Streetbeat News

Regulatory

IVVD

Invivyd is set to present data from its Phase 1 and Phase 3 clinical trials of Pemivibart at IDweek 2024 in Los Angeles. The conference will take place from October 16-19, 2024.

Portfolio Pulse from Benzinga Newsdesk

October 16, 2024 | 11:16 am

BLRX

BioLineRx has announced that the United States Patent and Trademark Office (USPTO) has allowed a new composition of matter patent for Motixafortide. This patent strengthens BioLineRx's intellectual property portfolio and could enhance its competitive position in the market.

Portfolio Pulse from Benzinga Newsdesk

October 16, 2024 | 11:07 am

OKYO

OKYO Pharma has commenced patient screening and recruitment for a Phase 2 trial of OK-101 for neuropathic corneal pain. The trial will involve 48 patients and aims to measure pain relief using the Visual Analog Scale.

Portfolio Pulse from Benzinga Newsdesk

October 16, 2024 | 11:05 am

CGEM

Cullinan Therapeutics has received FDA clearance for its investigational new drug application for CLN-978. The company can now proceed with a global Phase 1 trial in the U.S. to assess CLN-978 in patients with moderate to severe systemic lupus erythematosus.

Portfolio Pulse from Benzinga Newsdesk

October 16, 2024 | 11:02 am

ACET

Adicet Bio's stock is rising following the FDA's clearance of an IND amendment to study ADI-001 for idiopathic inflammatory myopathy and stiff person syndrome.

Portfolio Pulse from Benzinga Newsdesk

October 16, 2024 | 11:02 am

ACET

Adicet Bio has received FDA clearance for an IND amendment to evaluate ADI-001 in treating idiopathic inflammatory myopathy and stiff person syndrome. This development could potentially expand the therapeutic applications of ADI-001.

Portfolio Pulse from Benzinga Newsdesk

October 16, 2024 | 11:01 am

GSK

The FDA has accepted the US marketing application for GSK's gepotidacin, an oral antibiotic for uncomplicated urinary tract infections (uUTIs) in adult and adolescent females. The decision date is set for March 26, 2025. Gepotidacin could be the first new class of oral antibiotic for uUTIs in over 20 years, supported by positive phase III trial results.

Portfolio Pulse from Benzinga Newsdesk

October 16, 2024 | 10:37 am

MLEC

Moolec Science SA (NASDAQ:MLEC) has received USDA approval for its genetically engineered peas, marking a significant milestone in Molecular Farming. This is the third regulatory clearance from USDA-APHIS for Moolec, following approvals for safflower and soybean. The approval allows Moolec to expand field trials and commercialization, positioning the company as a leader in innovative, sustainable food production.

Portfolio Pulse from Benzinga Newsdesk

October 16, 2024 | 10:04 am

LNZA

LanzaTech Global, Inc. (NASDAQ:LNZA) has received a $3 million grant from the U.S. Department of Energy to support its project focused on converting waste carbon dioxide into valuable chemicals. This funding is part of a larger $29 million initiative by the DOE to advance carbon management technologies.

Portfolio Pulse from Benzinga Newsdesk

October 16, 2024 | 10:02 am

INTC

The China Cybersecurity Association has recommended a cybersecurity review of Intel products sold in China. This move could impact Intel's operations and sales in the Chinese market.

Portfolio Pulse from Benzinga Newsdesk

October 16, 2024 | 9:25 am