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Regulatory

NVDA

U.S. markets closed higher on Friday, led by Nvidia and a tech rally, despite a drop in ISM manufacturing PMI and consumer sentiment. Asian markets were mixed, with Japan's Nikkei reaching a record high. European markets and U.S. futures saw declines. Commodities showed mixed performance with crude oil slightly down and natural gas up. Nvidia's performance stands out due to the growing demand for artificial intelligence.

Portfolio Pulse from Akanksha Bakshi

March 04, 2024 | 12:29 pm

UNG

USO

VGK

The EU plans to advocate for the fossil fuel sector to contribute financially to the battle against climate change at this year's UN talks, according to a document cited by Reuters. This move could have significant implications for companies and ETFs involved in the fossil fuel and European markets.

Portfolio Pulse from Charles Gross

March 04, 2024 | 12:24 pm

AAPL

VGK

Apple has been fined $1.95 billion by the European Union as a result of an antitrust investigation. The company has announced its intention to appeal the EU's decision.

Portfolio Pulse from Charles Gross

March 04, 2024 | 12:11 pm

HSDT

Helius Medical Technologies announced it has secured HCPCS codes for its Portable Neuromodulation Stimulator (PoNS) mouthpiece and controller, a significant step for reimbursement and accessibility in the healthcare market.

Portfolio Pulse from Charles Gross

March 04, 2024 | 12:08 pm

BLRX

BioLineRx has received a Notice of Allowance for a U.S. patent on the manufacturing method of Motixafortide (BL-8040), enabling large scale production. The new patent will be valid until December 2041.

Portfolio Pulse from Benzinga Newsdesk

March 04, 2024 | 12:08 pm

UNCY

Unicycive Therapeutics, Inc. (NASDAQ:UNCY), a biotech company, announced that the FDA has granted orphan drug designation to UNI-494 for preventing Delayed Graft Function in kidney transplant patients. UNI-494 is a cytoprotective agent that works by activating KATP channels in mitochondria.

Portfolio Pulse from Benzinga Newsdesk

March 04, 2024 | 12:05 pm

EDAP

EDAP TMS SA announced its Focal One platform received FDA Breakthrough Device designation for treating deep infiltrating rectal endometriosis. Previously, in June 2018, the FDA cleared Focal One for prostatic tissue ablation.

Portfolio Pulse from Benzinga Newsdesk

March 04, 2024 | 12:02 pm

BDX

Becton, Dickinson (BDX) has started the AGILITY clinical study to evaluate the safety and effectiveness of its BD Vascular Covered Stent for Peripheral Arterial Disease. The study will involve 315 patients across the US, Europe, Australia, and New Zealand, with follow-ups ranging from one month to 36 months.

Portfolio Pulse from Benzinga Newsdesk

March 04, 2024 | 11:52 am

SWTX

SpringWorks Therapeutics has begun a rolling submission of a New Drug Application to the FDA for Mirdametinib, aimed at treating Neurofibromatosis Type 1-associated Plexiform Neurofibromas in both pediatric and adult patients. The submission process is expected to be completed by the second quarter of 2024.

Portfolio Pulse from Benzinga Newsdesk

March 04, 2024 | 11:37 am

IOVA

The FDA has lifted a partial clinical hold on Iovance Biotherapeutics' IOV-LUN-202 trial, which is investigating LN-145 TIL cell therapy for non-small cell lung cancer. This development could potentially accelerate the trial's progress and bring the therapy closer to market.

Portfolio Pulse from Benzinga Newsdesk

March 04, 2024 | 11:35 am