IGNYTA, INC. (NASDAQ:RXDX) Files An 8-K Regulation FD Disclosure

Item7.01

On May15, 2017, Ignyta, Inc., (Ignyta or the Company) issued a
press release announcing that the U.S. Food and Drug
Administration (the FDA) has granted Breakthrough Therapy
Designation for entrectinib for the treatment of NTRK
fusion-positive, locally advanced or metastatic solid tumors in
adult and pediatric patients who have either progressed following
prior therapies or who have no acceptable standard therapies. The
press release, dated May15, 2017, is attached hereto as Exhibit
99.1.

The information contained in this Item 7.01 and in Exhibit 99.1
of this Current Report on Form 8-K shall not be deemed filed for
purposes of Section18 of the Securities Exchange Act of 1934, as
amended (the Exchange Act), or incorporated by reference in any
filing under the Securities Act of 1933, as amended (the
Securities Act), except as expressly set forth by specific
reference in such a filing.

On May15, 2017, the Company issued a press release announcing
that the FDA has granted Breakthrough Therapy Designation for
entrectinib for the treatment of NTRK fusion-positive, locally
advanced or metastatic solid tumors in adult and pediatric
patients who have either progressed following prior therapies or
who have no acceptable standard therapies.

Forward-Looking Statements

This report contains forward-looking statements as that term is
defined in Section 27A of the Securities Act and Section 21E of
the Exchange Act. Statements in this report that are not purely
historical are forward-looking statements. Such forward-looking
statements include, among other things, references to Ignytas
ability to successfully conduct clinical trials for its product
candidates, the impact of breakthrough therapy designation for
entrectinib on Ignytas interactions with the FDA and the FDAs
commitment to the advancement of entrectinib. Actual results
could differ from those projected in any forward-looking
statements due to numerous factors. Such factors include, among
others, the inherent uncertainties associated with developing new
products or technologies and operating as a development stage
company; Ignytas ability to develop, initiate or complete
preclinical studies and clinical trials for, obtain approvals for
and commercialize any of its product candidates; changes in
Ignytas plans to develop and commercialize its product
candidates; the potential for final results of the ongoing
clinical trials of entrectinib or other product candidates, or
any future clinical trials of entrectinib or other product
candidates, to differ from preliminary or expected results;
Ignytas ability to raise any additional funding it will need to
continue to pursue its business and product development plans;
regulatory developments in the United States and foreign
countries; Ignytas ability to obtain and maintain intellectual
property protection for its product candidates; the risk that
orphan drug exclusivity may not effectively protect a product
from competition and that such exclusivity may not be maintained;
the potential for Ignyta to fail to maintain the CAP
accreditation and CLIA certification of its diagnostic
laboratory; the loss of key scientific or management personnel;
competition in the industry in which Ignyta operates; and market
conditions. These forward-looking statements are made as of the
date hereof, andIgnytaassumes no obligation to update the
forward-looking statements, or to update the reasons why actual
results could differ from those projected in the forward-looking
statements. Investors should consult all of the information set
forth herein and should also refer to the risk factor disclosure
set forth in the reports and other documents Ignyta files with
theSEC available atwww.sec.gov, including without
limitation Ignytas Annual Report on Form 10-K for the year
endedDecember 31, 2016and subsequent Quarterly Reports on Form
10-Q.