Incyte Says FDA Issued CRL For Ruxolitinib Extended-release Tablets

RTTNews | 952 hari yang lalu
Stocktwits
Incyte Says FDA Issued CRL For Ruxolitinib Extended-release Tablets

(RTTNews) - Incyte Corp. (INCY) announced Friday that the U.S. Food and Drug Administration (FDA) has issued a complete response letter for ruxolitinib extended-release (XR) tablets, a JAK1/JAK2 inhibitor, for once-daily (QD) use in the treatment of certain types of myelofibrosis (MF), polycythemia vera (PV) and graft-versus-host disease (GVHD).

The complete response letter states that the FDA cannot approve the application in its present form. The FDA acknowledged that the study submitted in the New Drug Application (NDA) met its objective of bioequivalence based on area under the curve (AUC) parameters but identified additional requirements for approval.

Incyte intends to meet with the FDA to determine appropriate next steps.

The NDA was based on two studies designed to show that ruxolitinib XR tablets are dosage strength proportional and bioequivalent to Jakafi (ruxolitinib) tablets.

Teg: INCY
Stocktwits
read more
Incyte Q4 Adj EPS Misses Estimates, But Revenues Top

Incyte Q4 Adj EPS Misses Estimates, But Revenues Top

Incyte Corp. (INCY) on Tuesday reported net income of $201.10 million or $0.89 per share for the fourth quarter, sharply higher than $28.46 million or $0.13 per share in the prior-year quarter.
RTTNews | 626 hari yang lalu
Incyte Q1 Results Top Estimates

Incyte Q1 Results Top Estimates

Incyte Corp. (INCY) on Tuesday reported net income of $161.43 million or $0.72 per share for the first quarter, up from $149.46 million or $0.67 per share in the prior-year quarter.
RTTNews | 1186 hari yang lalu
Japan Industrial Output Rebounds; Tokyo Inflation Accelerates

Japan Industrial Output Rebounds; Tokyo Inflation Accelerates

Japan's industrial production rebounded at a stronger-than-expected pace at the end of the third quarter and inflation in Tokyo accelerated further in October, official data revealed Friday. Industrial output advanced 2.2 percent month-on-month, in contrast to the 1.5 percent drop in August, the Ministry of Economy, Trade and Industry said. Output was forecast to grow moderately by 1.5 percent.
RTTNews | 1j 2min yang lalu
European Shares Seen Tad Lower At Open

European Shares Seen Tad Lower At Open

European markets may open slightly lower on Friday, although tech stocks may rise following strong earnings from e-commerce giant Amazon and iPhone maker Apple.
RTTNews | 2j 12min yang lalu
NZ Dollar Falls Against Majors

NZ Dollar Falls Against Majors

The New Zealand dollar weakened against other major currencies in the Asian session on Friday.
RTTNews | 2j 15min yang lalu
European Economic News Preview: Eurozone Flash Inflation Data Due

European Economic News Preview: Eurozone Flash Inflation Data Due

Flash inflation from the euro area and France are the top economic news due on Friday, headlining a busy day for the European economic news. At 3.00 am ET, Destatis is scheduled to issue Germany's retail sales and import prices. Sales are forecast to grow 0.2 percent month-on-month, reversing a 0.2 percent fall in August. Economists expect import prices to drop 0.2 percent.
RTTNews | 2j 28min yang lalu
Sensex, Nifty Modestly Higher In Early Trade

Sensex, Nifty Modestly Higher In Early Trade

Indian shares were slightly higher on Friday despite mixed cues from global markets. The benchmark BSE Sensex was up 180 points, or 0.2 percent, at 84,583 in early trade, while the broader NSE Nifty index edged up by 38 points, or 0.2 percent, to 25,915.
RTTNews | 3j 25min yang lalu
Alat
Kalendar Ekonomi
Waktu pasaran
Kadar faedah
Kalendar cuti
Pasaran Forex
Volatiliti Forex
Korelasi Forex
Berita Forex
Analisis Forex
Data COT
Kecairan
Kalkulator Forex
Peta Panas Forex
Petunjuk ekonomi
Komuniti
Komuniti
Sistem
Sistem Paling Popular
Strategi
Peraduan
Carta Forex
Sentimen Forex
Petunjuk Outlook
Ulasan
Broker
Firma Dagangan Proprietari
Perkhidmatan VPS
Penyedia Isyarat
Perkhidmatan Pengaturcaraan EA
Program Afiliasi
Perkhidmatan PAMM Broker
Perkhidmatan Program Rebat
Platform Dagangan
Penasihat Pakar
Pertukaran Kripto
Kursus dagangan
Broker
Spreads Forex
Sebut Harga Forex Broker
Pertukaran Broker Forex
Jumlah Broker Forex
Promosi Broker Forex
Siaran Akhbar
Platform
Widget
Ciri-ciri
API
RSS
Stock Portfolio
Affiliate Software
Carta Lanjutan
Sokongan
Soalan Lazim
Bantuan
Hubungi Kami
Laporkan pepijat!
Mengenai
Blog
&salin; 2025 Myfxbook Ltd. Hak Cipta Terpelihara.
PERINGATAN RISIKO TINGGI: Perdagangan pertukaran mata wang asing mempunyai risiko tinggi yang mungkin tidak sesuai untuk semua jenis pelabur. Leveraj menimbulkan risiko dan kerugian tambahan. Sebelum anda memutuskan untuk berdagang pertukaran mata wang asing, pertimbangkan dengan teliti objektif pelaburan, tahap pengalaman dan toleransi risiko anda. Anda berkemungkinan kehilangan sebahagian atau semua pelaburan awal anda. Jangan melaburkan wang yang anda tidak mampu untuk kehilangan. Didik diri anda tentang risiko yang berkaitan dengan perdagangan pertukaran asing, dan dapatkan nasihat daripada penasihat bebas kewangan atau cukai jika anda mempunyai sebarang pertanyaan mengenainya. Semua data dan maklumat yang disediakan adalah semata-mata untuk tujuan maklumat, dan bukan bertujuan untuk tujuan perdagangan atau nasihat. Prestasi masa lalu tidak semestinya menunjukkan hasil masa depan.