Item 7.01. Regulation FD Disclosure.
On December 16, 2019, Deciphera Pharmaceuticals, Inc., or the Company, issued a press release announcing submission of a New Drug Application to the U.S. FDA for ripretinib in patients with advanced gastrointestinal stromal tumors.
A copy of the press release is furnished as Exhibit 99.1 to this Current Report on Form8-K.
On December 16, 2019, the Company also updated its corporate presentation which will be posted on the Investors portion of the Company’s website (www.deciphera.com) under “Events and Presentations” and used for future presentations.
The furnishing of the attached press release is not an admission as to the materiality of any information therein. The information contained in the press release is summary information that is intended to be considered in the context of more complete information included in the Company’s filings with the U.S. Securities and Exchange Commission, or the SEC, and other public announcements that the Company has made and may make from time to time by press release or otherwise. The Company undertakes no duty or obligation to update or revise the information contained in this report, although it may do so from time to time as its management believes is appropriate. Any such updating may be made through the filing of other reports or documents with the SEC, through press releases or through other public disclosures. For important information about forward looking statements, see the “Cautionary Note Regarding Forward-Looking Statements” section of the press release in Exhibit 99.1 attached hereto.
The information in this Item 7.01 of this Current Report onForm 8-K and Exhibit 99.1 attached hereto shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or otherwise subject to the liabilities of that section or Sections 11 and 12(a)(2) of the Securities Act of 1933, as amended. The information contained in this Item 7.01 and in the press release attached as Exhibit 99.1 to this Current Report shall not be incorporated by reference into any filing with the SEC made by the Company, whether made before or after the date hereof, regardless of any general incorporation language in such filing, except as expressly set forth by specific reference in such filing.
Item 8.01 Other Events
On December 16, 2019, the Company announced the submission of a New Drug Application, or NDA, to the U.S. Food and Drug Administration (FDA) for ripretinib, the Company’s investigational broad-spectrum KIT and PDGFRα inhibitor, for the treatment of patients with advanced gastrointestinal stromal tumors (GIST) who have received prior treatment with imatinib, sunitinib and regorafenib. The NDA is being reviewed by the FDA under its Oncology Center of Excellence Real-Time Oncology Review, or RTOR, pilot program. The pilot program aims to explore a more efficient review process to ensure that safe and effective treatments are available to patients as early as possible, while maintaining and improving review quality.
This Report contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including, without limitation, statements regarding our expectations regarding our goal of bringing ripretinib to patients with advanced GIST, the potential for ripretinib to serve as an important new treatment option for people with advanced GIST, working with the FDA through its review of our NDA application via the FDA’s Real-Time Oncology Review pilot program and the possible benefits of that pilot program and breakthrough therapy designation, preparing for the potential launch of ripretinib in the United States, if approved, our readiness for commercial launch, and the estimated incidence and prevalence of GIST and related patient populations. The words “may,” “will,” “could,” “would,” “should,” “expect,” “plan,” “anticipate,” “intend,” “believe,” “estimate,” “predict,” “project,” “potential,” “continue,” “target” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Any forward-looking statements in this press release are based on management’s current expectations and beliefs and are subject to a number of risks, uncertainties and important factors that may cause actual events or results to differ materially from those expressed or implied by any forward-looking statements contained in this press release, including, without limitation, risks and uncertainties related to the delay of any current or planned clinical studies or the development of our product candidates, including ripretinib, our ability to successfully demonstrate the efficacy and safety of our product candidates including in later-stage studies, the preclinical and clinical results for our product candidates, which may not support further development of such product candidates, the possibility that results experienced in early, preliminary,top-line or initial data may not be indicative of the results experienced in final data, our ability to work with the FDA under its RTOR pilot program and timely respond to information requests or requirements in connection with our recently-filed NDA for ripretinib in advanced GIST, that acceptance into the RTOR pilot program does not guarantee or influence approvability of our NDA for ripretinib in advanced GIST, which is subject to the standard benefit-risk evaluation by FDA, and that we may not derive any benefit from inclusion in the RTOR pilot program, including, but not limited to, a more efficient review process compared to investigational drugs evaluated without this pilot program or under standard FDA procedures, the fact that the RTOR program is a pilot program being tested by FDA, is not a formal regulatory pathway with regulatory process, regulations or procedures, and may be suspended or halted at any time, including, without limitation, because FDA decides not to continue the pilot, or because FDA determines that our application no longer meets its criteria for inclusion in the RTOR pilot program, the fact that receipt of a breakthrough therapy designation for a product candidate, such as ripretinib, may not result in us receiving any of the benefits of such
