Welcome to our dedicated page for Deciphera Pharmaceuticals news (Ticker: DCPH), a resource for investors and traders seeking the latest updates and insights on Deciphera Pharmaceuticals stock.
Deciphera Pharmaceuticals, Inc. (symbol: DCPH) is a biotechnology company founded in 2003 with a deep scientific understanding of kinase inhibitors. Based in Boston, with research capabilities near the University of Kansas, Deciphera specializes in developing advanced kinase-inhibiting drugs for cancer and immunological diseases. The company has identified small molecule leads for over 50 kinase targets and has built a robust pipeline of drug candidates, including three clinical-stage and two research-stage programs.
The company's lead drug candidate, DCC-2618, is designed to inhibit mutant or amplified KIT and Pdgfra kinases, which drive cancers such as gastrointestinal stromal tumors, advanced systemic mastocytosis, gliomas, and other solid tumors. In addition, Deciphera is developing two other clinical-stage drug candidates, DCC-3014 and Rebastinib, which are focused on treating different types of cancers.
Geographically, Deciphera's operations are concentrated in the United States. The company has recently achieved significant milestones, including the successful completion of a tender offer by Ono Pharmaceutical Co., Ltd. to acquire all outstanding shares of Deciphera for approximately $2.4 billion. Following this acquisition, Deciphera became a wholly owned subsidiary of Ono, who will leverage its research and development capabilities in oncology and its sales power in Europe and the United States to expand its global presence.
The merger with Ono Pharmaceutical marks a new phase for Deciphera, where the combined expertise and resources are expected to accelerate the growth of their pipeline and contribute significantly to the global fight against cancer and other diseases.
Deciphera Pharmaceuticals has received marketing authorization in the UK for QINLOCK (ripretinib), a treatment for advanced gastrointestinal stromal tumors (GIST) in patients previously treated with multiple kinase inhibitors. The approval is based on the pivotal Phase 3 INVICTUS study, which showed an 85% reduction in disease progression or death risk and a median overall survival of 15.1 months compared to 6.6 months for placebo. Adverse reactions were reported in a pooled study population. This marks a significant milestone for patients in need of new treatment options.
Deciphera Pharmaceuticals (NASDAQ: DCPH) has announced a corporate restructuring to focus on the clinical development of vimseltinib and DCC-3116, while discontinuing the rebastinib program. A workforce reduction of approximately 35% will take place, impacting about 140 positions. The company plans to streamline commercial operations, focusing on QINLOCK in the US and select European markets, notably Germany and France. With cash reserves of $392 million as of September 30, 2021, these changes are expected to extend Deciphera's cash runway into 2024.
Deciphera Pharmaceuticals (NASDAQ: DCPH) received European Commission approval for QINLOCK (ripretinib) to treat advanced gastrointestinal stromal tumors (GIST) in adults previously treated with three or more kinase inhibitors. This approval marks the eighth global regulatory approval for QINLOCK, targeting a critical unmet need for GIST patients. The INVICTUS Phase 3 study showed QINLOCK reduced disease progression or death by 85% and improved overall survival to 15.1 months compared to 6.6 months for placebo. The company aims to ensure rapid access to eligible patients.
Deciphera Pharmaceuticals announced that its INTRIGUE Phase 3 clinical study of QINLOCK in patients with gastrointestinal stromal tumor (GIST) did not meet its primary endpoint of improved progression-free survival (PFS) compared to sunitinib. In the study involving 453 patients, QINLOCK showed a median PFS of 8.3 months for those with a KIT exon 11 mutation, compared to 7.0 months for sunitinib. CEO Steve Hoerter expressed disappointment but emphasized the study's design and commitment to patient access to QINLOCK, which remains the standard treatment for fourth-line GIST.
Mission BioCapital has announced the successful raising of
Deciphera Pharmaceuticals reported third quarter 2021 revenue of $23.2 million, driven by $21.7 million from QINLOCK (ripretinib) net product sales. The company anticipates key milestones including top-line results from the INTRIGUE Phase 3 study and EMA approval for QINLOCK in Q4 2021. They also expect to initiate the Phase 3 MOTION study of vimseltinib in the same quarter. R&D expenses rose to $66.4 million, contributing to a net loss of $79.8 million. As of September 30, 2021, cash reserves stood at $392.2 million, enabling operations into mid-2023.
Deciphera Pharmaceuticals (DCPH) will report its Q3 2021 financial results on November 2, 2021, at 4:30 PM ET. Management will hold a conference call to discuss the results and provide corporate updates. Investors can access the call by dialing (866) 930-5479 (domestic) or (409) 216-0603 (international) with conference ID 8178994. A webcast will be available on Deciphera's investor relations page.
Deciphera focuses on developing medicines for cancer, leveraging its switch-control kinase inhibitor platform.
Deciphera Pharmaceuticals (NASDAQ: DCPH) has received approval from the Swiss Agency for Therapeutic Products (Swissmedic) for QINLOCK (ripretinib) to treat adult patients with advanced gastrointestinal stromal tumor (GIST) after previous treatments. This marks the seventh global approval and the first in Europe. QINLOCK demonstrated significant clinical efficacy in the Phase 3 INVICTUS study, showing a median progression-free survival of 6.3 months, and a median overall survival of 15.1 months. The company anticipates further approvals by the European Commission by Q4 2023.
Deciphera Pharmaceuticals (NASDAQ: DCPH) has presented promising preclinical data for its selective ULK kinase inhibitor, DCC-3116, targeting non-small cell lung cancer (NSCLC) at the AACR-NCI-EORTC Conference. The data reveals that DCC-3116 inhibits autophagy induced by EGFR inhibitors, a resistance mechanism in NSCLC, and significantly reduces tumor burden when combined with osimertinib and afatinib. These findings support DCC-3116's potential in treating EGFR-mutant NSCLC, where approximately 30% of patients exhibit resistance. The drug is currently undergoing Phase 1 clinical trials.
Deciphera Pharmaceuticals (NASDAQ: DCPH) announced the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion for QINLOCK (ripretinib), aimed at treating adults with advanced gastrointestinal stromal tumors (GIST) who have undergone multiple prior therapies. This is a crucial step towards potential European Commission approval, expected by Q4 2021. The pivotal Phase 3 INVICTUS study showed QINLOCK significantly improved progression-free survival to 6.3 months and overall survival to 15.1 months, highlighting its efficacy where traditional treatments fail.
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