deliver highly innovative treatments for patients with rare cancers,” said Paris Panayiotopoulos, president and chief executive officer of ARIAD, “We look forward to continuing to work closely with the FDA during the brigatinib NDA review and remain committed to developing critical therapies for unserved and underserved small patient populations suffering from rare cancers.”

Stock Performance

Ariad Pharma’s share price finished yesterday’s trading session at $8.72, marginally sliding 0.68%. A total volume of 6.66 million shares exchanged hands. The stock has advanced 24.04% and 27.49% in the last six months and past twelve months, respectively. ARIAD’s stock price has plunged 36.30% in the past one month, the stock price declined after reports that the company increased prices on its leukaemia drug four times this year, resulting in a negative tweet from former presidential hopeful Bernie Sanders. Furthermore, since the start of the year, shares of the company have soared 39.52%. The stock currently has a market cap of $1.69 billion.

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