On January 13, 2020 Deciphera Pharmaceuticals, Inc. (NASDAQ:DCPH) reported a corporate update and highlighted key 2020 milestones in conjunction with its presentation at the 38th Annual J.P. Morgan Healthcare Conference in San Francisco (Press release, Deciphera Pharmaceuticals, JAN 13, 2020, View Source [SID1234553083]). The Company will webcast its presentation today at 11:00 a.m. PT (2:00 p.m. ET) at View Source
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"2019 was a year of many exciting accomplishments for Deciphera as we submitted our first New Drug Application (NDA) to the FDA for ripretinib in advanced gastrointestinal stromal tumors (GIST) based on positive results from the INVICTUS pivotal Phase 3 study and advanced our portfolio of wholly-owned product candidates," said Steve Hoerter, President and Chief Executive Officer of Deciphera. "We are preparing for a potential commercial launch in the U.S. and working to bring ripretinib to other parts of the world."
The Company announced today that two additional marketing applications have been submitted for ripretinib as part of the U.S. Food and Drug Administration’s (FDA) Project Orbis pilot program. The marketing applications of ripretinib for advanced GIST in Canada and Australia have both received priority review designations. The Project Orbis pilot program, an initiative of the FDA Oncology Center of Excellence, is designed to provide a framework for concurrent submission and review of oncology products among international partners. Additional information about Project Orbis can be found at: View Source
Mr. Hoerter continued, "In parallel with these efforts, we have laid the groundwork for further expansion across our pipeline of novel agents. We continued to activate sites and enroll patients in the INTRIGUE Phase 3 study in the 2nd line GIST patient population, advanced the DCC-3014 and rebastinib clinical development programs, and added a new internally-discovered candidate, DCC-3116, to our pipeline. We look forward to building on our momentum in 2020 as we work with the FDA towards a potential approval of ripretinib in advanced GIST and rapidly advance our additional programs."
In 2020, the Company seeks to achieve the following milestones:
Ripretinib
– Potential FDA approval and commercial launch of ripretinib in advanced GIST.
– Submit marketing authorization application to European Medicines Agency.
– Complete enrollment of INTRIGUE Phase 3 study in 2nd line GIST.
– Present Phase 1 study expansion data.
DCC- 3014
– Select Phase 2 dose for tenosynovial giant cell tumor (TGCT) patients and open expansion cohort.
– Provide update on Phase 1 data in TGCT patients.
Rebastinib
– Selected Phase 2 dose of 100 mg BID of rebastinib and activated Part 2 of Phase 1b/2 study in combination with carboplatin. (Completed January 2020)
– Present Phase 1b/2 data in combination with carboplatin.
– Present Phase 1b/2 data in combination with paclitaxel.
DCC-3116
– Submit an Investigational New Drug (IND) application to FDA.
Presentation at 38th Annual J.P. Morgan Healthcare Conference
Deciphera will webcast its corporate presentation from the 38th Annual J.P. Morgan Healthcare Conference in San Francisco on Monday, January 13, 2020 at 11:00 a.m. PT (2:00 p.m. ET). A live webcast of the presentation can be accessed under "Events & Presentations" in the Investors section of the Company’s website at deciphera.com. A replay of the webcast will be archived on the Deciphera website for at least two weeks following the presentation. In conjunction with the conference, the Company has also updated its corporate presentation which can be found here: View Source