| Item 7.01 | Regulation FD Disclosure. |
On September 17, 2021, Deciphera Pharmaceuticals, Inc. (the “Company”) issued a press release announcing that the European Medicines Agency’s Committee for Medicinal Products for Human Use (“CHMP”) adopted a positive opinion recommending the approval of QINLOCK® (ripretinib) for the treatment of adult patients with advanced gastrointestinal stromal tumor (“GIST”) who have received prior treatment with three or more kinase inhibitors, including imatinib. A copy of the press release in connection with the CHMP announcement is furnished herewith as Exhibit 99.1 to this Current Report on Form 8-K.
The information in this Item 7.01 of this Current Report on Form 8-K (including Exhibit 99.1 attached hereto) is intended to be furnished and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”) or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended (the “Exchange Act”), except as expressly set forth by specific reference in such filing.
On September 17, 2021, the Company announced that the CHMP adopted a positive opinion recommending the approval of QINLOCK for the treatment of adult patients with GIST who have received prior treatment with three or more kinase inhibitors, including imatinib. The CHMP opinion is a scientific recommendation for marketing authorization and is a step before the European Commission (the “EC”), which has the authority to grant marketing authorization for medicinal products in the European Union, issues a decision on the Company’s marketing authorization application. The Company expects a final approval decision from the EC in the fourth quarter of 2021.
Cautionary Note Regarding Forward-Looking Statements
This Current Report on Form 8-K contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including, without limitation, our expectations and timing regarding the EC decision on marketing approval for QINLOCK in fourth-line GIST. The words “may,” “will,” “could,” “would,” “should,” “expect,” “plan,” “anticipate,” “intend,” “believe,” “estimate,” “predict,” “project,” “potential,” “continue,” “seek,” “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 Current Report on Form 8-K 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 Current Report on Form 8-K, including, without limitation, risks and uncertainties related to the severity and duration of the impact of COVID-19 on our business and operations, our ability to successfully demonstrate the efficacy and safety of our drug candidates and in additional indications for our existing drug, the preclinical or clinical results for our product candidates, which may not support further development of such product candidates, our ability to manage our reliance on sole-source third parties such as our third party drug substance and drug product contract manufacturers, comments, feedback and actions of regulatory agencies, our ability to commercialize QINLOCK and execute on our marketing plans for any drugs or indications that may be approved in the future, our ability to build and scale our operations to support growth in additional geographies, the inherent uncertainty in estimates of patient populations, competition from other products, our ability to obtain and maintain reimbursement for any approved product and the extent to which patient assistance programs are utilized, our ability to comply with healthcare regulations and laws, our ability to obtain, maintain and enforce our intellectual property rights, any or all of which may affect the initiation, timing and progress of clinical studies and the timing of and our ability to obtain additional regulatory approvals, and other risks identified in our Securities and Exchange Commission (SEC) filings, including our Quarterly Report on Form 10-Q for the quarter ended June 30, 2021, and subsequent filings with the SEC. We caution you not to place undue reliance on any forward-looking statements, which speak only as of the date they are made. We disclaim any obligation to publicly update or revise any such statements to reflect any change in expectations or in events, conditions or circumstances on which any such statements may be based, or that may affect the likelihood that actual results will differ from those set forth in the forward-looking statements. Any forward-looking statements contained in this Current Report on Form 8-K represent our views only as of the date hereof and should not be relied upon as representing our views as of any subsequent date. We explicitly disclaim any obligation to update any forward-looking statements.
| Item 9.01 | Financial Statements and Exhibits. |
(d) Exhibits.
