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Regulatory

BHP

BHP forecasts a 70% increase in global copper demand by 2050, driven by economic growth, green energy, and digital developments. Despite recycling efforts, new mining projects are essential due to aging mines and declining ore grades.

Portfolio Pulse from Stjepan Kalinic

October 01, 2024 | 11:34 am

CTSO

CytoSorbents has submitted a De Novo marketing application to the FDA for its DrugSorb-ATR medical device. This device aims to reduce perioperative bleeding in patients on Ticagrelor undergoing coronary artery bypass graft surgery.

Portfolio Pulse from Benzinga Newsdesk

October 01, 2024 | 11:27 am

SGMT

The FDA has granted Breakthrough Therapy Designation to Sagimet Biosciences' drug Denifanstat for treating noncirrhotic metabolic dysfunction-associated steatohepatitis with moderate to advanced liver fibrosis. This designation could expedite the development and review process for the drug.

Portfolio Pulse from Benzinga Newsdesk

October 01, 2024 | 11:25 am

EDAP

EDAP TMS SA has initiated a Phase I/II trial for its Focal One® robotic HIFU technology to treat benign prostatic hyperplasia (BPH). The trial aims to establish optimal treatment parameters and validate the safety and efficacy of this less invasive approach.

Portfolio Pulse from Benzinga Newsdesk

October 01, 2024 | 11:21 am

SRDX

Surmodics has received FDA 510(k) clearance for its Pounce XL Thrombectomy System. The company plans a limited market release in the first half of 2025, followed by full commercialization.

Portfolio Pulse from Benzinga Newsdesk

October 01, 2024 | 11:08 am

EYEN

Eyenovia, Inc. has started manufacturing registration batches of its FDA-approved mydriasis product, Mydcombi, for the Gen-2 Optejet platform. This step is crucial for FDA approval, with testing expected to complete by the end of next year and a potential SNDA filing in early 2026.

Portfolio Pulse from Benzinga Newsdesk

October 01, 2024 | 11:07 am

IONS

Ionis Pharmaceuticals' drug zilganersen has received FDA Fast Track designation for treating Alexander disease, a rare neurological disorder. This designation aims to expedite the drug's development and review process. Topline data from the pivotal study is expected in the second half of 2025.

Portfolio Pulse from Benzinga Newsdesk

October 01, 2024 | 11:04 am

IVVD

Invivyd, Inc. (NASDAQ:IVVD) announced that the FDA has updated the EUA Fact Sheet for their COVID antibody PEMGARDA, confirming its neutralization power against key variants. The update removes previous concerns about reduced susceptibility to certain variants.

Portfolio Pulse from Benzinga Newsdesk

October 01, 2024 | 11:03 am

BNOX

Bionomics Limited plans to re-domicile from Australia to the US, creating a new parent company, Neuphoria Therapeutics Inc., which will be listed on Nasdaq. This move requires shareholder and regulatory approval.

Portfolio Pulse from Benzinga Newsdesk

October 01, 2024 | 10:37 am

SPY

The White House announced that President Biden and Vice President Harris are closely monitoring a strike at East Coast and Gulf Coast ports. The President has directed his Supply Chain Disruptions Task Force to meet daily to address potential disruptions.

Portfolio Pulse from Benzinga Newsdesk

October 01, 2024 | 10:25 am