Streetbeat News

Regulatory

BIIB

Biogen announced that QALSODY (tofersen), its therapy for a rare, genetic form of ALS, received a positive opinion from CHMP. The recommendation will be reviewed by the EC for marketing authorization in the EU, with a decision expected in Q2 2024.

Portfolio Pulse from Benzinga Newsdesk

February 23, 2024 | 12:01 pm

MRK

Merck announced receiving a positive opinion from the EU CHMP for KEYTRUDA, in combination with chemotherapy, as a neoadjuvant and then as a monotherapy adjuvant treatment for resectable NSCLC at high risk of recurrence. This marks a significant step forward in the treatment options available for NSCLC patients, potentially improving Merck's market position in oncology treatments.

Portfolio Pulse from Benzinga Newsdesk

February 23, 2024 | 11:24 am

BCLI

Brainstorm Cell Therapeutics has submitted a Special Protocol Assessment (SPA) request to the FDA for a Phase 3B trial of NurOwn in Amyotrophic Lateral Sclerosis (ALS). This step is crucial for advancing the treatment's development and potentially bringing it closer to market approval.

Portfolio Pulse from Benzinga Newsdesk

February 23, 2024 | 11:06 am

GM

General Motors Co's (NYSE:GM) self-driving car unit, Cruise, is set to resume robotaxi testing in Texas with safety drivers in the coming weeks, following a suspension due to a pedestrian accident. Despite a reported operating loss of $3.48 billion in 2023, GM remains committed to Cruise, planning to reduce spending but continue investing in self-driving technology.

Portfolio Pulse from Anan Ashraf

February 23, 2024 | 9:02 am

T

TMUS

VZ

AT&T (NYSE:T) experienced a nationwide service outage affecting calls, texts, and data, including 911 access, which was resolved within a day. The outage, caused by an internal error and not a cyber attack, impacted users across the U.S. The FCC is investigating the incident, and AT&T is taking steps to prevent future occurrences. Other carriers like Verizon (NYSE:VZ) and T-Mobile (NASDAQ:TMUS) were unaffected.

Portfolio Pulse from Rounak Jain

February 23, 2024 | 7:33 am

AMZN

GOOGL

MSFT

Saudi Arabia's Public Investment Fund (PIF) is positioning the kingdom as a potential AI hub outside the U.S., leveraging its energy resources and funding capabilities. The announcement was made by Yasir Al-Rumayyan at an investment event in Miami. Saudi Arabia plans to use its position as a global leader in energy and its financial resources to support AI projects, with PIF allocating over 70% of its funds domestically and 20%-25% internationally, aiming to increase its annual fund deployment to $70 billion by 2025-2030. This move aligns with Saudi Arabia's strategy to attract global tech giants and invest in AI infrastructure, despite financial strains.

Portfolio Pulse from Benzinga Neuro

February 23, 2024 | 7:11 am

REGN

SNY

Regeneron Pharmaceuticals and Sanofi have announced that their joint product, Dupixent, has been granted FDA Priority Review for the treatment of COPD with Type 2 inflammation. This comes after positive results from two Phase 3 trials. If approved, Dupixent would become the only biologic therapy for COPD, marking the first new treatment approach for the disease in over a decade. Regulatory submissions for Dupixent are also under review in China and Europe. Currently, Dupixent is the leading biologic treatment in the U.S. for all five of its FDA-approved indications.

Portfolio Pulse from Benzinga Newsdesk

February 23, 2024 | 6:40 am

BTCUSD

Cryptocurrency exchange Kraken is seeking to dismiss an SEC lawsuit, arguing that cryptocurrencies are commodities, not securities. The SEC had sued Kraken for operating without proper registration, but Kraken contends that the SEC's claims don't meet the Howey Test criteria for securities. Kraken also accuses the SEC of overstepping its jurisdiction without clear Congressional authorization.

Portfolio Pulse from Mehab Qureshi

February 23, 2024 | 5:58 am

BTCUSD

ETHUSD

MATICUSD

Reddit has disclosed investments in Bitcoin, Ethereum, and Polygon ahead of its $5B IPO filing. The social platform aims to use these cryptocurrencies for transactions and to enhance its product and engineering teams' understanding of digital assets. This move comes as Reddit prepares to list on the NYSE under the ticker RDDT.

Portfolio Pulse from Mehab Qureshi

February 23, 2024 | 5:10 am

BTCUSD

Former President Donald Trump, known for his criticism of cryptocurrencies and central bank digital currencies (CBDCs), has shown a softened stance towards Bitcoin (BTC) in a recent Fox News appearance. While still expressing a preference for the dollar, Trump acknowledged Bitcoin's growing popularity and its increasing use in payments, suggesting a potential need for regulation. This marks a notable shift from his previous outright opposition to cryptocurrencies.

Portfolio Pulse from Mehab Qureshi

February 23, 2024 | 4:50 am