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Regulatory

STLA

Stellantis NV (NYSE:STLA) is recalling over 1 million vehicles in the U.S. due to an issue with the rearview camera image display. The recall affects various models including Dodge Durango, Chrysler Pacifica, and Jeep Grand Cherokee L. Dealers will update the radio software free of charge.

Portfolio Pulse from Anan Ashraf

June 18, 2024 | 11:17 am

ZNTL

Zentalis Pharmaceuticals announced that the FDA has placed a partial clinical hold on ZN-c3-001, DENALI, and TETON monotherapy studies of Azenosertib following two recent deaths due to presumed sepsis in the DENALI study.

Portfolio Pulse from Benzinga Newsdesk

June 18, 2024 | 11:16 am

RGNX

Regenxbio has concluded a pre-biologics license application (BLA) meeting with the FDA for its RGX-121 treatment for Mucopolysaccharidosis Type II. The company plans to initiate a rolling BLA submission in Q3 2024, with a confirmatory trial expected to begin in H2 2025. The FDA has confirmed that the commercial bulk drug is comparable to the clinical material.

Portfolio Pulse from Benzinga Newsdesk

June 18, 2024 | 11:11 am

IONS

Otsuka Pharmaceutical has obtained exclusive rights across the Asia-Pacific region for Ionis Pharmaceuticals' donidalorsen for hereditary angioedema. Ionis will receive a $20M upfront payment and milestone payments. Ionis will handle primary development, while Otsuka will manage territory-specific development, regulatory filings, and commercialization in the Asia-Pacific region and Europe.

Portfolio Pulse from Benzinga Newsdesk

June 18, 2024 | 11:06 am

NVDA

SPY

The stock market has been on a record run, potentially driven by the changing presidential polling trends favoring Donald Trump. Analysts suggest that the market is pricing in a Trump victory due to his deregulation policies, which are expected to benefit Wall Street. The SPDR S&P 500 ETF Trust (SPY) and Nvidia Corp. (NVDA) are highlighted as key players in this market rally.

Portfolio Pulse from Shanthi Rexaline

June 18, 2024 | 11:02 am

ZNTL

Trading in Zentalis Pharmaceuticals (ZNTL) was halted at 6:56:04 a.m. ET pending news. Investors should stay tuned for further updates.

Portfolio Pulse from Benzinga Newsdesk

June 18, 2024 | 10:56 am

TSLA

Tesla Inc (NASDAQ:TSLA) announced that its Model 3 Long Range variant now qualifies for a $7,500 federal tax credit, making it only $1,000 more expensive than the cheapest variant. The Performance version also qualifies for the tax credit, while the cheapest rear-wheel drive Model 3 does not. All versions of the Model Y SUV and the Long Range variant of the Model X are also eligible for the tax credit. This move is expected to boost EV adoption by lowering the final purchase price for customers.

Portfolio Pulse from Anan Ashraf

June 18, 2024 | 10:50 am

KALV

KalVista Pharmaceuticals has submitted a New Drug Application (NDA) to the FDA for Sebetralstat, an oral plasma kallikrein inhibitor for treating hereditary angioedema (HAE) attacks. The FDA will review the NDA within 60 days, with a decision expected in September. KalVista plans to seek additional marketing authorizations globally in 2024.

Portfolio Pulse from Benzinga Newsdesk

June 18, 2024 | 10:32 am

CALT

Calliditas Therapeutics has received a patent for NOX inhibitors, which are intended for the treatment of cancer. This development could potentially enhance their product portfolio and market position in the oncology sector.

Portfolio Pulse from Benzinga Newsdesk

June 18, 2024 | 10:27 am

ASNS

AWIN

CHGG

MBIO

NLSP

QMCO

Chegg, Inc. (NYSE:CHGG) shares surged 20.7% in pre-market trading following the announcement of a restructuring plan, including a 23% headcount reduction and a focus on international programs. Other notable pre-market movers include Actelis Networks, Inc. (NASDAQ:ASNS) up 112.2%, NLS Pharmaceutics AG (NASDAQ:NLSP) up 62.8%, and Mustang Bio, Inc. (NASDAQ:MBIO) up 46.7%. On the losing side, AERWINS Technologies Inc. (NASDAQ:AWIN) fell 48.8% and Quantum Corporation (NASDAQ:QMCO) dropped 38%.

Portfolio Pulse from Avi Kapoor

June 18, 2024 | 9:28 am