Streetbeat News

Regulatory

PRCT

PROCEPT BioRobotics shares increased following the FDA 510(k) clearance of its HYDROS Robotic system, indicating positive market reception to the regulatory approval.

Portfolio Pulse from Benzinga Newsdesk

August 21, 2024 | 12:36 pm

AMIX

Autonomix Medical Technology will present at the 2024 CIRSE Annual Congress, discussing AI applications in interventional radiology and early results from their ongoing proof-of-concept human clinical trial.

Portfolio Pulse from Benzinga Newsdesk

August 21, 2024 | 12:36 pm

OGEN

Oragenics Inc. (NYSE:OGEN) has completed the manufacturing of its spray-dried drug formulation and intranasal device filling for ONP-002, a treatment for concussions. The company is preparing for a Phase 2a clinical trial in Australia, aiming to enroll 40 patients. The trial will assess the drug's efficacy in reducing negative outcomes after a concussion.

Portfolio Pulse from Vandana Singh

August 21, 2024 | 12:30 pm

OGEN

Oragenics has completed the spray dry drug manufacturing and intranasal device filling in preparation for a Phase IIa clinical trial targeting concussed patients.

Portfolio Pulse from Benzinga Newsdesk

August 21, 2024 | 12:30 pm

BA

GCAD

ITA

Boeing's 777X jetliner faces delays due to structural cracks found during test flights, potentially pushing the launch to 2026. This adds to Boeing's ongoing challenges, including FAA inspections and regulatory issues. Boeing shares are slightly up premarket.

Portfolio Pulse from Lekha Gupta

August 21, 2024 | 12:16 pm

MNPR

Monopar Therapeutics' stock is rising following the approval from Australia's human research ethics committee to begin a Phase 1 trial of its new radiopharmaceutical for advanced cancers.

Portfolio Pulse from Benzinga Newsdesk

August 21, 2024 | 12:10 pm

LXRX

Lexicon Pharmaceuticals announced that the FDA will hold an advisory committee meeting on October 31, 2024, to discuss the approval of Zynquista for use in adults with type 1 diabetes and chronic kidney disease. The PDUFA goal date is set for December 20, 2024.

Portfolio Pulse from Benzinga Newsdesk

August 21, 2024 | 12:06 pm

NNOX

Nanox.AI, a subsidiary of Nanox, has received FDA 510(k) clearance for its HealthCCSng V2.0 product, which introduces 'Zero Calcium' categorization and a numerical coronary artery calcium score. This marks the second FDA clearance for the HealthCCSng product.

Portfolio Pulse from Benzinga Newsdesk

August 21, 2024 | 12:05 pm

BLK

ETHE

GBTC

GS

Grayscale appoints Peter Mintzberg, a Wall Street veteran, as its new CEO to navigate growth and regulatory challenges. This move comes after converting its Bitcoin trust into an ETF and facing competition from BlackRock and Fidelity.

Portfolio Pulse from Murtuza Merchant

August 21, 2024 | 12:02 pm

MNPR

Monopar Therapeutics has received clearance from the Australia Human Research Ethics Committee to proceed with a Phase 1 trial of its novel radiopharmaceutical for advanced cancers. This marks a significant step in the development of their cancer treatment pipeline.

Portfolio Pulse from Benzinga Newsdesk

August 21, 2024 | 12:02 pm