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Regulatory

PHG

The FDA has expressed ongoing concerns about the potential health risks from Philips' Respironics' June 2021 recall of certain CPAP, BiPAP, and ventilator devices. The FDA remains unsatisfied with the recall status and believes Philips' testing to date is inadequate. Philips has agreed to conduct additional testing as requested by the FDA. Philips' market valuation declined by over 66% due to the recall, but the company has begun to experience a gradual resurgence in 2023. PHG shares are down 10.30% at $17.68 during the premarket session on the last check Friday.

Portfolio Pulse from Vandana Singh

October 06, 2023 | 1:01 pm

AMGN

MRTX

FDA advisers have expressed doubts about the reliability of data from a late-stage trial of Amgen Inc's Lumakras for advanced lung cancer, voting 10 'no' to 2 'yes' for traditional approval. The drug had initially received FDA approval in 2021 through an accelerated pathway, contingent on confirmatory trial data. The confirmatory study data revealed that Lumakras reduced the risk of disease progression in patients with advanced lung cancer by 34% compared to chemotherapy. A decision from the FDA on traditional approval is expected by December 24.

Portfolio Pulse from Vandana Singh

October 06, 2023 | 12:59 pm

NVNO

enVVeno Medical Corporation (NASDAQ:NVNO) has announced a private placement of $28 million, conducted as an at-the-market offering under Nasdaq rules. The transaction was led by Perceptive Advisors, Nantahala Capital, Kingdon Capital Management, Velan Capital, L1 Capital and other institutional investors. The company could receive up to an additional $75 million from milestone-driven warrants upon the release of initial topline efficacy data from the VenoValve pivotal trial and FDA pre-market approval of the VenoValve.

Portfolio Pulse from Benzinga Newsdesk

October 06, 2023 | 12:58 pm

PRZO

ParaZero shares are trading higher after the Australian regulator, the Civil Aviation Safety Agency, approved the first commercial drone flights in populated areas and near people using ParaZero safety systems.

Portfolio Pulse from Benzinga Newsdesk

October 06, 2023 | 12:58 pm

GM

GOOGL

TSLA

Dan O'Dowd, CEO of Green Hills Software and founder of the Dawn Project, criticized Tesla's Full Self-Driving (FSD) software in an interview with Benzinga. He called the FSD 'terrible' and stated that it could be banned. O'Dowd's team found flaws in Tesla's driver monitoring system and compared Tesla's FSD unfavorably with General Motors' Cruise and Alphabet's Waymo. He also accused Elon Musk of coordinating online attacks against him. Ark Investment Management CEO Cathie Wood and Future Fund’s Gary Black, however, expressed optimism about Tesla's FSD.

Portfolio Pulse from Anan Ashraf

October 06, 2023 | 12:50 pm

PHG

PXD

VCNX

Vaccinex (VCNX) shares are up 43% premarket after two large insider buys were reported. Pioneer Natural Resources (PXD) shares are trading higher following a report suggesting Exxon Mobil is nearing a $60 billion deal to buy the company. Philips (PHG) shares are down due to an update on its June 2021 recall, with the FDA stating that the testing and analysis Philips shared are inadequate to fully evaluate the risks posed to users from recalled devices.

Portfolio Pulse from ryanfaloona@benzinga.com

October 06, 2023 | 12:39 pm

ATVI

MSFT

SONY

Microsoft Corp is close to completing its $68.7 billion acquisition of Activision Blizzard, Inc, potentially by October 13. The deal is contingent on the approval of the U.K.'s Competition and Markets Authority (CMA), which had previously obstructed the deal. Microsoft secured preliminary approval from the CMA after restructuring the agreement to transfer cloud gaming rights for current and new Activision Blizzard games to Ubisoft. Microsoft had also cut similar deals with Nvidia Corp and Sony Group Corporation to win support for the acquisition.

Portfolio Pulse from Anusuya Lahiri

October 06, 2023 | 12:35 pm

SPY

The USA participation rate for September remained steady at 62.8%, unchanged from the prior month.

Portfolio Pulse from Benzinga Newsdesk

October 06, 2023 | 12:31 pm

SPY

The USA Nonfarm Payrolls for September came in at 336K, significantly higher than the estimated 170K and the prior figure of 227K.

Portfolio Pulse from Benzinga Newsdesk

October 06, 2023 | 12:30 pm

JNJ

Johnson & Johnson's Janssen has submitted a supplemental marketing application to the European Medicines Agency for Rybrevant (Amivantamab) in combination with chemotherapy for advanced non-small cell lung cancer with EGFR Exon 20 insertion mutations.

Portfolio Pulse from Benzinga Newsdesk

October 06, 2023 | 12:13 pm