Streetbeat News

Regulatory

AMGN

Amgen Inc (NASDAQ:AMGN) announced positive Phase 3 trial results for Uplizna in treating Immunoglobulin G4-related disease. The trial met all primary and secondary endpoints, showing significant efficacy and safety. Amgen plans to seek expanded US approval for Uplizna, which was acquired through a $27.8 billion deal with Horizon Therapeutics.

Portfolio Pulse from Vandana Singh

June 05, 2024 | 7:26 pm

ATAI

CYBN

MNMD

PSIL

FDA advisors rejected MDMA for PTSD treatment, causing a significant drop in psychedelic stocks. Cybin Inc (CYBN), Mind Medicine (MNMD), ATAI Life Sciences (ATAI), and AdvisorShares Psychedelics ETF (PSIL) all saw declines. The ruling is a setback for the industry, though the FDA is not bound by the advisory board's recommendation.

Portfolio Pulse from Aaron Bry

June 05, 2024 | 7:26 pm

MDT

Medtronic Plc (NYSE:MDT) has initiated a recall for some versions of its StealthStation S8 application due to a software error. The FDA classified the recall as Class I, the most serious kind. The error could lead to serious permanent injuries during cranial procedures. Medtronic plans to offer a software update to resolve the issue. MDT shares are down 1.41%.

Portfolio Pulse from Vandana Singh

June 05, 2024 | 7:23 pm

BNTX

JNJ

MRNA

NVAX

PFE

FDA advisers have recommended the inclusion of the JN1 COVID variant in vaccines. This decision could impact companies involved in vaccine production, such as BioNTech (BNTX), Johnson & Johnson (JNJ), Moderna (MRNA), Novavax (NVAX), and Pfizer (PFE).

Portfolio Pulse from Benzinga Newsdesk

June 05, 2024 | 7:23 pm

AZN

BNTX

JNJ

MRNA

NVAX

PFE

FDA advisers have voted in favor of recommending a new Covid vaccine targeting the JN.1 lineage for the 2024-25 campaign.

Portfolio Pulse from Benzinga Newsdesk

June 05, 2024 | 6:51 pm

FXI

USO

VGK

Russian President Vladimir Putin highlighted the strong prospects for high-tech cooperation between Russia and China, praised China's economic model, and criticized the USA for attempting to hinder China's economic development. Additionally, Putin noted the positive development of Russia-Iran relations and expressed a desire for increased high-tech collaboration with Iran.

Portfolio Pulse from Benzinga Newsdesk

June 05, 2024 | 6:34 pm

RIOT

Riot Platforms, Inc. (NASDAQ:RIOT) saw a significant stock decline following a bearish report from Kerrisdale Capital. The report criticized Riot's business model, emphasizing energy arbitrage and stock issuance over Bitcoin mining. Technical indicators suggest a continued bearish trend, with the stock trading below key moving averages and other indicators signaling selling pressure. Investors are advised to approach with caution.

Portfolio Pulse from Surbhi Jain

June 05, 2024 | 6:33 pm

ASNS

Actelis Networks, Inc. (NASDAQ:ASNS) shares surged 700% following new orders for its cyber-hardened technology to be deployed at three U.S. military bases. The company achieved critical government security certifications and aims to modernize military bases with its networking solutions.

Portfolio Pulse from Vaishali Prayag

June 05, 2024 | 6:25 pm

MRNA

Moderna shares are trading higher after the company announced that its COVID-19 vaccine for the JN.1 variant neutralizes newer strains. Additionally, the FDA will vote on vaccine recommendations for 2024-2025.

Portfolio Pulse from Benzinga Newsdesk

June 05, 2024 | 6:07 pm

STLA

Stellantis has announced that no additional recall actions are planned beyond the current announcements. However, the company has not ruled out the possibility of future precautionary recalls.

Portfolio Pulse from Benzinga Newsdesk

June 05, 2024 | 6:03 pm