Streetbeat News

Regulatory

MO

PM

The FDA has rescinded its June 2022 marketing denial orders for JUUL Labs, returning JUUL's applications to pending status under FDA review. This action is prompted by new case law and additional information from JUUL. The rescission is neither an authorization nor a denial.

Portfolio Pulse from Benzinga Newsdesk

June 06, 2024 | 1:09 pm

TLSA

Tiziana Life Sciences reported six-month qualitative results for 10 non-active Secondary Progressive Multiple Sclerosis (na-SPMS) patients in their Expanded Access Program. 80% of patients showed improvements in PET imaging. The FDA has allowed an additional 20 patients to be enrolled, and Tiziana has applied for FDA Orphan Drug Designation for foralumab.

Portfolio Pulse from Benzinga Newsdesk

June 06, 2024 | 1:09 pm

AAPL

TUR

The Competition Authority is conducting an inquiry into the mobile ecosystems sector, focusing on the structure and competition issues in smart mobile devices. The investigation includes examining Apple's agreements and App Store review guidelines for potential restrictions on developers' payment systems.

Portfolio Pulse from Benzinga Newsdesk

June 06, 2024 | 1:04 pm

MRNA

Moderna shares are trading higher after the FDA selected mRNA-3705 for the START pilot program, which supports clinical trials advancing rare disease therapeutics.

Portfolio Pulse from Benzinga Newsdesk

June 06, 2024 | 1:00 pm

CTHR

Charles & Colvard has regained compliance with Nasdaq's minimum bid price requirement, ensuring its continued listing on the exchange.

Portfolio Pulse from Benzinga Newsdesk

June 06, 2024 | 12:58 pm

LLY

FDA staff reviewers have reported a higher number of deaths in participants treated with Donanemab compared to those given a placebo. The deaths were not fully explained by ARIA or cerebral hemorrhage.

Portfolio Pulse from Benzinga Newsdesk

June 06, 2024 | 12:56 pm

F

GM

TSLA

Indonesia's president-elect Prabowo Subianto aims to continue building the nation's nickel industry and EV ambitions, which will likely increase coal consumption. The country is balancing its relationship with China, the largest investor in its nickel industry, and potential Western investors concerned about environmental impacts. Companies like Hyundai, General Motors, Ford, and Tesla are involved in Indonesia's EV and battery production plans.

Portfolio Pulse from Matt Whittaker

June 06, 2024 | 12:55 pm

SNGX

Trading for SNGX was halted and then resumed at 8:55:00 AM ET. The halt was due to pending news, and trading resumed after the news was released.

Portfolio Pulse from Benzinga Newsdesk

June 06, 2024 | 12:55 pm

NVAX

Novavax Inc. (NASDAQ: NVAX) shares surged 21.60% in pre-market trading after announcing plans to deliver a COVID-19 vaccine by September, following a recommendation from a U.S. regulatory advisory group.

Portfolio Pulse from Benzinga Neuro

June 06, 2024 | 12:46 pm

FRGT

NVAX

ONMD

Market-Moving News for June 6th highlights significant developments for Freight Technologies, Novavax, and OneMedNet Corp. Freight Technologies added new customers and carriers, Novavax received an FDA advisory committee recommendation for updated vaccines, and OneMedNet Corp joined the Amazon Web Services Partner Network.

Portfolio Pulse from ryanfaloona@benzinga.com

June 06, 2024 | 12:44 pm