Current Report Filing (8-k)
May 16 2017 - 4:02PM
Edgar (US Regulatory)
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM
8-K
CURRENT
REPORT
Pursuant to Section 13 or 15(d)
of the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): May 15, 2017
IGNYTA, INC.
(Exact
Name of Registrant as Specified in its Charter)
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Delaware
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001-36344
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45-3174872
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(State of Incorporation)
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(Commission
File Number)
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(IRS Employer
Identification No.)
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4545 Towne Centre Court
San Diego, California 92121
(Address of principal executive offices, including zip code)
Registrants telephone number, including area code: (858)
255-5959
Check the appropriate box below if the Form
8-K
filing is intended to simultaneously satisfy the filing obligation of
the registrant under any of the following provisions:
☐
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Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
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☐
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Soliciting material pursuant to Rule
14a-12
under the Exchange Act (17 CFR
240.14a-12)
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☐
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Pre-commencement
communications pursuant to Rule
14d-2(b)
under the Exchange Act (17 CFR
240.14d-2(b))
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☐
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Pre-commencement
communications pursuant to Rule
13e-4(c)
under the Exchange Act (17 CFR
240.13e-4(c))
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Indicate by check mark whether the
registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule
12b-2
of the Securities Exchange Act of 1934
(§240.12b-2
of this chapter).
Emerging growth company ☒
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying
with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Item 7.01
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Regulation FD Disclosure
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On May 15, 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 May 15, 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 Section 18 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 May 15, 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,
and Ignyta assumes 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 the SEC available at
www.sec.gov
, including without limitation Ignytas Annual Report on Form
10-K
for the year ended December 31, 2016 and subsequent Quarterly Reports on Form
10-Q.
Item 9.01.
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Financial Statements and Exhibits
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(d)
Exhibits
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Exhibit
No.
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Description
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99.1
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Press Release, dated May 15, 2017
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SIGNATURE
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned
hereunto duly authorized.
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Dated: May 16, 2017
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IGNYTA, INC.
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By:
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/s/ Jonathan E. Lim, M.D.
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Name:
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Jonathan E. Lim, M.D.
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Title:
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President and Chief Executive Officer
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EXHIBIT INDEX
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Exhibit
No.
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Description
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99.1
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Press Release, dated May 15, 2017
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