Streetbeat News

Regulatory

BMRA

Biomerica Inc has submitted the final H. Pylori data-set to the FDA, as requested during the FDA's recent review of the 510-k filed by the company.

Portfolio Pulse from Benzinga Newsdesk

September 19, 2023 | 5:24 pm

VYGR

Voyager Therapeutics has been granted a U.S. patent for AADC polynucleotides, which are used in the treatment of Parkinson's disease.

Portfolio Pulse from Benzinga Newsdesk

September 19, 2023 | 5:07 pm

CWBHF

A coalition of top cannabidiol (CBD) companies, ONE HEMP, has been launched to advocate for legislation and FDA regulation of hemp-derived CBD products as dietary supplements. The alliance includes major industry players such as Charlotte’s Web (OTCQX:CWBHF), BayMedica, Brands, FSOil, Hemp Beverage Alliance, Kazmira, MAD TASTY, Open Book Extracts, and Wyld. The coalition was formed in response to the FDA's decision not to regulate CBD products as food and dietary supplements and the subsequent potential framework presented by the agency.

Portfolio Pulse from Nina Zdinjak

September 19, 2023 | 4:31 pm

LMT

SPY

The White House's Pentagon spokesperson, John Kirby, has announced that the Pentagon will investigate and be transparent about the disappearance of an F-35. The F-35 is a stealth multirole fighter jet developed by Lockheed Martin.

Portfolio Pulse from Benzinga Newsdesk

September 19, 2023 | 4:29 pm

DIS

FOX

FOXA

Dwayne 'The Rock' Johnson's Pro Football League XFL and USFL, owned by Fox Corp, are considering a merger. The merger would require regulatory approval and aims to be finalized before the 2024 seasons. The merged league's game broadcasts may be divided between Fox and XFL media partner Walt Disney Co, while the USFL also has a broadcast agreement with NBC.

Portfolio Pulse from Anusuya Lahiri

September 19, 2023 | 4:27 pm

FXI

SPY

The White House's spokesperson, Kirby, announced that the U.S. is looking to reopen military-to-military communication with China. This news was reported by MSNBC.

Portfolio Pulse from Benzinga Newsdesk

September 19, 2023 | 4:25 pm

ARQT

Arcutis Biotherapeutics Inc announced that its INTEGUMENT-PED Phase 3 trial of roflumilast cream 0.05% for children with atopic dermatitis met its primary and all secondary endpoints. The company plans to submit a supplemental New Drug Application for the cream for children aged 2 to 5 years, following potential approval of roflumilast cream 0.15% for adults and children aged six years and older. ARQT shares are down 0.47% at $6.46.

Portfolio Pulse from Vandana Singh

September 19, 2023 | 4:20 pm

BRDS

Trading of Bird Global shares has been halted due to pending news.

Portfolio Pulse from Benzinga Newsdesk

September 19, 2023 | 4:03 pm

SPY

The U.S. House's procedural vote on a short-term funding measure has been delayed to allow more time for negotiations, according to House Minority Leader Kevin McCarthy.

Portfolio Pulse from Benzinga Newsdesk

September 19, 2023 | 4:01 pm

NSTG

The European Unified Patent Court (UPC) has granted a preliminary injunction against NanoString Technologies, Inc. (NASDAQ:NSTG) in 17 EU Member States, temporarily blocking the company's ability to market and sell its CosMx Spatial Molecular Imager products for RNA detection. This is part of an ongoing patent dispute with 10x Genomics and Harvard. NanoString plans to immediately appeal the decision and remains confident that it does not infringe the asserted patents. The ruling does not affect NanoString's ability to market or sell CosMx SMI products for protein detection in the EU, or any products in the US, the UK, or the rest of the world outside of the EU member states participating in the UPC system.

Portfolio Pulse from Benzinga Newsdesk

September 19, 2023 | 3:56 pm