Streetbeat News

Regulatory

NNOX

Nanox, known by its ticker NNOX, has received FDA clearance for its HealthFLD system, marking a significant milestone for the company. This approval could potentially open up new markets and increase the company's revenue streams, as it allows them to commercialize their HealthFLD system in the United States.

Portfolio Pulse from Benzinga Newsdesk

February 13, 2024 | 1:03 pm

CADL

Candel Therapeutics, Inc. (NASDAQ:CADL) announced that its CAN-3110, a herpes simplex virus-1 based immunotherapy for recurrent high-grade glioma, received FDA Fast Track Designation to improve overall survival.

Portfolio Pulse from Benzinga Newsdesk

February 13, 2024 | 12:31 pm

AAPL

MSFT

VGK

The European Commission concluded its market investigations under the Digital Markets Act, finding that neither Apple nor Microsoft qualify as gatekeepers for services like iMessage, Bing, Edge, and Microsoft Advertising.

Portfolio Pulse from Charles Gross

February 13, 2024 | 12:27 pm

RCKT

The FDA has extended the priority review period for Rocket Pharmaceuticals' Kresladi application for severe Leukocyte Adhesion Deficiency-I by three months to June 30, 2024. This extension is to allow additional time for the review of clarifying Chemistry, Manufacturing, and Controls (CMC) information submitted by Rocket in response to FDA requests. The FDA also confirmed that an advisory committee meeting is not needed.

Portfolio Pulse from Benzinga Newsdesk

February 13, 2024 | 12:27 pm

KRYS

The FDA has granted Fast Track designation to Krystal Biotech's KB707, an inhaled treatment for solid tumors with pulmonary metastases that are relapsed or refractory to standard of care therapy. This designation could accelerate the development and review process for KB707, potentially bringing it to patients sooner.

Portfolio Pulse from Benzinga Newsdesk

February 13, 2024 | 12:22 pm

QQQ

SPY

TRIP

ZI

Wall Street is set for a weaker open as traders await the consumer price inflation report for January, with concerns over overbought levels and the Federal Reserve's rate trajectory. Fund manager Louis Navellier expects benign inflation numbers, highlighting shelter costs as a key component. U.S. stocks closed mixed on Monday, with the Dow re-entering record territory. The SPDR S&P 500 ETF Trust and the Invesco QQQ ETF saw premarket declines. Several companies, including ZoomInfo Technologies and Tripadvisor, moved on earnings news or strategic announcements.

Portfolio Pulse from Shanthi Rexaline

February 13, 2024 | 11:39 am

KALV

KalVista Pharmaceuticals announced positive results from its Phase 3 Konfident trial, showing that Sebetralstat, an oral on-demand therapy for Hereditary Angioedema, has statistically and clinically significant efficacy. This marks a significant milestone for the company and potentially for patients suffering from this condition.

Portfolio Pulse from Benzinga Newsdesk

February 13, 2024 | 11:38 am

AAPL

FCC Commissioner Brendan Carr has urged an investigation into Apple Inc. (NASDAQ:AAPL) for blocking the Beeper Mini service, which aimed to make iMessage available on Android. Carr suggests this action may violate FCC's Part 14 rules on accessibility for individuals with disabilities. This follows Apple's decision to shut down Beeper Mini in December, leading to calls for an antitrust investigation into Apple's practices.

Portfolio Pulse from Benzinga Neuro

February 13, 2024 | 10:44 am

BYDDY

China's leading battery and car manufacturers, including BYD Co Ltd (OTC:BYDDY) and CATL, have formed the China All-Solid-State Battery Collaborative Innovation Platform (CASIP) to develop solid-state batteries for electric vehicles (EVs). This initiative aims to establish a solid-state battery supply chain by 2030, challenging the dominance of Japanese and Western companies in the EV market. The move is significant amid a U.S. ban on Pentagon battery procurements from Chinese manufacturers, set to commence in October 2027.

Portfolio Pulse from Benzinga Neuro

February 13, 2024 | 9:52 am

AN

CBAY

FANG

KO

LYFT

MAR

The CNN Money Fear and Greed index remained in the 'Extreme Greed' zone at 77.71. U.S. stocks had a mixed close with the Dow Jones hitting a record high. Diamondback Energy announced a merger with Endeavor Energy Resources, and Gilead Sciences agreed to acquire CymaBay Therapeutics. The U.S. Federal budget deficit decreased, and inflation data is awaited. Sectors like utilities, energy, and materials gained, while IT and real estate fell. Earnings from AutoNation, Lyft, Coca-Cola, and Marriott are anticipated.

Portfolio Pulse from Avi Kapoor

February 13, 2024 | 8:43 am