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Regulatory

TFFP

TFF Pharmaceuticals, Inc. (NASDAQ:TFFP) announced positive Phase 2 trial data for Tacrolimus Inhalation Powder (TFF TAC) for lung transplant rejection prevention, presented at the ISHLT Annual Meeting. The data show TFF TAC prevents rejection with lower doses and systemic exposures than oral tacrolimus, and normalizes rejection-related gene expressions. The company plans to advance the program into potentially registrational testing.

Portfolio Pulse from Benzinga Newsdesk

April 29, 2024 | 2:01 pm

AAPL

AMZN

GOOGL

META

MSFT

The European Commission has labeled Apple Inc.'s iPadOS as a 'gatekeeper' under the Digital Markets Act, affecting Apple and other tech giants like Alphabet Inc., Microsoft Corporation, Amazon.com Inc., and Meta Platforms Inc. This designation requires compliance with the DMA, potentially impacting Apple's operations and financials due to the risk of significant fines for non-compliance. The announcement follows a week of mixed news for Apple, including product updates and challenges in the market.

Portfolio Pulse from Benzinga Neuro

April 29, 2024 | 1:45 pm

IMMX

Immix Biopharma has been awarded the European Union Orphan Drug Designation for NXC-201, aimed at treating multiple myeloma. This designation grants NXC-201 ten years of market exclusivity in the EU, access to the EU centralized authorization procedure, and reduced fees for various regulatory and marketing processes.

Portfolio Pulse from Benzinga Newsdesk

April 29, 2024 | 1:39 pm

AZN

DSKYF

DSNKY

AstraZeneca reported positive results from a metastatic breast cancer treatment study for Enhertu, showing significant improvement in progression-free survival. Additionally, AstraZeneca's Truqap, in combination with Faslodex, is recommended for approval in the EU for certain breast cancer patients. Daiichi Sankyo, co-developer of Enhertu, also plays a role in these developments.

Portfolio Pulse from Vandana Singh

April 29, 2024 | 1:26 pm

BYDDF

NIO

TSLA

China's industrial association has released a list of 76 intelligent connected vehicle models that comply with the country's auto data security standards, including models from Tesla, BYD, Li Auto, Lotus, Hozon New Energy Automobile, and NIO. The vehicles underwent tests for compliance with data anonymization, non-collection of in-car data, in-car data processing, and notification of personal information processing, starting in November 2023.

Portfolio Pulse from Benzinga Newsdesk

April 29, 2024 | 1:19 pm

MULN

Mullen Automotive's stock is trading higher following the announcement that the California Air Resources Board has approved the 2024 Mullen THREE for inclusion in the Hybrid and Zero-Emission Truck and Bus Voucher Incentive Project.

Portfolio Pulse from Benzinga Newsdesk

April 29, 2024 | 1:17 pm

HCM

HUTCHMED's stock is trading higher following the announcement on Friday of a positive CHMP opinion for Fruquintinib.

Portfolio Pulse from Benzinga Newsdesk

April 29, 2024 | 1:17 pm

FCOM

META

XLC

The European Commission is set to investigate Meta Platforms Inc (NASDAQ:META) over concerns that Facebook and Instagram have not adequately combated Russian disinformation, potentially affecting electoral integrity. The probe will examine Meta's content moderation, political advertising, and the discontinuation of CrowdTangle, a tool for tracking disinformation. Meta has a five-day window to propose mitigation measures to comply with the EU's Digital Services Act, failing which could lead to regulatory actions. Meta's stock is trading lower by 1.1% in premarket trading.

Portfolio Pulse from Shivani Kumaresan

April 29, 2024 | 1:09 pm

MULN

Mullen Automotive announces the 2024 Mullen THREE EV truck, priced at $68,500, now eligible for up to $45,000 in HVIP incentives plus a $7,500 federal tax credit, potentially reducing its cost to under $17,000. The California Air Resources Board has approved the vehicle, highlighting its significance for businesses aiming to electrify their fleets. The Mullen THREE, a Class 3 low cab forward EV truck, offers a 125-mile range and is designed for various urban delivery and vocational needs.

Portfolio Pulse from Benzinga Newsdesk

April 29, 2024 | 1:05 pm

NKGN

NKGen Biotech's shares surged following the announcement of FDA clearance for its Investigational New Drug (IND) application for SNK01 NK cell therapy in Parkinson's Disease. This regulatory milestone is a significant step forward for the company's innovative treatment approach in a challenging therapeutic area.

Portfolio Pulse from Benzinga Newsdesk

April 29, 2024 | 12:52 pm