IGNYTA, INC. (NASDAQ:RXDX) Files An 8-K Regulation FD Disclosure
Item7.01
| Regulation FD Disclosure |
On March30, 2017, Ignyta, Inc., (the Company) announced data
demonstrating the successful treatment with entrectinibthe
Companys investigational, orally available, CNS-active tyrosine
kinase inhibitor targeting tumors that harbor TRK, ROS1 or ALK
fusionsof a patient with a primary brain tumor harboring a NTRK1
fusion. The study, exploring genetic alterations associated with
glioneuronal tumors, was led by researchers at Massachusetts
General Hospital and was published in Precision
Oncology. The press release, dated March30, 2017, announcing
the updated results is attached hereto as Exhibit 99.1.
The information contained in this Item7.01 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, or the
Exchange Act, except as expressly set forth by specific reference
in such a filing.
| Item8.01 | Other Events |
On March30, 2017, the Company announced data demonstrating the
successful treatment with entrectinibthe Companys
investigational, orally available, CNS-active tyrosine kinase
inhibitor targeting tumors that harbor TRK, ROS1 or ALK fusionsof
a patient with a primary brain tumor harboring a NTRK1 fusion.
Data presented in the study characterized a cohort of 26
glioneuronal tumors, which identified, through in-depth genomic analysis,
BRAF mutations in 34percent of tumors and oncogenic fusions in
30percent of tumors. Researchers discovered novel oncogenic
fusions involving members of the NTRK gene family in three out of
26 patients evaluated, and reported that in a patient with a
BCAN-NTRK1 fusion, treatment with entrectinib resulted in a
60percent regression in tumor size and the resolution of clinical
symptoms that was maintained for 11 months on treatment.
| Item9.01. | Financial Statements and Exhibits |
(d)Exhibits.
|
Exhibit No. |
Description |
|
| 99.1 | Press Release, dated March30, 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. IGNYTA, INC. (NASDAQ:RXDX) Recent Trading Information
IGNYTA, INC. (NASDAQ:RXDX) closed its last trading session down -0.05 at 8.50 with 219,009 shares trading hands.
