Streetbeat News

Regulatory

BBIO

The FDA has accepted BridgeBio Pharma's New Drug Application for Acoramidis for the treatment of Transthyretin Amyloid Cardiomyopathy, with a decision expected by November 29.

Portfolio Pulse from Benzinga Newsdesk

February 05, 2024 | 12:34 pm

MBOT

Microbot Medical has submitted an Investigational Device Exemption (IDE) application to the FDA, aiming to gain approval to start its pivotal clinical trial in the US. This step is crucial for advancing the company's medical device through the regulatory process and potentially bringing it closer to market.

Portfolio Pulse from Benzinga Newsdesk

February 05, 2024 | 12:33 pm

META

Meta's Oversight Board has criticized the company's current deepfake rules as 'incoherent' after reviewing a controversial video of President Joe Biden. The board suggests extending the manipulated media policy to cover all audio and video content, not just AI-generated material. Meta plans to update its policy to adapt to the evolving AI landscape. This comes amid growing concerns over deepfake content and its potential misuse, with Meta committed to advancing AI technology.

Portfolio Pulse from Benzinga Neuro

February 05, 2024 | 12:21 pm

BTAI

The U.S. Patent and Trademark Office has allowed a patent application for BioXcel Therapeutics' BXCL501, a treatment for agitation in Alzheimer's patients. The patent covers various formulations and is expected to expire on Dec. 29, 2037, with potential adjustments.

Portfolio Pulse from Benzinga Newsdesk

February 05, 2024 | 12:05 pm

BMY

TSVT

The FDA's Oncologic Drugs Advisory Committee is set to review Bristol Myers Squibb and 2Seventy Bio's supplemental application for Abecma, aimed at treating triple-class exposed relapsed or refractory multiple myeloma, in a virtual meeting on March 15.

Portfolio Pulse from Benzinga Newsdesk

February 05, 2024 | 12:02 pm

COIN

META

SQ

Dr. Craig Wright, claiming to be Bitcoin's creator, faces a UK trial to prove he is Satoshi Nakamoto. The trial, starting Feb. 5, could end speculation about Bitcoin's creator. Wright's involvement in Bitcoin SV and the trial's significance for Copa members like Block (SQ), Coinbase (COIN), and Meta (META) are highlighted.

Portfolio Pulse from Benzinga Neuro

February 05, 2024 | 11:57 am

TM

Toyota Motor Co (NYSE:TM) has clarified its stance on electric vehicles (EVs), stating that while it is not anti-EV, it does not view EVs as the sole solution to achieving carbon neutrality. The company is committed to a diversified strategy that includes battery electric vehicles (BEVs), hybrids, and potentially hydrogen fuel cell vehicles. This comes amid criticism from organizations like Greenpeace for Toyota's slow EV adoption and continued diesel production. Toyota's approach to environmental sustainability and its impact on the EV market share has been a topic of debate.

Portfolio Pulse from Benzinga Neuro

February 05, 2024 | 11:56 am

AAPL

META

Phil Schiller of Apple Inc. has expressed concerns about the EU's 'Alternative App Store' proposal under the Digital Markets Act, stating it could compromise iPhone users' security and privacy. Despite efforts to mitigate risks, including a notarization process for apps, limitations in user protections and feature access remain. The proposal has also faced criticism from Meta Platforms Inc.'s CEO, Mark Zuckerberg.

Portfolio Pulse from Rounak Jain

February 05, 2024 | 11:46 am

SPY

Peter Schiff criticized Federal Reserve Chair Jerome Powell for downplaying the national debt as a long-term issue, arguing it poses a significant short-term threat. Schiff's comments come amid concerns over the U.S. debt reaching $34.20 trillion and potential economic impacts. The SPDR S&P 500 ETF Trust (SPY) saw a 1.25% increase to $494.3.

Portfolio Pulse from Shanthi Rexaline

February 05, 2024 | 10:26 am

ALTM

BIGC

CYTK

GRPN

KB

LYG

MODG

SAN

U.S. stock futures were lower, with Dow futures down over 100 points. Banco Santander (SAN) and Lloyds Banking Group (LYG) shares fell in pre-market trading after reports that Iranian entities used their accounts to evade U.S. sanctions. Other stocks like Cytokinetics (CYTK), Groupon (GRPN), BigCommerce Holdings (BIGC), KB Financial Group (KB), Topgolf Callaway Brands (MODG), and Arcadium Lithium (ALTM) also recorded losses in pre-market trading.

Portfolio Pulse from Avi Kapoor

February 05, 2024 | 10:21 am