Incyte Says FDA Issued CRL For Ruxolitinib Extended-release Tablets

RTTNews | 950 days ago
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.

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 | 624 days ago
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 | 1184 days ago
Canadian Market Drifts Lower After BoC Rate Decision; Energy, Materials Shares Rise

Canadian Market Drifts Lower After BoC Rate Decision; Energy, Materials Shares Rise

The Canadian market is down in negative territory around noon on Wednesday, weighed down by losses in consumer, healthcare, industrials and real estate sectors. Investors are digesting the Bank of Canada's rate cut decision, and looking ahead to the Federal Reserve's interest rate announcement due later in the day.
RTTNews | 45 minutes ago
U.S. Pending Home Sales Unexpectedly Unchanged In September

U.S. Pending Home Sales Unexpectedly Unchanged In September

After reporting a sharp increase by pending home sales in the U.S. in the previous month, the National Association of Realtors released a report on Wednesday showing pending home sales unexpectedly came in flat in the month of September. NAR said its pending homes sales index was unchanged at 74.8 in September after surging by 4.2 percent in August.
RTTNews | 2h 48min ago
Bank Of Canada Cuts Interest Rates By Another Quarter Point

Bank Of Canada Cuts Interest Rates By Another Quarter Point

The Bank of Canada on Wednesday announced its widely expected decision to lower interest rates once again, cutting rates by a quarter point for the second consecutive meeting. The Canadian central bank said it reduced its target for the overnight rate by 25 basis points to 2.25 percent, with the Bank Rate at 2.5 percent and the deposit rate at 2.20 percent.
RTTNews | 2h 51min ago
FTSE 100 Advances As Miners, Pharma Stocks Rally

FTSE 100 Advances As Miners, Pharma Stocks Rally

The U.K. market is up firmly in positive territory on Wednesday, led by gains in mining and pharmaceutical sectors, thanks to a rebound in metal prices and stronger than expected earnings from drug major GSK.
RTTNews | 5h 6min ago
Pound Slides Amid UK Fiscal Concerns

Pound Slides Amid UK Fiscal Concerns

The British pound weakened against other major currencies in the European session on Wednesday, as investors expect that UK Chancellor of the Exchequer Rachel Reeves will have to make tough decisions over where to raise taxes and reduce spending in the approaching Autumn Budget.
RTTNews | 5h 35min ago