Streetbeat News

Regulatory

STLA

The U.S. National Highway Traffic Safety Administration (NHTSA) is investigating 781,459 Stellantis vehicles, including Jeep Wrangler and Gladiator models, for potential fire hazards. The probe follows a recall of over 1.2 million Ram 1500 vehicles due to software issues. The investigation focuses on fires occurring when the ignition is off, with reports indicating the power steering pump electrical connector as a potential source.

Portfolio Pulse from Benzinga Neuro

September 09, 2024 | 11:58 am

MRNA

Moderna's manufacturing facility in Laval, Quebec, has received a Drug Establishment License from Health Canada, allowing it to produce mRNA vaccines domestically. This milestone positions Moderna to ensure a reliable supply of vaccines in Canada, with production expected to start in 2025.

Portfolio Pulse from Benzinga Newsdesk

September 09, 2024 | 11:39 am

RZLT

Rezolute announced that the FDA has lifted the partial clinical holds on RZ358 (Ersodetug), a potential treatment for hypoglycemia caused by congenital hyperinsulinism (HI). This development could accelerate the clinical trials and potential market entry of RZ358.

Portfolio Pulse from Benzinga Newsdesk

September 09, 2024 | 11:33 am

RDHL

RedHill Biopharma's Talicia has been included as a first-line treatment option for Helicobacter Pylori infection in the new American College of Gastroenterology guidelines.

Portfolio Pulse from Benzinga Newsdesk

September 09, 2024 | 11:14 am

RNAC

The FDA has granted Rare Pediatric Disease Designation to Cartesian Therapeutics' Descartes-08 for the treatment of Juvenile Dermatomyositis, a rare inflammatory disease. This designation could potentially expedite the development and review process for Descartes-08.

Portfolio Pulse from Benzinga Newsdesk

September 09, 2024 | 11:12 am

TNXP

Tonix Pharmaceuticals presented promising data on its potential Mpox vaccine, TNX-801, at an immunology symposium. The vaccine showed efficacy in protecting animals and improved tolerability in immunocompromised subjects. It has been selected by NIH's Project NextGen for clinical testing.

Portfolio Pulse from Benzinga Newsdesk

September 09, 2024 | 11:11 am

ACB

Aurora Cannabis Inc. has launched a new CBD lozenge in Canada, developed in collaboration with Vectura Fertin Pharma. The product is available through Aurora's e-commerce platform, marking Vectura's first medical cannabis product in Canada.

Portfolio Pulse from Benzinga Newsdesk

September 09, 2024 | 11:08 am

IMVT

ROIV

Immunovant reported positive Phase 2a trial results for Batoclimab in Graves' Disease, showing a 76% response rate in patients uncontrolled on antithyroid drugs. The company plans to start a pivotal trial for IMVT-1402 by the end of 2024, with FDA alignment and IND clearance.

Portfolio Pulse from Benzinga Newsdesk

September 09, 2024 | 11:06 am

AKRO

Akero Therapeutics has initiated the Phase 3 Synchrony Outcomes trial by dosing the first patient. This study will assess the efficacy and safety of Efx for treating compensated cirrhosis, fibrosis stage 4, due to metabolic dysfunction-associated steatohepatitis.

Portfolio Pulse from Benzinga Newsdesk

September 09, 2024 | 11:03 am

NVDA

Nvidia is under early-stage antitrust investigation by the DOJ and FTC over its dominance in the AI chip market. The investigation is part of a broader scrutiny of tech giants' market practices. Despite a recent stock decline, Nvidia remains a favorite among analysts due to its strong AI sector position.

Portfolio Pulse from Benzinga Neuro

September 09, 2024 | 9:35 am