Streetbeat News

Regulatory

TLSA

The U.S. Food and Drug Administration (FDA) has approved at-home dosing of Intranasal Foralumab for multiple sclerosis patients. This decision was announced by Tiziana Life Sciences.

Portfolio Pulse from Benzinga Newsdesk

October 18, 2023 | 11:02 am

NTLA

Intellia Therapeutics has received FDA clearance for its IND application to initiate a pivotal Phase 3 trial of NTLA-2001 for the treatment of Transthyretin (ATTR) Amyloidosis with Cardiomyopathy.

Portfolio Pulse from Benzinga Newsdesk

October 18, 2023 | 11:01 am

AAPL

MSFT

TSLA

Microsoft CEO Satya Nadella has expressed concerns about the potential dangers of artificial intelligence (AI) and called for guidance from moral philosophers and developers. He compared AI to cars and airplanes, which are regulated and used within well-defined laws, suggesting a need for AI regulation. Earlier this year, over 1000 tech experts, including Elon Musk and Steve Wozniak, signed an open letter calling for a pause in AI developments until safety protocols are created.

Portfolio Pulse from Rounak Jain

October 18, 2023 | 10:45 am

SAGE

The FDA has granted Orphan Drug Designation to Sage Therapeutics' SAGE-718 for Huntington's Disease. This designation is given to drugs that are intended to treat rare diseases, providing certain benefits to the drug developer.

Portfolio Pulse from Benzinga Newsdesk

October 18, 2023 | 10:32 am

IMRN

Immuron Limited has commenced the second cohort of a clinical trial to evaluate the efficacy of Travelan for the prevention of infectious diarrhea caused by enterotoxigenic Escherichia coli. The study is being led by Dr Mohamed Al-Ibrahim at the Pharmaron CPC FDA inspected Clinical Research Facility Inpatient Unit in Baltimore, Maryland US.

Portfolio Pulse from Benzinga Newsdesk

October 18, 2023 | 10:03 am

BCLI

BrainStorm Cell Therapeutics is set to meet with the US FDA to discuss the development plan for NurOwn, a treatment for ALS. The company is withdrawing its Biologics License Application (BLA) for NurOwn, a decision coordinated with and viewed by the FDA as a withdrawal without prejudice. BrainStorm remains committed to the ALS community and is exploring next steps for NurOwn, including publishing emerging clinical data and developing a protocol for an additional clinical study.

Portfolio Pulse from Benzinga Newsdesk

October 18, 2023 | 10:03 am

SPY

VGK

Russian President Vladimir Putin has criticized the US for supplying ATACMS to Kyiv, calling it a mistake. He also ordered Russian warplanes equipped with Kinzhal missiles to regularly patrol the Black Sea, according to reports from Reuters, Tass, and IFAX.

Portfolio Pulse from Charles Gross

October 18, 2023 | 9:58 am

SPY

Federal Reserve's Harker has called for an extension of the pause on interest-rate increases, suggesting to 'see how things evolve' over the next few months. This news was reported by the Wall Street Journal.

Portfolio Pulse from Charles Gross

October 18, 2023 | 9:39 am

EIS

SPY

USO

President Biden, in a meeting with Israeli Prime Minister Netanyahu, suggested that the recent conflict was initiated by 'the other team', not Israel, according to NBC News.

Portfolio Pulse from Charles Gross

October 18, 2023 | 9:36 am

IHI

Elon Musk's Neuralink could generate over $220M in revenue from its N1 brain implant for ALS patients by 2030, according to Ark Investment Management analyst Pierce Jamieson. The N1 implant and R1 surgical robot are awaiting FDA approval. The technology could transform medicine and accelerate the link between humans and artificial intelligence, Jamieson said. Neuralink recently received FDA approval to commence its first-in-human clinical trial.

Portfolio Pulse from Shanthi Rexaline

October 18, 2023 | 9:16 am