IGNYTA, INC. (NASDAQ:RXDX) Files An 8-K Regulation FD Disclosure
Item7.01 Regulation FD Disclosure
Beginning on June7, 2017, the slide presentation attached as
Exhibit99.1 will be presented in various investor meetings by
JonathanE. Lim,M.D., Chairman, President and Chief Executive
Officer of Ignyta, Inc. (the Company), and Jacob Chacko,M.D.,
Chief Financial Officer of the Company. Information from this
slide presentation may also be used by management of the Company
in future meetings regarding the Company.
The information contained in this Item7.01 and in Exhibit99.1 of
this Current Report on Form8-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, or the
Exchange Act, except as expressly set forth by specific reference
in such a filing.
Item8.01 Other Events
Beginning on June7, 2017, the slide presentation attached as
Exhibit99.1 will be presented in various investor meetings by
JonathanE. Lim,M.D., Chairman, President and Chief Executive
Officer of the Company, and Jacob Chacko,M.D., Chief Financial
Officer of the Company. The slide presentation attached as
Exhibit99.1 includes updated data for entrectinib, demonstrating
a high CNS objective response rate by Blinded Independent Central
Review (BICR-ORR).
As of the May15, 2017 data cut-off, the findings showed:
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Of the 11 TKI-Nave ROS1 NSCLC patients with central nervous system (CNS) metastases, 7 had measurable disease at baseline; |
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5 of these 7 patients with measurable disease had confirmed intracranial responses by RECIST 1.1, for an intracranial BICR-ORR of 71%. |
Item9.01. Financial Statements and Exhibits
(d) Exhibits.
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ExhibitNo. |
Description |
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| 99.1 | Slide Presentation, dated June 2017. |
About IGNYTA, INC. (NASDAQ:RXDX)
Ignyta, Inc. is an oncology biotechnology company. The Company focuses on an integrated therapeutic (Rx) and companion diagnostic (Dx) strategy for treating cancer patients. Its Rx is focused on discovering, in licensing or acquiring, then developing and commercializing molecularly targeted therapies that, sequentially or in combination, are foundational for eradicating residual disease. Its Dx focuses on pairing the product candidates with biomarker-based companion diagnostics that are designed to identify, at the molecular level, the patients likely to benefit from the therapies. Its entrectinib is an orally bioavailable, small molecule tyrosine kinase inhibitor directed to the tropomyosin receptor kinase (Trk) family tyrosine kinase receptors (TrkA, TrkB and TrkC), ROS1 and anaplastic lymphoma kinase (ALK) proteins for the treatment of solid tumors. Its entrectinib is in Phase II/III of clinical development. Its taladegib is a small molecule and hedgehog or smoothened antagonist.
