Streetbeat News

Regulatory

ZIMV

ZimVie shares are trading higher following the announcement of FDA clearance and the U.S. launch of GenTek Restorative Components.

Portfolio Pulse from Benzinga Newsdesk

July 23, 2024 | 12:14 pm

ZIMV

ZimVie Inc. (NASDAQ:ZIMV) has announced the U.S. launch of its GenTek® Genuine Restorative Components product portfolio following FDA 510(k) clearance. This launch expands ZimVie's prosthetic offerings, building on the success of the GenTek portfolio in Europe since 2019.

Portfolio Pulse from Benzinga Newsdesk

July 23, 2024 | 12:13 pm

AZTR

Azitra, Inc. (NYSE:AZTR) has strengthened its global intellectual property portfolio with newly granted and allowed patents in the U.S., China, and Canada. These patents protect a filaggrin-secreting strain of Staphylococcus epidermidis for the treatment of atopic dermatitis and other skin diseases. This development broadens Azitra's IP position for its precision dermatology platform.

Portfolio Pulse from Benzinga Newsdesk

July 23, 2024 | 12:12 pm

GH

Guardant Health has launched an enhanced version of its Guardant360 test on the Guardant Infinity platform. The new test covers 10 times more genes and quantifies tumor burden with 10 times higher sensitivity. Medicare and major private payers cover the test for comprehensive genomic profiling of advanced solid tumors.

Portfolio Pulse from Benzinga Newsdesk

July 23, 2024 | 12:09 pm

ENLV

Enlivex has received authorization from the Israeli Ministry of Health to initiate a Phase I clinical trial for Allocetra in patients with psoriatic arthritis.

Portfolio Pulse from Benzinga Newsdesk

July 23, 2024 | 12:08 pm

EWQ

INSP

Inspire Medical Systems announced the publication of reimbursement for Inspire Therapy in France, which could positively impact the company's financial performance and market position.

Portfolio Pulse from Benzinga Newsdesk

July 23, 2024 | 12:07 pm

GCTS

The FCC has certified GCT Semiconductor's Luna Cat-12 LTE module, enabling its use in nationwide private networks utilizing licensed mid-band spectrum. Ligado Networks and GCT Semiconductor have announced the commercial availability of this module, advancing the LTE Band 54 ecosystem for critical infrastructure.

Portfolio Pulse from Benzinga Newsdesk

July 23, 2024 | 12:06 pm

ATNF

180 Life Sciences Corp. (NASDAQ:ATNF) has been granted an extension by the Nasdaq Listing Qualifications Panel to regain compliance with Nasdaq's continued listing requirements. The company has until September 20, 2024, to meet the Equity Rule and maintain its listing on Nasdaq.

Portfolio Pulse from Benzinga Newsdesk

July 23, 2024 | 12:06 pm

ATRC

AtriCure has received approval from the National Medical Products Administration (NMPA) to sell its AtriClip devices in China. This regulatory milestone opens up a significant market for the company, potentially boosting its revenues and market presence in the Asia-Pacific region.

Portfolio Pulse from Benzinga Newsdesk

July 23, 2024 | 12:05 pm

ADIL

Adial Pharmaceuticals (NASDAQ:ADIL) has advanced to the second cohort in its pharmacokinetics study of AD04, a treatment for Alcohol Use Disorder. The study, which began in June 2024, is expected to conclude in Q4 2024, with topline results anticipated in the same quarter. The results will inform the design of a Phase 3 Clinical Trial.

Portfolio Pulse from Vandana Singh

July 23, 2024 | 12:00 pm