Item 7.01 Regulation FD Disclosure.
On
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.
Item 8.01 Other Events.
On
Copies of the e-poster presentations for rebastinib in combination with paclitaxel and vimseltinib are filed herewith as Exhibit 99.2 and Exhibit 99.3, respectively, to this Current Report on Form 8-K, and are incorporated herein by reference.
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 pivotal
study plans and timing of study initiation for vimseltinib in TGCT patients and
for the rebastinib/paclitaxel combination in PROC patients, subject to feedback
from regulators. 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
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Item 9.01 Financial Statements and Exhibits.
(d) Exhibits. Exhibit No. Description 99.1 Press Release issued byDeciphera Pharmaceuticals, Inc. onSeptember 17, 2021 , furnished herewith 99.2 Poster titled "A phase 1b/2 study of rebastinib and paclitaxel in advanced/metastatic platinum-resistant ovarian cancer" 99.3 Poster titled "Safety and preliminary efficacy of vimseltinib in tenosynovial giant cell tumor (TGCT)" 104 Cover Page Interactive Data File (embedded within the Inline XBRL document)
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