TGCT

Deciphera Pharmaceuticals to be Acquired by ONO Pharmaceutical For $2.4 Billion

Retrieved on: 
Monday, April 29, 2024
Biotechnology, Pharmaceutical, Health, Oncology, USD, Patient, Cancer, Acquisition, Research, Growth, GIST, Tenosynovial giant cell tumor, ONO, ULK, TGCT, Ono Pharmaceutical, Disease, BofA Securities, Drug discovery, Pharmaceutical industry

Together, ONO and Deciphera will accelerate their shared vision to deliver innovative new drugs and serve patients around the world.

Key Points: 
  • Together, ONO and Deciphera will accelerate their shared vision to deliver innovative new drugs and serve patients around the world.
  • If the tender offer conditions are not satisfied, ONO may be required to extend the tender offer under certain circumstances.
  • Upon completion of the Acquisition, Deciphera will operate as a standalone business of ONO Group, from its headquarters in Waltham, Massachusetts.
  • J.P. Morgan Securities LLC is serving as exclusive financial advisor to Deciphera and Goodwin Procter LLP is serving as legal counsel.

Deciphera Pharmaceuticals Announces Fourth Quarter and Full Year 2023 Financial Results

Retrieved on: 
Tuesday, February 6, 2024
Biotechnology, Pharmaceutical, Health, Oncology, OS, KIT, European, Investigational New Drug, Trial of the century, DNA, Research, Patient, IND, Autophagy, ASCO, GIST, Public expenditure, FDA, EMA, MAA, Part, Food, Society, TGCT, Gastrointestinal stromal tumor, European Medicines Agency, Sunitinib, Neoplasm, Cancer, INSIGHT, Tenosynovial giant cell tumor, NDA, Nature Medicine, Pharmaceutical industry

Deciphera Pharmaceuticals, Inc. (NASDAQ: DCPH), a biopharmaceutical company focused on discovering, developing, and commercializing important new medicines to improve the lives of people with cancer, today announced financial results for the fourth quarter and year ended December 31, 2023 and provided a corporate update.

Key Points: 
  • Deciphera Pharmaceuticals, Inc. (NASDAQ: DCPH), a biopharmaceutical company focused on discovering, developing, and commercializing important new medicines to improve the lives of people with cancer, today announced financial results for the fourth quarter and year ended December 31, 2023 and provided a corporate update.
  • Expects to present updated results from the Phase 1/2 study of vimseltinib in TGCT in the second half of 2024.
  • Expects to initiate a Phase 2 proof-of-concept study of vimseltinib for the treatment of chronic graft versus host disease (cGVHD) in the fourth quarter of 2024.
  • Cost of Sales: Cost of sales were $1.8 million in the fourth quarter of 2023, which includes $0.9 million in cost of product sales, compared to cost of product sales of $0.7 million for the fourth quarter of 2022.

Deciphera Pharmaceuticals Announces Planned 2024 Corporate Milestones Supporting Evolution to a Self-Sustaining, Multi-Product Company

Retrieved on: 
Monday, January 8, 2024
Research, Biotechnology, Other Health, Health, Pharmaceutical, General Health, Other Science, Science, Oncology, Gastrointestinal stromal tumor, Food, Neoplasm, IND, INSIGHT, Autophagy, FDA, MAA, Cetuximab, European, Encorafenib, Public expenditure, KIT, NDA, Cancer, European Medicines Agency, Part, TGCT, MEK, Patient, GIST, Pharmaceutical industry

Deciphera Pharmaceuticals, Inc. (NASDAQ: DCPH), a biopharmaceutical company focused on discovering, developing, and commercializing important new medicines to improve the lives of people with cancer, today highlighted its strategic outlook for 2024 and planned 2024 corporate milestones, and announced preliminary unaudited fourth quarter and full year 2023 revenue.

Key Points: 
  • Deciphera Pharmaceuticals, Inc. (NASDAQ: DCPH), a biopharmaceutical company focused on discovering, developing, and commercializing important new medicines to improve the lives of people with cancer, today highlighted its strategic outlook for 2024 and planned 2024 corporate milestones, and announced preliminary unaudited fourth quarter and full year 2023 revenue.
  • Present updated data from the Phase 1/2 study of vimseltinib in TGCT in the second half of 2024.
  • Initiate a Phase 2 proof-of-concept study of vimseltinib for the treatment of cGVHD in the fourth quarter of 2024.
  • Initiate a Phase 1 study for DCC-3084, a potential best-in-class pan-RAF inhibitor, in the first half of 2024.

Merck KGaA, Darmstadt, Germany Strengthens Oncology Portfolio Through Commercialization Agreement With Abbisko for Phase III Asset, Pimicotinib

Retrieved on: 
Monday, December 4, 2023
Science, Other Science, Biotechnology, Research, Pharmaceutical, Oncology, Health, Clinical Trials, Medicine, Independent Review Committee, Safety, Therapy, RECIST, Disease, Stiffness, Patient, TGCT, Joint, Merck, Tenosynovial giant cell tumor, Partnership, Pain, Swelling, Health care, Merck Group, Pharmaceutical industry, Hong Kong

The agreement grants Merck KGaA, Darmstadt, Germany a license to commercialize pimicotinib in mainland China, Hong Kong, Macau and Taiwan, with an option for rest of world.

Key Points: 
  • The agreement grants Merck KGaA, Darmstadt, Germany a license to commercialize pimicotinib in mainland China, Hong Kong, Macau and Taiwan, with an option for rest of world.
  • In addition, Merck KGaA, Darmstadt, Germany has the option to co-develop pimicotinib in additional indications under certain conditions.
  • Merck KGaA, Darmstadt, Germany will provide Abbisko with an upfront payment of $70 million and upon exercising the option, will provide Abbisko an option fee.
  • Abbisko will receive additional payments for the achievement of certain regulatory and commercial milestones, as well as double-digit tiered royalties on net sales by Merck KGaA, Darmstadt, Germany.

Merck Strengthens Oncology Portfolio Through Commercialization Agreement With Abbisko for Phase III Asset, Pimicotinib

Retrieved on: 
Monday, December 4, 2023
Biotechnology, Health, Pharmaceutical, Clinical Trials, Oncology, Medicine, Independent Review Committee, Safety, Therapy, RECIST, Disease, Stiffness, Patient, TGCT, Science, Joint, Tenosynovial giant cell tumor, Partnership, Pain, Swelling, Health care, Pharmaceutical industry, Merck, Hong Kong

The agreement grants Merck a license to commercialize pimicotinib in mainland China, Hong Kong, Macau and Taiwan, with an option for rest of world.

Key Points: 
  • The agreement grants Merck a license to commercialize pimicotinib in mainland China, Hong Kong, Macau and Taiwan, with an option for rest of world.
  • The ongoing randomized, double-blind, placebo-controlled Phase III MANEUVER trial is evaluating the efficacy and safety of pimicotinib 50 mg QD in patients with unresectable TGCT.
  • Merck will provide Abbisko with an upfront payment of $70 million and upon exercising the option, will provide Abbisko an option fee.
  • Abbisko will receive additional payments for the achievement of certain regulatory and commercial milestones as well as double-digit tiered royalties on net sales by Merck.

Abbisko Therapeutics Announces that U.S. FDA Has Granted Fast Track Designation for Its CSF-1R Inhibitor Pimicotinib (ABSK021)

Retrieved on: 
Thursday, December 14, 2023
Pancreatic cancer, QD, Policy, Therapy, Contributor License Agreement, NMPA, EMA, Patient, TGCT, BTD, U.S. FDA, FDA, FTD, License, Tenosynovial giant cell tumor, ORR, Fast Track, Merck Group, Pharmaceutical industry, Hong Kong

SHANGHAI, Dec. 13, 2023 /PRNewswire/ -- Abbisko Therapeutics Co., Ltd. ("Abbisko Therapeutics") today announced that its CSF-1R inhibitor pimicotinib (ABSK021) has been granted the fast track designation ("FTD") by the U.S. FDA for the treatment of tenosynovial giant cell tumor ("TGCT") patients that are not amenable to surgery.

Key Points: 
  • SHANGHAI, Dec. 13, 2023 /PRNewswire/ -- Abbisko Therapeutics Co., Ltd. ("Abbisko Therapeutics") today announced that its CSF-1R inhibitor pimicotinib (ABSK021) has been granted the fast track designation ("FTD") by the U.S. FDA for the treatment of tenosynovial giant cell tumor ("TGCT") patients that are not amenable to surgery.
  • Previously, pimicotinib was granted the breakthrough therapy designation ("BTD") by the U.S. FDA for TGCT in January, 2023.
  • Fast Track is a policy designed to facilitate the development and expedite the review of drugs in order to treat serious conditions and fulfill unmet medical needs.
  • Pimicotinib is a novel, orally available, highly selective, and potent small molecule CSF-1R inhibitor, independently developed by Abbisko Therapeutics.

87.5% ORR | Abbisko presented two clinical updates of Pimicotinib at the 2023 CTOS Annual Meeting

Retrieved on: 
Tuesday, November 7, 2023
PD, US, BTD, TGCT, Priority, Human, European Medicines Agency, IDMC, Male, Liver injury, Hip, BIRC, Ankle, PRO, Pain, IRC, Completeness, Part Two, Response evaluation criteria in solid tumors, QD, 1.1, MRI, Itch, AST, US FDA, CSF1, Motion, Rash, Neoplasm, Independent Review Committee, PK, ORR, Part, Safety, Therapy, ALT, Patient, LDH, ASCO, PDGFR, Contraindication, Nilotinib, III, DOR, Imatinib, Breakthrough therapy, Clinical trial, Hepatotoxicity, Knee, FDA, Dyslipidemia, CPK, RES, SD, RECIST, Pharmaceutical industry, Nursing

SHANGHAI, Nov. 6, 2023 /PRNewswire/ -- Abbisko Therapeutics Co., Ltd. ("Abbisko Therapeutics" hereafter) announced that two major clinical updates of its CSF-1R inhibitor pimicotinib（ABSK021）were presented at the 2023 Connective Tissue Oncology Society Annual Meeting, which is held in Ireland from November 1 to 4, 2023.

Key Points: 
  • SHANGHAI, Nov. 6, 2023 /PRNewswire/ -- Abbisko Therapeutics Co., Ltd. ("Abbisko Therapeutics" hereafter) announced that two major clinical updates of its CSF-1R inhibitor pimicotinib（ABSK021）were presented at the 2023 Connective Tissue Oncology Society Annual Meeting, which is held in Ireland from November 1 to 4, 2023.
  • The two clinical updates include reporting the design of the pivotal global multi-center phase III clinical trial and the further update of the phase Ib clinical trial of pimicotinib.
  • In 2023, the U.S. FDA conferred Breakthrough Therapy Designation and the European Medicines Agency granted Priority Medicine Designation upon Pimicotinib treatment of TGCT.
  • Here, we report the phase 1b safety and efficacy results of Pimicotinib in TGCT patients over a 1-year follow-up.

Deciphera Pharmaceuticals Announces Positive Top-line Results from MOTION Pivotal Phase 3 Study of Vimseltinib in Patients with Tenosynovial Giant Cell Tumor (TGCT) and Updated Results from Phase 1/2 Study of Vimseltinib in TGCT

Retrieved on: 
Monday, October 30, 2023
Biotechnology, Health, Pharmaceutical, Clinical Trials, Oncology, Week, IRR, TGCT, Neoplasm, ITT, CSF1R, Leiden University Medical Center, Caregiver, Medicine, Stiffness, ORR, RECIST, Part, Safety, Cancer, Patient, Pharmaceutical industry

“TGCT has a significant negative impact on the daily life of patients who face substantial pain, stiffness, and impaired mobility.

Key Points: 
  • “TGCT has a significant negative impact on the daily life of patients who face substantial pain, stiffness, and impaired mobility.
  • Success across both the primary and all key secondary endpoints in MOTION underscores vimseltinib’s ability to help TGCT patients feel and function better.
  • “The totality of data shown today demonstrate the potential for vimseltinib to offer a new and differentiated treatment option for patients with TGCT.
  • The open-label Part 2 portion of MOTION, in which patients from both the vimseltinib and placebo arms receive treatment with vimseltinib, remains ongoing.

Deciphera Pharmaceuticals Announces Third Quarter 2023 Financial Results

Retrieved on: 
Monday, October 30, 2023
Oncology, Health, Clinical Trials, Research, Science, Pharmaceutical, Biotechnology, Week, KIT, TGCT, ITT, CSF1R, ORR, GIST, INSIGHT, Cancer, Tenosynovial giant cell tumor, Patient, Pharmaceutical industry

Deciphera Pharmaceuticals, Inc. (NASDAQ: DCPH), a biopharmaceutical company focused on discovering, developing, and commercializing important new medicines to improve the lives of people with cancer, today announced financial results for the third quarter ended September 30, 2023 and provided a corporate update.

Key Points: 
  • Deciphera Pharmaceuticals, Inc. (NASDAQ: DCPH), a biopharmaceutical company focused on discovering, developing, and commercializing important new medicines to improve the lives of people with cancer, today announced financial results for the third quarter ended September 30, 2023 and provided a corporate update.
  • “QINLOCK achieved another record quarter of product revenue with continued strength in commercial demand,” said Steve Hoerter, President and Chief Executive Officer of Deciphera Pharmaceuticals.
  • Cost of Sales: Cost of sales were $1.3 million in the third quarter of 2023 compared to cost of sales of $3.3 million for the third quarter of 2022.
  • Deciphera will host a conference call and webcast to discuss this announcement today, October 30, 2023, at 8:00 AM ET.

Deciphera Pharmaceuticals Announces First Quarter 2023 Financial Results

Retrieved on: 
Wednesday, May 3, 2023
Oncology, Health, Clinical Trials, Research, Science, Pharmaceutical, Biotechnology, GIST, KRAS, DNA, AACR, INSIGHT, Pfizer, CRC, Autophagy, TGCT, Breakthrough therapy, BRAF, Mutation, BTD, Tenosynovial giant cell tumor, MEK, Cetuximab, Sale, Binimetinib, Trial of the century, II, ASCO, KIT, Public expenditure, Journal of the National Comprehensive Cancer Network, American Society of Clinical Oncology, Patient, American Association for Cancer Research, Colorectal cancer, Annual general meeting, Neoplasm, Exon, FDA, GCN2, Regulation of tobacco by the U.S. Food and Drug Administration, IND, Society, CSF1R, III, Food, D, Pharmaceutical industry, Video game, Medical imaging, Vaccine, Reinsurance, Cancer

Deciphera Pharmaceuticals, Inc. (NASDAQ: DCPH), a biopharmaceutical company focused on discovering, developing, and commercializing important new medicines to improve the lives of people with cancer, today announced financial results for the first quarter ended March 31, 2023 and provided a corporate update.

Key Points: 
  • Deciphera Pharmaceuticals, Inc. (NASDAQ: DCPH), a biopharmaceutical company focused on discovering, developing, and commercializing important new medicines to improve the lives of people with cancer, today announced financial results for the first quarter ended March 31, 2023 and provided a corporate update.
  • In the third quarter of 2022, Deciphera completed the sale of zero cost inventories of QINLOCK that had been expensed prior to FDA approval.
  • R&D Expenses: Research and development expenses for the first quarter of 2023 were $54.8 million, compared to $47.4 million for the same period in 2022.
  • Deciphera will host a conference call and webcast to discuss this announcement today, May 3, 2023, at 8:00 AM ET.