Business Wire

Incyte Announces Data for Pemigatinib, its Selective FGFR Inhibitor, to be Featured at the ESMO 2018 Congress

Jaa

Incyte (Nasdaq:INCY) announces that interim Phase 2 data on its investigational, selective FGFR1/2/3 inhibitor, pemigatinib (INCB54828), will be presented at the upcoming European Society for Medical Oncology (ESMO) 2018 Congress taking place in Munich, Germany from October 19-23, 2018.

Data at ESMO 2018 will include poster presentations on the FIGHT-202 study of pemigatinib in patients with previously treated advanced/metastatic or surgically unresectable cholangiocarcinoma (bile duct cancer) with fibroblast growth factor (FGF)/FGFR genetic alterations, as well as the FIGHT-201 study of pemigatinib in patients with metastatic or surgically unresectable urothelial carcinoma (bladder cancer) harboring FGF/FGFR genetic alterations.

“We are pleased that data on pemigatinib – part of our targeted therapy portfolio – have been selected for presentation at this year’s ESMO Congress,” stated Steven Stein, M.D., Chief Medical Officer, Incyte. “We look forward to sharing updated interim data from the ongoing FIGHT-202 trial of pemigatinib in patients with cholangiocarcinoma, which continue to support our plan for a 2019 NDA submission in this indication, as well as updated data from the FIGHT-201 study of pemigatinib in patients with urothelial carcinoma, which support recruitment into the continuous dosing cohort of this study.”

Abstracts were made available today on the ESMO Congress website at https://www.esmo.org/Conferences/ESMO-2018-Congress.

Poster details:

Interim Results of FIGHT-202, a Phase 2, Open-Label, Multicenter Study of INCB054828 in Patients (pts) with Previously Treated Advanced/Metastatic or Surgically Unresectable Cholangiocarcinoma (CCA) with/without Fibroblast Growth Factor (FGF)/FGF Receptor (FGFR) Genetic Alterations (Abstract #756P, poster display session)

  • Sunday, 21 October 2018 from 12:45 p.m. CEST to 1:45 p.m. CEST (6:45 a.m. ET to 7:45 a.m. ET) in Hall A3 – Poster Area Networking Hub

Interim Results of FIGHT-201, a Phase 2, Open-Label, Multicenter Study of INCB054828 in Patients (pts) with Metastatic or Surgically Unresectable Urothelial Carcinoma (UC) Harboring Fibroblast Growth Factor (FGF)/FGF receptor (FGFR) Genetic Alterations (GA) (Abstract #900P, poster display session)

  • Monday, 22 October 2018 from 12:45 p.m. CEST to 1:45 p.m. CEST (6:45 a.m. ET to 7:45 a.m. ET) in Hall A3 – Poster Area Networking Hub

Full session details and data presentation listings for ESMO 2018 can be found at:
https://cslide.ctimeetingtech.com/esmo2018/attendee/.

About FGFR and Pemigatinib (INCB54828)

Fibroblast growth factor receptors (FGFRs) play an important role in tumor cell proliferation and survival, migration and angiogenesis (the formation of new blood vessels). Activating mutations, translocations and gene amplifications in FGFRs are closely correlated with the development of various cancers.

Pemigatinib is a potent, selective, oral inhibitor of FGFR isoforms 1, 2 and 3 which, in preclinical studies, has demonstrated selective pharmacologic activity against cancer cells with FGFR alterations. Phase 2 studies investigating the safety and efficacy of pemigatinib monotherapy across several FGFR-driven malignancies are ongoing—the FIGHT (FIbroblast Growth factor receptor in oncology and Hematology Trials) clinical trial program currently comprises FIGHT-201 in patients with metastatic or surgically unresectable bladder cancer, including with activating FGFR3 alterations; FIGHT-202 in patients with metastatic or surgically unresectable cholangiocarcinoma who have failed previous therapy, including with activating FGFR2 translocations; and FIGHT-203 in patients with myeloproliferative neoplasms with activating FGFR1 translocations.

About Incyte

Incyte Corporation is a Wilmington, Delaware-based biopharmaceutical company focused on the discovery, development and commercialization of proprietary therapeutics. For additional information on Incyte, please visit the Company’s website at www.incyte.com.

Follow @Incyte on Twitter at https://twitter.com/Incyte.

Forward-Looking Statements

Except for the historical information set forth herein, the matters set forth in this press release, including statements regarding the presentation of data from the Company’s ongoing clinical development program for pemigatinib and its potential in treating cholangiocarcinoma and urothelial carcinoma and the Company’s plans to file an NDA for pemigatinib and the expected timing of such filing, contain predictions, estimates and other forward-looking statements.

These forward-looking statements are based on the Company’s current expectations and subject to risks and uncertainties that may cause actual results to differ materially, including unanticipated developments in and risks related to: unanticipated delays; further research and development and the results of clinical trials possibly being unsuccessful or insufficient to meet applicable regulatory standards or warrant continued development; the ability to enroll sufficient numbers of subjects in clinical trials; determinations made by the FDA; the Company’s dependence on its relationships with its collaboration partners; the efficacy or safety of the Company’s products and the products of the Company’s collaboration partners; the acceptance of the Company’s products and the products of the Company’s collaboration partners in the marketplace; market competition; sales, marketing, manufacturing and distribution requirements; greater than expected expenses; expenses relating to litigation or strategic activities; and other risks detailed from time to time in the Company’s reports filed with the Securities and Exchange Commission, including its Form 10-Q for the quarter ended June 30, 2018. The Company disclaims any intent or obligation to update these forward-looking statements.

Contact information

Incyte
Media
Catalina Loveman, +1-302-498-6171
cloveman@incyte.com
or
Investors
Michael Booth, DPhil, +1-302-498-5914
mbooth@incyte.com

Tietoja julkaisijasta

For more than 50 years, Business Wire has been the global leader in press release distribution and regulatory disclosure.

Tilaa tiedotteet sähköpostiisi

Haluatko tietää asioista ensimmäisten joukossa? Kun tilaat mediatiedotteemme, saat ne sähköpostiisi välittömästi julkaisuhetkellä. Tilauksen voit halutessasi perua milloin tahansa.

Lue lisää julkaisijalta Business Wire

Arch Insurance Announces Strategic Leadership Changes19.10.2018 16:10Tiedote

Arch Insurance today announced that Matt Shulman will assume the newly created role of CEO, Arch Insurance North America, effective January 1, 2019. In this role, he will lead Arch Insurance’s operations in the United States and Canada. He will report to Nicolas Papadopoulo, Chairman and CEO of Arch Worldwide Insurance Group. Mr. Shulman, who has more than 20 years of experience in the insurance industry, has been with Arch Insurance since 2009 and has served as the President and CEO of Arch Insurance Europe since 2016. “Matt brings significant U.S. and international experience to this role. Under his leadership, together with our senior team, Arch Insurance will continue to enhance our value proposition to our customers through a robust, diversified product portfolio, creative solutions and excellent service,” Mr. Papadopoulo said. Arch Insurance has also created a new organizational structure with three Chief Underwriting Officers (CUO) dedicated to specific lines of business. These

Takeda to Present Results from Phase 3 ALTA-1L Trial Highlighting Intracranial Efficacy of ALUNBRIG® (brigatinib) Versus Crizotinib in First-Line Advanced ALK+ Non-Small Cell Lung Cancer19.10.2018 15:00Tiedote

Takeda Pharmaceutical Company Limited (TSE: 4502) today announced that intracranial efficacy data from the Phase 3 ALTA-1L (ALK in Lung Cancer Trial of BrigAtinib in 1 st Line) trial showed improved intracranial progression-free survival (PFS) and intracranial objective response rate (ORR) with ALUNBRIG (brigatinib) compared to crizotinib among anaplastic lymphoma kinase-positive (ALK+) non-small cell lung cancer (NSCLC) patients. Data for these secondary endpoints will be presented in a poster discussion at the European Society for Medical Oncology (ESMO) 2018 Congress on Friday, October 19 at 2:00 p.m. CET in Munich, Germany. These results further support ALUNBRIG as a potential treatment for adults with ALK+ locally advanced or metastatic NSCLC who had not received a prior ALK inhibitor. ALUNBRIG is currently not approved as first-line therapy for advanced ALK+ NSCLC. “ALK+ NSCLC often spreads to the brain, so having options that can clearly demonstrate efficacy both in the brain an

Vertex Receives European CHMP Positive Opinion for KALYDECO® (ivacaftor) to Treat Patients With Cystic Fibrosis Aged 12 to <24 months With Certain Mutations in the CFTR Gene19.10.2018 14:54Tiedote

Vertex Pharmaceuticals (Europe) Limited today announces that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion for KALYDECO® (ivacaftor) to include the treatment of people with cystic fibrosis (CF) aged 12 to <24 months who have at least one of the following nine mutations in their cystic fibrosis transmembrane conductance regulator (CFTR) gene: G551D, G1244E, G1349D, G178R, G551S, S1251N, S1255P, S549N or S549R. If the European Commission issues a favorable adoption of the EMA CHMP opinion for the extension of indication, ivacaftor will be the first and only medicine approved in Europe to treat the underlying cause of CF in patients aged 12 to <24 months, who have specific mutations in the CFTR gene. “Cystic fibrosis is a chronic, progressive disease that is present at birth, with symptoms often occurring in infancy, so early treatment is crucial to deliver the best possible outcomes for patients,” said Reshma Kewalr

Tradeshift Announces Q3 2018 Results19.10.2018 14:00Tiedote

Tradeshift, the leader in supply chain payments and marketplaces, today announced results from the third quarter of 2018, marking the tenth quarter in a row of successive growth and beating targets. Tradeshift’s third quarter growth stats announced today include: YoY revenue grew 400 percent (trailing 12 months) YoY new bookings grew 284 percent YoY gross merchandise volume (GMV) grew 262 percent New total contract value grew by $47M in Q3 Tradeshift’s customer roster continued strong growth this quarter adding 27 new customers, including Hertz, Shiseido, ECU, and Fortune 500 leaders in retail apparel, agriculture, engineering and construction, hospitality, travel and food delivery. Tradeshift also expanded its app ecosystem by adding a key partnership with Coface, a global credit insurer. Coface has announced a new app solution on the Tradeshift platform offering risk and business information services to help businesses make decisions by ensuring greater financial transparency between

Schlumberger Announces Third-Quarter 2018 Results19.10.2018 14:00Tiedote

Schlumberger Limited (NYSE: SLB) today reported results for the third quarter of 2018. (Stated in millions, except per share amounts) Three Months Ended Change Sept. 30, 2018 Jun. 30, 2018 Sept. 30, 2017 Sequential Year-on-year Revenue $8,504 $8,303 $7,905 2% 8% Pretax operating income $1,152 $1,094 $1,059 5% 9% Pretax operating margin 13.5% 13.2% 13.4% 36 bps 15 bps Net income - GAAP basis $644 $430 $545 50% 18% Net income, excluding charges & credits* $644 $594 $581 8% 11% Diluted EPS - GAAP basis $0.46 $0.31 $0.39 48% 18% Diluted EPS, excluding charges & credits* $0.46 $0.43 $0.42 7% 10% North America revenue $3,189 $3,139 $2,602 2% 23% International revenue $5,215 $5,065 $5,147 3% 1% North America revenue, excluding Cameron $2,572 $2,546 $2,086 1% 23% International revenue, excluding Cameron $4,559 $4,387 $4,430 4% 3% *These are non-GAAP financial measures. See section below entitled "Charges & Credits" for details. Schlumberger Chairman and CEO Paal Kibsgaard commented, “Our third

Alibaba’s Robust Ecosystem Supercharges 2018 11.11 Global Shopping Festival19.10.2018 13:15Tiedote

Alibaba Group Holding Limited (NYSE:BABA) today officially kicked off the 2018 11.11 Global Shopping Festival in China’s capital, promising this year’s mega-event will be the largest-ever in terms of scale and reach. Businesses within the Alibaba ecosystem will jointly offer hundreds of millions of consumers an enriching experience that supports their pursuit of high-quality products, entertainment and fast, reliable services. The Festival will also demonstrate the enthusiasm of consumers and brands embracing Alibaba’s New Retail strategy – the convergence of online and offline retail through technology. “This year marks the 10th anniversary of 11.11. On the back of China’s explosive digital transformation, the Festival’s astounding growth over the past decade has powered the steady growth of quality consumption sought by Chinese shoppers. The evolution also showcases the development of the Alibaba ecosystem over time expanding well beyond e-commerce,” said Alibaba Group CEO Daniel Zha

Uutishuoneessa voit lukea tiedotteitamme ja muuta julkaisemaamme materiaalia. Löydät sieltä niin yhteyshenkilöidemme tiedot kuin vapaasti julkaistavissa olevia kuvia ja videoita. Uutishuoneessa voit nähdä myös sosiaalisen median sisältöjä. Kaikki STT Infossa julkaistu materiaali on vapaasti median käytettävissä.

Tutustu uutishuoneeseemme