Streetbeat News

Regulatory

ONCY

Oncolytics Biotech (NASDAQ:ONCY) received positive feedback from the FDA for its planned trial of pelareorep in HR+/HER2- metastatic breast cancer. The FDA supports progression-free survival as the primary endpoint and overall survival as a key secondary endpoint.

Portfolio Pulse from Benzinga Newsdesk

June 27, 2024 | 11:05 am

ETHE

GBTC

Galaxy Research projects that Ethereum ETFs could attract significant capital, potentially reshaping the Ethereum ecosystem. The report estimates net inflows into ETH ETFs to be 20-50% of BTC ETF inflows, with a target of $1 billion/month. The SEC has approved applicant filings, but S-1 filings are still pending. The conversion of the Grayscale Ethereum Trust into an ETF is also expected to influence market dynamics.

Portfolio Pulse from Murtuza Merchant

June 27, 2024 | 11:01 am

FXI

NVO

Novo Nordisk will limit the launch of its weight-loss drug Wegovy in China to avoid disrupting global supply. The company aims to manage demand and ensure availability in other markets.

Portfolio Pulse from Benzinga Newsdesk

June 27, 2024 | 10:59 am

SFTBF

TEM

SoftBank Group Corp (OTC:SFTBF) and Tempus AI Inc (NASDAQ:TEM) have announced a joint venture, SB TEMPUS Corp., to enhance precision medicine in Japan using AI. The venture, launching in July 2024, aims to revolutionize cancer treatment by leveraging Tempus' AI technology. Both companies will invest JPY 15.0 billion each. Tempus also received FDA clearance for its AI-driven ECG-AF device.

Portfolio Pulse from Shivani Kumaresan

June 27, 2024 | 10:50 am

KALV

KalVista Pharmaceuticals has initiated the KONFIDENT-KID trial of sebetralstat in pediatric patients with hereditary angioedema. The trial will enroll approximately 24 children aged 2 to 11 years. If approved, sebetralstat would be the first oral on-demand therapy for this age group and the second FDA-approved on-demand therapy of any type in this population.

Portfolio Pulse from Benzinga Newsdesk

June 27, 2024 | 10:37 am

ELAN

Elanco Animal Health has announced the completion of major technical sections for Zenrelia, with FDA final approval expected in late Q3 2024. Additionally, the final FDA approval for Credelio Quattro is now anticipated in Q4 2024.

Portfolio Pulse from Benzinga Newsdesk

June 27, 2024 | 10:31 am

IONM

Assure Holdings filed two Form RWs on Wednesday, requesting the withdrawal of its offering and business combination filings.

Portfolio Pulse from Benzinga Newsdesk

June 27, 2024 | 10:08 am

NKTX

Nkarta has started the Ntrust-1 clinical trial for NKX019 in lupus nephritis and received FDA clearance for a second IND application for NKX019 in autoimmune diseases. The Ntrust-2 trial will target systemic sclerosis, idiopathic inflammatory myopathy, and ANCA-associated vasculitis. Clinical data from both trials are expected in 2025.

Portfolio Pulse from Benzinga Newsdesk

June 27, 2024 | 10:04 am

NKTX

Nkarta has initiated the Ntrust-1 study of NKX019 in lupus nephritis, with the first patient in screening. Additionally, the FDA has cleared a second investigational new drug application for NKX019 in autoimmune disease.

Portfolio Pulse from Benzinga Newsdesk

June 27, 2024 | 10:04 am

NOK

Nokia has signed a deal with the French State to sell its Submarine Networks Business (ASN) for €350M. Nokia will retain a 20% shareholding with board representation until a targeted exit, expected at the end of 2024 or beginning of 2025, pending regulatory approvals.

Portfolio Pulse from Benzinga Newsdesk

June 27, 2024 | 9:56 am