Corporate News Blog – EMA Grants PRIME Designation to Ignyta’s Entrectinib in NTRK Fusion-Positive Solid Tumors

LONDON, UK / ACCESSWIRE / October 19, 2017 / Pro-Trader Daily takes a look at the latest corporate events and news making the headlines for Ignyta, Inc. (NASDAQ: RXDX), following which we have published a free report that can be viewed by signing up at http://protraderdaily.com/optin/?symbol=RXDX. The Company announced on October 17, 2017, that it has received the Priority Medicines (PRIME) designation for entrectinib by the European Medicines Agency (EMA) for the treatment of NTRK fusion-positive, locally advanced/metastatic solid tumors in adult and pediatric patients who have either progressed following prior therapies or who have no acceptable standard therapy. The PRIME designation for entrectinib was based on data from the Phase-2 global study, STARTRK-2. For immediate access to our complimentary reports, including today’s coverage, register for free now at:

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PRIME Designation Validates Broad Potential of Entrectinib as Novel Treatment for NTRK-Positive Tumors Patients

Jonathan Lim, M.D., Chairman and Chief Executive Officer (CEO) of Ignyta, expressed that the PRIME designation recognition is the result of the efforts of Ignyta’s team to ensure that the entrectinib development was global in nature from its earliest days, and further validates the broad potential of entrectinib as a novel treatment for patients, regardless of age, with NTRK-positive tumors, a group of cancers for which there currently is no approved treatment. Lim added that the Company is looking forward to collaborating with the EMA, as well as other global regulatory authorities, on the accelerated assessment of entrectinib with the goal to provide a new therapy for patients in need.

Ignyta Received FDA Orphan Drug Designation and Breakthrough Therapy Designation for Entrectinib

News release suggests that on July 10, 2017, the US Food and Drug Administration (FDA) granted an orphan drug designation to Ignyta’s entrectinib for the treatment of NTRK fusion-positive solid tumors. In May 2017, the FDA also granted a breakthrough therapy designation to entrectinib.

About Entrectinib

Entrectinib is an investigational drug with preliminary antitumor activity. It is an orally available, CNS-active tyrosine kinase inhibitor, targeting tumors that harbor NTRK1/2/3 or ROS1 gene fusions, which is in a Phase-2 clinical study and two Phase-1 clinical studies in molecularly defined adult patient populations for the treatment of solid tumors, and a Phase-1/1b clinical study in pediatric patients with advanced solid tumor malignancies.

About Priority Medicines (PRIME)

PRIME is a scheme launched by EMA in 2016 to enhance support for the development of medicines that target an unmet medical need, and may offer a major therapeutic advantage over existing treatments, or benefit patients without treatment options. Through PRIME, the EMA offers early and proactive support to medicine developers to optimize the generation of robust data on a medicine’s benefits and risks and enable accelerated assessment of medicines applications.

STARTRK-2 Clinical Trial

STARTRK-2 is an open-label, global Phase-2 basket study of entrectinib for the treatment of patients with locally advanced/metastatic solid tumors that harbor NTRK1, NTRK2, NTRK3, ROS1, or ALK gene fusions. The patient outcomes will be analyzed by basket, according to tumor type and gene fusion. Ignyta’s STARTRK-2 trial of entrectinib is now recruiting patients with fusions of the ROS1, ALK, and NTRK genes.

About Ignyta, Inc.

Founded in 2011, Ignyta is a leader in biotechnology and precision medicine for cancer, engaged in the identification of the genomic causes of cancer, and creating targeted cancer drugs that attack cancer at its source. The Company’s integrated ‘Rx/Dx’ approach combines precision medicines and in-house molecular diagnostics for a distinct advantage in both identifying and targeting hard-to-treat cancers. Ignyta is headquartered in San Diego, California.

Last Close Stock Review

Ignyta’s share price finished yesterday’s trading session at $16.25, surging 13.24%. A total volume of 11.94 million shares have exchanged hands, which was higher than the 3-month average volume of 842.62 thousand shares. The Company’s stock price soared 84.66% in the last three months, 90.06% in the past six months, and 191.22% in the previous twelve months. Additionally, the stock skyrocketed 206.60% since the start of the year. The stock currently has a market cap of $930.80 million.

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