Streetbeat News

Regulatory

CARM

Carisma Therapeutics has received FDA clearance for its Investigational New Drug (IND) application for CT-0525, a novel HER2-targeting CAR-monocyte therapy. The company plans to begin a Phase 1 study soon and anticipates treating the first patient in the first half of 2024.

Portfolio Pulse from Benzinga Newsdesk

November 28, 2023 | 12:05 pm

SWTX

The FDA has approved SpringWorks Therapeutics Inc's Ogsiveo for adult patients with progressing desmoid tumors, marking it as the first drug for this condition. The approval is based on the Phase 3 DeFi trial results, which showed a 71% reduction in the risk of disease progression and a 41% objective response rate compared to placebo. Ogsiveo will be available in the U.S. soon and a European application is expected in the first half of 2024. Analysts project U.S. sales of $3 million in 2023, $79 million in 2024, and peak sales of $544 million in 2032. SpringWorks' shares rose 9.24% in premarket trading.

Portfolio Pulse from Vandana Singh

November 28, 2023 | 11:43 am

AMZN

Senator Elizabeth Warren has criticized the $10 billion buyout of Subway by Roark Capital, which also owns Jimmy John's and Arby's, due to concerns over a potential sandwich shop monopoly. The FTC is investigating the deal. Warren's stance received mixed reactions on social media. The FTC's recent antitrust lawsuit against Amazon was also mentioned in the context of government scrutiny of monopolistic practices.

Portfolio Pulse from Shanthi Rexaline

November 28, 2023 | 11:22 am

EZFL

Ezfill Holdings has filed a Form S-1 with the SEC for a firm commitment public offering of its common stock. The size of the offering has not been disclosed.

Portfolio Pulse from Charles Gross

November 28, 2023 | 11:18 am

NVAX

The World Health Organization has granted Emergency Use Listing to Novavax's Nuvaxovid XBB.1.5 COVID-19 vaccine for active immunization in individuals aged 12 and older.

Portfolio Pulse from Benzinga Newsdesk

November 28, 2023 | 11:02 am

GS

Goldman Sachs CEO David Solomon highlighted that geopolitical tensions, especially between the US and China, are a significant obstacle for economic growth and may persist for years due to substantial differences, as reported by Reuters citing a Financial Times event.

Portfolio Pulse from Charles Gross

November 28, 2023 | 10:47 am

COIN

Coinbase CEO Brian Armstrong commented on Binance's $4.3 billion settlement with the U.S. federal government, suggesting that the era of crypto companies skirting regulation is over. Armstrong believes this enforcement action against Binance allows Coinbase to potentially become the leading crypto exchange. Despite facing its own lawsuit by the SEC, Armstrong is confident about Coinbase's regulatory compliance. He also highlighted the growing institutional interest in crypto and the potential impact of spot Bitcoin ETF approvals on the influx of capital into the crypto market.

Portfolio Pulse from Mehab Qureshi

November 28, 2023 | 10:25 am

META

Instagram, owned by Meta Platforms Inc. (NASDAQ:META), is under scrutiny for suggesting sexualized content of minors to adult users. The Wall Street Journal and the Canadian Centre for Child Protection confirmed these practices. Meta faces a lawsuit from 33 states for not addressing harm to young girls and failing to close underage accounts. Advertisers like Match and Bumble are reportedly withdrawing ads from Instagram. Meta has responded, emphasizing their commitment to preventing such content. This controversy raises questions about Meta's enforcement of policies against explicit content, especially following recent NSFW malware attacks on Facebook and criticism from a whistleblower.

Portfolio Pulse from Ananya Gairola

November 28, 2023 | 9:07 am

TSLA

Tesla Inc (NASDAQ:TSLA) was cleared by the U.S. labor board of wrongful dismissal claims in its Autopilot software department. The allegations, filed by Workers United, suggested the layoffs were to disrupt union organization. While these claims were dismissed, the board confirmed separate claims regarding Tesla's use of technology rules and attempts to solicit worker grievances to undermine union support. If Tesla doesn't settle, the NLRB will issue a complaint for an administrative judge to hear. This is part of a larger unionization effort at Tesla, with the company denying any illegal union-busting activities.

Portfolio Pulse from Benzinga Neuro

November 28, 2023 | 7:26 am

ARGX

argenx reported that its ADVANCE-SC study of VYVGART Hytrulo in Primary Immune Thrombocytopenia failed to meet primary or secondary endpoints, although it maintained a favorable safety and tolerability profile.

Portfolio Pulse from Benzinga Newsdesk

November 28, 2023 | 7:18 am