Incyte Says FDA Issued CRL For Ruxolitinib Extended-release Tablets

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.

Oil Prices Tumble As Recession Worries Mount

Oil prices fell more than 2 percent on Friday to extend losses from the previous session on concerns about the impact on demand from a possible recession or further banking upheaval.

Benchmark Brent crude futures fell 2.2 percent to $74.28 a barrel, while WTI crude futures were down 2.4 percent at $68.2.

Bank worries persist, overshadowing hopes that central banks would shortly halt interest rates rises.

Banking stocks fell across the board in Europe after Deutsche Bank saw a spike in credit default swaps on Thursday night.

Separately, the Bloomberg reported that Credit Suisse Group and UBS Group AG are among the banks under scrutiny in a U.S. Justice Department probe for potentially helping Russian oligarchs evade sanctions.

Oil prices also remain under pressure from worries about potential oversupply after U.S. Energy Secretary Jennifer Granholm said refilling the country’s Strategic Petroleum Reserve (SPR) may take several years.

CMA Narrows Scope Of Concerns In Microsoft – Activision Deal

The Competition and Markets Authority in the UK has issued updated provisional findings in its assessment of Microsoft’s proposed acquisition of Activision. Having considered the additional evidence provided, the CMA has provisionally concluded that the merger will not result in a substantial lessening of competition in console gaming services because the cost to Microsoft of withholding Call of Duty from PlayStation would outweigh any gains from taking such action.

“Our provisional view that this deal raises concerns in the cloud gaming market is not affected by today’s announcement. Our investigation remains on course for completion by the end of April,” Martin Coleman, chair of the independent panel of experts, said.

In February, the CMA published provisional findings setting out that the deal raises competition concerns in relation to both console gaming and cloud gaming services in the UK.

U.S. Leading Economic Index Falls For Eleventh Straight Month In February

The Conference Board released a report on Friday showing its reading on leading U.S. economic indicators declined for the eleventh consecutive month in February.

The report said the leading economic index fell by 0.3 percent in February, matching the decrease seen in January. Economists had expected the index to dip by 0.2 percent.

“Negative or flat contributions from eight of the index’s ten components more than offset improving stock prices and a better-than-expected reading for residential building permits,” said Justyna Zabinska-La Monica, Senior Manager, Business Cycle Indicators, at The Conference Board.

She added, “While the rate of month-over-month declines in the LEI have moderated in recent months, the leading economic index still points to risk of recession in the US economy.”

Meanwhile, the report said the coincident economic index inched up by 0.1 percent in February after rising by 0.2 percent in January.

The Conference Board said the lagging economic index also increased by 0.2 percent in February after edging up by 0.1 percent in the previous month.

Recon Technology Posts Loss In H1; Total Revenues Down 16.3%

Recon Technology, Ltd (RCON) posted a net loss of RMB 29.9 million for the six months ended December 31, 2022 compared to net income of RMB 111.4 million for the same period in 2021. Loss per share was RMB 0.88 compared to profit of RMB 3.87.

Total revenue decreased by 16.3% to RMB 45.6 million from RMB 54.4 million for the same period in 2021. The company said the overall decrease in revenue was mainly due to decrease revenue from automation product and software, oilfield environmental protection and platform outsourcing services segments, which was partially offset by the increased revenue from equipment and accessories segment during the six months ended December 31, 2022.

As of December 31, 2022, the company had cash in the amount of approximately RMB 269.1 million.

For more earnings news, earnings calendar, and earnings for stocks, visit rttnews.com.

Pan American Gets Mexican Regulatory Nod For Arrangement With Yamana And Agnico Eagle

Pan American Silver Corporation (PAAS), and Yamana Gold Inc. (AUY), announced on Friday that the Mexican Federal Economic Competition Commission has approved Pan American Silver’s arrangement with Yamana and Agnico Eagle. The arrangement is now expected to be completed on or about March 31.

According to the arrangement, Pan American would acquire all shares of Yamana, following the sale by Yamana of its Canadian assets, including certain units and partnerships which hold Yamana’s interests in the Canadian Malartic mine, to Agnico Eagle Mines Limited.

In addition, Pan American Silver has declared a cash dividend of $0.10 per share, payable on or about May 12, to shareholders of record on April 14.