Streetbeat News

Regulatory

GRCL

Gracell Biotechnologies has received FDA clearance for its Investigational New Drug (IND) application, allowing it to proceed with a Phase 1 trial in the U.S. for GC012F, a treatment for early-line multiple myeloma.

Portfolio Pulse from Benzinga Newsdesk

January 29, 2024 | 12:04 pm

TNXP

Tonix Pharmaceuticals has received conditional acceptance from the FDA for 'Tonmya' as the trade name for its drug TNX-102 SL, which is designed for the management of fibromyalgia.

Portfolio Pulse from Benzinga Newsdesk

January 29, 2024 | 12:03 pm

BOOM

Trading for the stock with the symbol BOOM has been halted at 6:55 a.m. ET due to pending news. The halt is in place to manage market orderliness and investor protection pending the release of material news.

Portfolio Pulse from Benzinga Newsdesk

January 29, 2024 | 11:55 am

GSK

GSK plc (NYSE:GSK) received marketing authorization from the European Commission for Omjjara (momelotinib), a treatment for splenomegaly or symptoms in adult patients with certain types of myelofibrosis. GSK is also seeking EMA approval to expand the use of its RSV vaccine to adults aged 50-59.

Portfolio Pulse from Benzinga Newsdesk

January 29, 2024 | 11:38 am

BATRK

BTSG

GCT

MOR

NUKK

PHG

RVNC

RYAAY

Philips (NYSE:PHG) shares fell 5.6% in pre-market trading after Q4 results and a consent decree with the FDA. Other stocks also moved lower: Nukkleus (NASDAQ:NUKK), Atlanta Braves Holdings (NASDAQ:BATRK), BrightSpring Health Services (NASDAQ:BTSG), GigaCloud Technology (NASDAQ:GCT), Revance Therapeutics (NASDAQ:RVNC), MorphoSys AG (NASDAQ:MOR), and Ryanair Holdings (NASDAQ:RYAAY) due to various company-specific news and recent performance.

Portfolio Pulse from Avi Kapoor

January 29, 2024 | 10:07 am

AAPL

Bloomberg columnist Mark Gurman suggests that iOS 18 could be the most significant update in iPhone history, with anticipated features like RCS support and enhanced Siri functionality using generative AI. Apple Inc. (NASDAQ:AAPL) plans to release iOS 18 in September, following a strategic pause in development to focus on AI capabilities and software quality. This update is crucial as Apple shifts focus to software innovation amid fewer hardware breakthroughs expected for the iPhone 16.

Portfolio Pulse from Ananya Gairola

January 29, 2024 | 9:52 am

BP is facing pressure from activist investors to abandon its commitment to clean energy initiatives. These investors are pushing for a focus on more profitable oil and gas operations, challenging the company's strategy to transition towards more sustainable energy sources.

Portfolio Pulse from Charles Gross

January 29, 2024 | 9:40 am

CCGDF

China plans to merge three state-owned bad debt asset managers with its sovereign wealth fund, China Investment Corp, to stabilize the capital markets and restore investor confidence. This follows a stock market drop due to financial risks in the real estate sector and a recent suspension of restricted share lending. The merger is part of Beijing's reform agenda and comes after the central bank's move to ease the cash crunch for developers. Despite efforts to reassure investors, concerns about China's economic health and potential banking system collapse remain.

Portfolio Pulse from Benzinga Neuro

January 29, 2024 | 9:22 am

ALVO

Alvotech (NASDAQ:ALVO) announced positive top-line results from a pharmacokinetic study for AVT03, a proposed biosimilar for Prolia and Xgeva. The study met its primary endpoints, demonstrating pharmacokinetics, safety, and tolerability of AVT03 compared to Prolia in healthy adults. Further studies, including a confirmatory efficacy study and a PK study comparing AVT03 to Xgeva, are in progress.

Portfolio Pulse from Benzinga Newsdesk

January 29, 2024 | 9:02 am

BABA

BIDU

XIACF

China has approved over 40 AI models for public use in the last six months, aiming to compete with U.S. AI development. The approval process, introduced in August, has seen companies like Xiaomi, 4Paradigm, and 01.AI benefit from the endorsement of 14 large language models. Baidu, Alibaba, and ByteDance were among the first to receive approval. Despite the AI push, there hasn't been a significant increase in cloud services spending in China. Concerns over AI misuse for espionage have been raised by the FBI. Baidu's Ernie Bot reached 100 million users in December.

Portfolio Pulse from Benzinga Neuro

January 29, 2024 | 8:41 am