Streetbeat News

Regulatory

MRK

The FDA has granted priority review to Merck's application for Keytruda, in combination with concurrent chemoradiotherapy, for the treatment of newly diagnosed high-risk locally advanced cervical cancer. The Prescription Drug User Fee Act date is set for January 20, 2024.

Portfolio Pulse from Benzinga Newsdesk

September 20, 2023 | 10:48 am

RYAAY

Italy's competition watchdog has launched an investigation into Ryanair Holdings plc's market practices in the country. The probe focuses on Ryanair's dominance in services for tourists, including car rental and hotel bookings. The authority suggests that Ryanair's controlling position could harm travel agencies and clients. This comes amidst a dispute between the Italian government and Ryanair over a price cap for domestic airline tickets to the country’s island destinations.

Portfolio Pulse from Shivani Kumaresan

September 20, 2023 | 10:47 am

AIU

CART

NKLA

RVNC

SPRY

TM

Several stocks recorded losses in Wednesday's pre-market trading session. ARS Pharmaceuticals shares dipped 46.8% after the FDA requested additional study for its neffy® Epinephrine nasal spray. Revance Therapeutics shares declined 5.8% following the company's plan to exit the OPUL payments business. Instacart shares fell 4.4% despite pricing its IPO at the top end of the expected range. Meta Data Limited, Nikola Corporation, and Toyota Motor Corporation also experienced declines.

Portfolio Pulse from Lisa Levin

September 20, 2023 | 10:23 am

ABBV

The FDA has accepted Alvotech's resubmitted Biologics License Application (BLA) for AVT02, a high-concentration interchangeable biosimilar candidate to Humira. This could potentially impact the market share of Humira, which is produced by AbbVie Inc.

Portfolio Pulse from Benzinga Newsdesk

September 20, 2023 | 8:33 am

TCEHY

Epic Games, owned by Tencent Holdings Ltd. (OTCPK: TCEHY), is set to pay out a $245 million settlement as ordered by the US Federal Trade Commission (FTC). The fine was imposed after the FTC found that Epic Games was charging for unwanted in-game purchases and locking out customers who disputed these charges. Eligible users, including those who were charged for unwanted items and whose accounts were locked between January 2017 and September 2022, can now file their claims.

Portfolio Pulse from Rounak Jain

September 20, 2023 | 7:45 am

SPRY

The FDA has issued a Complete Response Letter for ARS Pharma's neffy® Epinephrine Nasal Spray, requesting additional study. The company plans to appeal the issuance.

Portfolio Pulse from Benzinga Newsdesk

September 20, 2023 | 7:09 am

EWG

VGK

Germany's Producer Price Index (PPI) for August has increased by 0.3%, beating the estimated 0.2% and showing a significant improvement from the previous -1.1%.

Portfolio Pulse from Benzinga Newsdesk

September 20, 2023 | 6:01 am

EWU

The U.K. Producer Price Index Input for August increased by 0.4%, which is higher than the estimated 0.2% and a significant improvement from the previous -0.4%.

Portfolio Pulse from Benzinga Newsdesk

September 20, 2023 | 6:01 am

EWU

The U.K. Consumer Price Index (CPI) for August was reported at 0.3%, lower than the estimated 0.7% and a significant increase from the previous -0.4%.

Portfolio Pulse from Benzinga Newsdesk

September 20, 2023 | 6:01 am

EWU

The U.K. Consumer Price Index (CPI) for August was reported at 6.7%, slightly below the estimated 7% and the prior figure of 6.8%.

Portfolio Pulse from Benzinga Newsdesk

September 20, 2023 | 6:00 am